Title 10 CFR Part 850, Chronic Beryllium Disease ...Inhalation of beryllium dust or particles can cause chronic beryllium disease (CBD) or beryllium sensitization. CBD is a chronic,

fede

ral r

egiste

r WednesdayDecember 8, 1999

Part III

Department ofEnergy10 CFR Part 850Chronic Beryllium Disease PreventionProgram; Final Rule

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\A08DE0.189 pfrm04 PsN: 08DER3

68854 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations

DEPARTMENT OF ENERGY

10 CFR Part 850

[Docket No. EH–RM–98–BRYLM]

RIN 1901–AA75

Chronic Beryllium Disease PreventionProgram

AGENCY: Office of Environment, Safetyand Health, Department of Energy.

ACTION: Final rule.

SUMMARY: The Department of Energy(DOE) is today publishing a final rule toestablish a chronic beryllium diseaseprevention program (CBDPP) to reducethe number of workers currentlyexposed to beryllium in the course oftheir work at DOE facilities managed byDOE or its contractors, minimize thelevels of, and potential for, exposure toberyllium, and establish medicalsurveillance requirements to ensureearly detection of the disease. Thisprogram improves and codifiesprovisions of a temporary CBDPPestablished by DOE directive in 1997.

EFFECTIVE DATE: This rule is effectiveJanuary 7, 2000.

FOR FURTHER INFORMATION CONTACT:Jacqueline D. Rogers, U.S. Departmentof Energy, Office of Environment, Safetyand Health, EH–51, 1000 IndependenceAvenue SW, Washington, DC 20585,301–903–5684.

SUPPLEMENTARY INFORMATION:I. Introduction

A. BackgroundB. Chemical Identification and UseC. Health Effects1. Chronic Beryllium Disease2. Beryllium Exposures at DOE Operations3. Epidemiology4. Value of Early Detection

II. Legal Authority and Relationship to OtherPrograms

III. Overview of the Final RuleIV. Section-by-Section Discussion of

Comments and Rule ProvisionsA. Subpart A—General ProvisionsB. Subpart B—Administrative

RequirementsC. Subpart C—Specific Program

RequirementsList of Commenters

V. Procedural RequirementsA. Review Under Executive Order 12866B. Review Under the Regulatory Flexibility

ActC. Review Under the Paperwork Reduction

ActD. Review Under the National

Environmental Policy ActE. Review Under Executive Order 13132F. Review Under Executive Order 12988G. Review Under the Unfunded Mandates

Reform Act of 1995

H. Review Under Small BusinessRegulatory Enforcement Fairness Act of1996

Appendix A to the Preamble—ReferencesAppendix B to the Preamble—Questions and

Answers Concerning the BerylliumInduced Lymphocyte Proliferation Test(Be–LPT), Medical Records, and theDepartment of Energy (DOE) BerylliumRegistry

I. IntroductionThis final rule implements a chronic

beryllium disease prevention program(CBDPP) for the Department of Energy(DOE or the Department). This programwill reduce the number of workerscurrently exposed to beryllium at DOEfacilities managed by DOE or itscontractors, minimize the levels of, andpotential for, exposure to beryllium,establish medical surveillancerequirements to ensure early detectionof disease, and improve the state ofinformation regarding chronic berylliumdisease and beryllium sensitization.

On December 3, 1998, DOE publisheda Notice of Proposed Rulemaking(NOPR) for public comment in theFederal Register (63 FR 66940)proposing regulations for a chronicberyllium disease prevention program.The public comment period for theNOPR ended on March 9, 1999. DOEreceived 36 comment letters. Inaddition, public hearings were held onFebruary 3, 1999, in Oak Ridge,Tennessee; February 9, 1999, in Golden,Colorado; and February 11, 1999, inWashington, DC. Comment letters werereceived from private individuals, DOEcontractors, other federal agencies, tradeassociations, academia, public healthand medical professionals, andattorneys.

On June 3, 1999, DOE published anotice of limited reopening of thecomment period (64 FR 29811) to solicitpublic comments on options that DOEwas considering for the criteria to beused for the release or transfer ofequipment and other items previouslyused in DOE beryllium operations,either to other DOE facilities or to thepublic. In response to this reopening ofthe comment period, DOE received 15additional comments.

DOE has carefully considered thecomments and data from interestedparties, as well as reference works,journal articles, and other informationrelevant to the subject of therulemaking.

A. BackgroundDOE has a long history of beryllium

use because of the element’s broadapplication to many nuclear operationsand processes. Beryllium metal andceramics are used in nuclear weapons,

as nuclear reactor moderators orreflectors, and as nuclear reactor fuelelement cladding. At DOE, berylliumoperations have historically includedmelting, casting, grinding, and machinetooling of parts.

Inhalation of beryllium dust orparticles can cause chronic berylliumdisease (CBD) or berylliumsensitization. CBD is a chronic, oftendebilitating, and sometimes fatal lungcondition. Beryllium sensitization is acondition in which a person’s immunesystem becomes highly responsive(allergic) to the presence of beryllium inthe body. There has long been scientificconsensus that exposure to airborneberyllium is the only cause of CBD.

As of September 1999, among the11,266 current and former DOE federaland contractor workers who werescreened for the disease, 130 workershad been diagnosed with CBD, andanother 277 workers had becomesensitized to beryllium. DOE anticipatesan increase in the number of workerswho may be exposed to beryllium asDOE moves forward with deactivatingand decommissioning former nuclearweapons production facilities.

The current worker protectionpermissible exposure limit (PEL) of 2µg/m3, measured as an 8-hour, time-weighted average (TWA), was adoptedby the Occupational Safety and HealthAdministration (OSHA) in 1971 andcodified in 29 CFR 1910.1000, Tables Z–1, Z–2 and Z–3 by reference to existingnational consensus standards. DOE’spredecessor agency, the Atomic EnergyCommission (AEC), had previouslyestablished the same limit of 2 µg/m3 forapplication at its facilities in 1949, andthat limit has remained in effect atDOE’s facilities up to the present. In1977, the National Institute forOccupational Safety and Health(NIOSH), a federal agency,recommended to OSHA an exposurelimit of 0.5 µg/m3 for beryllium. NIOSH,at the same time, classified beryllium asa potential occupational carcinogen.

Between the 1970s and 1984, thereappeared to be a significant reduction inthe incidence rate of CBD. This, coupledwith the long latency period for thedisease, led to the assumption that CBDwas occurring only among workers whohad been exposed to high levels ofberyllium decades earlier (e.g., in the1940s). However, the number ofconfirmed cases of CBD, more recentdata suggesting the occurrence of CBDamong workers with low-levelexposures, and the expected futureincrease in the number of workerspotentially exposed to beryllium (duringdecontamination and decommissioningactivities) all indicate a need for more


68855Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations

1 Individual members and groups of membersmade BRAC recommendations. Therecommendations were generated by the facilitatedprocess used during the meetings and were notadopted by the committee as consensus opinions.For convenience of reference theserecommendations are referred to as the ‘‘BRACrecommendations.’’

aggressive workplace controls tominimize worker exposure to berylliumin the DOE complex.

In December 1998, the AmericanConference of Governmental IndustrialHygienists (ACGIH) published a Noticeof Intended Change for its berylliumexposure limit. ACGIH is a professionalorganization that develops andpublishes consensus occupationalhealth standards. In the Notice, ACGIHproposed an 8-hour TWA of 0.2 µg/m3

to help minimize the occurrence of CBDand sensitization. DOE’s NOPR did notaddress ACGIH’s proposed changebecause publication of the NOPRpreceded ACGIH’s announcement.

DOE has reviewed current technicalinformation and is of the opinion that itis difficult to determine the exposurelevel that is necessary to eliminate therisk of contracting CBD. Until OSHAcompletes its rulemaking, DOE hasdecided to implement an aggressive,two-pronged exposure reduction andminimization program that is expectedto further protect DOE federal andcontractor workers from the hazardsassociated with exposure to beryllium.While DOE acknowledges that this rulemay not eliminate the risk of contractingCBD, DOE believes that this rule willsignificantly decrease the number ofworkers exposed and the level ofexposure to beryllium, and therefore, isexpected to decrease disease. First, DOEis establishing an 8-hour TWA actionlevel of 0.2 µg/m3 that triggers certainworkplace precautions and controlmeasures. Second, DOE is requiring itscontractors and any covered DOEemployers to establish in their CBDPPsexposure reduction and minimizationmeasures designed to reduce potentialexposure to levels below the actionlevel. This program will enhance andsupplement existing worker protectionprograms established under DOE Order440.1A, Worker Protection Managementfor DOE Federal and ContractorEmployees.

This rulemaking initiative waspreceded by several years of informationgathering and data analysis. In 1996,DOE surveyed its contractors tocharacterize the extent of berylliumusage, the types of tasks involvingberyllium usage, the controls in placefor each task, the estimated number ofworkers exposed during each task, andthe estimated exposure levels associatedwith each task. This survey found thatbetween 1994 and 1996, 10 of the 15DOE sites surveyed performed 64different operations or processes thatcould expose workers to beryllium. Thesurveyed DOE sites estimated thatbetween 518 and 530 workers in 58different job categories were potentially

exposed to beryllium in theperformance of these 64 operations orprocesses. These estimates wereupdated in 1999 through a cost surveyconducted by the Office ofEnvironment, Safety and Health (1999Environment, Safety and Health CostSurvey). In this survey, 14 DOE sitesindicated that they would be affected bythe proposed rule. These sites reportedthat 1,634 workers in more than 100different job categories would bepotentially exposed to beryllium and1,236 of these workers (75.6 percent)would be potentially exposed at theproposed action level or PEL.

The 1996 survey also providedinformation on exposure levelsexperienced by workers at the surveyedsites. Although the exposure data werenot comprehensive, the reported 8-hourTWA exposure data (personal breathingzone monitoring results) for theseworkers ranged from nondetectable to25 µg/m3. Most of these exposure levelswere reported to be below the 2 µg/m3

8-hour TWA PEL. To control workerexposures in the affected processes oroperations, the surveyed sites reportedthe use of various engineering andadministrative controls, includingventilation hoods, glove boxes, wetmachining methods, high-efficiencyparticulate air (HEPA) vacuums,regulated areas, action levels andadministrative warning levels, andpersonal protective equipment. Thesurvey showed that beryllium exposurecontrols varied considerably among theDOE facilities.

To supplement the data obtained fromthe 1996 survey, the Departmentpublished a Federal Register notice onDecember 30, 1996, requesting scientificdata, information, and views relevant toa new DOE beryllium health standard(61 FR 68725). This was followed bytwo Beryllium Public Forums, one heldin Albuquerque, New Mexico, and oneheld in Oak Ridge, Tennessee, inJanuary 1997.

Acting on the information compiledfrom these various sources, and in viewof the time needed to promulgate a rule,then-Secretary of Energy Pena directedthe Office of Environment, Safety andHealth to publish a new DOE policy toprotect the workforce while theDepartment moved forward with itsrulemaking process. DOE Notice 440.1,Interim Chronic Beryllium DiseasePrevention Program, was signed bySecretary Pena and issued on July 15,1997. This interim Notice established aCBDPP that enhanced andsupplemented worker protectionprograms under DOE Order 440.1A.

Because of the complexity andsignificance of issues regarding the

development of a DOE beryllium workerprotection rule, Secretary Pena alsoestablished the Beryllium Rule AdvisoryCommittee (BRAC) in June 1997 toadvise DOE on issues pertinent to theproposed rulemaking. The BRAC, whichconsisted of a diverse set of stakeholdersand recognized experts from DOE, otherfederal agencies, industry, labor,medicine, and academia, exploredissues and generated recommendationsfor consideration in the development ofa CBDPP rule.1

B. Chemical Identification and Use

Beryllium (atomic number 4) is asilver-gray, metallic element with adensity of 1.85 g/cm3 and a highstiffness. The second lightest of themetals, beryllium also has a highmelting point (1285° C) and heatabsorption capacity; a pound ofberyllium will absorb as much heat as5 pounds of copper.

Beryllium occurs naturally in theearth’s surface in about 30 mineralsfound in rocks, coal and oil, soil, andvolcanic dust. Beryllium used inindustry begins as a silicate (BeSiO3) inberyl and bertrandite ores. In very purecrystalline form, beryl takes the form ofgems, such as blue-green aquamarineand green emeralds. Bertrandite ismined in Utah. The United States is theworld’s leading producer, processor,and consumer of beryllium products.

Beryllium, discovered in 1798, wasnot widely used in industry until the1940s and 1950s. Beryllium can be usedas a pure metal, mixed with othermetals to form alloys, processed to saltsthat dissolve in water, and processed toform oxides and ceramic materials.

Beryllium metal has been producedfor various industrial uses, especially inthe aerospace and defense industries.Both structural and instrument gradematerials are manufactured, includingwindshield frames and other structuresin high-speed aircraft and spacevehicles, aircraft and space shuttlebrakes, satellite mirrors and spacetelescopes, inertial guidance systemsand gyroscopes, neutron moderators orreflectors in nuclear reactors, X-raywindows, and nuclear weaponscomponents.

In alloys, beryllium confers on metalspecific properties of resistance tocorrosion, wear, and fatigue; highelectrical and thermal conductivity;



2 A list of commenters is included as an appendixto the Section-by-Section Discussion of Commentsand Rule Provisions in this SupplementaryInformation section.

3 A listing of references is included as anappendix to this Supplementary Informationsection.

strength; and hardness. Beryllium-copper (BeCu) alloys usually containabout 2 percent beryllium, but varygreatly in composition to meet differentindustrial and consumer needs.Beryllium is also added to aluminum,nickel, zinc, and zirconium for someapplications. Beryllium alloys are usedfor springs, switches, relays, andconnectors in automobiles, computers,radar and telecommunicationsequipment, and other instruments; high-strength non-sparking tools; molds orcasts to make metal, glass, and plasticitems; sports equipment such as golfclubs and bicycle frames; and dentalbridges and related applications.

Other beryllium materials includesoluble salts and oxides. Berylliumsoluble salts, such as beryllium fluoride,chloride, and sulfate, are used innuclear reactors, in glass manufacture,and as catalysts for certain chemicalreactions. Beryllium Oxide (BeO) isused to make ceramics for electronics,and other electrical equipment.Beneficial properties of BeO includehardness, strength, excellent heatconductivity, and good electricalinsulation.

C. Health EffectsDOE received a number of comments

(Exs. 2, 5, 14, 19, 20, 22, 23, 24, 26, 29,30) 2 regarding the ‘‘Health Effects’’section of the NOPR. DOE has carefullyconsidered these comments and hasrevised the following health effectsdiscussion as appropriate.

1. Chronic Beryllium DiseaseChronic beryllium disease (CBD) is a

granulomatous lung disease that iscaused by the body’s immune systemresponse (similar to an allergic reaction)to inhaled dust or fumes containingberyllium metal, alloys, berylliumcompounds or mixtures, or insolubleberyllium salts. The body’s immunesystem response to beryllium is oftencalled beryllium sensitization.Beryllium sensitization precedes thedevelopment of CBD. Sensitization canoccur quickly or many years afterexposure to beryllium, progressing intodisease at a rate of approximately 10percent a year (ref. 1) 3.

It is hypothesized that beryllium is ahapten (a substance that provokes animmune response only when combinedwith another substance, generally aprotein) that binds to peptides on

mucosal surfaces. In susceptibleindividuals the beryllium-peptidecomplex initiates an immune response,which may progress ultimately togranuloma formation in the pulmonaryinterstitium. Data have suggested thatCBD can occur at relatively lowexposure levels and, in some cases, afterrelatively brief durations of exposure.The International Agency for Researchon Cancer (IARC) and ACGIH classifyberyllium as a human carcinogen.

Frequently reported symptomsinclude one or more of the following:dyspnea (shortness of breath) onexertion, cough, fever, night sweats, andchest pain and, less frequently,arthralgias (neuralgic pain in joints),fatigue, weight loss, or appetite loss. Onphysical examination, a doctor may findsigns of CBD results, such as rales(changes in lung sounds), cyanosis (lackof oxygen), digital clubbing, orlymphadenopathy (enlarged lymphnodes). A radiograph (X-ray) of thelungs may show many small scars.Patients may also have an abnormalbreathing test, pulmonary function test,and a blood test, the peripheral bloodberyllium-induced lymphocyteproliferation test (Be–LPT). Examinationof the lung tissue under the microscopemay show granulomas, which are signsof damage due to the body’s reaction toberyllium. CBD may be confused withother lung diseases, especiallysarcoidosis. In advanced cases, theremay be manifestations of right-sidedheart failure, including cor pulmonale(enlarged right ventricle of the heartcaused by blockage in the lungs).

The Be-LPT is highly specific forberyllium sensitivity and has a highpredictive value for beryllium disease. Itis the most definitive means of rulingout beryllium disease as the cause ofnon-specific lung and other symptoms.Therefore, this measurement ofsensitization to beryllium identifies at-risk individuals, as well as individualswhose lung problems are not berylliumrelated (ref. 1). For individuals whoseBe-LPT screening results exceed acertain threshold, an additional Be-LPTis conducted on cells washed from asegment of the lung. The presence ofgranulomata in the lung of an individualwith a positive lung Be-LPT confirmsthe presence of CBD. In the absence ofgranulomata or other clinical evidenceof CBD, individuals with a positive Be-LPT are classified as sensitized toberyllium.

The clinical course of CBD is highlyvariable. Some individuals deterioraterapidly; most experience long, gradualdeterioration. Treatment consists of oralcorticosteroid therapy. Individuals withimpaired respiratory gas exchange may

require continuous oxygenadministration.

Individuals sensitized to berylliumare asymptomatic and not physicallyimpaired. Once sensitization hasoccurred, it is medically prudent toprevent additional exposure toberyllium. Individuals with CBD have aclinical illness varying from mild tosevere. In severe cases, the affectedindividuals may be permanently andtotally disabled. Mortality of thesensitized individuals directlyattributable to CBD and itscomplications is estimated to be 30percent (ref. 2). This estimate is basedupon historical data reflecting both thehigher levels of exposure that occurredin the workplace prior to regulation ofworkplace exposure in the late 1940sand a tracking of the medical history ofsubjects of CBD over several decades.DOE’s more recent experience withimproved diagnoses and treatments mayresult in a lower mortality rate for CBDcases.

2. Beryllium Exposures at DOEOperations

DOE’s medical surveillance programsare discovering cases of CBD amongworkers who were first exposed after1970, when DOE facilities wereexpected to maintain workers exposureto beryllium below the OSHA PEL. Asof June 1999, 119 workers (88 at theRocky Flats facility in Golden Colorado,29 at the Y–12 Plant in Oak Ridge,Tennessee, and two at the Hanfordfacility in Richland, Washington) havebeen diagnosed with CBD, and another258 workers (197 at the Rocky Flatsfacility, 59 at the Y–12 Plant, one at theHanford facility, and one at the Moundfacility in Miamisburg, Ohio) have beendiagnosed as sensitized to berylliumfrom among approximately 10,000current and former DOE federal andcontractor workers who were screenedfor the disease.

A worker’s exposure is measured bypersonal monitoring, which isaccomplished by sampling the airwithin the breathing zone of the worker.Personal monitoring of occupationalexposures to beryllium was not widelyadopted at DOE sites until the 1980s.Prior to the 1980s, many sites relied onarea monitoring to assess occupationalexposures to beryllium. However,results from area monitoring have beenshown to significantly underestimateactual exposure levels. Since 1984,personal sampling data have providedmore precise information onoccupational exposure to beryllium atDOE sites.

Available personal sampling dataprovides a clear indication of the low

VerDate 29-OCT-99 18:10 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\08DER3.XXX pfrm03 PsN: 08DER3


levels of beryllium exposure that can beachieved in both fabrication andmachining operations, anddecommissioning and decontaminationprojects, when effective controlstrategies are implemented. Mostberyllium fabrication and machiningoperations at DOE have occurred to dateat the Rocky Flats facility, and at the Y–

12 Plant. Over time, engineeringimprovements and advanced controlstrategies have significantly reducedoccupational beryllium exposure levelsin these operations.

Since 1980, and continuing through1996, about 1600 personal samples werecollected at the Oak Ridge Y–12 Plant(Table 1). These samples were taken at

several different Y–12 operationsassociated with CBD, with a bias towardsampling those jobs where exposurepotential was greatest or where previousmonitoring results were high. Despitethis bias, over two-thirds of sampleresults were below the limit of detectionof 0.1 µg/m3 for the sampling andanalytical method used at Y–12.

TABLE 1.—OAK RIDGE Y–12 PLANT PERSONAL SAMPLING FOR BERYLLIUM EXPOSURE

1980 to 1989 1990 to 1996

Number of Samples ................................................................................................................ 148 .............................................. 1448Estimated Arithmetic Mean Level of Exposure 1 .................................................................... 0.9 µg/m3 ..................................... 0.3 µg/m3

Percent of Samples Less Than 2 µg/m3,2 .............................................................................. 94% ............................................. 98%

1 The arithmetic mean was estimated from the samples using linear regression.2 Samples were analyzed using flame spectroscopy with a detection limit of about 0.1 µg/m3.

These Y–12 data are from berylliumoperations where cases of CBD havebeen found. The facilities where theseoperations take place have not beenremodeled since the 1970s. Thus thedifferences between sampling resultsmeasured before and after 1990 areattributed to changing work practices.For example, increased monitoring in

the 1990s identified a greater number ofexposures over the existing exposurelimit. The investigations of theseexposures resulted in changes to workpractices that had contributed to thehigh exposures. This focus onoperations with elevated exposurelevels also led to a significant reductionin average exposure levels.

Personal sampling data from theRocky Flats Building 444 BerylliumMachine Shop (Table 2) collected in1984–85 and then again in 1986 afterextensive remodeling to the ventilationsystem illustrates the impact andeffectiveness of engineeringmodifications to control exposure.

TABLE 2.—ROCKY FLATS BUILDING 444 BERYLLIUM MACHINE SHOP PERSONAL SAMPLING DATA (BERYLLIUM EXPOSURE)

1984 to 1985 1986

Number of Samples ........................................................................... 99 ................................................ 279Estimated Arithmetic Mean Level of Exposure1 ............................... 1.19 µg/m3,1 ................................. 0.035 µg/m3

Percent of Samples Less Than 2 µg/m3,2 ......................................... 84% ............................................. 99.6%

1 The arithmetic mean was estimated from the samples using linear regression.2 Samples were analyzed using graphite furnace atomic absorption (AA) or Inductively Coupled Plasma (ICP) spectroscopy with a detection

limit of about 0.01 µg/m3.

The samples collected in 1984 and1985 were the first personal samplescollected in this shop following thediscovery of a case of CBD in 1984.Controls in that machine shop hadpreviously been judged to be adequatebased on area monitoring. In addition tothe extensive remodeling of theventilation system in the shop tominimize leakage from ventilationhoods, operations performed outside ofhoods were eliminated to the extentpossible. The improved engineeringcontrols in this shop reduced averageexposure levels by a factor greater than30, to levels approaching 1% of theexisting PEL.

A final example, taken from personalsampling data collected during thedecontamination of Rocky FlatsBuildings 865 and 867 in 1995–1996,further demonstrates the low levels ofberyllium exposure which can beachieved through the implementation ofeffective controls (Table 3). Each workerwas sampled during each work shiftduring this time period.

TABLE 3.—DECONTAMINATION OFROCKY FLATS BUILDINGS 865 AND867 PERSONAL SAMPLING—1995 TO1996

Number of Samples ............. 7,673Arithmetic Mean Level of Ex-

posure.0.03 µg/m3

Percent of Samples LessThan 2 µg/m3.

99.8%

As can be seen from the foregoingexamples, machining and D&Doperations at Y–12 and Rocky Flatsachieved an exceptional level ofexposure control.

While the application of controlseliminates predictable sources ofexposure, there still can be large day-to-day variations in exposure. Theexposures that remain are likely toreflect accidents, equipment failures, orpoor work planning. Meeting exposureminimization goals will requireplanning to limit the potential for suchoccurrences, and monitoring to detectthose that do occur, so they can be

investigated and future occurrences canbe prevented.

3. Epidemiology

Epidemiology is the field of publichealth that examines relationshipsbetween disease in people, andexposures or events that are related tothat disease. Occupational epidemiologyis the study of the effects of workplaceexposures on the frequency anddistribution of diseases and injuries.

Hardy and Tabershaw (ref. 3) reportedthe first evidence of the existence ofCBD in a 1946 paper. The paperdescribed ‘‘delayed chemicalpneumonitis’’ among fluorescent lampworkers exposed to berylliumcompounds. The differential diagnosisincluded sarcoidosis (an immunedisease of unknown etiology) andtuberculosis.

There also are reports of CBD inindividuals without knownoccupational exposure to beryllium.Under the direction of Dr. ThomasMancuso, 16 cases of CBD were



diagnosed by X-ray examination among20,000 residents living near a berylliumproduction facility in Lorain, Ohio (ref.4). Likewise, a 1949 report described 11patients with CBD who lived near aberyllium extraction plant (ref. 5). Tenof these 11 lived within 3⁄4 of a mile ofthe plant, and exposure from plantdischarges into the air was the suggestedcause of their CBD. Measurements of airconcentrations of beryllium at variousdistances from the plant provided thebasis for the Environmental ProtectionAgency’s (EPA’s) communitypermissible exposure limit (24-hourambient air limit of 0.01 microgram ofberyllium per cubic meter of air [µg/m3]).

In addition, CBD has been reportedamong family members of berylliumworkers who were presumably exposedto contaminated work clothing duringthe 1940s and 1950s (refs. 6, 7). Thevirtual disappearance of CBD caused byair pollution or household exposureshas been attributed to more stringentcontrol of air emissions and improvedwork practices, such as mandatory workclothing exchange. However, as recentlyas 1989, a woman previously diagnosedwith sarcoidosis was diagnosed withCBD. She had no occupationalexposure, but her husband was aberyllium production worker. This isthe first new case of non-occupationalCBD reported in 30 years (ref. 8).

Sterner and Eisenbud suggested thatCBD was a highly selectiveimmunologic response. Theirconclusion was based on epidemiologicevidence that (1) severe cases haveoccurred at low exposure; (2) the levelof beryllium contained in tissue did notcorrelate with the extent of the disease;(3) there was a correlation betweendisease and low atmosphericconcentration, but not highconcentrations; (4) the onset ofsymptoms could occur years after thetermination of exposure; and (5)pulmonary lesions were not easilyreproduced in animals (ref. 7).

A registry of production plant CBDcases was started at ColumbiaUniversity in 1947. A second registry ofphosphor-lamp CBD cases was startedaround the same time. In 1952, aBeryllium Case Registry was establishedat the Massachusetts Institute of

Technology (MIT), where files from theother beryllium registries wereconsolidated. The consolidatedBeryllium Case Registry was moved toMassachusetts General Hospital in the1960s, and ultimately was relocated tothe National Institute for OccupationalSafety and Health (NIOSH) in 1978. Atthat time, the Beryllium Case Registrycontained 622 cases of CBD, 224 casesof acute beryllium disease, and 44 acutecases that developed into CBD. Twenty-three cases were attributed to householdexposures and 42 to air pollution (ref.6). The Beryllium Case Registry, whichis now inactive, was criticized asdeficient in acquiring data on cases,identifying populations at risk(denominator data), maintaining follow-up of questionable cases, and obtainingexposure data (ref. 9).

According to criteria utilized by theBeryllium Case Registry, the diagnosisof CBD included at least four of thefollowing six criteria, with one of thefirst two conditions required: (1) theestablishment of beryllium exposurebased on occupational history or resultsof air samples, (2) the presence ofberyllium in lung tissue or thoraciclymph tissue or in the urine, (3)evidence of lower respiratory tractdisease and a clinical course consistentwith beryllium disease, (4) pathologicalchanges consistent with berylliumdisease upon examination of lung tissueor thoracic lymph nodes, (5) radiologicevidence of interstitial lung disease, and(6) decreased pulmonary function tests(ref. 10).

The beryllium-induced lymphocyteproliferation test (Be-LPT) in blood andbronchoalveolar lavage (BAL) fluid haveallowed earlier identification of thedisease. The BAL Be-LPT now is one ofthe criteria required for diagnosis (refs.11–13). Beryllium has been found to actas a specific antigen, causingproliferation and accumulation ofberyllium-specific helper Tlymphocytes (CD4∂) in the lung (ref.14). Current data suggest that theperipheral blood Be-LPT is a specificand sensitive method for testingberyllium sensitivity (ref. 11). Thepresence of granulomatous tissue in thelung along with a positive BAL Be-LPTis considered definitive evidence fordiagnosis of CBD (ref. 12). When a

worker has clear signs and symptoms ofinterstitial lung disease and a positiveBe-LPT, CBD may be presumed only ifperforming a bronchoscopy on theworker is deemed to be too risky giventhe health status of that of that worker.

An article published by Cullen et al.in 1987 reported on an epidemiologystudy of CBD among precious-metalrefinery workers (ref. 15). In 1993,researchers at the National JewishMedical and Research Center (NJMRC)published two reports on epidemiologystudies that were designed to determinethe incidence of CBD among berylliumworkers and the value of the Be-LPT indetecting CBD (refs. 16, 17). One ofthese two studies was conducted atDOE’s Rocky Flats EnvironmentalTechnology Site (Rocky Flats). Thesethree epidemiology studies showed thatCBD incidence among exposed workerswas the same as had been reportedamong workers exposed in the 1940s,when the disease was first recognized.This exposure limit was originallyderived by analogy to other toxic metals(ref. 18). A decline in the number ofreports of CBD in the 1970s and up to1984 led to the assumption that the 2µg/m3 limit had been effective inpreventing CBD (ref. 6). DOE recognizesthat the 1980s–1990s studies used moreeffective screening and diagnosticmethods than the earlier studies.Nevertheless, these 1980s–1990s studiesprovide strong evidence that adherenceto the OSHA standard has not preventednew cases of disease.

In 1991, responding to NJMRCfindings, DOE’s Office of Environment,Safety and Health initiated a berylliumworker health surveillance program atRocky Flats to provide medicalscreening to current and formerberyllium workers who had notparticipated in the NJMRC studies. Inaddition, the Office of Environment,Safety and Health initiated a study atthe Oak Ridge Y–12 Plant (Y–12) in1991 to learn if the NJMRC findings onCBD incidence and the effectiveness ofthe Be-LPT could be replicated. Resultsto date confirm NJMRC findings thatCBD incidence rates are high and thatthe Be-LPT is an effective screening testfor CBD as shown in Table 4.

TABLE 4.—RESULTS OF MEDICAL SCREENING OF BERYLLIUM-EXPOSED WORKERS AT THREE DOE SITES THROUGHDECEMBER 1997

Rocky Flats Y–12 Mound

Individuals Examined .................................................................................................... 6,257 ...................... 1,949 ...................... 632Abnormal Be-LPT Number (percent) ............................................................................ 221 (3.5%) ............. 77 (4%) .................. 1 1

Completed Diagnostic Exams ....................................................................................... 186 ......................... 33 ........................... 0



TABLE 4.—RESULTS OF MEDICAL SCREENING OF BERYLLIUM-EXPOSED WORKERS AT THREE DOE SITES THROUGHDECEMBER 1997—Continued

Rocky Flats Y–12 Mound

CBD Number (percent) 2 ............................................................................................... 79 (1.3%) 3 ............. 25 (1.3%) 4 ............. 0

1 The one Mound employee who was found to be consistently positive declined diagnostic testing. Four others had one positive blood test re-sult and were awaiting retesting.

2 Includes 44 cases confirmed through biopsy and testing of lavage cells and 35 presumptive cases in which the pulmonologist diagnosed CBDbut biopsy and/or lavage could not be completed.

3 Includes 56 cases found through the surveillance program since 1991, 17 cases through the 1987–1991 NJMRC study, and 6 cases between1984 and 1987 for a total of 79 CBD cases. Six of the 79 cases had consistently normal Be-LPT results and were identified through lung diseasesymptoms or abnormal chest X-rays.

4 Includes 17 cases found in the surveillance program since 1993, 2 cases found in 1991 among beryllium workers who had been diagnosedwith other lung diseases, and 6 cases found by the site clinic in 1993 among 146 currently exposed beryllium workers who were provided theBe-LPT.

In 1996, three studies reported onexposure to beryllium associated withCBD and immunologic sensitization toberyllium (refs. 19–21). Two of thestudies reported on cases of CBD atRocky Flats (refs. 19, 20). The thirdreported on an epidemiology study of aprivate sector beryllium ceramicsfabrication plant that began operating in1981 (ref. 21). Both Rocky Flats and theceramics plant were extensivelymonitored for compliance with thecurrent OSHA 8-hour TWA exposurestandard of 2 µg/m3. The authorsconcluded that exposures among thehighest exposed groups in the plantswere, on average, below the 2 µg/m3

limit. At both plants, cases of CBD andsensitization to beryllium were foundnot only among the highest exposedworkers, but also among the lowestexposed workers, includingadministrative and other personnel whodid not work directly with beryllium.

Stange and colleagues reported on thefindings of a health surveillanceprogram at Rocky Flats that used the Be-LPT to screen for CBD (ref. 19). Of 97individuals who tested positive on theBe-LPT, 28 were found to have CBD.

The article included an analysis of thework histories of these 97 current andformer workers. A qualitative exposureestimate based on the work histories ofindividuals who developed CBDconcluded that exposures varied bymore than one order of magnitude.Extensive air monitoring data wereavailable for machinists, which wereone of the highest exposed groups.

Barnard and colleagues completed anextensive analysis of the monitoringdata associated with machiningoperations at Rocky Flats (ref. 20). Priorto 1984, air monitoring wasaccomplished with fixed area monitorslocated near the machine tools that werethought to be the primary sources ofemissions into the work-rooms. In 1984,personal sampling was initiated, whichwas more representative of individualexposure. The article reported a highdegree of uncertainty in exposureassessments prior to 1984 due to thelack of correlation between areamonitoring and personal monitoring.The authors concluded that machinists,as a group, shared similar exposurepotential, that average exposures wereless than but near the 2 µg/m3 limit, and

that excursions above the limit werecommon.

Kreiss and colleagues studied CBDoccurring in a beryllium oxide ceramicmanufacturing plant (ref. 21). Theyfound that machinists had the highestincidence rate of beryllium sensitizationand the highest exposure potential. Thearea monitoring conducted in this plantwas aimed at estimating exposuresassociated with job titles and was foundto correlate with personal sampling. Theauthors concluded, ‘‘the existing datasuggests that the machining exposuresresulting in the 14.3 odds ratio forberyllium sensitization were largelywithin those permitted by currentregulations.’’ This article confirmed thefindings of a study of CBD in theneighborhood of a beryllium extractionplant, which showed a correlationbetween ambient beryllium levels andincidence of CBD (ref. 5). Furtheranalyses of CBD incidence at RockyFlats, as yet unpublished, showed asimilar higher risk for machinistscompared to that for other workers (SeeTable 5).

TABLE 5.—INCIDENCE RATES OF CBD AT ROCKY FLATS

Job category Number tested CBD casesIncidencerate (per-

cent)

Beryllium Machinist .......................................................................................................................... 223 21 9.4Administrative .................................................................................................................................. 1,903 23 1.2Professional ..................................................................................................................................... 1,396 15 1.1All Employees Tested ...................................................................................................................... 6,254 64 1.0

Cases of CBD have occurred inmachinists who worked in the Y–12beryllium ceramic machine shop, wherelevels have been quite low. Only a smallpercentage of samples there havedetected beryllium. Continuous area airmonitors have operated in the shopthroughout its existence. One areasample indicated levels above 2 µg/m3

when a machine tool was operated with

an exhaust duct that was disconnected.No other area measurements above2 µg/m3 were recorded, and the medianmeasurement was at the level ofdetection.

Kreiss (ref. 22) describes the relativehazards in sectors of the berylliumindustry, and risk factors for CBD andsensitization related to work processesin a beryllium manufacturing plant that

produced pure metal, oxide, alloys, andceramics. Employees in the pebble plant(producing beryllium metal) had thehighest prevalence of CBD (6.4%)compared with other workers (1.3%).The pebble plant was not associatedwith the highest gravimetric industrialhygiene measurements, indicating thattotal beryllium was probably not a goodindicator for hazard surveillance. The



report indicates that particle size orother characteristics may be moreimportant contributors to risk than thetotal mass of breathing zone particles,that daily-weighted averages are poorestimates of personal exposure, and thatmethods of exposure assessment maypoorly reflect actual exposures fromaccidents.

Several authors have highlighted theuncertainty that exists in the exposureassessments (refs. 20, 21, 23). Thechemical composition of the berylliummaterials used and the particle sizedistribution of the aerosol created by thework operation affect the bioavailabilityof beryllium, and neither is accountedfor by current personal sampling andanalytical methods. It is not knownwhat percentage of measurable airborneberyllium is capable of reaching theregions of the lung where health effectsoccur. In addition, area monitoring usedin the past does not correlate with thepersonal monitoring that is thought tobe more representative of exposure (refs.20, 23).

Epidemiologic investigations to datehave failed to show whether the timecourse of exposure (dose rate) isbiologically significant. High day-to-dayvariation in exposure level andexcursions above the 2 µg/m3 limit haveoccurred in all groups studied for whichexposure data is available. Excursionsmake up a significant contribution toindividuals’ total doses, confoundingattempts to understand if dose rate is animportant risk factor. Beryllium oxideand metal in the lung dissolve slowlyover a period of months and years (ref.24), producing the beryllium ion thatelicits an immune response (ref. 25).The persistent presence of the berylliumion in the lung makes CBD a chronicdisease (ref. 26). Both intermittent highand continual low exposures toinsoluble forms of beryllium can createand maintain a lung burden that willnot clear for many years, if at all (ref.27).

Certain individuals are moresusceptible to CBD than others. It haslong been suspected that geneticpredisposition plays an important role

in determining who will develop CBD.Recent advances in genetics andimmunology have made it possible forresearchers to investigate the basis forCBD and to identify a geneticcomponent (ref. 28).

Differences in individualsusceptibility have made it difficult tounderstand the relationship betweenexposure and CBD. Early epidemiologystudies detected similar disease ratesamong high- and low-exposureoccupational groups (Table 6). TheNJMRC researchers detected differencesin disease rates among the workers theystudied (Table 7). The DOE surveillancefindings supported this conclusion (SeeTable 5). NJMRC researchers have foundcases of CBD among those who had beenexposed for periods as short as onemonth and those who had unrecognizedor seemingly trivial exposure. However,the NJMRC also found evidence thatdisease incidence increased withincreasing exposure and concluded thatexposure to beryllium should beminimized.

TABLE 6.—CHRONIC BERYLLIUM DISEASE RATES

Exposed during the 1940s Estimatedexposed Cases

Estimated in-cidence per

100 exposed

Estimatedlevel of expo-sure µg/m 3

Residents Living Within 0.25 Mile of a Beryllium Extraction Plant 1 ........................... 500 5 1.0 1Fluorescent Lamp Manufacturing: 1

Massachusetts ...................................................................................................... 15,000 175 1.16 100Ohio ...................................................................................................................... 8,000 32 0.4 100

Machine Shop 1 ............................................................................................................ 225 11 4.9 500Beryllium-Copper Foundry 1 ......................................................................................... 1,000 13 1.3 500Beryllium Extraction: 1

Lorain, Ohio .......................................................................................................... 1,700 22 1.3 1,000Painesville, Ohio ................................................................................................... 200 0 0.0 1,000Reading, Pennsylvania ......................................................................................... 4,000 51 1.3 1,000

Exposed from the 1970s to the 1980s Study par-ticipants Cases Incidence per

100 exposed

Estimatedlevel of expo-sure µg/m 3

Beryllia Ceramics Plant 2 ............................................................................................. 505 9 1.8 NAThe DOE Rocky Flats Plant 3 ...................................................................................... 895 15 1.7 1Second Beryllia Ceramics Plant 4 ................................................................................ 709 8 1.1 0.5

1 Eisenbud and Lisson, ‘‘Epidemiologic Aspects of Beryllium-Induced Non Malignant Lung Disease: A 30-Year Update,’’ JOM, Vol. 25, pp 196–202, 1983.

2 Kathleen Kreiss et al., ‘‘Beryllium Disease Screening in the Ceramics Industry,’’ JOM, Vol. 35, pp 267–274, 1993.3 Kathleen Kreiss et al., ‘‘Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,’’ Am. Rev. Res. Dis., Vol. 148, pp 985–991,

1993.4 Kathleen Kreiss et al., ‘‘Machining Risk of Beryllium Disease and Sensitization with Median Exposures Below 2 µg/m3,’’ Am. J. Ind. Med., Vol.

30, pp 16–25, 1996.

TABLE 7.—BERYLLIUM SENSITIZATION AND DISEASE RATES AT ROCKY FLATS 1

Beryllium process title Workerssensitized

Workersdoing

process

Sensitiza-tion rate(percent)

Cleaning Tools, Machines ................................................................................................................... 7 255 2.7Machining ............................................................................................................................................. 6 189 3.2Inspection ............................................................................................................................................. 2 138 1.4Metallurgical Sample Preparation ........................................................................................................ 3 115 2.6Sawing ................................................................................................................................................. 5 6 4.7Trepanning ........................................................................................................................................... 3 77 3.9Band Sawing ........................................................................................................................................ 4 67 6.0



TABLE 7.—BERYLLIUM SENSITIZATION AND DISEASE RATES AT ROCKY FLATS 1—Continued

Beryllium process title Workerssensitized

Workersdoing

process

Sensitiza-tion rate(percent)

Decanning, Shearing ........................................................................................................................... 2 65 3.1Precision Grinding ............................................................................................................................... 2 31 6.5

All participants Number Participants Rate (per-cent)

Sensitized ............................................................................................................................................ 18 895 2.0Confirmed CBD Cases ........................................................................................................................ 15 895 1.7

1 Kathleen Kreiss et al. ‘‘Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,’’ Am. Rev. Res. Dis., Vol. 148, pp 985–991,1993.

A recent publication by Eisenbud inJanuary 1998 (ref. 29) consolidated theprevious epidemiology studies that havequestioned the relevance of the currentPEL after evaluating the effect of thelevel of exposure on disease. In thisarticle, Eisenbud concludes that it‘‘appears’’ the current 2 µg/m3 standardis not protective enough. Rather thanrecommend an alternative exposurelimit, however, Eisenbud points to theneed for the development of an animalmodel to aid in better understanding theetiology of CBD and suggests thatinnovative measures may be needed tocontrol the disease.

In summary, evidence suggests higherincidence of CBD among workers withhigher exposures (e.g., machinists), but,at lower exposure levels, other factorsmay operate to confound a clear dose-response relationship. These factorsinclude: (1) the effect of peak exposures(such that most of the exposure resultsfrom short-term episodes; (2) theinadequacy of area monitoring inreflecting actual exposure; (3) the effectof chemical composition, size, andshape on the bioavailability of theinhaled particles; (4) inadequatemonitoring of the chemical berylliumcomposition, size, and shape of inhaledparticles; and (5) the effect of geneticpredisposition on developing berylliumsensitization and CBD. As a result, theexisting literature does not point to aspecific tolerance level for exposure toberyllium.

4. Value of Early Detection

Early detection of a disease is of valueif it leads to earlier treatment and abetter prognosis for the individual beingtested. Screening for CBD with the Be-LPT can provide earlier detection thanis possible with other tests. In somecases this has led to treatment of CBDto reduce lung damage that would nothave been possible if the CBD remainedundiagnosed by other tests, such aschest X-ray. Researchers at the NJMRCcompared the lung functions of patients

with CBD who had been identifiedthrough abnormal chest X-rays orclinical symptoms to those of patientswhose CBD had been identified throughpositive Be-LPTs (ref. 30). Twelve out of21 Be-LPT-identified patients had lungabnormalities, including reducedexercise tolerance. Fourteen of 15patients identified through chest X-raysor clinical symptoms had abnormal lungfunction, and their abnormalities weremore severe. The authors concludedthat the Be-LPT was useful because itpermitted detection of affectedindividuals earlier in the diseaseprocess.

DOE’s experience is consistent withthis conclusion. The 79 cases of CBDdiagnosed among Rocky Flats workersshowed a range of severity. Thirty-nineindividuals had symptoms that requiredtreatment ranging from inhaledbronchodilators to corticosteroids tooxygen. Two individuals died of CBD.Seventy-three of the 79 cases wereidentified among individuals who hadabnormal Be-LPT results but normalchest X-rays or pulmonary functionscreening test results. Clinicalevaluations using computer aidedtomography (CAT) scan,bronchoalveolar lavage-BeLPT (BAL Be-LPT), transbronchial biopsy, and gasdiffusion studies of workers confirmedthe presence of CBD in these workers.

There is no direct evidence thatremoval from exposure improves theprognosis of patients with CBD, becausefollow-up studies have not been done.However, beryllium does clear from thelung over time, and a reduced level ofantigen in the lung should reduce theseverity of the inflammation and theamount of lung damage (ref. 27).Additionally, members of the work forcewho are consistently positive on the Be-LPT are those most likely to eventuallydevelop CBD. Treating physiciansgenerally recommend that theseindividuals receive more frequent andmore extensive pulmonary functiontesting so that the lung damage

associated with CBD can be minimizedthrough early detection and treatment.Sensitized and early CBD patients canbe removed from jobs with berylliumexposure.

Finally, beryllium sensitization foundthrough screening with the Be-LPT isthe earliest indication that workingconditions and work practices areaffecting the health of exposed workers.This allows for an earlier opportunity toinitiate corrective actions and possiblyto prevent cases of CBD. Early detectionenhances the contribution of medicalsurveillance to the management of theCBDPP.

II. Legal Authority and Relationship toOther Programs

Today’s rule, which establishesminimum requirements for theprotection of beryllium-associatedworkers, is promulgated pursuant toDOE’s authority under section 161 ofthe Atomic Energy Act of 1954 (AEA) toprescribe such regulations as it deemsnecessary to govern any activityauthorized by the AEA, specificallyincluding standards for the protection ofhealth and minimization of danger tolife or property (42 U.S.C. 2201(i)(3) and(p)). Additional authority for the rule,insofar as it applies to DOE Federalemployees, is found in section 19 of theOccupational Safety and Health Act of1970 (29 U.S.C. 668) and ExecutiveOrder 12196, ‘‘Occupational Safety andHealth Programs for FederalEmployees,’’ (5 U.S.C. 7902 note),which require Federal agencies toestablish comprehensive occupationalsafety and health programs for theiremployees.

DOE intends this final rule to beintegrated with the existing workerprotection management program forDOE Federal and contractor employeesestablished by DOE Order 440.1A. Therequirements in this final rule willsupersede any conflicting provisions ofDOE Order 440.1A on the effective dateof the rule. On that date the rule also



will supersede DOE Notice 440.1,‘‘Interim Chronic Beryllium DiseasePrevention Program,’’ established bythen-Secretary Pena on July 15, 1997.

Some comments on the NOPR raisedquestions about the effect of the rule oncollective bargaining and grievance-arbitration processes established bycollective bargaining agreements. Oneunion urged (Ex. 22) DOE to clarifywhether the terms of this rule aresubject to negotiation between a unionand a contractor.

DOE has concluded that there is acompelling need for the CBDPPrequirements in this final rule in orderfor DOE to meet its obligation under theAEA to protect the health of itsemployees and other workers at DOEfacilities. The regulatory requirementsof this rule will by operation of lawapply to DOE contracts. Therefore, theapplication and enforcement of this ruleare not subject to the Work SmartStandards Program or other relatedprocesses. DOE believes that thismandatory application of the CBDPPrequirements to all DOE berylliumactivities is appropriate given thehazardous nature of beryllium-relatedwork.

While the minimum requirements inthe rule are non-negotiable and may notbe waived, the rule does not precludeall collective bargaining on mattersrelated to beryllium exposureprotections. Some rule provisions, suchas the requirement for a berylliumexposure reduction and minimizationprovision in an employer’s CBDPP, areperformance-based and allow fornegotiation between the employer andemployee representatives. Other rulerequirements, however, are stated inspecific terms that do not permit anychange. For example, section 850.24(e)of the rule specifies the accuracy thatmust be achieved by exposuremonitoring of workers: not less thanplus or minus 25 percent, with aconfidence level of 95 percent, forairborne concentrations of beryllium atthe action level. DOE’s objectives ofcontrolling worker exposure to airborneberyllium and obtaining better exposuredata would be defeated if accuracy ofmonitoring were a subject of collectivebargaining. Although today’s rule mayincidentally affect collective bargaining,it is neutral with respect to the balanceof bargaining power of organized laborand management. The rule applies to allDOE contractors whether or not they areinvolved in collective bargaining.

This final rule is not beingpromulgated as a nuclear safetyrequirement under 10 CFR Part 820,Procedural Rules for Nuclear Activities,

because beryllium generally is not anuclear material. Any radiologicalimplications of the two radioisotopicforms of beryllium would be addressedunder the provisions of 10 CFR part 835,Occupational Radiation Protection.

III. Overview of the Final Rule

The final rule strengthens the workerprotection program established underDOE Order 440.1A, Worker ProtectionManagement for DOE Federal andContractor Employees (or DOE Orders5483.1B, 5480.4, 5480.8A, and 5480.10for operations not covered by DOEOrder 440.1A), by supplementing thegeneral worker protection programrequirements with provisions that arespecifically designed to manage andcontrol beryllium exposure hazards inthe DOE workplace. These hazard-specific provisions are derived largelyfrom DOE Notice 440.1, ‘‘InterimChronic Beryllium Disease PreventionProgram,’’ but a number of provisionshave been modified as a result of DOE’sconsideration of comments received inthe rulemaking.

Consistent with DOE Notice 440.1,this final rule establishes a CBDPP thatis designed to reduce the occurrence ofCBD among DOE federal and contractorworkers and any other individuals whoperform work at DOE facilities. TheCBDPP will accomplish this disease-reduction mission through provisionsthat: (1) Reduce the number of currentworkers who are exposed to berylliumby clearly identifying and limitingworker access to areas and operationsthat contain or utilize beryllium; (2)minimize the potential for, and levelsof, worker exposure to beryllium byimplementing engineering and workpractice controls that prevent the releaseof beryllium into the workplaceatmosphere and/or capture and containairborne beryllium particles beforeworker inhalation; (3) establish medicalsurveillance to monitor the health ofexposed workers and ensure earlydetection that makes possible earlytreatment of disease; and (4) establishcontinual monitoring of theeffectiveness of the program inpreventing CBD and implementingprogram enhancements as appropriate.Another key purpose of the rule is thecollection of consistent data, which willimprove the information available tobetter understand the cause of CBD.

DOE has made numerous changes inthe final rule after considering thepublic comments on the proposed rule.The principal changes are as follows:

• The final rule requires responsibleemployers to assign a qualifiedindividual, such as a Certified Industrial

Hygienist, to manage and superviseberyllium inventories, hazardassessments, and exposure monitoring.

• The final rule establishes theairborne beryllium concentration actionlevel, which in this rule triggers keyworker protection measures, at 0.2µg/m3, instead of 0.5 µg/m3 as proposed.The STEL has been deleted, because theproposed STEL would not provide anyadded protection for workers given thatthe new action level of 0.2 µg/m3 wouldbe exceeded in less than 15 minuteswhere exposure levels are at 10µg/m3.

• The final rule provides thatresponsible employers must requireworkers to use respirators in areaswhere the beryllium exposure level is ator above the action level, rather than ator above the PEL as proposed in theNOPR, and must provide a respirator toany worker exposed to beryllium whorequests one, regardless of theconcentration of airborne beryllium.

• The final rule includes criteria andrequirements to govern the release ofberyllium-contaminated equipment andother items at DOE sites for use by otherDOE facilities or the public.

• The final rule requires responsibleemployers to offer medical surveillanceto any ‘‘beryllium-associated worker,’’defined to include any current workerwho is exposed through beryllium workor who had past exposure or potentialexposure to beryllium at a DOE facility.

• The final rule contains medicalremoval protection and multiplephysician review provisions that aremodeled on provisions of three ofOSHA’s expanded health standards.

The provisions of the rule arepresented in three subparts. Subpart Adescribes the purpose and applicabilityof the rule, defines terms that are criticalto the rule’s application andimplementation, and establishes DOEand contractor responsibilities forexecuting the rule. Subpart B establishesadministrative provisions requiringresponsible employers to develop andmaintain a CBDPP and to perform allberyllium-related activities according tothe CBDPP. Subpart C establishesrequirements for the content andimplementation of the CBDPP. Some ofthe provisions of Subpart C apply onlywhen it is determined that the airborneconcentration of beryllium in a specificworkplace or operation rises above aspecified limit. Table 8 summarizesthese provisions and indicates the levelsof beryllium at which the provisionsapply.



TABLE 8.—LEVELS AT WHICH THE PROVISIONS OF THE CBDPP APPLY

Provision

Worker exposure or potential exposurelevels (8–Hour TWA)

Be oper-ations/loca-

tions 1

≥Actionlevel (0.2µg/m 3)

≥PEL (8-hrTWA) (2.0

µg/m 3)

Baseline Inventory (850.20) ..................................................................................................................... X .................... ....................Hazard Assessment (850.21) .................................................................................................................. X .................... ....................Initial Exposure Monitoring (850.24) ........................................................................................................ X .................... ....................Periodic Exposure Monitoring (850.24) ................................................................................................... .................... X ....................Exposure Reduction and Minimization (850.25) ..................................................................................... X 2 X3 X4

Regulated Areas (850.26) ....................................................................................................................... .................... X ....................Hygiene Facilities and Practices (850.27) ............................................................................................... .................... X ....................Respiratory Protection (850.28) ............................................................................................................... X 5 X ....................Protective Clothing and Equipment (850.29) .......................................................................................... X 6 X ....................Housekeeping (850.30) ........................................................................................................................... X 7 .................... ....................Release Criteria (850.31) ........................................................................................................................ X 8,9 .................... ....................Medical Surveillance (850.34) ................................................................................................................. X 10 .................... ....................Training and Counseling (850.37) ........................................................................................................... X11 .................... ....................Warning Signs (850.38) ........................................................................................................................... .................... X ....................

1 Applies to beryllium operations and other locations where there is a potential for beryllium contamination.2 Responsible employers must implement actions for reducing and minimizing exposures, if practicable.3 Responsible employers must establish a formal exposure reduction and minimization program, if practicable.4 Responsible employers must reduce exposures to or below the PEL.5 Responsible employers must provide respirators when requested by the worker.6 Responsible employers must provide protective clothing and equipment where surface contamination levels are above 3 µg/100 cm2.7 Housekeeping efforts must maintain removable surface contamination at or below 3 µg/100 cm2 during non-operational hours.8 Removable contamination on equipment surfaces must not exceed 0.2 µg/100 cm2 when released to the public or for non-beryllium use.9 Removable contamination on equipment surfaces must not exceed 3 µg/100 cm2 when released to other beryllium handling facilities.

10 Responsible employers must provide medical surveillance for all beryllium-associated workers.11 Training is required for all workers who could be potentially exposed. Counseling is required for beryllium-associated workers diagnosed with

CBD or beryllium sensitization.

IV. Section-by-Section Discussion ofComments and Rule Provisions

This section of the SupplementaryInformation responds to significantcomments on specific proposed ruleprovisions. It also contains explanatorymaterial for some final rule provisionsin order to provide interpretiveguidance to DOE offices and DOEcontractors that must comply with thisrule. All substantive changes from thenotice of proposed rulemaking (NOPR)are explained in this section. However,some non-substantive changes, such asthe renumbering of paragraphs andchanges to clarify the meaning of ruleprovisions, are not discussed.

DOE has determined that therequirements set forth in this final ruleare those which, based on currentlyavailable data, are necessary to provideprotection to workers who may beexposed to beryllium.

A. Subpart A—General Provisions

Section 850.1—Scope

The CBDPP required by this rule willenhance, supplement, and be integratedinto existing worker protection programrequirements for DOE Federal andcontractor employees. DOE hasstructured the rule this way for twomain reasons: (1) to take advantage ofexisting and effective comprehensiveworker protection programs that have

been implemented at DOE facilities; and(2) to minimize the burden on DOEcontractors by clarifying that contractorsneed not establish redundant workerprotection programs to protect workersfrom hazards of exposure to airborneberyllium.

Section 850.2—Applicability

As in the proposed rule, section 850.2specifies that this rule applies to DOEoffices and DOE contractors withresponsibility for operations or activitiesthat involve present or past exposure, orthe potential for exposure, to berylliumat DOE facilities. It also applies to anycurrent DOE employee, DOE contractoremployee, or any other current workerat a DOE facility who is or was exposedor potentially exposed to beryllium at aDOE facility, regardless of whichorganization currently employs theworker.

Except at the few DOE-operatedfacilities, DOE federal workers are notusually directly involved in productiontasks or other activities in which theywould be exposed to airborne beryllium.However, in performing managementand oversight duties, DOE federalworkers may enter facilities whereberyllium is handled. Federal agenciesare required to ensure the protection offederal workers under the health andsafety provisions of 29 CFR Part 1960,‘‘Basic Program Elements for Federal

Employee Occupational Safety andHealth Programs and Related Matters,’’as well as Executive Order (EO) 12196,‘‘Occupational Safety and HealthPrograms for Federal Employees.’’DOE’s intent in section 850.2(a)(1) is tosupplement these general workerprotection requirements with specificberyllium-related requirements in thelimited instances where DOE federalworkers may have the potential forberyllium exposure.

Section 850.2(a)(2) specifies that therule also applies to DOE contractorswith operations or activities involvingexposure or the potential for exposure toberyllium. As clarified in the definitionof ‘‘DOE contractor’’ (section 850.3),DOE’s intent is that the contractorscovered under this rule include anyentity under contract to perform DOEactivities at DOE-owned or -leasedfacilities, including contractors awardedmanagement and operating contracts,integrating contractors, andsubcontractors. This section furtherclarifies that the requirements of theCBDPP apply only to contractors andsubcontractors who work in areas or onDOE activities that involve the potentialfor worker exposure to beryllium.

The provisions of this rule do notapply to former DOE workers; toactivities at DOE facilities that do notinvolve exposure or potential exposureto beryllium; or to activities not



conducted at a DOE facility, such as theoff-site laundering of beryllium-contaminated protective clothing from aDOE site.

Section 850.2(b) exempts ‘‘berylliumarticles’’ from the rule (see thedefinition of ‘‘beryllium article’’ undersection 850.3). DOE recognizes thatsome beryllium-containingmanufactured items may not poseberyllium hazards where they have beenformed to specific shapes or designs andtheir subsequent uses or handling willnot result in the release of airborneberyllium. This exemption for berylliumarticles is consistent with the approachtaken by OSHA in regulating hazardousmaterials under the HazardCommunication standard at 29 CFR1910.1200.

Section 850.2(c) establishes that therule does not apply to the DOElaboratory operations involvingberyllium that are subject to therequirements of OSHA’s OccupationalExposure to Hazardous Chemicals inLaboratories standard, 29 CFR1910.1450, commonly called OSHA’sLaboratory standard. Three commenters(Exs. 30, 31, 32) opposed thisexemption, stating that lesser protectionwould be afforded to laboratory workersthan to those workers covered by therule. One commenter (Ex. 30) suggestedthat laboratory exposures are difficult topredict and that a lack of samplingresulting from the perception that littlehazard is present in laboratory settingsmay lead to incomplete exposurecharacterizations.

In establishing its Laboratorystandard, OSHA clarified its intent that29 CFR 1910.1450 supersede all otherOSHA regulations for bench-toplaboratory-scale activities, noting thatthe provisions of the standard weremore relevant and suitable to the uniquecharacteristics of laboratory activities.DOE agrees with OSHA’s approach andbelieves that the provisions of OSHA’sLaboratory standard are adequate toprotect workers from berylliumexposures in facilities that fall withinthe scope of the standard.

DOE notes the laboratory exemptiononly applies in instances whererelatively small quantities of berylliumare used in a non-production activity. Inaddition, OSHA’s Laboratory standardhas specific provisions to ensure thatprotective laboratory practices arefollowed. Many of the provisions inOSHA’s Laboratory standard are thesame as, or similar to, those in this finalrule. For instance, OSHA’s Laboratorystandard establishes provisions foridentifying the presence of hazardouschemicals (baseline inventory),establishing a chemical hygiene plan

(hazard assessment), performingperiodic monitoring at the action level,implementing exposure reductionmeasures at the PEL, training employeeson related hazards, and providingemployees the opportunity for medicalconsultation and examination. In partbecause each of these aspects of theberyllium rule is already included in theOSHA Laboratory standard, DOE hasretained the laboratory operationsexemption in section 850.2(b)(2).

Section 850.3—Definitions

Commenters on the proposed rule’s‘‘Definitions’’ section typicallyrequested clarification or modificationof the proposed definitions.

New terms. In response to publiccomment, the following additionalterms have been defined in section850.3: ‘‘beryllium-associated worker,’’‘‘Head of DOE Field Element,’’‘‘removable contamination,’’‘‘responsible employer,’’ and ‘‘uniqueidentifier.’’ A discussion of each term isincluded in the alphabetical listing ofdefinitions provided below.

Terms and definitions deleted. Inresponse to public comment, thefollowing definitions in the NOPR aredeleted in the final rule: ‘‘acceptedapplicant,’’ ‘‘short term exposure limit(STEL),’’ and ‘‘surface contamination.’’The deletions are explained in thesection-by-section discussion of the ruleprovisions in which the terms werepreviously used.

Section 850.3 defines key terms usingtraditional industrial hygieneterminology and terminology used byOSHA in its regulations. The use ofsuch terminology is consistent withDOE’s increased emphasis on industrialhygiene compliance through the use ofaccepted occupational safety and healthrequirements and procedures. Thefollowing discussion explains thedefinitions in the rule. Although someof these terms are commonly used, DOEbelieves that these definitions will helpensure that their meaning as used in thecontext of the rule is clear.

Action level means the level ofairborne concentration of berylliumestablished pursuant to Subpart C,which, if met or exceeded, requires theimplementation of certain specifiedprovisions of the rule. Using an actionlevel to trigger certain provisions of therule is consistent with the approachapplied in many of OSHA’s substance-specific standards. The word‘‘exceeded’’ was amended to read ‘‘metor exceeded’’ in the final rule to clarifyDOE’s intent that worker protectionprovisions must be implemented incases where worker exposure levels are

measured at, as well as above, the actionlevel.

Authorized person means any personrequired by work duties to be inregulated areas. The concept ofauthorized person is consistent withOSHA standards and with contractorpractice in many DOE facilities, and isintended to ensure that the populationof potentially exposed individuals isreduced to the lowest possible numberand that workers who are granted accessto regulated areas have the knowledgethey need to protect themselves andother workers. Under this rule,authorized individuals are to be trainedin the hazards of beryllium and in themeans of protecting themselves andthose around them against such hazards.Training requirements for individualsworking with beryllium are specified insection 850.37 of the rule. DOE did notreceive any comments on thisdefinition, which remains unchanged inthe final rule.

Beryllium means elemental berylliumand any insoluble beryllium compoundor alloy containing 0.1 percentberyllium or greater that may bereleased as an airborne particulate. Thisdefinition of beryllium reflects the focusof this rule on worker exposure toairborne beryllium. One commenter (Ex.26) questioned whether exposure tonaturally occurring berylliumcompounds in excess of 0.1 percent wascovered by the DOE program. However,as correctly noted by the samecommenter, sections 850.2(a)(1) and (2)provide that the rule only applies toexposures and potential exposures toberyllium that occur in connection withfacility operations. Another commenter(Ex. 10) suggested that 0.1 percentberyllium was too inclusive, andsuggested that a level of 0.5 percent beused instead. DOE notes, however, thatthe concentration specified in thedefinition is consistent with thecriterion that OSHA uses for acarcinogenic mixture, i.e., one thatcontains a carcinogenic component at aconcentration of 0.1 percent (or 1,000parts per million [ppm]) or greater, byweight or volume. Therefore, DOE hasnot changed the definition in the finalrule.

Beryllium activity means an activityperformed for, or by, DOE at a DOEfacility that can expose workers toairborne concentrations of beryllium.Activities within the scope of thisdefinition may involve design,construction, operation, maintenance,and decommissioning. The definitionfurther explains that a ‘‘berylliumactivity’’ may involve one DOE facilityor operation, or a combination offacilities and operations. This definition



is broad enough to include activitiessuch as repair work performed bysupport-service subcontractors who visitthe site infrequently. DOE did notreceive comments on this proposeddefinition. However, DOE modified thelanguage to clarify that maintenanceoperations are within the scope of theterm.

Beryllium article means amanufactured item that is formed to aspecific shape or design duringmanufacture, that has end-use functionsthat depend in whole or in part on theitem’s shape or design, and that doesnot release beryllium or otherwise resultin exposure to airborne concentrationsof beryllium under normal useconditions. DOE has included thisdefinition of ‘‘beryllium article’’ todistinguish between forms of berylliumthat may result in exposure to airborneberyllium and manufactured itemscontaining beryllium that do not releaseberyllium or otherwise result inexposure to airborne concentrations ofberyllium. All of the persons (Exs. 9, 26,30, 31) commenting on this definitionagreed that exempting beryllium articlesfrom the program is a logical approach.Two of these commenters (Exs. 9, 26)stated that an item destined formachining should be considered aberyllium article up to the time of thatmachining. In response to thesecomments DOE notes that the berylliumarticle definition is consistent with theapproach employed by OSHA informulating its definition of ‘‘article’’ inthe Hazard Communication standard (29CFR 1910.1200). The key concept is thatan article, if used as intended, does nothave the potential to result in hazardousexposures. However, an item ceases tobe an ‘‘article’’ when it is subjected tomachining, cutting, drilling, or similaraction other than its intended end use.Similarly, if an item is manufactured forthe purpose of being machined later, itis not considered an article. Anothercommenter (Ex. 31) suggested thatexamples of activities that could releaseberyllium, such as burning, grindingand chipping, be included in aparenthetical listing in the definition.DOE recognizes that there are manyactivities that could lead to a release,and is concerned that providingexamples could be interpreted toexclude other activities. To avoid suchconfusion, DOE believes that examplesshould not be included in thedefinition, but rather should beincluded in a companionimplementation guide for the rule.

Beryllium-associated worker means acurrent worker who is or was exposedor potentially exposed to airborneconcentrations of beryllium at a DOE

facility. This individual may be a DOEFederal or contractor worker, anemployee of a subcontractor to a DOEcontractor, or a visitor who, pursuant toa DOE-approved arrangement, performswork at a DOE facility. This definitionclarifies DOE’s intent that the ruleapplies only to current workers. Thedefinition further clarifies that currentworkers who have been removed fromberyllium exposure as part of themedical removal plan are beryllium-associated workers under the rule, butthey are not ‘‘beryllium workers’’ (seedefinition of ‘‘beryllium worker’’).

Beryllium emergency means anyoccurrence such as, but not limited to,equipment failure, container rupture, orfailure of control equipment oroperations, that unexpectedly releases asignificant amount of beryllium. Thisdefinition is particularly importantwhen determining appropriateemergency response procedures that fallwithin the scope of OSHA’s HazardousWaste Operations and EmergencyResponse standard, 29 CFR 1910.120.This definition is based on OSHA’sinterpretation of the term ‘‘emergency’’as applied in 29 CFR 1910.120 andrefers to any untoward event, such as amajor spill of powdered beryllium or anunexpected upset that releases asignificant amount of beryllium into theworkplace atmosphere. Twocommenters (Exs. 24, 31) expressedconcern that the term ‘‘significantrelease’’ was open to too muchinterpretation and needed furtherclarification. Emergency situations, bytheir very nature, are difficult toanticipate and describe. DOE believesthat the examples listed provide ageneral indication as to what constitutesa significant release. The use of the term‘‘beryllium emergency’’ is used insection 850.33, which requires DOEcontractors to develop emergencyprocedures and training to addressemergency scenarios.

Beryllium-induced lymphocyteproliferation test (Be-LPT) means an invitro measure of the beryllium antigen-specific, cell-mediated immuneresponse. This test measures the extentto which lymphocytes, a class of whiteblood cells, respond to the presence ofberyllium by replicating in thelaboratory. Medical personnel use theBe-LPT to identify workers who havebecome sensitized to beryllium throughtheir occupational exposure. DOE didnot receive any comments on thisproposed definition, which remainsunchanged in the final rule.

Beryllium worker means a currentworker who is regularly employed in aDOE beryllium activity. Section 850.3 ofthe NOPR defined ‘‘beryllium worker’’

as ‘‘a current worker who is exposed orpotentially exposed to airborneconcentrations of beryllium at or abovethe action level or above the STEL orwho is currently receiving medicalremoval protection benefits.’’ Thisproposed definition included DOEFederal or contractor workers, workersemployed by a subcontractor to a DOEcontractor and visitors performing workat DOE facilities. Consistent with otherprovisions of the proposed rule, DOEintended this definition to apply only tocurrent workers. DOE specifically statedin the NOPR that former workers wouldnot be included in the proposed‘‘beryllium worker’’ definition, butinstead would be addressed under aseparate initiative.

DOE received eight comments on thedefinition of ‘‘beryllium worker’’ in theproposed rule. Five commenters (Exs. 2,14, 16, 17, 28) stated that the termberyllium worker was too limiting.These commenters argued that theproposed definition of beryllium workershould not be limited to those workersexposed to levels of beryllium at orabove the action level, but rather shouldinclude all workers with the potentialfor beryllium exposure. Threecommenters (Exs. 2, 14, 28) supportedthis position by noting that currentscientific evidence does not suggest a‘‘safe’’ level of beryllium exposure, andthat CBD has been identified inindividuals thought to have only low orincidental exposure to beryllium. DOEshares this concern, and has omitted thereference to the action level from thedefinition of ‘‘beryllium worker’’ in thefinal rule. DOE has revised thedefinition in the final rule to apply toeach ‘‘current worker who is regularlyemployed in a DOE beryllium activity.’’

These same five commenters (Exs. 2,14, 16, 17, 28) also argued that medicalsurveillance should be offered to allindividuals with beryllium exposureand that the beryllium workerdefinition, therefore, should beexpanded to include reassigned andformer workers with prior berylliumexposure. These commenters wereconcerned that restricting medicalsurveillance to ‘‘beryllium-workers,’’ asdefined in section 850.3 of the proposedrule, would exclude workers withincidental beryllium exposure who alsomay be at risk of contracting CBD.

Two commenters (Exs. 2, 28)questioned the need for separatemedical surveillance programs forformer and current beryllium workers.These two commenters raised the issuesof increased cost, lack of continuity, andthe added confusion to participantsassociated with maintaining separatesurveillance programs.



In response to these comments, DOEadded the term ‘‘beryllium-associatedworker,’’ which is more inclusive thanthe term ‘‘beryllium worker.’’ (Seedefinition of ‘‘beryllium-associatedworker.’’) The term ‘‘beryllium-associated worker’’ is used in provisionsof the rule where DOE has determinedthat coverage should not be limited toworkers regularly employed in DOEberyllium activities. Use of the term‘‘beryllium-associated worker’’ clarifiesDOE’s intent that current employeeswith past beryllium exposures orpotential exposures, as well as currentindividuals who are exposed to airborneberyllium at DOE facilities, be includedunder the following rule provisions:850.5 (dispute resolution), 850.10(development and approval of theCBDPP), 850.33 (medical surveillance),850.34 (medical removal), 850.35(medical consent), 850.36 (training andcounseling) and 850.39 (berylliumregistry).

DOE, however, has not expanded thedefinition to include former workers.DOE previously established the FormerBeryllium Workers MedicalSurveillance Program and offers medicalexaminations to former (retired andseparated) workers who are at risk fordeveloping CBD due to their work atDOE. The elements of the FormerBeryllium Workers MedicalSurveillance Program are: (1)identification of beryllium workers whohave retired or separated fromemployment; (2) notifying workers oftheir eligibility to participate in theprogram, and general announcements toprovide former workers an opportunityto self-identify as a former berylliumworker; (3) informed consent on therisks and benefits of participating in theprogram; (4) screening for CBD using theBe-LPT, a standardized questionnaire onrespiratory symptoms, and a chestradiograph if indicated by responses tothe questionnaire; (5) an offer ofdiagnostic medical examinations toindividuals found to have either apositive Be-LPT or signs or symptoms ofCBD; (6) periodic medical monitoring;(7) funds for medical care that is notcovered by insurance; and (8)epidemiologic surveillance to identifyhigh risk operations where additionalprimary preventative actions areneeded.

One commenter (Ex. 23) took issuewith the phrase ‘‘potentially exposed’’in the proposed definition of ‘‘berylliumworker,’’ arguing that it is too vague andcould allow too much room forindividual interpretation. DOE believesthat limiting the definition to workerswith actual personal exposuremonitoring results at or above a

specified airborne level wouldunnecessarily limit responsibleemployers’ options for meeting theexposure monitoring requirements ofthis rule. For instance, if the phrase‘‘potentially exposed’’ were removedfrom the definition, the use ofrepresentative sampling would nolonger be an acceptable option formeeting the exposure monitoringrequirements in the rule. Employerswould be required to determine actualexposures for all workers to determinewhether the workers are beryllium-associated workers. DOE believes thatsuch an inflexible requirement would beburdensome and inconsistent withsound industrial hygiene practices andthe provisions of section 850.21 of therule, which requires qualified industrialhygienists to apply their professionalknowledge and experience in theperformance of beryllium hazardassessments. Accordingly, the final rule(in the definitions of ‘‘beryllium-associated worker’’ and ‘‘berylliumactivity’’) requires responsibleemployers to consider potentialexposures in identifying berylliumworkers.

Another commenter (Ex.16) statedthat the proposed definition of‘‘beryllium worker,’’ as applied indetermining a worker’s eligibility toparticipate in the medical surveillanceprogram, could be too narrow in somerespects and too broad in others. Thiscommenter favored including currentworkers no longer working withberyllium and those with exposuresbelow the action level in the definitionof ‘‘beryllium worker.’’ This commenterrecommended allowing the industrialhygiene and medical staff to use a‘‘graded approach’’ to determine whichworkers received medical surveillance,based on the needs of the individualand ‘‘common sense judgement aboutcost and benefit.’’ DOE agrees thatcurrent workers no longer working withberyllium and those with exposuresbelow the action level should be eligiblefor medical surveillance and, thus, hasincluded such individuals in the finalrule’s definition of ‘‘beryllium-associated workers.’’ DOE does notagree, however, that determiningwhether a worker should receivemedical surveillance should be left tothe discretion of the industrial hygieneand medical staff. DOE believes thatsuch discretionary application ofmedical surveillance will result in aninconsistent level of protection forworkers across the DOE complex.Therefore, section 850.34 of the finalrule requires responsible employers todevelop and implement a medical

surveillance program for all beryllium-associated workers (see discussion ofsection 850.34).

Breathing zone is the hemisphereforward of the shoulders, centered onthe mouth and nose, with a radius of 6to 9 inches. This definition is usedprincipally in section 850.24, ExposureMonitoring, which requires DOEcontractors to determine workerexposures to beryllium by monitoringfor the presence of contaminants in theworker’s personal breathing zone. Onecommenter (Ex. 9) stated that thisproposed definition was imprecise. DOEdisagrees and views this definition asbeing consistent with sound andaccepted industrial hygiene practice. Itwill ensure that samples collected forpersonal exposure monitoring representthe air inhaled by workers whileperforming their duties in affected workareas. Therefore, DOE has not revisedthis definition in the final rule.

DOE means the Department of Energy.DOE contractor means any entity

under contract with DOE, including asubcontractor, with responsibility forperforming DOE activities at DOE-owned or -leased facilities. This termdoes not apply to a contractor orsubcontractor who provides only‘‘commercial items’’ as defined underthe Federal Acquisition Regulations(FAR). Such contractors would not beperforming DOE beryllium activities. Asexplained in the discussion of section850.10, subcontractors who are coveredunder the rule normally will not bedesignated to prepare the writtenCBDPP for a site. However, thesesubcontractors will be included in theCBDPP that encompasses all beryllium-related activities at the site.

DOE facility means any facilityoperated by or for DOE, whether ownedor leased by DOE.

Head of DOE Field Element is thehigh-level DOE official in a DOE field oroperations office who has theresponsibility for identifying thecontractors and subcontractors coveredby this part and for ensuring compliancewith this part.

High-efficiency particulate air (HEPA)filter means a high-efficiency filtercapable of trapping and retaining atleast 99.97 percent of 0.3-micrometermonodisperse particles. Such filters arecommonly used in heating andventilating systems, respiratoryprotection equipment, local exhaustventilation, etc., to remove toxic orhazardous particulates like beryllium.

Immune response refers to the seriesof cellular events by which the immunesystem reacts to a specific antigen.Types of immune responses includeacquired immunity and sensitization.



The body’s immune response toberyllium is sensitization and isindicated by the results of the Be-LPT.

Medical removal protection benefitsare employment rights established insection 850.35 for beryllium-associatedworkers temporarily or permanentlysubject to medical removal fromworking in regulated areas followingmedical evaluations. These provisionsgive contractors an incentive to makereasonable efforts to find and offeralternate employment to workers whohave suffered negative health effects dueto exposure to beryllium. The definitionof medical removal protection benefitsand the requirements in section 850.35ensure that such workers would sufferno reductions in total earnings,seniority, or other worker rights andbenefits for two years after permanentmedical removal. The two-year periodfor medical removal protection benefitsafter permanent removal will allow thecontractor to make a reasonable effort tofind alternate employment for aremoved worker or, through jobretraining and out-placement programsoperated by many sites, to locatealternate outside employment for theworker.

Regulated area means an areademarcated and managed by theresponsible employer where theairborne concentration of berylliumexceeds, or can reasonably be expectedto exceed, the action level (see thedefinition of ‘‘action level.’’). Employeesworking in regulated areas must beauthorized to do so by the responsibleemployer, and must be trained andequipped with protective clothing andequipment. The purpose of such areas isto limit potential exposure to berylliumto as few workers as possible. Regulatedareas are commonly used throughoutDOE, particularly with regard toradiation protection, and their use isconsistent with OSHA’s expandedhealth standards for toxic particulates.

Removable contamination meansberyllium contamination that can beremoved from surfaces bynondestructive means, such as casualcontact, wiping, brushing, or washing.This term was adopted from DOE’sRadiological Control Manual, April1994. One commenter (Ex. 23) statedthat ‘‘surface contamination’’, a termdefined in the proposed rule, shouldrefer to contamination that is removable,not simply beryllium on surfaces. DOEagrees with this commenter that onlyremovable surface contamination canbecome airborne and inhaled byworkers, and has replaced the term‘‘surface contamination’’ with‘‘removable contamination.’’

Responsible employer means the DOEcontractor office that is directlyresponsible for the safety and health ofDOE contractor employees whileperforming a beryllium activity or otheractivity at a DOE facility; or for DOEemployees, the DOE office that isdirectly responsible for the safety andhealth of DOE Federal employees whileperforming a beryllium activity or otheractivity at a DOE facility; and anyperson acting directly or indirectly forsuch office with respect to terms andconditions of employment of beryllium-associated workers. This definition isadded to clarify DOE’s intent thatprovisions of the final rule apply to bothDOE Federal and contractor workers atDOE facilities.

Site Occupational Medical Director(SOMD) means the physicianresponsible for the overall direction andoperation of the site occupationalmedicine program. DOE intends,through this definition, to ensure that aphysician administers each DOEfacility’s occupational medicineprogram.

Unique identifier means a number oralphanumeric code used to identifyeach worker individually anddistinctively while protecting theworker’s privacy. Unique identifiers areused in DOE’s health surveillanceprogram to help identify the exposureseach worker has experienced in thecourse of his or her work in a DOEfacility without personally identifyingthe worker. The unique identifiers willallow DOE to link worker’s exposureand occupational health data.

Worker means a person who performswork at a DOE facility including (butnot limited to) a DOE employee, anindependent contractor, or a DOEcontractor employee. As clarified in thedefinition of ‘‘DOE contractor,’’ anemployee of a covered subcontractor isa contractor employee under this part.

Worker exposure means the airborneconcentration of beryllium in thebreathing zone of the worker that wouldoccur if the worker were not usingrespiratory protective equipment. Thisdefinition is consistent with acceptedindustrial hygiene practice and withOSHA’s definition of the term‘‘employee exposure’’ as applied in theOSHA expanded health standards.

Section 850.4–EnforcementDOE proposed that enforcement of the

CBDPP requirements in Part 850 wouldbe through contractual remedies,including contract termination orreduction in fee. Section 850.4 of thefinal rule adheres to this approach. Thissection provides that DOE may takeappropriate steps under its contracts to

ensure compliance with this rule,including (but not limited to) contracttermination or reduction in fee.

One union commented (Ex. 22) thatthe proposed enforcement provisionwould be inadequate because DOE isnot likely to terminate a primecontractor’s contract for failure tocomply with health and safetyrequirements, and because award feereductions are only useful if thecontracting officer is aware of, andqualified to investigate, noncompliance.The union requested that the rule beenforced under DOE’s nuclear safetyrequirement enforcement procedures in10 CFR Part 820 or pursuant to section3131 of the National DefenseAuthorization Act for Fiscal Years 1992and 1993 (42 U.S.C. 7274d). The unionalso suggested that while awaiting acompliance officer, a worker shouldhave the right to shut down the jobwithout loss of pay.

DOE has not adopted the commenter’srecommendation to enforce this ruleunder 10 CFR Part 820 or section 3131of the National Defense AuthorizationAct for Fiscal Years 1992 and 1993. Part820, ‘‘Procedural Rules For DOENuclear Activities,’’ containsprocedures for enforcement of DOEnuclear safety requirements. Berylliumis not normally considered a nuclearmaterial, and, therefore, enforcement ofthis rule would not fall within the scopeof Part 820. DOE also cannot enforcethis rule under section 3131 of theNational Defense Authorization Actbecause that section’s scope is limited,authorizing only the imposition of civilpenalties against a DOE contractor forfailing to train or certify to DOE theadequacy of employee training inhazardous substance response oremergency response (42 U.S.C.7274d(b)).

In DOE’s view, the existingmechanisms and contractual remediesavailable for enforcing DOE contractorworker protection programs areadequate for enforcement of this rule.For instance, under DOE Order 440.1A,DOE and, to the extent incorporated intocontracts, DOE contractors are requiredto implement worker protectionprograms that ensure compliance withapplicable health and safetyrequirements. The worker protectionprogram must provide workers withcertain rights, including, among otherthings, the right to accompany DOEworker protection personnel duringworkplace inspections on official time;the right to express concerns related toworker protection; to decline to performan assigned task based on a reasonablebelief that the task poses an imminentrisk of death or serious bodily harm



when there is insufficient time to obtainredress through normal reporting andabatement procedures; the right toobserve monitoring or measuring ofhazardous agents and have access to theresults of exposure monitoring; the rightto be notified if monitoring resultsindicate they were overexposed tohazardous materials; and the right toreceive results of inspections andaccident investigations upon request.These provisions of DOE Order 440.1Acontinue to apply under the CBDPP.

Additionally, a contractor employee isprotected from retaliation for a refusal towork under certain circumstances, asspecified in an interim final rule thatDOE promulgated on March 15, 1999,which substantially revises 10 CFR part708, DOE Contractor EmployeeProtection Program (64 FR 12862 asamended at 64 FR 37396). An employeeof a contractor (or a subcontractor) mayfile a complaint under the‘‘whistleblower’’ regulations if he or sheis subject to retaliation for refusing toparticipate in an activity based on areasonable fear of serious injury (10 CFR708.5(c)).

Section 850.5–Dispute ResolutionIn the NOPR, DOE proposed that

disputes arising under this part that arebrought by beryllium workers beresolved through applicable grievance-arbitration processes or, if suchprocesses are not available, throughreferral to the DOE’s Office of Hearingsand Appeals.

A union commented (Ex. 22) that theproposal to relegate a worker to thegrievance and arbitration provision ofthe collective bargaining agreementwould be inadequate because iterroneously assumes that an arbitratorwould find a final rule to be part of thecollective bargaining agreement. Theunion stated that unless DOE requiredemployers to propose this rule, andunions accepted it as a contractcondition, an arbitrator would declineto enforce this rule. The samecommenter asked that DOE clarify in thefinal rule that an employeerepresentative may file grievances undera collective bargaining agreement orseek other remedies under the laborlaws to compel contractor complianceor deter contractor retaliation forseeking enforcement of the rule.

A DOE contractor (Ex. 23) expressedconcern that proposed section 850.5might interfere with existing disputeresolution processes, or might violateFederal law by imposing an obligationon the employment relationshipbetween a DOE contractor and itsemployees who are subject to the termsof a collective bargaining agreement.

In proposing section 850.5, DOEsought to avoid creating opportunitiesfor workers represented by labororganizations to circumvent collectivebargaining agreement procedures forresolving disputes concerning terms andconditions of employment. Thus, DOEproposed that workers use availablegrievance-arbitration procedures forresolution of disputes related to thesubject of this rule. However, DOEagrees with the comment that anarbitrator deciding a grievance under acollective bargaining agreement mightnot look beyond the collectivebargaining agreement in making adecision. Because this rule establishesminimum requirements that areindependent of collective bargainingagreements, available grievance-arbitration procedures may not in somecases be sufficient to ensure compliancewith the rule.

DOE, therefore, has modified the textof section 850.5 to permit any adverselyaffected person to refer a disputeregarding compliance with the rule tothe Office of Hearings and Appeals forresolution, but employees who arerepresented by a labor organization arerequired first to exhaust any grievance-arbitration procedure that is availablefor resolving disputes over terms andconditions of employment. This is theapproach DOE took in its interim finalrule for the DOE Contractor EmployeeProtection Program, 10 CFR part 708 (64FR 12862, March 15, 1999). Consistentwith section 708.13(a) of the ContractorEmployee Protection Program rule, DOEhas revised section 850.5 in the finalrule to provide that a worker will bedeemed to have exhausted all applicablegrievance-arbitration procedures if 150days have passed after the filing of agrievance and a final decision on it hasnot been issued.

B. Subpart B—AdministrativeRequirements

Subpart B of the final rule establishesgeneral and administrative requirementsto develop, implement, and maintain aCBDPP and to perform all beryllium-related activities according to theCBDPP.

Section 850.10—Development andApproval of CBDPP

Section 850.10 establishes theprocedures for the development andapproval of the CBDPP. Section850.10(a)(1) requires a responsibleemployer in charge of DOE berylliumactivities to prepare a CBDPP for itsoperations and submit the CBDPP to theappropriate Head of DOE Field Elementfor approval. This section establishes a90-day time frame from the effective

date of the rule for responsibleemployers’ submission of the CBDPP tothe appropriate Head of DOE FieldElement. DOE is aware of the burden ofdocumentation that can be generated bynew programs. However, mostresponsible employers have alreadydeveloped CBDPPs in response to DOENotice 440.1. DOE expects theadditional effort required to refine theexisting CBDPPs to meet therequirements of the rule will beminimal.

Section 850.10(a)(2) requires that asingle CBDPP be submitted toencompass all beryllium-relatedactivities at a site. Because DOErecognizes that one site may encompassmultiple contractors and numerouswork activities, this section clarifies thatthe CBDPP for a given site may includespecific sections for individualcontractors, work tasks, etc. DOEbelieves that this allowance for asegmented CBDPP structure willminimize the burden associated withthe CBDPP update and approvalrequirements because it allowsindividual contractors to update andsubmit for approval only the section ofthe CBDPP pertaining to their specificactivities. If multiple contractors areinvolved, the DOE contractor designatedby the Head of DOE Field Element musttake the lead in compiling the overallCBDPP and coordinating the input fromvarious other contractors,subcontractors or work activities. Thissection further clarifies that in suchcases the designated contractor mustreview and approve the CBDPPs of othercontractors engaged at the site before aconsolidated CBDPP can be submittedto the Head of DOE Field Element forfinal review and approval.

One commenter (Ex. 31) stated thatthe rule did not clearly designate an‘‘ultimate authority’’ responsible fordesignating physical areas covered bythe rule. DOE notes that in sections850.20 and 850.21, the responsibleemployer is assigned the responsibilityof developing a baseline berylliuminventory and, where appropriate,conducting a beryllium hazardassessment. The actions effectivelydetermine which areas of the facility arecovered by the rule. DOE believes thatthe responsible employer is the mostfamiliar with activities and operationsthat occur on a given DOE site and,thus, is best equipped to make thisdetermination through the performanceof the baseline beryllium inventory andhazard assessment.

Section 850.10(b) requires Heads ofDOE Field Elements to review andapprove CBDPPs. DOE believes that itsreview and approval is necessary to



ensure that each contractor’s CBDPP isconsistent with the requirements andobjectives of this final rule. Throughthese sections, DOE hopes to establishclear lines of authority for review andapproval of contractors’ CBDPPs. Onecommenter (Ex. 23) was concerned thatlocal approval of the CBDPPs by DOEfield offices could lead to unevenenforcement and increased cost ofcompliance. DOE does not agree withthis assessment, and believes that theHead of DOE Field Element is not onlyresponsible for operations within his orher jurisdiction, but is also familiar withthe operations and any related specialcircumstances or unique situations thatmay affect implementation oreffectiveness of the CBDPP. Thus, DOEbelieves the Head of DOE Field Elementis the most appropriate DOE approvalauthority for CBDPPs. DOE notes,however, that mechanisms exist toprovide independent oversight of DOE’sfield organizations. Specifically, theOffice of Oversight within the Office ofEnvironment, Safety and Health ischarged with providing information andanalysis needed to ensure that DOE’stop management officials, Congress andthe public have an accurate andcomprehensive understanding of theeffectiveness, vulnerabilities, and trendsof DOE’s environment, safety, health,nuclear safeguards, and security policiesand programs. DOE believes that thisindependent oversight will help assureconsistency among CBDPPs across thecomplex.

Section 850.10(b)(1) establishes a 90-day period for DOE to review and eitherapprove or reject the CBDPP. During itsreview, DOE may direct the contractorsto modify the CBDPP. If DOE takes noaction within 90 days, the initial CBDPPis considered approved. DOEestablished this 90-day time frame tofacilitate timely implementation ofprogram elements by responsibleemployers and to ensure that Heads ofDOE Field Elements respond toresponsible employers’ submissions.

One commenter (Ex.18) stated thatlabor organizations should receiveinitial and updated CBDPPs. DOE notesthat proposed section 850.10(b)(2)would require contractors to giveinterested DOE offices, affected workers,and designated worker representatives acopy of the CBDPP, upon request. Thisprovision is retained in section850.10(b)(2) of the final rule. Thissection ensures that workers and theirrepresentatives have access toinformation that is related to theprotection of their health during theperformance of DOE activities.

Section 850.10(c) requires responsibleemployers to update the written CBDPP

in two circumstances: (1) whenever asignificant change or addition is madeto the program, and (2) whenever acontractor or subcontractor changes.DOE believes that such updates arewarranted to ensure that the CBDPPaccurately reflects workplace conditionsand appropriately addresses specificworkplace beryllium exposure hazards.

This section also requires thatresponsible employers review theirwritten CBDPPs at least annually andrevise these programs as necessary toreflect any significant changes. Onlythose sections of the CBDPP that requirea change will have to be resubmitted tothe Head of DOE Field Element forapproval. DOE considers the annualreview cycle to be appropriate andnecessary to ensure that CBDPPs remainup-to-date and that they accuratelyreflect workplace conditions andrequired control procedures.

Section 850.10(d) ensures thatCBDPPs are developed andimplemented consistent with therequirements imposed by the NationalLabor Relations Act (NLRA), 29 U.S.C.141 et seq., on employers in thiscontext, and not to create obligations inexcess of those that would be found insuch circumstances under the NLRA.

Section 850.11–General CBDPPRequirements

Section 850.11 establishes the generalrequirements of the CBDPP. Section850.11(a) specifies that the CBDPP mustaddress all existing and anticipatedoperational tasks that fall within itsscope. In addition, the section requiresall responsible employers to developand implement a CBDPP that isintegrated into DOE’s existing workerprotection program. By including thisprovision, DOE notes the importance ofcontrolling beryllium hazards withinthe framework of the worker protectionprogram established under DOE Order440.1A (or, if applicable, underpredecessor orders) and related DOEhealth and safety initiatives. Theexisting industrial hygiene andoccupational medicine programsprovide the basis for protecting DOEFederal and contractor workers fromhealth hazards like beryllium exposure.DOE believes that establishing aberyllium exposure control programoutside the framework of this acceptedprogram may create redundant andpotentially inconsistent requirements.

One commenter (Ex. 23) stated thatthe proposed requirement to specify inthe CBDPP existing and plannedoperational tasks within the scope of therule would not be feasible fordecontamination and decommissioning(D&D) closure sites. This commenter

argued that, due to the non-routine andunpredictable nature of D&D projects,identifying D&D tasks in the CBDPPwould result in unnecessary costs,project delays, and administrativeburdens because the CBDPP would haveto be constantly updated. DOE stronglydisagrees, and believes that identifyingoperational tasks within the scope of theCBDPP at D&D closure sites is practicaland necessary. The non-routine andunpredictable nature of operations onD&D closure sites often makes suchoperations more hazardous than routineproduction operations involvingberyllium. DOE believes that theappropriate way to protect workers fromthis increased hazard potential isthrough the implementation of thestructured assessment, planning, andcontrol provisions of the CBDPP. Basedon experience under the interim CBDPPpolicy, DOE believes the CBDPP isfeasible for D&D operations. DOE alsonotes that OSHA’s Hazardous WasteOperations and Emergency Responsestandard, 29 CFR 1910.120, requiresemployers at hazardous wasteremediation sites, in addition toconducting ongoing task-specific hazardanalyses, to develop a site specificsafety and health plan that addressesexisting and planned activities. Thus,DOE has retained this requirement inthe final rule.

Section 850.11(b) requires responsibleemployers to tailor the scope andcontent of their CBDPPs to the specifichazards associated with the DOEberyllium activities being performed. Inaddition, section 850.11(b)(1) requiresthat these programs include formalplans outlining how responsibleemployers will ensure that occupationalexposures to beryllium are maintainedat or below the PEL (8-hour TWA PELof 2 µg/m3).

Section 850.11(b)(2) further specifiesthat the responsible employer’s CBDPPmust, at a minimum, address eachrequirement in Subpart C of the rule.Section 850.11(b)(3) clarifies that theCBDPP provisions must focus on: (i)Minimizing the number of currentworkers exposed and potentiallyexposed to beryllium; (ii) minimizingthe number of opportunities for workersto be exposed to beryllium; (iii)minimizing the disability and lost timeexperienced by workers due to CBD,beryllium sensitization, and associatedmedical care; and (iv) settingchallenging exposure reduction andminimization goals to facilitate theminimization of worker exposures. DOEbelieves that the establishment ofexposure reduction and minimizationgoals is essential to the success of theCBDPP and in moving toward the



ultimate goal of preventing CBD withinthe DOE complex.

DOE is sensitive to concerns that existwithin its community regarding theneed to approach exposure reductionand minimization objectives in aresponsible and realistic manner.Accordingly, section 850.11(b)(3)(iv)establishes a performance-basedrequirement that will allow responsibleemployers to establish their ownexposure reduction and minimizationgoals tailored to their unique workplaceneeds and conditions, subject to DOEreview and approval pursuant to section850.10(b). DOE intends for responsibleemployers to establish reasonable, butchallenging, goals based on soundindustrial hygiene principles and thespecific circumstances for each affectedDOE workplace and location. DOEexpects responsible employers toconsider, in establishing these goals, thecurrent level of worker exposures, thenumber of workers exposed, the existingcontrols that are in place, the technicalfeasibility and exposure reductionpotential of possible additional controls,and the cost and operational impact ofthe controls.

Section 850.12–ImplementationProposed in section 850.12 required

responsible employers to manage andcontrol beryllium exposures in all DOEberyllium activities consistent with theapproved CBDPP, the rule, or any otherprogram, plan, schedule or otherprocess established by this part, as wellas requirements in other applicableFederal statues and regulations. Onecommenter (Ex. 16) believed that thepreceding requirement should bechanged to state that DOE andcontractor personnel follow the CBDPPonly. This commenter’s concern wasthat including all applicable programs,plans, etc., was too broad. DOE agreesand has deleted including all applicableprograms, plans, etc., from the finalrule.

Section 850.12(c) clarifies DOE’sposition that tasks involving potentialberyllium exposure that are not coveredunder the CBDPP may not be initiateduntil the CBDPP has been updated toinclude them and the updated plan hasbeen approved by the appropriate Headof DOE Field Element. The ruleprovides an exception to thisrequirement for urgent and unexpectedsituations. In such cases, the task couldproceed with the written approval fromthe Head of DOE Field Element prior tothe CBDPP being revised and approved.One commenter (Ex. 16) soughtclarification as to when a change in theCBDPP was required. This commenterproposed that when new beryllium

activities require additional controlsand/or procedures, a change in theCBDPP is warranted. Also, when newactivities are within the range ofpotential exposures to beryllium asdescribed in the existing CBDPP, thecommenter suggested that no revisionshould be necessary. DOE’s position isconsistent with the views of thiscommenter. In general, only thoseactivities outside the scope of theexisting CBDPP would require arevision to the CBDPP.

Section 850.12(d) recognizes that,depending on the circumstances of thework, responsible employers may haveto take other actions to protect theirworkers, and DOE does not intend topreclude such actions by the provisionsof the rule. DOE recognizes thatindividuals responsible forimplementing CBDPP activities mustuse their professional judgment inprotecting the health and safety ofworkers. Nothing in the rule should beviewed as relieving these individuals oftheir professional responsibility to takewhatever actions are warranted toprotect the health and safety of theworkforce.

Section 850.13–ComplianceSection 850.13(a) requires responsible

employers to conduct DOE activitiesinvolving beryllium in compliance withtheir respective CBDPP that has beenapproved by the Head of DOE FieldElement. Through this provision, DOErecognizes that even the best CBDPPwill not adequately protect workers if itis not followed at the site. Section850.13(b) requires that once the ruletakes effect, responsible employers have2 years to fully implement all aspects ofthe program (written plans, schedules,and other measures). Although DOEseeks to lessen the burden onresponsible employers by permittingthem to phase in costly controls over the2-year period, DOE expects employersto implement portions of the program assoon as practical during the 2-yearperiod.

Section 850.13(c) provides that theresponsible employer in charge of anactivity involving a potential forberyllium exposure is responsible forcomplying with the rule. When nocontractor is responsible for the activityand Federal employees perform theactivity, this section requires DOE to beresponsible for compliance.

Subpart C—Specific ProgramRequirements

Subpart C of this rule establishesperformance-based requirements for theCBDPP. These requirements aredesigned principally to prevent CBD by

reducing the number of workersexposed to beryllium, minimizing thepotential level of beryllium in theworkplace atmosphere, and continuallymonitoring worker health to ensure thatworkplace controls are sufficientlyprotective. DOE expects implementationof the rule to increase its understandingof the development and course of CBD,which may lead DOE, at some futuredate, to propose modifications of thisrule.

Section 850.20—Baseline BerylliumInventory

Section 850.20(a) requires responsibleemployers to develop a baselineberyllium inventory. By developing thebaseline inventory, responsibleemployers will accomplish thefollowing functions that are critical tothe success of the CBDPP: (1)Identification of locations andoperations that should be physicallyisolated from other areas to prevent thespread of contamination, (2)identification of areas in which workeraccess should be restricted to minimizethe number of workers who could beexposed, (3) identification of berylliumcontamination that must be controlledin facilities that are scheduled fordecontamination and decommissioning,(4) identification of berylliumcontamination in facilities that are beingused for non-beryllium activities, todetermine the need for cleanup, and (5)the determination of which workersshould be covered under the CBDPP.

Section 850.20(b) supplements thegeneric inventory requirement underDOE Order 440.1A by requiringresponsible employers to review currentand historical records, interviewworkers, and sample as necessary todocument the characteristics andlocations of beryllium at DOE sites.These supplemental requirements arenecessary because those persons whoare responsible for activities at DOEsites may not recognize that activitiesunder their supervision involveberyllium or are conducted in areaswhere beryllium was used in the past.Workers often know of past berylliumactivities for which no records exist.Sampling can identify berylliumcontamination where the record reviewsand worker interviews are notconclusive. These supplementalrequirements are particularly necessarybecause past beryllium operations atDOE facilities were often conducted inuncontrolled work areas.

Section 850.20(b)(3) requires thatresponsible employers conduct air,surface, and bulk sampling proceduresto characterize the beryllium.Characterizing the beryllium is



necessary to assess and controlberyllium workplace hazards.Responsible employers should conductthe sampling that is appropriate for thespecific workplace conditions and thesuspected types and locations ofberyllium contamination. Samplingtechniques could include collecting areaand wipe samples and collectingpersonal breathing zone samples.(Sections 850.24(a), (b), and (e)–(g)address the personal monitoring thatmay be a component of the baselineinventory.)

Section 850.20(c) requires responsibleemployers to ensure that individualsconducting the baseline berylliuminventory activities have sufficientqualifications in industrial hygiene.DOE believes that this provision isnecessary to ensure that the inventory isaccurate and complete. DOE requestedin the NOPR that interested partiessubmit comments on the need toprovide further specification in the ruleregarding the minimum qualificationsthat an individual must possess toperform certain components of theCBDPP, such as hazard assessments andexposure monitoring. One alternativeapproach suggested was use of OSHA’s‘‘competent person’’ definition to definecompetency of the individual. Anotheralternative was to require that hazardassessments and exposure monitoringbe performed by a ‘‘certified industrialhygienist’’ (CIH) as defined by theAmerican Board of Industrial Hygiene(ABIH).

DOE received 14 comments inresponse to this request. Two of the 14commenters (Exs. 4, 16) agreed withDOE’s approach in proposed sections850.20(c), 850.21(b) and 850.24(a). Acommenter (Ex. 16) noted that if moreprescriptive definitions are used todefine personnel qualifications, thedefinitions should be appropriate to therequired task. For instance, CIHs shouldconduct hazard assessments, whileindividuals possessing a lower level ofknowledge should conduct exposuremonitoring. Another commenter (Ex. 4)favored the use of OSHA’s ‘‘competentperson’’ definition over requirements fora CIH if DOE elected to use one of thesemore prescriptive definitions.

Two commenters (Ex. 20, 29) statedthat the industrial hygiene competencyrequirements in proposed sections850.20(c), 850.21(b) and 850.24(a) weretoo subjective and recommendedinstead, the use of OSHA’s ‘‘competentperson’’ definition. A commenter (Ex.20) further noted that OSHA’s AsbestosStandard, 29 CFR 1926.1101(b),included definitions for ‘‘competentperson,’’ ‘‘industrial hygienist,’’ and‘‘certified industrial hygienist’’ and

outlined specific training courses that acompetent person must complete. Twoother commenters (Exs. 3, 31) favoredthe use of OSHA’s ‘‘competent person’’definition in lieu of the industrialhygiene competencies, but tookexception to the last phrase of thedefinition: ‘‘and who has theauthorization to take prompt correctivemeasures to eliminate [hazards].’’ Thecommenters were concerned thatlimiting the performance of assessmentsand monitoring to individuals with theauthority to take prompt correctiveactions would exclude other qualifiedindividuals, such as third-partyindustrial hygienists.

Nine of the 14 commentersrecommended that a CIH participate atsome level in the performance ofberyllium inventories, hazardassessments, and exposure monitoring.One commenter (Ex. 30) stated thatmonitoring and assessments must beperformed by a CIH, while the othercommenters (Exs. 3, 11, 13, 16, 19, 26,28, 31) suggested that qualified andtrained persons working under thedirect supervision of a CIH couldconduct these tasks, and that limitingthe actual performance of monitoringand assessments to CIHs would be toorestrictive and unnecessary. Althoughthese commenters did not believe that aCIH is needed to actually performmonitoring and assessments, many didbelieve that minimum qualifications forthose individuals performing these tasksmust be specified in the final rule. Forinstance, one commenter (Ex. 11)recommended that DOE require thatthese individuals possess sufficientindustrial hygiene experience inaddition to knowledge. Anothercommenter (Ex. 13) suggested that aCIH, Industrial Hygienist in Training(IHIT) as defined by the ABIH, or personwith ‘‘demonstrably equivalentqualifications’’ perform assessments andmonitoring. Another commenter (Ex. 23)suggested that the industrial hygienistdefinitions in DOE’s ‘‘Functional AreaQualification Standard,’’ or as definedby AIHA, be used to prescribe thequalifications required to performmonitoring and assessments.

DOE agrees with the overwhelmingmajority of commenters who favored amore prescriptive definition. DOEbelieves that a more prescriptivedefinition will ensure proficiency andconsistency in the conduct ofassessments and monitoring as well asin the overall implementation of theCBDPP. Accordingly, DOE has providedlanguage in sections 850.20(c), 850.21(b)and 850.24(a)(1) of the final rule for theuse of qualified individuals such as aCIH to manage and supervise beryllium

inventories, hazard assessments, andexposure monitoring, and the use ofindividuals with sufficient industrialhygiene knowledge and experience toactually perform these tasks. DOEbelieves this will provide the level ofconsistency required to ensure thathazards are properly identified andworkers are appropriately protectedwithout being overly prescriptive. Inthis regard, DOE agrees with thecommenters who stated that the level ofexpertise needed to perform berylliuminventories, hazard assessment, andexposure monitoring does not require aCIH, and that such a requirement wouldcause an unnecessary resource strain onboth DOE and its contractors.

Five persons commented on otherprovisions of the proposed baselineinventory section. Three of thecommenters (Exs. 9, 21, 28) suggestedthat DOE provide in the final rulegreater specificity than DOE proposedfor baseline inventory requirements.DOE agrees with these commenters andin the final rule has modified therequirement for reviewing records tocover both current and historicalrecords. The final rule also modifies therequirement for conducting sampling tospecify air, surface, and bulk sampling.DOE believes that these changes clarifyDOE’s intent, express good industrialhygiene practice, and continue to allowthe responsible employer appropriateflexibility in conducting the baselineinventory. One commenter (Ex. 9)suggested that DOE also specify in thefinal rule that baseline inventoriesinclude the locations where berylliumactivities are planned. DOE considerslocations where beryllium activities areplanned to be locations of potentialberyllium contamination and exposurethat must be included in the baselineinventory under paragraph (a), and,therefore, no change is needed.

One commenter (Ex. 18)recommended that the final rulemandate the disclosure of health andsafety documents related to pastberyllium emissions and exposures.DOE has not included such a provisionin the final rule because the Freedom ofInformation Act (5 U.S.C. 552) alreadyprovides for the release of federalgovernment records, except for specifiedtypes of records that contain sensitiveinformation, such as classifiedinformation relating to national defenseor foreign policy, information inpersonnel and medical files, and tradesecrets or other confidential businessinformation. Requests to DOE for releaseof information related to past berylliumuse and exposures may be submitted tothe appropriate DOE field office. Suchrequests should follow DOE’s



procedures for Freedom of InformationAct requests in 10 CFR Part 1004. Alsosee the discussion of public access toberyllium records in the preamblediscussion of section 850.39(Recordkeeping and use of information).

The same commenter (Ex. 18)recommended that the final rule providefor independent review of theresponsible employer’s implementationof the CBDPP. DOE does not think thatsuch a provision is necessary, becauseexisting mechanisms already provideindependent oversight of DOE’scontractors and include independentoversight of DOE’s field organizations.The DOE Office of Environment, Safetyand Health’s Office of Oversight ischarged with providing information andanalysis needed to ensure that DOE’stop management officials, Congress, andthe public have an accurate andcomprehensive understanding of theeffectiveness, vulnerabilities, and trendsof DOE’s environment, safety, health,nuclear safeguards, and security policiesand programs. In addition, anyinterested individual or organizationmay conduct a review of a responsibleemployer’s compliance with this rulebased on information obtained fromDOE.

One commenter (Ex. 14)recommended that the final rule providefunding for the baseline inventory, andcontended that responsible employerswill not conduct the baselineinventories unless the funding requiredfor this task is explicitly established bythe final rule. DOE does not require itscontractors to perform unfunded tasks,but funding of DOE programs isappropriately handled through thefederal government’s budget processand not through the regulatory process.DOE expects that its program officeswill request the funds needed to meetthe obligations and objectives of theirprograms and activities, includingcompliance with the CBDPP.

Section 850.21—Hazard AssessmentBecause the identification of the

possible presence of beryllium in aworkplace does not, in and of itself,suffice to determine whether a hazardexists or whether various controlmeasures must be employed, section850.21 of the final rule requiresresponsible employers to conduct aberyllium hazard assessment tocharacterize workplace berylliumexposure hazards. This requirementallows each site the flexibility todetermine the appropriate risk-basedapproach for assessing beryllium-relatedhazards in its worksites where thebaseline inventory has established thatberyllium is present. As noted by one

commenter (Ex. 25), flexibility inconducting hazard assessments isparticularly important becauseoperations, conditions, and the potentialfor exposure may vary greatly fromoperation to operation and facility tofacility.

Section 850.21(a) requires theresponsible employer to conduct ananalysis of existing worksite conditions,exposure data, medical surveillancetrends, and the exposure potential ofplanned activities. In addition, section850.21(a) specifies that the responsibleemployer must prioritize potentialexposure activities so that the activitieswith the greatest risks of exposure areevaluated first. DOE believes thatprioritizing activities is a logical firststep in initiating a hazard assessment.Targeting high-risk beryllium operationsis an effective way to reduce potentialberyllium exposures throughout DOEfacilities.

Section 850.21(b) requires responsibleemployers to ensure that hazardassessments are managed by qualifiedindividuals (e.g., a CIH), and that theindividuals assigned to conduct hazardassessments have sufficient knowledgeand experience to perform suchactivities properly. DOE requested inthe NOPR that interested personssubmit comments on the need to furtherspecify in the rule the minimumqualifications that an individual mustpossess to perform certain keycomponents of the CBDPP, such ashazard assessments. DOE received 14comments in response to this request.As noted in the preamble discussion ofsection 850.20(c), 10 of the commenterseither suggested or supportedestablishing an additional specificationthat hazard assessments be performedunder the supervision of a CIH. DOEgenerally agrees with these commentersabout the need for a qualified individualto manage hazard assessments andcertain other tasks required by the rule.But DOE will not require that person tobe in all cases a CIH. Thus, DOEprovides in section 850.21(b)(1) that aqualified individual, such as a CIH,must manage hazard assessmentsperformed for the CBDPP. By use of thislanguage, DOE leaves open thepossibility that a responsible employer,in a particular case, may determine thatsomeone who is not a CIH possesses therequisite qualifications to manage thehazard assessments.

In addition to the comments on theCIH issue, DOE received only minorcomments on section 850.21. Onecommenter (Ex. 21) suggested that theexposure potential of planned activitiesshould be rank ordered to better focuseach site’s resources and efforts. DOE

agrees with this commenter, and in thefinal rule has modified the requirementfor hazard assessments to require theprioritization of beryllium activities,beginning with those activities thatpresent the greatest risks of exposure.Another commenter (Ex. 30) wasconcerned about the use of existingdata, such as exposure monitoringresults, in the hazard assessment. Whilethis commenter believed that usingexisting data is appropriate, thecommenter warned against the potentialfor errors when relating existing data tocurrent operations. In particular, thiscommenter suggested that existing datarelating to exposure monitoring is oftennot well documented or is of poorquality, thus making it difficult todetermine whether the sampling isrepresentative of current berylliumoperations. DOE agrees that existingdata can be a valuable tool if collectedand documented properly, and in manycases use of such data will expedite thehazard assessment process. At the sametime, DOE also shares this commenter’sconcerns regarding the accuracy andapplicability of existing data and hasretained in section 850.21(b) therequirement for the hazard assessmentto be managed by a qualified individual,such as a CIH. DOE’s intent is that thisrequirement will help ensure that thedata considered in the hazardassessment accurately reflects currentsite conditions and hazards.

Another commenter (Ex. 24) favoredthe triggering of a hazard assessment atdetectable airborne beryllium levelsfrom personal air samples. DOE agreesthat if such data is available, it must beconsidered in the hazard assessment. Asanother commenter (Ex. 28) pointed out,however, a hazard assessment shouldnot be limited to the inhalation risksposed by beryllium but must alsoinclude the presence and characteristicsof beryllium contamination in a facility.Accordingly, the final rule requires theresponsible employer to perform ahazard assessment whenever thebaseline inventory establishes thepresence of beryllium in an area.

Still another commenter (Ex. 11)requested that DOE include a non-mandatory appendix to the rule toprovide guidance on how to perform ahazard assessment. This commenter wasconcerned that inexperienced industrialhygienists may be called upon toperform a hazard assessment, andsuggested that additional guidancewould be needed to assure accuracy andconsistency. DOE believes this concernis addressed in section 850.21(b), whichrequires that hazard assessments bemanaged by qualified individuals, suchas CIHs, and performed by individuals



with sufficient knowledge andexperience to perform such tasks.Accordingly, DOE has not included therequested appendix to provide guidanceon how to perform a hazard assessmentas a part of this rulemaking.

Section 850.22—Permissible ExposureLimit

In the NOPR preamble, DOE reviewedthe scientific evidence suggesting thatthe current OSHA 8-hour TWA PELdoes not sufficiently protect workerhealth. However, DOE also stated that,in its view, it is difficult to determinefrom this scientific evidence theexposure level necessary to eliminatethe risk of contracting CBD. For thisreason, DOE retained the existing OSHA8-hr TWA PEL in proposed section850.22, and proposed other provisionsto minimize worker exposure toairborne beryllium in DOE facilities. Inaddition, DOE included in proposedsection 850.22 language providing thatDOE would adopt a more stringent 8-hour TWA PEL if OSHA promulgatedone through the rulemaking process.Finally, DOE requested in the NOPRthat interested persons submit anycompelling scientific evidence thatwould assist DOE in establishing a new,more protective exposure limit for DOEfacilities.

Fifteen persons commented on the 8-hour TWA permissible exposure limitrequirements in the proposed rule. Ofthese 15 commenters, four supportedDOE’s proposal to retain the OSHA 8-hour TWA PEL (Exs. 4, 19, 26, 29). Oneof these four (Ex. 29) took issue withDOE’s conclusion that the existingOSHA PEL was not protective. Thiscommenter pointed to the inaccuraciesassociated with the use of areamonitoring data in referenced studiesand the fact that most of the referencedstudies acknowledged that infrequentexposures above the PEL had occurredwithin the study group. As a result, thiscommenter felt that the OSHA PELshould be retained as the exposure limitin DOE work places.

Two commenters cited DOE’s policyestablished in DOE Order 440.1 to adoptthe more protective of either OSHA’sPEL or ACGIH’s threshold limit value(TLV) and recommended that DOEadopt the ACGIH’s proposed 8-hourTWA TLV of 0.2 µg/m3 as the new DOEexposure limit (Exs. 28, 30). Onecommenter (Ex. 28) also supportedadopting the proposed ACGIH TLV asan 8-hour TWA action level, which DOEhas done in the final rule. (See section850.23 in this Section-by-SectionDiscussion for further discussion of theaction level.) Another commenteropposed adopting the proposed ACGIH

limit and took issue with the policy inDOE Order 440.1A, stating that any newDOE limit should be subject to therulemaking process (Ex. 16).

Five other persons suggested that DOEadopt one of a variety of lower exposurelimits ranging from the limit ofdetection to the NIOSH RecommendedExposure Limit (REL), which is a ceilinglimit of 0.5 µg/m3. These commenterscited the occurrence of CBD amongworkers exposed to beryllium at levelsbelow the 8-hour TWA PEL, and someof these commenters argued that studiespresented in the Health Effectsdiscussion of the NOPR provided asufficient basis for the establishment ofa new exposure limit. For example, onecommenter (Ex. 35) cited two studiesthat evaluated the occurrence of CBDamong the general population around aberyllium plant in Lorain, Ohio (refs. 5and 6). Relying on these studies, thiscommenter suggested that the U.S.Environmental Protection Agency’sambient air criterion for beryllium of0.01 µg/m3 could be used as a basis fora new 8-hour TWA exposure limit. Twoother commenters (Exs. 14, 24) cited thetwo Lorain, Ohio community studies,the occurrence of CBD among workerswith beryllium exposures ‘‘well belowthe PEL,’’ a study published in 1997(ref. 31) which suggests that berylliumsensitization occurs at airborneberyllium exposure levels as low as 0.01µg/m3, and the DOE policy to provide aworkplace free of recognized hazards(DOE Order 440.1A) to support theirposition that workers should not beexposed to any detectable level ofberyllium. The remaining twocommenters that offered suggestions foran alternative exposure limit agreedwith DOE’s conclusion that the OSHA8-hour TWA PEL was not sufficientlyprotective and recommended adoptinglimits established by other occupationalhealth groups. One commenter (Ex. 18)suggested that DOE adopt NIOSH’s RELas a DOE exposure limit while the other(Ex. 22) suggested that DOE apply asafety factor of 4 to the ACGIH 8-hourTLV and use 0.05 µg/m3 as the new DOElimit.

Two other commenters (Ex. 20, 32)agreed with DOE’s conclusion that theOSHA 8-hour TWA PEL is notsufficiently protective andrecommended that DOE establish a newexposure limit. These commenters,however, did not offer suggestions foralternative new exposure limits.Another commenter did not directlyaddress DOE’s proposal to retain theOSHA PEL, but instead recommendedthat DOE should consider the possibleeffects of particle size on the occurrenceof CBD.

DOE has carefully considered each ofthese comments and available scientificdata, and continues to believe that itsoriginal conclusion, as outlined in theproposed rule, remains valid.Specifically, DOE believes that existingscientific data indicates that there arereasonable grounds to conclude that theOSHA 8-hour TWA PEL for berylliummay not be sufficiently protective ofworker health, a conclusion supportedby 12 of the 15 commenters thataddressed this section of the proposedrule. DOE is particularly influenced bythe published studies (refs. 16–17, 21)indicating that workers exposed belowthe current PEL are contractingberyllium disease and exhibiting Be-LPT sensitivity. A recent article byEisenbud (ref. 29) also concludes that it‘‘appears’’ the current PEL is notprotective enough.

However, DOE also believes, based onavailable scientific data, that it isdifficult to determine the exposure levelnecessary to eliminate the risk ofcontracting CBD and, therefore, that thebest approach to providing improvedworker protection is through theestablishment of a conservative 8-hourTWA action level, coupled withaggressive exposure reduction andminimization efforts, and the collectionof medical surveillance data to betterunderstand the cause of CBD.Accordingly, DOE has retained theOSHA 8-hour TWA PEL in section850.22 of the final rule and has retainedthe action level concept of the proposedrule, although at a lower level (seesection 850.23 discussion). Section850.22 has been revised to simplyreference 29 CFR 1910.1000, instead ofspecifying the current numerical limit.DOE intends this provision to result inthe automatic incorporation of a morestringent PEL that OSHA maysubsequently promulgate. This does notrepresent a substantive change to theprovision as proposed.

In this rule, however, DOE hasdecided not to follow the policy underthe more general worker protectionprogram established by DOE Order440.1A of adopting the more protectiveof either the OSHA PEL or the ACGIHTLV. The incorporation of any newACGIH TLV in this rule would requirethat DOE conduct a rulemaking on thespecific exposure level and present thescientific basis for public comment. Asstated previously in this SUPPLEMENTARYINFORMATION section, DOE believes,based on the existing scientificevidence, that such a rulemaking ispremature. By contrast, DOE mayincorporate an OSHA PEL in this rulebecause the OSHA PEL is promulgatedfollowing notice and comment



4 The rule does not require that exposurereduction and minimization efforts (e.g.,engineering controls and work practices) betriggered by the action level. DOE expects, however,that affected sites will specify that someengineering controls and work practices betriggered by the action level in their CBDPP plans.

5 DOE did alter the set of controls that aretriggered by the action level between the proposedand the final rule. This, however, was not done asa result of setting a lower action level, but was inresponse to comments on the proposed rule.

rulemaking, and the rules of the Officeof the Federal Register permit areference to another part of the Code ofFederal Regulations.

DOE proposed, in section 850.22(a) ofthe NOPR, to adopt the STELestablished by the ACGIH of 10 µg/m3,averaged over a 15-minute samplingperiod. In the final rule the STEL hasbeen deleted, because the proposedSTEL would not provide any addedprotection for the worker given that thenew action level of 0.2 µg/m3 would beexceeded in less than 15 minutes whereexposure levels are at 10µg/m3. DOE didnot seek to establish a lower STELbecause, as in the case of a lower PEL,available scientific data do not providea sufficient basis for the establishmentof a new STEL.

Section 850.23—Action LevelDOE proposed in the NOPR to

establish an 8-hour TWA action level of0.5 µg/m3. In selecting the proposedaction level, DOE considered a numberof factors. DOE considered OSHA’ssubstance-specific health standards,which typically establish action levelsfor hazardous and toxic substances atone-half the 8-hour TWA PEL. Applyingthis approach to beryllium would haveresulted in a proposed 8-hour TWAaction level of 1.0 µg/m3. OSHA’s actionlevels are premised on the safety of itsPELs, and are set to provide anadditional margin of safety. Asexplained in the preceding discussion,however, there is a body of evidencesuggesting that the OSHA PEL forberyllium does not adequately protectworker health. Therefore, DOE decidedthat a lower action level is appropriatefor DOE facilities. According to theresults of the 1996 DOE survey of DOEfacilities which reported potentialberyllium exposures, two DOE facilities(Pantex and Rocky Flats) had alreadyemployed an action level of 0.5 µg/m3.Another facility (Lawrence LivermoreNational Laboratory) reported the use ofan ‘‘administrative warning range’’ of0.2 to 2.0 µg/m3, which triggered arequirement for an investigation, and sixDOE facilities employed an action levelof 1.0 µg/m3. In light of this experience,DOE proposed adopting an action levelat the lower end of existing DOEcomplex action levels (0.5 µg/m3), ratherthan follow the typical OSHA practice,in order to implement aggressive yetachievable exposure minimization.

The majority of comments received onthe proposed rule agreed with the DOE’sapproach of using an action level that islower than the typical OSHA actionlevel, but called for an even lower levelthan DOE had proposed. The mostcommonly recommended level was 0.2

µg/m3, which is the same level as theACGIH proposed TLV. Mostcommenters believed that this levelwould prevent additional cases ofberyllium sensitization and disease.DOE believes that there is reasonabletechnical basis for selecting 0.2 µg/m3 asan action level, based on the followingscientific analyses.

The U.S. Environmental ProtectionAgency’s (EPA) Integrated RiskInformation System includes aReference Concentration of 0.02 µg/m3

for beryllium, which is ‘‘an estimate(with uncertainty spanning perhaps anorder of magnitude) of a continuousinhalation exposure to the humanpopulation (including sensitivesubgroups) that is likely to be withoutan appreciable risk of noncancer effectsduring a lifetime’’ (ref. 33). Thisconcentration is based on epidemiologystudies. This continuous 24-hour perday, level translates into an 8-hour TWAlevel of 0.84 µg/m3.

Merrill Eisenbud conducted a study ofCBD based on air sampling, atmosphericdispersion modeling, and analysis of aberyllium production plant’s pastoperations. Eisenbud concluded that thelowest beryllium concentration at the 3/4-mile boundary, beyond which nocommunity cases of chronic berylliumdisease were found, was 0.025 µg/m3

during the 7-year period the plantoperated at full capacity (ref. 29). This24-hour per day level translates into an8-hour TWA level of 0.84 µg/m3, whichessentially is the same level that theEPA found to be without appreciablerisk of causing noncancer effects (i.e.,CBD).

The ACGIH, a professionalorganization that publishesoccupational health consensusstandards, has proposed to change its 8-hour TWA TLV from 2 µg/m3 to 0.2 µg/m3, based on its review of recentberyllium epidemiology studies (ref.32).

The DOE recognizes that the EPA(0.84 µg/m3), Eisenbud (0.84 µg/m3), andACGIH (0.2 µg/m3) levels are normallyused as exposure limits rather thanaction levels. However, based onlimitations of the studies done to date,the difficulties in determining a safethreshold level for occupationalexposure to beryllium, and DOE’sdecision to implement aggressiveexposure reduction and minimizationefforts, DOE has decided that the mostprudent course is to lower the actionlevel to 0.2 µg/m3 rather than set a newexposure limit. The available sciencesuggests that this level would beprotective; is one-quarter of the EPA andEisenbud levels and the same as theACGIH proposed level. This is the

lowest action or trigger level reported byany DOE facility under the interimCBDPP, and a lower level has not beendemonstrated as being practicable.Lowering the action level to 0.2 µg/m3

will result in greater protection for theaffected DOE work force by triggeringadditional monitoring, surveillance,respiratory protection, and otherprotective measures.

Benefits of lowering the action level.As specified in this rule, the action leveltriggers the use of a number of controlsand protective measures designed toprotect employees from exposures toberyllium, including:

• Periodic exposure monitoring (10CFR 850.24 (c));

• Exposure reduction andminimization measure (10 CFR850.25); 4

• Regulated areas (10 CFR 850.26);• Hygiene facilities and practices (10

CFR 850.27);• Respiratory protection (10 CFR

850.28); and• Protective clothing and equipment

(10 CFR 850.29).Thus, DOE sites where exposure

levels exceed the action level would berequired to implement these controls toprovide further protection to workersexposed above the action level. Thisadditional protection will reduce theexposure levels experienced by theseworkers, consequently reducing theirrisk of developing beryllium-relateddisease and other health effects. Settingthe action level at 0.2 µg/m3, as opposedto 0.5 µg/m3, does not alter the set ofcontrols that are triggered,5 but doesalter the timing of these additionalcontrols. The additional protectivemeasures triggered by the action levelwill be put into effect earlier. Forexample, consider an activity whereairborne concentrations of berylliumstart very low (below 0.2 µg/m3), but riseover time (e.g., over a course of days orweeks) in the workplace. Assume alsothat airborne concentrations willeventually exceed 0.5 µg/m3. If theresponsible employer recognizes thepotential for exposures to exceed theaction level in this activity, this rule (aswell as prudent industrial hygienepractice) would require the responsibleemployer to conduct exposure



6 The lower bound estimate (342) is the differencebetween the number of workers exposed above the0.5 µg/m3 action level estimated in the EconomicAnalysis (EA) for the proposed rule (894 workers)and the number of workers exposed above the 0.2µg/m3 action level estimated in the EA for the finalrule (1,236 workers). The estimates contained in thetwo versions of the EA are not, however, completely

comparable. In developing the EA for the final rule,DOE obtained new data from the sites on thenumber of workers exposed above 0.2 µg/m3. Forsome sites, the reported number of workers exposedabove 0.2 µg/m3 was less than DOE’s previousestimate of the number exposed above 0.5 µg/m3.To correct for this inconsistency, DOE used theminimum of the two estimates for each site as an

estimate of the number exposed above 0.5 µg/m3.This resulted in an estimated 776 workers exposedabove 0.5 µg/m3. The difference between this newestimate and the estimated number exposed above0.2 µg/m3 (1,236 workers) provides the upper boundestimate (460 workers).

monitoring to determine if and whenthe action level is exceeded. In thissituation, once the 0.2 µg/m3 thresholdis crossed, the responsible employerwould be required to implement thecontrols specified above, and workerswould benefit from the additionalprotection provided by those controls.Under an action level of 0.5 µg/m3,protective measures would not beimplemented until the airborneconcentrations exceeded 0.5 µg/m3.Thus, during the time that exposures arebetween 0.2 µg/m3 and 0.5 µg/m3,workers would not be afforded theadditional protection of the triggeredcontrols. Thus, the first incrementalbenefit of setting the action level loweris the reduction in risk afforded by thecontrols triggered during the time thatexposures are between 0.2 µg/m3 and0.5 µg/m3 (See Table 9).

The second benefit from setting theaction level lower is to expand thenumber of workers afforded theadditional controls (See Table 10). DOEbelieves there are a number of workersexposed to airborne concentrations ofberyllium between 0.2 µg/m3 and 0.5

µg/m3, but who are never exposed above0.5 µg/m3. DOE estimates that between342 and 460 workers may be exposed atthese levels.6 Under an action level of0.5 µg/m3, these workers would not beafforded the protection of controlstriggered by the action level. Under anaction level of 0.2 µg/m3, however, theseworkers are afforded the additionalcontrols. These additional controls willreduce the exposures faced by theseworkers, leading to a reduction in theirrisk of developing beryllium-relateddisease and other health effects. Thus,the second benefit of using the loweraction level is a reduction in risk amongworkers exposed to airborneconcentrations between 0.2 µg/m3 and0.5 µg/m3.

Quantitative estimates of thereduction in risk and the consequentreduction in the incidence of beryllium-related disease and other health effectsare not possible due to a lack ofnecessary information. As discussed inthis preamble and the EconomicAnalysis (Chapter 1, Section 1.1), noquantitative dose-response relationshiphas been defined for beryllium. Without

this information, DOE is unable toprovide a quantitative estimate of thebenefit of using a lower action level.Nevertheless, DOE believes that the useof 0.2 µg/m3 action level as opposed tothe 0.5 µg/m3 is justified based on thebenefits discussed above and thenumber of comments that suggested thatan action level lower than 0.5 µg/m3 isnecessary.

Other issues. This revision to the finalrule does not accommodate thecomments (Exs. 12, 18, 32) that urgedDOE to lower its action level to anydetectable level of beryllium. DOEbelieves it would not be practicable touse any detectable level of beryllium asits action level because beryllium isubiquitous; it can be detected virtuallyanywhere if a sufficiently large airsample is taken. Furthermore, accordingto the EPA’s Integrated Risk InformationSystem, discussed above, the UnitedStates population is being exposed todetectable background levels ofberyllium without an appreciable risk ofcontracting CBD in their lifetime.Therefore, that level is not supported bythe available science.

TABLE 9.—COMPARATIVE COST ANALYSIS FOR DIFFERENT ACTION LEVELS

Category/requirement

Annualizedcost for 0.2µg/m3 ac-tion level(final rule)

0.5 µg/m3 action level 0.1 µg/m3 Action level

Annualizedcost

Differencefrom 0.2 µg/

m3 actionlevel

Annualizedcost

Differencefrom 0.2 µg/

m3 actionlevel

Requirements Triggered By The Action Level in the Final Rule:Periodic exposure monitoring ........................................................... $1,962,620 $1,104,421 ($858,199) $3,574,937 $1,612,317Notify workers monitoring results ..................................................... 66,932 40,411 (26,521) 82,104 15,171Exposure reduction and minimization .............................................. 2,707,636 2 2,707,636 0 3,579,513 871,877Regulated areas ............................................................................... 0 0 0 8,496 8,496Change rooms and showers ............................................................ 249,730 249,730 0 272,337 22,607Respiratory protection ....................................................................... 9,085 9,085 0 342,495 333,410Protective clothing ............................................................................ 0 0 0 382,528 382,528Disposal of protective clothing .......................................................... 0 0 0 42,738 42,738

Subtotal ......................................................................................... 4,996,004 4,111,284 (884,720) 8,285,149 3,289,144Other Requirements ................................................................................. 26,555,397 26,555,397 0 26,555,397 0

Total for all requirements 1 ............................................................ 31,551,401 30,666,680 (884,720) 34,840,545 3,289,144

Note: Column totals may contain some rounding error.1 For this row, the annualized cost represents the annualized cost of the proposed rule for the specified action level.2 The costs for exposure reduction and minimization may be lower with a 0.5 µg/m3 action level since fewer requirements would be triggered

under the higher action level. The information provided to DOE by the sites, however, did not contain enough information to make an estimate ofthe reduction in the costs for this category.



TABLE 10.—ESTIMATED NUMBER OF WORKERS BY EXPOSURE LEVEL

Beryllium exposure levels (µg/m3)Estimatednumber ofworkers 1

Percent of allaffected work-

ers

0.0 to 0.1 .................................................................................................................................................................. 0 00.1 to 0.2 .................................................................................................................................................................. 398 24.40.2 to 0.5 .................................................................................................................................................................. 342 to 460 20.9 to 28.2Above 0.5 ................................................................................................................................................................. 776 to 894 47.5 to 54.7

Total .............................................................................................................................................................. 1,634 100Total Above 0.1 ............................................................................................................................................. 1,634 100Total Above 0.2 ............................................................................................................................................. 1,236 75.6

1 The Economic Analysis (EA) for the final rule estimates that 1,236 workers are exposed above the action limit of 0.2 µg/m3 and that a total of1,634 workers are currently exposed to beryllium. Thus, 398 workers must be exposed below 0.2 µg/m3 (398 = 1,634¥1,236). Given that meas-urements of exposure levels below 0.1 µg/m3 begin to near the detection limits, DOE assumes that all workers exposed below 0.2 µg/m3 wouldbe in the 0.1 to 0.2 group. Next, DOE estimated the upper bound of the above 0.5 group by taking the estimated number of workers exposedabove 0.5 µg/m3 from the EA for the proposed rule (i.e., 894 workers). The difference between this number and 1,236 (the number exposedabove 0.2 µg/m3) provided the lower bound of the 0.2 to 0.5 group (342 = 1,236+894). To provide the lower bound of the above 0.5 group (776workers), DOE corrected for an inconsistency between the EA for the proposed rule and the EA for the final rule. In developing the EA for thefinal rule, DOE obtained new data from the sites on the number of workers exposed above 0.2 µg/m3. For some sites, the reported number ofworkers exposed above 0.2 µg/m3 was less than DOE’s previous estimate of the number exposed above 0.5 µg/m3 (in the EA for the proposedrule). To correct for this inconsistency, DOE used the minimum of the two estimates (i.e., the estimated number of workers exposed above 0.2µg/m3 in the EA for the final rule and the estimated number of workers exposed above 0.5 µg/m3 in the EA for the proposed rule) for each siteas an estimate of the number exposed above 0.5 µg/m3. This resulted in an estimated 776 workers exposed above 0.5 µg/m3 which DOE usesas the lower bound for that group. The difference between this number and the estimated number exposed above 0.2 µg/m3 (1,236 workers) pro-vides the upper bound estimate for the 0.2 to 0.5 group (460 = 1,236¥776).

NOTE: Column total may contain some rounding error.

Section 850.24—Exposure MonitoringSection 850.24 establishes CBDPP

worker exposure monitoringrequirements. The exposure monitoringprovisions in this section are necessaryto determine the extent of exposure atthe worksite; prevent workeroverexposure; identify the sources ofexposure to beryllium; collect exposuredata so that the responsible employercan select the proper control methods tobe used; evaluate the effectiveness ofselected controls; and provide continualfeedback on the effectiveness of theprogram in controlling exposures. Theserequirements are more specific than theprovisions of exposure monitoring inDOE Order 440.1A.

Exposure monitoring is important notonly to determine the level of berylliumto which workers are exposed and thefrequency at which workers should bemonitored, but also to determinewhether other protective provisions ofthe rule need to be implemented. Theemployer’s obligation to providerespiratory protection under section850.28, for example, is triggered bymonitoring results showing that aworker is exposed at or above the actionlevel. Exposure monitoring results alsomay help DOE to resolve uncertaintiesregarding the adequacy of the existingberyllium PEL and to refine therequirements of this rule as needed toprotect worker health.

Because of the importance ofadequately characterizing andmonitoring worker exposures toberyllium, DOE included a specificrequest in the NOPR asking interested

persons for views or information on theneed for daily exposure monitoring ofall beryllium workers. DOE wasconsidering whether daily exposuremonitoring was needed to documentand characterize more completely aworker’s exposure to beryllium, and tobetter evaluate the adequacy of existingexposure levels or determineappropriate levels for alternativeexposure limits. Of the ten commenterswho responded to this request forinformation, three favored a dailymonitoring requirement while sevenwere opposed.

The commenters who favored dailymonitoring for all workers (Exs. 18, 25,30) argued that daily monitoring of eachworker would more accuratelydocument and characterize berylliumexposures. One commenter (Ex. 16)suggested that initial daily monitoringcould be replaced with periodicmonitoring after sufficient data wasobtained. Another (Ex. 30) noted thatdaily exposure monitoring might be theonly accurate way to determineexposures during changing workplaceconditions. This commenter suggestedthat daily monitoring is important inidentifying specific work activities thatcontribute to the worker exposures.

The majority of commentersresponding to this request (Exs. 3, 4, 16,17, 26, 28, 29) objected to dailymonitoring of all workers to determineberyllium exposures. These commentersstated that daily monitoring wouldgenerate large amounts of data, at greatcost, while producing little or no addedbenefit. Some of these commenters (Exs.

3, 26, 28, 29) favored representativesampling of the workplace, usingstatistical analysis to determine thenumber of samples required. Thesecommenters asserted that the principalbenefits of a statistically-basedmonitoring strategy would be thereduction in the number of samplesneeded and resources used.

After considering all of the comments,DOE agrees that daily monitoring wouldbe unnecessarily burdensome forresponsible employers, and that astatistically-based approach will ensurethe adequate characterization of workerexposures. This position is reflected insection 850.24(b), as discussed below.

Section 850.24(a) requires thatexposure monitoring be managed by aqualified individual such as a CIH, andconducted by individuals withsufficient industrial hygiene knowledgeand experience. DOE requested in theNOPR that interested persons submitcomments on the need to further specifythe minimum qualifications that anindividual must possess to performcertain key functions under the CBDPP,including exposure monitoring. Most ofthe commenters suggested or supportedadding a requirement that exposuremonitoring be performed under thesupervision of a CIH. DOE agrees that aCIH is often best qualified to manageexposure monitoring activities, andprovides in section 850.24(a)(1) thatexposure monitoring performed for theCBDPP be managed by a qualifiedindividual, such as a CIH. However, inkeeping with the performance-basedphilosophy underlying this rule, DOE



does not preclude a responsibleemployer from determining, in aparticular situation, that a person otherthan a CIH possesses the requisiteknowledge to perform this function.Most of the commenters were of theview that individuals conducting themonitoring, under the management of aqualified individual, need sufficientknowledge and experience but notnecessarily the same level ofqualification as a CIH.

Section 850.24(b) requires theresponsible employer to perform initialexposure monitoring for all persons whowork in areas that may have airborneconcentrations of beryllium, asdetermined through the baselineberyllium inventory and hazardassessment. The responsible employermust employ a statistically-basedmonitoring strategy to obtain thenumber of samples needed tocharacterize worker exposures. Theinitial exposure information isnecessary to determine the need forengineering and work practice controls,to select appropriate personal protectiveclothing and respiratory protectiveequipment where needed, and toidentify the need to establish regulatedareas. One commenter (Ex. 28)recommended that sampling should beconducted to determine particle sizeand chemical characterization of thepotential exposure, and anothercommenter (Ex. 30) recommended useof particle size-selective personalmonitoring. DOE has decided to leavedetails of this nature to the qualifiedindividual who manages exposuremonitoring under the CBDPP, ratherthan attempt to prescribe them inregulations. This type of issue also maybe addressed in future DOE guidance onimplementing the CBDPP.

Section 850.24(b)(1) requires theresponsible employer to determine theberyllium exposure of workers bycollecting personal breathing zonesamples that reflect worker’s exposureto airborne concentrations of berylliumover an eight-hour period. As specifiedin the definition of ‘‘worker exposure’’in section 850.3, this is a measurementof the exposure that would occur if theworker were not using respiratoryprotective equipment. Section 850.3also includes a definition of ‘‘breathingzone,’’ which means ‘‘a hemisphereforward of the shoulders, centered onthe mouth and nose, with a radius of 6to 9 inches.’’ Thus, a breathing zonesample is taken as close as practical tothe nose and mouth of the worker. Fora full description of breathing zonesamples, see OSHA’s Instruction CPL 2–2.20B, CH–1, Nov. 13, 1990.

DOE recognizes that many of itsresponsible employers may haveperformed initial monitoring as part oftheir efforts to implement DOE Notice440.1. DOE does not intend to requireemployers to repeat these efforts if theyare adequate under the rule.Accordingly, section 850.24(b)(2) allowsemployers to use initial monitoring datacollected within 12 months before theeffective date of this rule to satisfy therule’s initial monitoring requirements.One commenter (Ex. 31) cautioned DOEthat any sampling performed prior tothe issuance of the final beryllium ruleshould only be accepted by DOE if thework conditions during the samplingperiod are the same as currentconditions. DOE agrees with thiscommenter, and notes that severalprovisions of the final rule requireresponsible employers to ensure thatsampling results reflect currentworkplace conditions. Specifically,section 850.24(b) requires that theresponsible employer obtain a sufficientnumber of sample results to adequatelycharacterize exposures, and section850.24(d) requires that the responsibleemployer perform additional monitoringif operations, maintenance, orprocedures change, or if the responsibleemployer has any reason to suspect achange has occurred which may resultin new or additional exposures. Further,DOE believes that the requirement thatexposure monitoring be managed by aqualified individual will help assurethat exposure monitoring resultsaccurately characterize workerexposures.

Section 850.24(c) requires theresponsible employer to conductperiodic exposure monitoring ofworkers who work in areas whereairborne concentrations of beryllium areat or above the action level. Periodicmonitoring provides the responsibleemployer with assurance that workersare not experiencing higher exposuresthat may require the use of additionalcontrols. In addition, periodicmonitoring reminds workers andresponsible employers of the continuedneed to protect against the hazardsassociated with exposure to beryllium.The collection of exposure monitoringdata also enables the SOMD to beinformed of the existence and extent ofpotential sources of beryllium exposure.

Some commenters argued that theperiodic monitoring requirements in therule should be more conservative thanproposed in the NOPR. For instance,one commenter (Ex. 13) recommendedthat the requirement for periodicmonitoring be implemented if employeeexposures exceed 10% of the PEL whileanother commenter (Ex. 18) suggested

that periodic monitoring be required forall workers regardless of previouslymeasured exposures. DOE hasaddressed the first commenter’sconcerns by establishing the action levelin the final rule at no greater than 0.2µg/m3 (ten percent of the PEL). DOEdoes not believe that periodicmonitoring should be mandated for allworkers regardless of exposure level, assuggested by the other commenter, butrather that the responsible employershould determine the frequency ofperiodic monitoring where levels arebelow the action level. However, DOEdoes encourage sites to establish loweraction levels to trigger components oftheir CBDPP, as part of their exposurereduction and minimization effortsrequired under section 850.25.

A third commenter (Ex. 14),addressing the periodic monitoringrequirements of proposed section850.24(c), stated that periodicmonitoring on a continuous basis is theonly way to determine workerexposures. While DOE acknowledgesthat certain operations may warrantcontinuous monitoring due to thedynamic nature of day-to-dayoperations, DOE believes that aninflexible, one-size-fits all monitoringpolicy is inappropriate due to the widerange of beryllium-related operationswithin the DOE complex. Accordingly,DOE provides responsible employersthe flexibility to determine themonitoring frequency that is needed tosufficiently characterize workerexposures. DOE believes thatresponsible employers are bestpositioned to evaluate the potentialvariability of worker exposures in theiroperations and to tailor their periodicmonitoring approaches as appropriate.Nevertheless, because slight process orprocedural changes may go unnoticedover time and because equipmentmaintenance, aging, or deterioration canaffect performance, DOE, in section850.24(c), is requiring a minimumexposure monitoring frequency of every3 months (quarterly) for workers whoare exposed to airborne concentrationsof beryllium at or above the action level.

DOE recognizes that the minimumquarterly monitoring of workersexposed at or above the action level ismore frequent than is required in mostOSHA expanded health standards.However, DOE considers this minimummonitoring frequency to be necessarydue to the uncertainties regarding theadequacy of the current PEL. Tosupplement this periodic monitoringrequirement, section 850.24(d) requiresthat responsible employers performadditional exposure monitoring whenberyllium-related operations or



procedures change, or they have anyreason to suspect a change, which maycause new or additional exposures toworkers. This additional monitoring isneeded to protect workers from elevatedexposures resulting from changedcircumstances, to quantify how changesaffect worker exposure to airborneberyllium, to ensure the continuedeffectiveness of existing engineering andwork-practice controls, and to identifythe need for additional control measuresto minimize worker exposure toberyllium.

To obtain accurate exposuremonitoring results, section 850.24(e)requires that responsible employers usemonitoring and analytical methods thathave accuracy, at a confidence level of95 percent, of not less than plus orminus 25 percent for airborneconcentrations of beryllium at the actionlevel. The main reason DOE is requiringthis degree of accuracy for exposuremonitoring results is to ensure thatexposure monitoring results aresufficiently accurate at the exposurelevel that is relevant for the CBDPP.Accuracy of measurements is critical,since certain central requirements of therule (e.g., engineering controls, exposurereduction and minimization, respiratoruse, and regulated areas) are triggeredby measured worker exposures thatmeet or exceed the action level. Inaddition, the medical removal provisionrequires that a removed worker not beplaced in a job where exposure levelsare at or above the action level.

Section 850.24(f) further ensures thequality of monitoring results byrequiring that all laboratory analyses ofair sampling data be performed in alaboratory accredited for metals by theAIHA, or a laboratory that demonstratesquality assurance for metals that isequivalent to AIHA accreditation.Equivalency to AIHA’s accreditationmeans that a laboratory can demonstratethat their testing protocols meet theaccreditation standards of AIHA. Theseaccuracy and quality requirements areconsistent with similar requirementsthat appear in many of OSHA’sexpanded health standards for toxicsubstances. The only commenter (Ex.13) to address this issue agreed withDOE that the use of an AIHA accreditedlaboratory will ensure the qualitycontrol, consistency, and accuracy ofberyllium sample analyses. DOE hasadded to the final rule the language ‘‘ora laboratory that demonstrates qualityassurance for metals analysis that isequivalent to AIHA accreditation,’’ toprovide responsible employers moreflexibility in selecting a laboratory andto allow the use of an appropriate

laboratory currently being used by theemployer.

Section 850.24(g)(1) requiresresponsible employers to notify affectedworkers of monitoring results, inwriting, within 10 working days ofreceipt of the monitoring results. Thissection also provides responsibleemployers with two alternative methodsof worker notification: (1) writtennotification to each affected worker, or(2) posting of monitoring results in alocation or locations readily accessibleto affected workers. Two commenters(Exs. 16, 23) expressed concern aboutthe use of personal identifiers in postedmonitoring results, citing workerprivacy concerns.

One commenter (Ex. 26) objectedstrongly to DOE’s proposal to providenotice to workers in a manner that doesnot identify the worker. This commenterargued that not only is there no right toprivacy implicated by posting ofsampling results, but that anonymousnotification would not further personalaccountability for work practices. Thiscommenter cited the Atomic WeaponsEstablishment’s (AWE) experience at itsCardiff (United Kingdom) facility toshow the beneficial effects of peerpressure on individual workers’adherence to good work practice. DOErecognizes AWE’s experience and thebenefits of peer pressure on workers’adherence to good work practices.However, DOE is following theapproach used in OSHA’s substance-specific standards that have postingrequirements, which does notincorporate the principle of applyingpeer pressure to establish good workpractice procedures. DOE, therefore,provides in the final rule that when theposting option is selected, responsibleemployers must post the results withoutdisclosing the identity of the affectedworkers. This protection of workers’privacy is consistent with OSHA’ssubstance-specific standards that haveposting requirements.

Sections 850.24(g)(2) and (3) dealwith cases in which monitoring resultsindicate that the worker exposure levelmeets or exceeds the action level. Insuch cases, the responsible employer isrequired by paragraph (g)(2) to includein the notice to workers a description ofthe corrective actions being taken toreduce worker exposure to below theaction level. Paragraph (g)(3) requiresthe responsible employer to notify theSOMD of the results within 10 workingdays of receipt of the monitoring results.DOE believes that the SOMD must beinformed of such exposures in order torefine, as appropriate, the medicalsurveillance protocol for affectedworkers to ensure effective monitoring

and early detection of beryllium-relatedhealth effects.

Section 850.25—Exposure Reductionand Minimization

Section 850.25 establishes theexposure reduction and minimizationprovisions of the CBDPP that reflectDOE’s goal of achieving aggressivereduction and minimization of workerexposures to airborne beryllium.

Section 850.25(a) establishes thebaseline requirement that responsibleemployers ensure that no worker isexposed to airborne beryllium at levelsabove the exposure limit established insection 850.22.

Section 850.25(b)(1) requires theresponsible employer to include in theCBDPP a formal exposure reduction andminimization program to reduceexposure levels that are at or above theaction level to below the action level, ifpracticable. Sections 850.25 (b)(1)(i)-(iv)provide that the formal exposurereduction and minimization programmust include: (1) exposure reductionand minimization goals, (2) the rationaleto support the goals and a strategy forachieving them, (3) the specific actionsthat the responsible employer plans totake to achieve the goals, and (4) ameans of tracking progress towardsmeeting the goals or demonstrating thatthe goals have been met. Where levelsare below the action level, section850.25(b)(2) requires responsibleemployers to include in their CBDPP adescription and rationale for the stepsthey plan to take to reduce andminimize exposures, if such steps arepracticable. Such steps are applicablewhen exposures are measured below theaction level to provide additionalworker protection. This requirementassures responsible employer’scommitment to address and furtherreduce exposures, as practicable, belowthe action level and implementing thesteps included in their CBDPP.

Section 850.25(c) provides thatresponsible employers must apply thehierarchy of industrial hygiene controls,as already required under DOE Order440.1A, to achieve exposure control.This hierarchy dictates that responsibleemployers first must implement feasibleengineering controls, followed byadministrative controls, in their effortsto reduce and minimize exposures.Responsible employers can supplementthese controls with personal protectiveclothing and equipment to reduceexposures where engineering andadministrative controls are not feasible.

In summary, section 850.25establishes a graded approach toreducing and minimizing berylliumexposures to levels as low as



practicable. This approach is familiar tothe DOE community because it issimilar to DOE’s ‘‘as low as reasonablyachievable’’ approach to radiationprotection. DOE’s requirement that theresponsible employer establish a formalprogram of setting and trackingreduction goals for exposures above theaction level will result in greatermanagement attention to potential highexposures. The requirement that theresponsible employer take steps toreduce and minimize exposures that arebelow the action level commits DOE tocontinue reducing and minimizingexposures, but without the same level ofmanagement attention since theseexposures are believed to represent alower risk to workers.

Six persons commented on theexposure reduction and minimizationrequirements of the proposed rule. Twoof the commenters (Exs. 18, 23)recommended that the rule requireresponsible employers to initiatereduction and minimization actions tomaintain exposures below the actionlevel, rather than below the exposurelimit. DOE would essentially be settinga new DOE exposure limit if it followedthis recommendation. As previouslyexplained, DOE believes that setting anew exposure limit would beinappropriate because the scientific datais not fully developed and does not yetprovide an adequate basis fordetermining an appropriate new limit.The discussion of section 850.22,Permissible Exposure Limit, providesgreater detail on the issue of loweringthe exposure limit.

Three of the commenters (Exs. 4, 18,33) made recommendations that relateto the appropriate trigger for requiringresponsible employers to initiatereduction and minimization actionswhere exposure levels are below theaction level. Two commenters (Exs. 18,33) recommended that the rule requireresponsible employers to initiatereduction and minimization actionswherever beryllium is detected. Onecommenter (Ex. 4) interpreted Table 5 inthe NOPR preamble to mean that DOEwould expect the responsible employerto undertake actions anywhere exposurelevels are greater than zero. DOEbelieves that using either the limit ofdetection or greater than zero as thetrigger is not practicable because tracelevels of beryllium are ubiquitous, andberyllium levels in air can be measuredeverywhere if a large enough air sampleis taken to accumulate sufficientberyllium to exceed the lower detectionlimit of the analytic method being used.DOE believes that final section850.25(b)(2) best meets DOE’s intentionof establishing an effective performance-

based rule by requiring responsibleemployer actions, if practicable, whereexposure levels are below the actionlevel.

Another commenter (Ex. 3)questioned the efficacy of enforcing arule that allows each site to establishindividual exposure reduction andminimization goals. DOE believes thatthis approach is adequately enforceablebased on its positive experience usingcontractual mechanisms to enforcesimilar requirements in radiationprotection regulations.

Section 850.26—Regulated AreasSection 850.26 establishes the

regulated area provisions of the CBDPP.Regulated areas are an effective meansof minimizing the number of workersexposed to airborne concentrations ofberyllium because they prevent orminimize the spread of beryllium toclean areas. This is consistent with goodindustrial hygiene practice wheneverexposure to a toxic substance can causeserious health effects.

The final rule’s requirements forregulated areas are essentially the sameas those proposed, with certain goodhygiene practices being added inresponse to a commenter’s (Ex. 1)concern discussed below under section850.26(d).

Section 850.26(a) requires theresponsible employer to establishregulated areas where, based onbreathing zone samples, the employerdetermines that workers are exposed toairborne concentrations of beryllium ator above the action level.

Three commenters addressed thisprovision, as proposed, and suggestedeither alternate or supplemental criteriato trigger the establishment of regulatedareas. One commenter (Ex. 18)suggested that the trigger level belowered to require that regulated areasbe established wherever beryllium isdetected. DOE believes that the finalrule’s significantly lower action levelprovides a suitable mandatory trigger forthe establishment of regulated areas. Inaddition, DOE believes that the CBDPPexposure reduction and minimizationprovisions will result in the use of aneven lower site-specific action level asimproved controls become feasiblethroughout the DOE complex.

The two other commenters (Ex. 3, 34)suggested that the proposed provisionfor regulated areas be supplementedwith a surface contamination level limitthat would trigger the establishment ofregulated areas. No reliable correlationhas been established between surfacecontamination level and airborneconcentrations of beryllium. DOE,therefore, believes that using a surface

contamination level limit as a trigger forthe establishment of regulated areaswould produce minimal benefits toworker health and has not adopted thisrecommendation.

One of the commenters (Ex. 3)suggested that if engineering or processcontrols bring exposure levels to belowthe action level in a regulated area, thearea should remain a regulated area toensure that controls remain in place.DOE does not agree with this comment.While the rule would not preventresponsible employers fromimplementing such a practice, requiringthat regulated area provisions remain ineffect after exposures have been reducedto acceptable levels would imposeadditional financial burdens onemployers with no correspondingimprovement in worker protection. Inaddition, DOE believes that such amandatory provision could underminethe incentives this rule creates foremployers to implement effectiveengineering or process controls. Ifemployers were required to maintainregulated areas regardless of whetherthey had implemented effectiveengineering controls, employers mighthave less motivation to implement thecontrols. This commenter’s concern is atleast partly addressed by section850.24(d), which requires theperformance of additional exposuremonitoring if operations or procedureschange or if the employer suspects achange that could affect exposure levels.

Section 850.26(b) of the rule requiresresponsible employers to demarcateareas where worker exposures are at orabove the action level in a manner thatalerts workers to the boundaries of suchareas. Under section 850.38 of this part,warning signs must be posted, statingthat only authorized personnel areallowed in the area. Due to the seriousnature of the adverse health effectsassociated with exposure to beryllium,no one should be in a regulated areawithout proper personal protection.

Section 850.26(c) requires responsibleemployers to limit access to regulatedareas to authorized persons only. DOEintends that only individuals who areessential to the performance of work inthe regulated area will be authorized toenter regulated areas. Responsibleemployers will have to evaluate theaffected operation and determine whichpersonnel (including managers,supervisors, and workers) are necessaryfor the performance of the work andthus are authorized to enter. Methodsfor preventing unauthorized personsfrom entering a regulated area mayinclude posting a sign indicating thatonly authorized persons may enter, theuse of locked access doors, and other



security measures as required byworksite conditions. DOE believes thatemployers are best equipped todetermine whether any access controlmethods are needed in addition towarning signs specified in section850.38.

Two commenters (Exs. 1, 31)suggested the incorporation ofadditional personal hygiene controls,specifically recommending that the ruleprohibit smoking, eating, and drinkingin regulated areas. DOE agrees withthese commenters and has included insection 850.27 a prohibition onsmoking, eating, and drinking in areaswhere beryllium is above the actionlevel (i.e., in regulated areas).

Section 850.26(d) requires responsibleemployers to keep a record of allpersons who enter regulated areas. Therecord must include the name of theperson who entered, the date of entry,the time in and time out, and the typeof work performed. One commenter (Ex.26) stated that a log of worker activitiesis not needed unless DOE is conductinga ‘‘prospective risk assessment.’’ Thiscommenter believed that a simple log,only documenting who enteredregulated areas, would be sufficient. Theintended function of these records isclarified in section 850.39,Recordkeeping and Use of Information.DOE believes that recordkeeping mustbe adequate to permit DOE to monitorthe effectiveness of each responsibleemployer’s compliance activities and toprovide information regarding eachworker’s history of potential exposures.This information will assist theresponsible employer’s occupationalmedicine staff in establishingappropriate medical surveillanceprotocols and will aid in DOE’s effortsto establish links between workingconditions and potential healthoutcomes. DOE has retained theproposed regulated area recordkeepingrequirements in section 850.26(d) of thefinal rule.

Section 850.27—Hygiene Facilities andPractices

Section 850.27 of the final rule retainsthe NOPR requirements for responsibleemployers to provide change rooms orareas and hand washing and showerfacilities for beryllium workers. Inaddition to these provisions, the finalrule also requires responsible employersto provide lunchroom facilities that arereadily accessible to beryllium workers,ensure that tables for eating are free ofberyllium, that no worker is exposed atany time at or above the action level,and specifies that all of these facilitiesmust comply with the requirements of29 CFR 1910.141. These hygiene

provisions are common in OSHA’sexpanded health standards designed toprotect workers from exposures tohazardous particulates.

Sections 850.27(a)(1) and (2) requiresresponsible employers to assure thatworkers observe prohibitions on theavailability and use of cosmetics,tobacco and chewing products, and foodand beverages in areas where berylliumis above the action level. Section850.27(a)(3) requires responsibleemployers to prevent beryllium workersfrom exiting areas that containberyllium with contamination on theirbodies or their personal clothing. DOEbelieves that these provisions promotesound work place hygiene practices thatmay protect workers from exposure toother substances present in theworkplace, as well as beryllium. Theseprovisions are commonly included inOSHA’s substance-specific healthstandards.

Section 850.27(b) requires responsibleemployers to provide clean changerooms or areas for workers who work inregulated areas. In addition, section850.27(b)(1) requires that separatefacilities be provided for workers tochange into and store personal clothingand clean protective clothing andequipment. DOE believes that suchprovisions are necessary to preventcross-contamination between work andpersonal clothing and the subsequentspread of beryllium into clean areas ofthe facility and into workers’ privateautomobiles and homes. Theseprovisions also address the need toprevent contamination of cleanprotective clothing and equipment,ensuring that protective clothing andequipment actually protect workersrather than contribute to theirexposures.

Section 850.27(b)(2) requires that thechange-rooms used to removeberyllium-contaminated clothing andprotective equipment be maintainedunder negative pressure, or be located ina manner or area that preventsdispersion of beryllium contaminationinto clean areas.

DOE received two comments on thehygiene facilities and practicesprovisions of the NOPR. A commenter(Ex. 25) suggested that the requirementto provide change rooms, hand washingfacilities, and showers be based on ahazard assessment. DOE believes thatrequiring responsible employers toperform a separate hazard assessment todetermine the need for change roomsand showers is unnecessary and overlyburdensome to responsible employers.The requirement for change rooms andshowers is triggered by the requirementto establish regulated areas. Regulated

areas, in turn, are required wherever ahazard assessment identifies thepotential for worker exposures at orabove the action level. Thus, therequirement for change rooms andshowers is already indirectly triggeredby the results of a hazard assessment.

A commenter (Ex. 23) expressedconcern that the impact and burden ofconstructing new change rooms for D&Dclosure sites has not been considered inthe development of the change roomprovisions, and argued that alternativemethods of compliance should beconsidered for D&D operations. In fact,DOE has addressed the economicimpact of requiring responsibleemployers to provide change rooms forworkers in the economic analysisprepared for the NOPR and madeavailable for public review. Based onthat economic analysis, DOE is awarethat the cost of change rooms may besubstantial for some DOE facilities.However, DOE believes that providingchange rooms and showers for workerswho work in regulated areas is the mosteffective method for preventing workersfrom carrying beryllium contaminationon their work clothes and bodies fromregulated areas to other areas of DOEfacilities and to workers’ privateautomobiles and homes. DOE isunaware of any equally effectivealternative method for achieving thisobjective and, thus, has retained thechange room and shower provisions inthe final rule. The economic burdenmay be lessened by steps employersalready have taken to comply withexisting hygiene facility requirements.For example, 29 CFR 1910.120(n)(7) ofOSHA’s Hazardous Waste Operationsand Emergency Response standardalready requires employers to provideshowers and change rooms for workerson D&D operations of six monthsduration or longer. DOE contractors atDOE sites are subject to this requirementthrough their contracts, which requirecompliance with DOE Order 440.1A orother analogous Orders or standards.

Consistent with the goal of preventingthe spread of contamination intoadjacent work areas and into affectedworkers’ homes, section 850.27(c)(1)requires responsible employers toprovide shower and hand-washingfacilities for workers assigned toregulated areas. In addition tocontrolling the spread of contamination,showering also reduces the worker’speriod of exposure to beryllium byremoving any beryllium that may haveaccumulated on the skin and hair.Requiring workers to change out of workclothes, which are segregated from theirstreet clothes, and to shower beforeleaving the plant, leaving work clothing



at the workplace, significantly reducesthe movement of beryllium from theworkplace. These steps ensure that theduration of beryllium exposure does notextend beyond the work shift and, thus,protect workers and their families fromoff-site exposures. DOE recognizes thatthe installation of such facilities maytake time in some cases. Accordingly,section 850.13(b) of the final rule allowsresponsible employers two years toachieve full compliance with therequirements of the rule.

Section 850.27(d) requires responsibleemployers to provide beryllium workersworking in regulated areas with readilyaccessible lunchroom facilities in whichtables for eating are free of berylliumand no worker is exposed at any timeto a concentration of beryllium at orabove the action level. DOE believesthat it is imperative that workers havea clean place to eat to reduce thelikelihood of additional exposure toloose beryllium dust through inhalationor ingestion.

Responsible employers must alsoassure that workers in regulated areasdo not enter the lunchroom wearingprotective clothing unless the clothingis properly cleaned beforehand.Responsible employers are givendiscretion to choose any method forremoving surface beryllium from theclothing that does not disperse the dustinto the air. These requirements aresimilar to the hygiene facilities andpractices provisions in a number ofOSHA’s health standards.

Section 850.28–Respiratory Protection

Section 850.28 establishes therespiratory protection requirements forthe CBDPP. Section 850.28(a) requiresthat responsible employers comply withOSHA’s Respiratory Protection standard(29 CFR 1910.134). Section 850.28(b)requires that responsible employersprovide appropriate respiratoryprotective equipment for all workersexposed, or potentially exposed basedupon task analyses, to airborneconcentrations of beryllium at or abovethe action level. This section alsorequires the responsible employer toensure that workers use respirators.Section 850.28(c) requires theresponsible employer to include in therespiratory protection program anyberyllium-associated worker whorequests to use a respirator, regardless ofexposure level. Section 850.28(d)requires that responsible employersselect and use only National Institute forOccupational Safety and Health(NIOSH)-approved respiratoryprotective equipment or, if none existfor a DOE beryllium activity, DOE-

accepted respiratory protectiveequipment.

Some of the requirements of section850.28 are not new. For instance, DOEcontractors have historically beenrequired to comply with OSHAstandards, including 29 CFR 1910.134,through contract provisions requiringcompliance with DOE Order 440.1A andits predecessor orders. DOE also hasfollowed OSHA standards inimplementing the Federal EmployeeOccupational Safety and HealthProgram. DOE Order 440.1A requiresemployers to provide, and DOE workersto use, appropriate respiratoryprotective equipment necessary toprotect workers from exposures tohazardous substances. In addition, theprovisions of 29 CFR 1910.134 includea requirement that employers selectonly NIOSH-approved respirators. DOEOrder 440.1A expands this requirementto allow for the use of DOE-acceptedrespiratory protection if NIOSH-approved respiratory protection doesnot exist for a specific DOE task. Theprovisions of section 850.28 that arenew in this final rule are therequirements for the use of respiratoryprotection: (1) at the action level (ratherthan at OSHA’s PEL); (2) based on theanalyses of job activities (rather thanonly on measured levels); and (3) whenrequested by beryllium-associatedworkers regardless of exposure level.DOE does not expect that these newprovisions will greatly increase thenumber of workers who wear respiratorsat DOE sites. Under current practice,DOE sites require use of respirators attheir established action level (rangingfrom 0.2 to 1.0 µg/m3) rather than at thePEL (see CBDPP Economic Analysis,Chapter 3, Section 3.2.8).

The NOPR (Section V, Request forInformation) requested comments onchanging the trigger for requiringrespiratory protection from the PEL tothe action level. Seven of the thirteencommenters on respiratory protection(Exs. 16, 18, 23, 25, 26, 28, 30)recommended that the rule be moreprotective of workers’ health byrequiring the use of respiratoryprotection at the proposed action level.None of the remaining four commenterson this issue (Exs. 3, 4, 20, 31)recommended retaining the PEL as atrigger. The seven supporters of usingthe action level as a trigger represent awide variety of stakeholders. Thesecommenters’ predominant reason forrecommending the more protective levelas the trigger is the uncertainty aboutthe protection afforded by the currentPEL. These commenters provided thefollowing additional reasons forlowering the respiratory protection

trigger from the PEL to the action level:(1) To provide a greater margin of safetybecause of the imperfections inmeasuring exposure levels; (2) toprovide a greater margin of safetybecause of the imperfections inunderstanding how to set exposurelimits for materials, such as beryllium,for which the cause of illness is thebody’s immune system reaction; and (3)to establish an internally consistentCBDPP which includes consistenttriggers for its protective provisions and,therefore, is rational and easy tocommunicate. DOE generally agreeswith these comments and has revisedsection 850.28 to require the use ofrespirators when exposures are at orabove the action level.

One commenter (Ex. 3) was concernedthat using the action level as a trigger forrespiratory protection would render theaction level a de facto PEL, becauseOSHA uses the PEL as the trigger forrespiratory protection in OSHAsubstance-specific standards. Similarly,two commenters (Exs. 4, 20) believedthat using the action level as a trigger forrespiratory protection signifies that DOEbelieves that the PEL is not adequatelyprotective. Section I.C., Health Effects,of the Supplementary Informationsection provides a detailed explanationof the difficulties of determining a safethreshold level for occupationalexposure to beryllium, given the currentstate of knowledge of occupationalexposures and the etiology of berylliumdisease. DOE’s strategy is to require arigorous program to prevent chronicberyllium disease by reducing andminimizing exposures, while studiescontinue that may provide the dataneeded to establish a safe level ofexposure to airborne beryllium. Thepreamble discussions of sections 850.22and 850.23 explain in greater detailDOE’s rationale for continuing to deferto OSHA’s PEL, while establishing amore protective action level for DOE.

One commenter (Ex. 26)recommended that the responsibleemployer provide respiratory protectionwhen warranted based upon an analysisof the worker’s job activities. DOErecognizes that many tasks involvingberyllium may result in highconcentrations of airborne berylliumdue to a procedure error, a work error,or an equipment failure. An analysis ofthe worker’s job activities willdetermine whether respiratoryprotection is necessary for such tasks.Therefore, DOE added section850.28(b)(2) requiring responsibleemployers to provide respiratoryprotection for task involving suchcircumstances.



Two commenters (Exs. 26, 30)recommended that the responsibleemployer provide respiratory protectionwhen it is not otherwise required ifrequested by a worker due to theuncertainty about what is a safe leveland uncertainties in monitoring andcontrolling a substance like airborneberyllium. DOE agrees with thesecommenters and has added section850.28(c), which requires theresponsible employer to providerespiratory protection upon the requestof the beryllium-associated workerregardless of measured exposure levels.

One commenter (Ex. 3) recommendedrequiring respiratory protection forexposures at or above the STEL. DOEagrees with the commenter that theSTEL would have been an appropriatetrigger for respiratory protection if theaction level had remained at 0.5 µg/m3.However, a STEL of 10 µg/m3 for 15minutes, as proposed in the NOPR,would provide no added protection forworkers as a trigger for respiratoryprotection in the final rule because itsaction level of 0.2 µg/m3 will beexceeded in less than 15 minutes whereexposure levels are at 10 µg/m3. Asexplained in the discussion of section850.22, DOE has decided that it wouldnot be appropriate, given the currentscience, to establish a lower STEL inthis rule.

DOE has clarified its expectations onthe use of DOE-accepted respirators inresponse to one commenter (Ex. 31) whoquestioned the use of DOE-acceptedrespirators rather than NIOSH-approvedrespirators. This requirement asproposed in section 850.28(c) couldhave been interpreted, as it was by thiscommenter, to mean that responsibleemployers could choose betweenNIOSH-approved respirators and DOE-accepted respirators. This was notDOE’s intent. DOE’s revision in section850.28(d)(2) clarifies that responsibleemployers may use the DOE-acceptedrespirators only if NIOSH-approvedrespirators do not exist for particularDOE tasks. This section also referencesDOE’s Respirator Acceptance Programto clarify that DOE only accepts for userespirators that DOE deems acceptablebased upon the results of a formaltesting and evaluation program.

One commenter (Ex. 31)recommended that the rule specify thatall respiratory protective equipment befurnished at no cost to the worker.Section 850.28(a) requires thatresponsible employers comply with 29CFR 1910.134, Respiratory Protection,which currently requires in section1910.134(c)(4), that employers providerespirators at no cost to the employee.Accordingly, DOE will continue to rely

upon OSHA’s requirements in lieu ofmaking specific changes to the rule.

Section 850.29–Protective Clothing andEquipment

Section 850.29 establishes theprotective clothing and equipmentprovisions (other than respirator use) ofthe CBDPP. The objectives of thissection are to provide clothing andequipment that protects workers againstthe hazards of skin and eye contact withdispersible forms of beryllium and toprevent the spread of contaminationoutside work areas that could occurfrom the improper handling ofberyllium-contaminated clothing andequipment.

DOE has clarified the proposedrequirement for the responsibleemployer to provide protective clothingand equipment where skin or eyecontact with beryllium is possible.Section 850.29(a) requires thatresponsible employers provideprotective clothing and equipment toberyllium workers where dispersibleforms of beryllium may contact workers’skin, enter openings in workers’ skin, orcontact workers’ eyes.

The openings in workers’ skin couldinclude fissures, cuts, and abrasions.DOE recognizes that the potential for thedevelopment of contact dermatitis,chronic ulcerations, and conjunctivitisis mainly associated with contact withsoluble forms of beryllium compoundsthat are not included in the definitionof ‘‘beryllium’’ in this rule. Insolubleberyllium, however, has also beenshown to cause chronic ulcerations ifintroduced into or below the skin viacuts or abrasions (ref. 34). DOE believesthat it is prudent industrial hygienepractice to avoid skin or eye contactwith a material that causes chroniculcerations and, therefore, has includedprotecting workers’ skin and eyes fromcontact with insoluble beryllium insection 850.29(a). The protectiveequipment required by this sectioncould include coveralls, overalls,jackets, footwear, headwear, faceshields, goggles, gloves, and gauntlets,depending on the nature of theoperation and the related skin and eyeexposure hazards involved.

In the NOPR, DOE requestedinformation regarding the presence ofsoluble beryllium compounds withinthe DOE complex and theappropriateness of the exclusion of suchcompounds from the definition of‘‘beryllium’’ in the proposed rule. Inaddition, DOE requested commentsregarding the need for the protectiveclothing and equipment provisions ofproposed section 850.29(a)(2), given aDOE survey that had found that soluble

beryllium compounds apparently werenot present within the DOE complex.One commenter (Ex. 4) recommendedexcluding soluble beryllium fromsection 850.29 based on that surveyresult. However, as a result of otherpublic comments, DOE learned that thatsurvey result was incorrect because oneDOE commenter (Ex. 16) indicated thatits facilities contain soluble beryllium.Moreover, other commenters (Exs. 26,30) pointed out that DOE facilities maycontain soluble beryllium in the future.

Nevertheless, DOE has not changedthe definition of ‘‘beryllium’’ in the finalrule to include soluble forms ofberyllium, because the principal focusof this rule is on preventing CBD, whichis caused by exposure to insoluble formsof beryllium. One commenter (Ex. 26)correctly pointed out that the skin andeye effects that this section is intendedto prevent are different health effectsthan CBD. Although another commenter(Ex. 25) questioned DOE’s view thatsoluble beryllium exposure to the lungsdoes not cause CBD, DOE finds noevidence in the information on healtheffects presented in section I.C. thatexposure of the lungs to soluble formsof beryllium causes CBD. DOE expectsresponsible employers to addresssoluble beryllium hazards in existingworker protection programs under DOEOrder 440.1 or analogous Orders orstandards cited in responsibleemployers’ contracts with DOE.

Section 850.29(a)(1) requiresresponsible employers to provideprotective clothing and equipment toberyllium workers, at no cost, whereairborne beryllium levels are measuredor presumed to be at or above the actionlevel, because elevated airborne levelsare likely to generate elevated surfacelevels which represent a skin and eyehazard. DOE has included ‘‘presumed tobe’’ in section 850.29(a)(1) in responseto a recommendation that onecommenter (Ex. 26) made with respectto respiratory protection that appliesequally to protective clothing andequipment. The commenterrecommended that the responsibleemployer provide respiratory protectionwhen warranted based upon taskanalyses. DOE recognizes that manytasks involve beryllium that couldreadily become airborne in highconcentrations due to a procedure error,a worker error, or an equipment failure,but which will have no measurableexposure level unless one or more ofthese problems occur. DOE believes thatan analysis of the worker’s job activitieswould show the need for protectiveclothing and equipment, and respiratoryprotection to perform such activities.



Another commenter (Ex. 3)recommended that DOE add a surfacecontamination level that would alsotrigger the requirement to provideprotective clothing and equipment. DOEagrees with this commenter becauseelevated surface levels represent a skinand eye hazard, and, accordingly, DOEhas added paragraphs (a)(2) and (a)(3) tothis section. Section 850.29(a)(2)requires responsible employers toprovide protective clothing andequipment to beryllium workers wheresurface contamination levels aremeasured to be, or prior to initiatingwork are presumed to be, above thehousekeeping level prescribed insection 850.30. Section 850.29(a)(3)requires responsible employers toprovide protective clothing andequipment to beryllium workers wheresurface contamination level resultsobtained to confirm housekeepingefforts are above the prescribedhousekeeping level.

Section 850.29(a)(2) addresses thesituation in which the responsibleemployer is planning to conduct a taskinvolving beryllium and has time tomeasure or estimate surface levelsbefore the task begins. Section850.29(a)(3) addresses the situation inwhich the responsible employer learnsfrom routine surface monitoringconducted at the end of a shift thathousekeeping efforts did not reducesurface levels to below the surfacecontamination level specified in section850.30. DOE recognizes that sampling toconfirm the adequacy of housekeepingefforts at the end of shifts, and theturnaround time of as much as 24 hoursfor sample analysis, could result inworkers not using protective clothingand equipment for more than a daywhere surface contamination levelsexceed the prescribed surfacecontamination level. However, DOEbelieves that these situations will berare, because routine post-shift cleaningshould keep these surfacecontamination levels from becomingexcessive. Also, DOE believes thatresponsible employers will be motivatedto reduce turnaround times for analysesin their efforts to reduce and minimizeexposures. DOE selected the term‘‘results’’ in section 850.29(a)(3) to avoidcreating a situation in which theresponsible employer would violate therule simply because the employer didnot know that the housekeepingcriterion had been exceeded untilsurface monitoring results wereavailable.

Section 850.29(a)(4) requires theresponsible employer to provideprotective clothing and equipment uponthe request of the beryllium-associated

worker, regardless of measuredexposure levels.

Section 850.29(b) incorporates intothis rule 29 CFR 1910.132, PersonalProtective Equipment GeneralRequirements. This OSHA standard isresponsive to a commenter’s (Ex. 31)recommendation that the rule shouldrequire the responsible employer tofurnish the clothing and equipment atno cost to the employee, and coversother well-established practices, such asthe topics to be included in protectiveclothing and equipment training, andensuring that protective clothing andequipment fits properly. Thisrequirement to comply with 29 CFR1910.132 is consistent with the generalworker protection provisions of DOEOrder 440.1A, and analogous Orders orstandards cited in the responsibleemployer’s contract with DOE.

Section 850.29(c)(1) requires theresponsible employer to establishprocedures for donning, doffing,handling, and storing protectiveclothing and equipment that preventberyllium workers from exiting areasthat contain beryllium withcontamination on their bodies or theirpersonal clothing. DOE added thisprovision because one commenter (Ex.3) correctly pointed out that it wasomitted in the proposed rule and isneeded to ensure that workers do nottrack contamination out of areas thatcontain beryllium. The same commenterrecommended that DOE explicitlyrequire HEPA vacuuming ofcontaminated protective clothing andequipment as part of the requireddoffing procedure. This final rule doesnot include a requirement to includeHEPA vacuuming in doffing procedure,because DOE believes that this wouldnot allow the employer sufficientflexibility in selecting cleaningprocedures.

Section 850.29(c)(2) requires that theprocedures for donning, doffing,handling, and storing protectiveclothing and equipment include arequirement that beryllium workersexchange their personal clothing forfull-body protective clothing andfootwear (work shoes or booties) beforebeginning work in regulated areas. Thischange from personal clothes intoprotective work clothing must occur ina change room that protects the worker’spersonal clothes and clean protectiveclothing from beryllium contamination.DOE believes that the use of full-bodyprotective clothing in lieu of personalclothes in regulated areas is necessary toprevent the spread of berylliumcontamination into adjacent work areasand to preclude the possible transport ofberyllium onto affected workers’ private

property. A recent study (ref. 35) hasdocumented the transport from workareas of beryllium on workers’ handsand inside their personal vehicles.

One of DOE’s objectives is to preventthe spread of beryllium contamination,thereby reducing the number of personsexposed and the opportunities forpotential exposures. Thus, sections850.29(d) through (f) establishprovisions to control the handling,maintenance, cleaning, and disposal ofberyllium-contaminated protectiveclothing and equipment.

Section 850.29(d) requires theresponsible employer to ensure thatworkers do not remove beryllium-contaminated protective clothing andequipment from areas that containberyllium, except for authorizedactivities such as cleaning and repairingthe clothing and equipment. DOEreplaced ‘‘site’’ in the proposed rulewith ‘‘area that contains beryllium’’ inthe final rule to clarify its intent tominimize contamination of other areasat the site as well as outside the site.

Section 850.29(e) requires theresponsible employer to prohibit theremoval of beryllium from protectiveclothing and equipment by blowing,shaking, or other means that maydisperse beryllium into the air.Although DOE generally believes thatresponsible employers should have theflexibility to determine the mostappropriate means to cleancontaminated clothes based on theirown specific worksite conditions, DOEhas included this well recognized andaccepted industrial hygiene control toprevent the dispersion of berylliumparticles into the workplaceatmosphere.

Section 850.29(f), which wasproposed as section 850.29(c), requiresresponsible employers to clean, launder,repair, and replace protective clothingand equipment as needed to ensure itscontinued effectiveness in protectingworkers. This section allows contractorsflexibility in determining the requiredfrequency for laundering protectiveclothing based on specific workconditions and the potential forcontamination.

Section 850.29(f)(1), which wasproposed as section 850.29(b),paragraphs (1)–(2), requires theresponsible employer to ensure thatprotective clothing and equipmentremoved for laundering, cleaning,maintenance, or disposal, is placed incontainers that prevent the dispersion ofberyllium dust, and that thesecontainers are labeled in accordancewith section 850.38. These warninglabels will help ensure appropriatesubsequent handling of beryllium-



contaminated materials and mayprevent inadvertent exposures thatcould result if laundry, maintenance, ordisposal personnel are not aware of theberyllium contamination and theprecautions prescribed by theresponsible employer to prevent therelease of airborne beryllium. In section850.29(f)(1) of the final rule, DOE hasdeleted the words ‘‘impermeable’’ and‘‘are designed’’ which were in proposedsection 850.29(b)(1) in response to acommenter’s (Ex. 8) recommendation toclarify DOE’s intent. This changeeliminates the possible implication thatDOE expects responsible employers toprovide special containers even ifexisting containers are capable ofpreventing the spread of contamination.

Section 850.29(f)(2), which wasproposed as section 850.29(d), requiresthe responsible employer to ensure thatorganizations that launder or clean DOEberyllium-contaminated protectiveclothing or equipment are informed thatexposure to beryllium is potentiallyharmful, and that clothing andequipment should be laundered orcleaned in the manner prescribed by theresponsible employer to prevent therelease of airborne beryllium. DOEreplaced ‘‘any individual’’ with‘‘organizations’’ to clarify that DOE’sobjective for this section is to ensurethat any organization that laundersberyllium contaminated clothing isinformed of the hazards of handlingberyllium contaminated items so thatthe organization can take steps toprotect its workers. The proposedwording ‘‘any individual’’ could havebeen interpreted as establishing a directrelationship between the responsibleemployer that generated thecontaminated clothing and theemployee of the laundry or cleaningorganization, which is not DOE’s intent.Also, DOE clarifies in section850.29(f)(2) that this section requiresinforming both on-site cleaning andlaundry services, as well as off-sitecleaning and laundry vendors. On-sitecleaning and laundry services arecovered by this rule, but may not knowabout the presence and hazards ofberyllium on the clothing andequipment unless the responsibleemployer informs them.

DOE has deleted the words ‘‘at orabove the action level or above theSTEL,’’ which in proposed section850.29(a) qualified the requirement toinform downstream launderers orcleaners of beryllium-contaminatedprotective clothing and equipment. Thischange is consistent with final section850.25, which requires reduction andminimization, if practicable, where

exposure levels are below the actionlevel.

One commenter (Ex. 31)recommended including in the ruleprovisions for preventing heat stress.DOE recognizes that requiring protectiveclothing and equipment for dispersibleforms of beryllium compounds at thefinal rule’s lower action level is likelyto result in greater use of protectiveclothing and equipment, includingrespirators, and consequently greaterpotential for heat stress. DOE believesthat the health benefit from lowering therisk of CBD outweighs any increasedhealth risk caused by heat stress thatresults from the requirements of thissection. DOE has not included heatstress provisions in this rule because itis a potential problem for many DOEactivities that require the use ofprotective clothing and equipment; andDOE expects heat stress issues to beaddressed in the responsible employer’sexisting worker protection program.

Section 850.30—Housekeeping

Section 850.30 establishes thehousekeeping provisions of the CBDPP.Good housekeeping practices arenecessary in operational areas whereberyllium is used or handled, to preventthe accumulation of berylliumcontamination on surfaces throughoutthe workplace. Such accumulations, ifnot controlled, may lead to the spreadof beryllium contamination on surfacesand the re-suspension of berylliumparticles into the air, both in the areawhere beryllium dusts were originallygenerated and in other work areas. Inaddition, the uncontrolled accumulationof beryllium-contamination onequipment in the workplace increasesthe potential for worker exposure toberyllium during the performance ofequipment maintenance, handling, anddisposal tasks.

DOE in section 850.30(a) hasestablished that the removablecontamination housekeeping level onsurfaces must not exceed 3 µ/100 cm2

during non-operational periods.Establishing a surface removablecontamination limit reduces thepotential for spread of berylliumcontamination. Responsible employersmust perform measurements todetermine if the operational work areais in compliance with the rule. Inaddition, monitoring surfacecontamination levels is anindispensable tool for ensuring thatberyllium emissions from operations areunder control. The only practicalmethod of monitoring surface levels isto maintain the surface contamination atan established housekeeping level so

that elevations above that level canreadily be detected.

The performance of housekeepingtasks can, in and of itself, lead to workerexposures to beryllium-contaminateddust. Therefore, the housekeepingsection also seeks to prevent the spreadand re-suspension of dust duringhousekeeping activities.

Two commenters (Exs. 26, 28)questioned the scientific basis forestablishing a 3 µg/100 cm2 surfaceremovable contamination level. Inaddition, these two commenters statedthat the variability associated with wipesampling makes surface samplingmethod an unreliable method forsampling. DOE views wipe sampling asa useful and accepted method forproviding qualitative information onchemical contamination of worksurfaces, and agrees with the followingstatement in the OSHA TechnicalManual (Section II: Chapter 2, Samplingfor Surface Contamination): ‘‘Wipesampling is an important tool of worksite analysis for both identifyinghazardous conditions, and in evaluatingthe effectiveness of * * *housekeeping, and decontaminationprograms.’’ Accordingly, thisrequirement is intended only as ahousekeeping performance measure,and should not be viewed as amechanism for measuring, or predictingairborne concentrations of beryllium. Inaddition, this requirement only appliesto removable or loose surfacecontamination, which could become re-suspended in the workplace air orspread to non-controlled areas.

DOE does not intend the requirementfor surface wipe sampling in this rule topreclude the use of other surfacesampling methods for measuringberyllium contamination. DOE agreeswith comments calling for moreresearch (Exs. 16, 28) and encouragesthe use, research, and development ofnew technologies such as direct readinginstruments, which may provide betterresults than wipe sampling.

Section 850.30(a) requires thatresponsible employers conduct routinesurface sampling in operational areas, toensure the effectiveness of theirhousekeeping efforts. This samplingwould not include the interior ofinstalled closed systems such asenclosures, glove boxes, chambers, orventilation systems. Sampling shouldnot be carried out during a normal workshift, but rather it should be undertakenafter normal clean-up and during non-operational periods.

Affected sites throughout DOE havealready established, under the interimCBDPP, allowable beryllium surfacecontamination levels to ensure the



effectiveness of their housekeepingprocedures. These levels range from 1 togreater than 5 µg/100 cm2, with themajority of the sites usingapproximately 3 µg/100 cm2 or less asthe criterion for determining thecleanliness of their workingenvironment outside of regulated areas.Comments on the NOPR called forsetting levels ranging from less than 1µg/100 cm2 (Exs. 14, 18) to 5 µg/100 cm2

(Ex. 24). Information collected from thesites during the development of theinterim beryllium CBDPP indicated thatthe Pantex and Y–12 facilities currentlyhave an allowable surface concentrationlevel of 25 µg/100 cm2 for regulatedareas. Los Alamos National Laboratory(LANL) procedures call for re-evaluationof the operations with additionalcleaning of beryllium operations areas atlevels greater than 26 µg/ft2 (2.8 µg /100cm2). Lawrence Livermore NationalLaboratory (LLNL) indicated those areaswith surface concentrations greater than3 µg/100 cm2 are designated as regulatedareas. Rocky Mountain RemediationServices (a sub-contractor at RockyFlats) indicated that a surfacecontamination level greater than 25 µg/ft (2.7 µg/100 cm2) outside of regulatedareas triggers clean up actions at its site.The AWE facility at Cardiff (UnitedKingdom) has utilized a surface actionlevel of 10 µg/ft2 (1 µg/100 cm2) outsideof regulated areas since 1990. Based onthis range of data, DOE adopted the 3µg/100 cm2 housekeeping level in theproposed rule and continues to believeit is a reasonable surface removablecontamination level that should not beexceeded.

One commenter (Ex. 3) recommendedthat the surface removablecontamination level be the same level asthe criterion for releasing contaminatedequipment for other uses. Anothercommenter (Ex. 23) objected toestablishing a single surface limit forremovable beryllium contamination thatwould be both a housekeeping andrelease level, recommending instead atiered approach, with different levels fornormal or safe work conditions (and freerelease of equipment), for berylliumwork, and for special work conditions.For the reasons discussed under section850.31, Release Criteria, DOE hasadopted different levels for the releaseof equipment that depend on theintended future use of the equipment.

One commenter (Ex. 24) expressedconcern that certain beryllium oxideweapons components could not meetthe 3 µg/100 cm2 level, andrecommended that weaponscomponents be exempt from surfacecontamination limits. DOE has revisedsection 850.30 to clarify that the surface

removable contamination level is to bemeasured post-shift, and that thepurpose of the surface level is not tohave an absolute value of 3 µg/100 cm2

at all times during the machining orworking with beryllium or berylliumparts. DOE is aware that it may not bepossible to maintain surface levels ofberyllium in an operational work areabelow the 3 µg/100 cm2 limit at alltimes. Again, the surface removablecontamination level is intended as apost-shift measure of the effectiveness ofroutine housekeeping efforts.

DOE emphasizes that thehousekeeping concerns addressed bysection 850.30 apply to areas whereworkers may be exposed to beryllium,not to closed-off rooms or buildings. Tomake this clear, DOE has added the term‘‘operational areas’’ in section 850.30(a).If routine surface sampling during non-operational or post-shift periods showsthat the removable contamination levelhas been exceeded, clean-up measuresmust be instituted.

DOE agrees with the comment (Ex. 28)that the meaning of the term‘‘removable’’ contamination may not beclear. Therefore, DOE has added a newdefinition of ‘‘removablecontamination’’ and deleted thedefinition of ‘‘surface contamination’’ insection 850.3. The definition of‘‘removable contamination’’ is takenfrom the U.S. Department of EnergyRadiological Control Manual (DOE/EH–0256T Revision 1, April 1994). Use ofthis language in this rule maintains aconsistent approach with DOE’sradiological surface sampling program.

Two commenters suggested the use ofwet wipes for surface sampling, whileanother commenter (Ex. 24) indicatedthat there is no basis for the applicationof a wet method. NIOSH, in its recentpublication on beryllium contaminationinside worker vehicles, supports the useof a wet wipe sampling method tocollect beryllium samples in potentiallycontaminated employee vehicles (ref.35).

The use of diverse sampling methods(e.g., differences in type of samplemedia, type of solvent (if any) on thesample media, area sampled, etc.) mayeasily lead to the reporting ofinconsistent results. To reduce thevariability in reported surfacecontamination across the DOE complex,DOE recommends, but does not require,the use of a single sampling method:NIOSH method 9100 (NIOSH Manual ofAnalytical Methods, 4th Edition, August15, 1994, Lead in Surface WipeSamples). This method may have to bemodified for surfaces smaller than 100cm2 using a procedure such as thatdescribed in Appendix D of 10 CFR part

835. Sites using other methods, e.g., drywipe sampling, should transition to theNIOSH method in a cost-effectivemanner. Current data is not clear on therelative efficiency of dry verses wetsampling on the variety of surfacesfound in the DOE. Therefore, immediateadoption of the NIOSH method at sitesacross DOE may be impractical and addno immediate value to worker healthand safety. In the long term, byrecommending a single method (a wetmethod) for conducting the surfacesampling, DOE believes that thevariability associated with surfacesampling will be reduced withoutspecifying a particular method in therule.

One commenter (Ex. 3) suggested thatthe term ‘‘routine’’ in section 850.30(a)should be more clearly defined, i.e.,weekly or monthly. Because DOEbelieves that this rule should be asperformance-based as possible, thefrequency of ‘‘routine’’ monitoringprocedures under this section should bedeveloped by the local health and safetyspecialist (industrial hygienist) based onthe specific circumstances at the site.

Section 850.30(b) prohibits the use ofcompressed air or dry methods andrequires the use of vacuuming, wet orsimilar methods for the cleaning ofberyllium-contaminated floors and othersurfaces. The purpose of using thesemethods is to reduce or eliminate thepotential for re-suspension of berylliumdust into the air and breathing zone ofthe worker.

One commenter (Ex. 23) requestedflexibility in cleaning methods, such aspermitting the use of sticky tack cloths.DOE agrees with the comment and inthe final rule has allowed the use ofother cleaning methods, such as stickytack cloths, that have the same endresult as wet vacuuming (i.e., areduction of dust-producing cleaningmethods). These are appropriatemethods for complying with thehousekeeping requirement of the rule.

Section 850.30(c) requires the use ofHEPA filters in all vacuumingoperations used to clean contaminatedor potentially contaminated surfaces,and further requires filter replacementas needed, to maintain the captureefficiency of the vacuum system. Theuse of wet methods for reducing orminimizing the dispersal of dust duringgeneral housekeeping tasks, such assweeping, is a common industrialhygiene practice. HEPA filters must beused to prevent the spread of dust byeffectively collecting the dust that iscollected by vacuum systems.Responsible employers should haveprocedures for the cleaning orreplacement of filters that ensure



minimum employee exposure toberyllium dust on the filter.

As discussed in earlier sections of thisanalysis, the movement of contaminatedequipment from a regulated area to anonregulated area may result in thespread of beryllium contamination tothe nonregulated area. To prevent thepotential spread of contamination fromthe performance of housekeepingactivities required by this rule, section850.30(d) requires that cleaningequipment used in areas where surfacesare contaminated or potentiallycontaminated with beryllium be labeled,controlled, and not used for other, non-hazardous materials. These proceduresare similar to those required underOSHA’s asbestos standard forequipment used during cleanup orremoval of asbestos from buildings.

Section 850.31—Release Criteria

Section 850.31 establishes berylliumcontamination levels and otherrequirements that must be met beforeequipment and other items used inberyllium work areas may be released ortransferred to the general public andnon-beryllium areas of DOE facilities, orto facilities engaged in work involvingberyllium. DOE requested comments onthe setting of ‘‘beryllium free-release’’public contamination levels in theNOPR. After considering the commentsreceived in response to this broadrequest for views and information, DOEreopened the comment period on June3, 1999, to invite public comment onspecific options for release criteria thatwere being considered by DOE (64 FR29811). Section 850.31 reflects DOE’sconsideration of the substantial numberof comments received fromorganizations and individuals on thistopic.

In the notice of reopening of thecomment period, DOE suggested that areasonable contamination level forrelease of equipment and other items tothe public for non-beryllium uses wouldbe 0.1 µg/100cm2. This level was basedon the housekeeping and release levelsbelieved to be in effect at various DOEfacilities and the AWE facility in theUnited Kingdom. DOE also stated that itwas inclined to adopt a contaminationlevel of 3 µg/100 cm2 for release of itemsfor beryllium work in other facilities.This level was based principally on thepractice at the Rocky Flats.

Ten organizations and individualssubmitted comments that recommendedrelease level values. These valuesranged from non-detectable to 3 µg/100cm2 for public release and non-detectable to 10 µg/100 cm2 for releaseto beryllium facilities.

One commenter (Ex. 47) stated thatthere should be a single contaminationlevel for both the housekeepingstandard for beryllium areas and forrelease of items for beryllium and non-beryllium uses. Another commenter (Ex.43) urged DOE to adopt a singlecriterion for release to the public andDOE non-beryllium facilities and toberyllium-handling facilities because itwould be simpler to administer. DOEdoes not agree with these comments,because the workers in operational areaswhere beryllium is used have beentrained in the hazards of beryllium andthe proper use of protective equipmentthat is required to be worn in thoseareas. DOE does not believe that thegeneral population or DOE non-beryllium workers should be exposed tothe same level of a hazardous materialas workers who have been trained in thesafe handling of that material. DOE,therefore, has included in the ruleseparate requirements for the release ofberyllium-contaminated equipment andother items to facilities engaged inberyllium work and for releases to thegeneral public or DOE non-berylliumfacilities.

Section 850.31(a) requires theresponsible employer to cleanberyllium-contaminated equipment andother items to a contamination level thatis as low as practicable, but not toexceed the removable contaminationlevels specified in section 850.31(b), forrelease to the general public or to non-beryllium areas of DOE facilities, andsection 850.31(c), for release to facilitiesperforming work with beryllium. Inaddition, DOE has included in thesesections other requirements that aredesigned to protect workers and othersfrom the hazards associated withexposure to beryllium. DOE uses thewords ‘‘and other items’’ after‘‘equipment’’ in section 850.31(a) tocover tools, supplies, documents, etc.,and any personal property in beryllium-handling areas that may not beencompassed by the term ‘‘equipment.’’The phrase ‘‘equipment and otheritems’’ does not include real property orbuildings.

Release to the public and for use inDOE non-beryllium areas. Section850.31(b)(1) sets the removablecontamination level for equipment andother items to be released to the generalpublic or for use in DOE non-berylliumwork areas at 0.2 µg/100cm2 or theconcentration level of beryllium in soilat the point of release, whichever ishigher. The equipment also must belabeled, in accordance with section850.38(b), to warn recipients ofpotential beryllium hazards. Theresponsible employer must condition

the release of equipment and otheritems to the public based on therecipient’s commitment to implementcontrols to ensure that exposure doesnot occur. Such a commitment shouldbe based on the nature and possiblefuture uses of the equipment and otheritems, the nature of the berylliumcontamination, and whether exposure toberyllium is foreseeable.

In the notice of reopening, DOEreferenced a comment by the AWE (Ex.1) which reported that the housekeepingsurface action level in its Cardiff, Walesfacility had been reduced to 1 µg/ft2(about 0.1 µg/100 cm2) in 1990. DOEreasoned that, based on the AWEexperience and release limits includedin DOE facilities’ interim CBDPPs, apublic release limit as low as 0.1 µg/100cm2 would be achievable. Severalcommenters (Exs. 41, 43, 46, 47, 51)argued that this level would be difficultand costly to achieve, and that there isno technical basis for concluding that itwould be more beneficial than a higherlevel. AWE (Ex. 38) commented that itis not using 0.1 µg/100 cm2 as a releaselevel; its current policy is to dispose ofcontaminated items in a landfill site.The Pantex Plant (Ex. 46) stated that itsreported use of 0.1 µg/100 cm2 as arelease criterion was incorrect, possiblydue to a typographical error, and itrecommended using 3 µg/100 cm2 forthe public release limit. Rocky Flats (Ex.47) pointed out significant differencesbetween the AWE Cardiff facility, whichis a stable work environment, and theRocky Flats facility, which is engaged indecontamination and decommissioningwork. Two commenters (Exs. 43, 46)argued that a surface removablecontamination level of 0.1 µg/100 cm2

could easily be exceeded by backgroundlevels of beryllium.

Other commenters (Exs. 44, 45, 48,49) took the position that any detectablelevel of beryllium on the surface of anitem should be presumed to present ahealth risk and, therefore, that no itemhaving a detectable level of berylliumshould be released to anyone for anypurpose. One commenter (Ex. 48) statedthat the correlation between surfaceberyllium levels and associated healthhazards is unknown, and the possibilityexists for fixed or inaccessible berylliumto be liberated when equipment isworked on or repaired. Anothercommenter (Ex. 49) stated that DOEshould take a cautious stance because ofthe current lack of informationregarding the nature of the exposure-response relationship and the factorsthat underlie individual sensitizationtowards beryllium. Two commenters(Exs. 49, 52) recommended life-cycle



administrative controls for beryllium-contaminated equipment.

Section 850.31(b)(3) responds to therecommendation of comments (Exs. 26,38) calling for a risk assessment thatconsiders the downstream user’sexposure potential, the history and typeof equipment, and the nature of thecontamination, in order to decidewhether and how to release equipmentand other items for non-beryllium uses.As recognized by DOE in the reopeningnotice, surface or wipe sampling is notan adequate means of characterizingpotential exposure risk. For example, alathe or other piece of equipmentreleased because it is determined to beberyllium-free on the surface maycontain internal beryllium dust thatcould become airborne and present ahealth hazard during futuremaintenance. On the other hand, othertypes of equipment may contain internalberyllium that is combined with othersubstances (e.g., grease) which wouldmake it unlikely that the berylliumwould ever become airborne. Thepresence of this type of suspendedcontamination, even at levels above thesurface release criterion, would notnecessarily present a health hazard.Accordingly, an assessment of potentialrisk of exposure should be undertakenbefore the release of any equipment orother item to either the general publicor to DOE for non-beryllium uses. Basedupon the assessment, the decisionshould be made as to ultimatedisposition of the equipment and anyconditions that should be placed on itsfuture use.

After considering the comments, DOEis persuaded that it would be costly, ifnot infeasible, to implement acontamination level of 0.1 µg/100 cm2

or lower as the public release criterion.Section 850.31(a)(1) requiresresponsible employers to cleanequipment and other items to the lowestcontamination level practicable and toensure that removable contamination onsurfaces does not exceed 0.2 µg/100 cm2

or the concentration level of berylliumin local soil. This removablecontamination criterion is based, inlarge measure, on information providedin comments submitted by thecontractor that manages the Rocky Flatsfacility (Ex. 47). To comply with theinterim CBDPP established by DOENotice 440.1, Rocky Flats conducted anextensive site characterization (over6000 samples) using 0.2 µg/100 cm2 asthe target contamination level. RockyFlats reported that they found the 0.2µg/100 cm2 to be an achievable leveland determined (using recentlypublished re-suspension factors) thatany airborne beryllium generated from

re-suspending beryllium from surfaces,even with some beryllium surface levelsabove 0.2 µg/100 cm2, would beexpected to be well below the EPA’sNational Emission Standards forHazardous Air Pollutants (NESHAP)limit of 0.01 µg/m3 and therefore, at safelevels. EPA’s NESHAP is the nationalstandard for community air that thepopulation continuously breathes.

DOE has addressed the concerns ofcommenters (Exs. 46, 50) that it may notbe possible to clean equipment andother items to below the naturalbackground of beryllium in local soil. Itis highly unlikely that this rule wouldapply to soil because soils generallycontains less than 0.1 percent berylliumand, therefore, is not consideredberyllium for the purposes of this rule.Nonetheless, DOE included in section850.31(b)(3) the words ‘‘or theconcentration level of beryllium in localsoil at the point of release’’ to eliminatethe possibility that the rule wouldcompel a responsible employer to cleanlocal soil off of equipment and otheritems before release.

DOE does not agree with the view ofsome commenters that, in the absence ofscientific evidence of a threshold or‘‘safe’’ level of exposure to beryllium,the surface contamination release levelshould be at the limit of detection orzero. Although one commenter (Ex. 45,45B) submitted information indicatingthat re-suspension of beryllium in theair is possible on surfaces with less than1.0 µg/100 cm2 of beryllium, therecurrently is no scientific evidence thatsurfaces cleaned to that level wouldresult in airborne concentrations ofberyllium at levels that would beharmful to workers.

DOE has addressed the concern aboutthe potential for exposure to re-suspended beryllium by requiring acase-by-case assessment of risk beforeequipment and other items are releasedfor non-beryllium uses. There is likelyto be wide variation in these situations,and DOE is not prepared at this time toprescribe uniform management controls.However, this is an area for which DOEmay develop guidance to assist fieldelements, as experience is gained underthis rule.

One commenter (Ex. 43)recommended establishing a generalsurface release level of 1 µg/100 cm2,plus labeling of items. The commentersuggested the use of labels to shiftresponsibility for controlling futureexposures to the recipients of theequipment or items. DOE does notbelieve that simply cleaning the outsideof the equipment and other items andproviding warning to the new user isadequate because some recipients,

particularly recipients who have notperformed work using beryllium, maynot fully understand the risks associatedwith beryllium exposure.

Release for beryllium work. Section850.31(c)(1) sets the contamination levelfor equipment or other items releasedfor use in other facilities engaged inberyllium work at 3 µg/100 cm2. Theequipment or item also must be labeledin accordance with section 850.38(b).Section 850.31(c)(3) requires theresponsible employer to ensure that areleased item is enclosed or placed insealed, impermeable bags or containersto prevent exposure to beryllium duringhandling and transportation to itsdestination. Enclosure of equipment andother items to be released to otherberyllium operations can beaccomplished by any practical means,such as wrapping in plastic.

Several commenters recommendedthat DOE establish a higher surfacecontamination release level forequipment and other items to betransferred to another facility forberyllium work than is allowed foritems released to the public or for usein DOE non-beryllium work (Exs. 38, 41,42, 46, 51). Surface contamination levelsrecommended by the commenters (seeTable 9) for release of equipment andother items to be used in berylliumareas range from 0 and non-detectable to10 µg/100 cm2. Rocky Flats (Ex. 47)previously established a release level forequipment and other items to betransferred to other DOE facilities forberyllium work at 2.5 µg/100 cm2.Several commenters (Exs. 41, 42, 51)and a number of the DOE sites reportingrelease levels support the use of 3 µg/100 cm2 or less as a release level forequipment and other items that will beused for beryllium work.

Based upon current surface samplingtechnology, DOE sees no appreciabledifference between 2.5 µg/100 cm2 and3 µg/100 cm2 and, therefore, hasadopted the 3 µg 100 cm2 value forrelease of equipment and other items toother facilities for beryllium work.Adoption of this value also maintains aconsistency with the housekeepingrequirements for operational berylliumareas, which will simplifyimplementation by DOE facilities.

Other issues. One commenter (Ex. 51)recommended that the rule specify thatan industrial hygienist shoulddetermine the number and location ofswipe samples. DOE views thedetermination of the number andlocation of swipe samples to be part ofthe hazard assessment, which must bemanaged by a qualified individual suchas a CIH (see discussion for section850.21).



Two commenters (Exs. 49, 50) wereconcerned with dermal exposures toberyllium. DOE agrees that there is apotential health hazard associated withdermal exposure to beryllium, and hasimposed requirements under sections850.29 and 850.37 to protect workershandling beryllium. The hazardsassociated with dermal exposures alsoare dealt with in the DOE facilities’health and safety programs under DOEOrder 440.1A or, analogous Orders orstandards cited in responsibleemployers’ contract with DOE.

Section 850.32—Waste DisposalSection 850.32 (proposed as section

850.31) establishes the waste disposalprovisions of the CBDPP. Like many ofthe provisions of the rule (e.g., regulatedareas, protective clothing andequipment, and housekeeping), thewaste disposal provisions are designedto minimize the spread of berylliumcontamination throughout the facility orbeyond the sites boundaries.

DOE believes that the most effectiveway to control the spread ofcontamination resulting from wastedisposal activities is to prevent orminimize the generation of berylliumwaste. Accordingly, section 850.32(a) ofthe final rule requires responsibleemployers to employ wasteminimization principles in conductingberyllium activities. Good housekeepingpractices, required by section 850.30,aid in this effort by continuallyremoving beryllium dust accumulationsfrom work surfaces, thereby reducingthe level of contamination of workplaceequipment. The performance of hazardanalyses on operations with thepotential to generate wastes, as requiredby section 850.21, can help responsibleemployers identify potential sources ofwastes and evaluate possible controlsthat could be implemented to prevent orreduce waste generation. Other wasteminimization practices, such asminimizing the equipment and materialthat is exposed to berylliumcontamination, will also assist inreducing the amount of material thatmust be disposed of as beryllium orberyllium-contaminated waste, thusreducing the potential berylliumexposure hazards.

Section 850.32(b) of the final rulerequires responsible employers todispose of beryllium-containing waste,and beryllium-contaminated equipmentand other items that are disposed of aswaste, in sealed impermeable bags,containers, or enclosures that arelabeled in accordance with section850.38. Enclosure can be any practicalmechanism for sealing, such aswrapping in plastic. DOE believes these

waste disposal provisions are necessaryto prevent the re-suspension ofberyllium contamination into theworkplace atmosphere. Warning labelsare necessary to ensure that workers areaware that bags, containers, orenclosures contain beryllium so thatthey can take appropriate precautions.Furthermore, responsible employersmust comply with applicable Federal,state, and local regulations governingthe management, transportation, anddisposal of waste that containberyllium.

DOE received two commentsregarding the waste disposal provisionsof the NOPR. One commenter (Ex. 31)applauded DOE for including wasteminimization principles as a controlmeasure for reducing berylliumexposures. This commenter suggestedthat DOE consider developing a non-mandatory appendix to the rule orstand-alone guidance to illustrate wasteminimization principles and provideideas for workers and employers. DOErecognizes the utility of non-mandatoryguidance in assisting responsibleemployers in implementing certainmandatory requirements of the CBDPP.DOE notes, however, that the U.S.Environmental Protection Agency andother Federal agencies have alreadydeveloped a wide variety of guidancematerials addressing wastemanagement, waste minimization, andpollution prevention principles andpractices. Not only are these guidesreadily available to the DOEcommunity, but many DOE sites haveused these guides to develop their ownhazardous waste management plans. Forthis reason, DOE believes that thedevelopment of an additional guidancedocument to address wasteminimization principles for the finalCBDPP rule is not necessary. DOE isdeveloping an implementation guide forthe CBDPP rule that will providegeneral guidance for disposal ofberyllium waste.

The other commenter (Ex. 18)suggested that the waste disposalprovisions should address thedeclassification of beryllium parts thatare classified for national securitypurposes at certain DOE sites. Thissection of the final rule requiresresponsible employers to control thegeneration of beryllium-containingwaste, and beryllium-contaminatedequipment and other items that aredisposed of as waste and to dispose ofthis equipment and other items in a safemanner. DOE does not intend for theseprovisions to alter or affect theclassification of beryllium-contaminatedequipment and other items, nor tosupersede the applicable requirements

for protection of such equipment anditems. Accordingly, beryllium-contaminated materials that areclassified must be handled inaccordance with the governing nationalsecurity regulations, standards, andpolicies. Responsible employers alsomust dispose of such materials inaccordance with the provisions of thisrule.

Section 850.33—Beryllium EmergenciesSection 850.33 (proposed as section

850.32) establishes the beryllium-relatedemergency provisions of the CBDPP.Such provisions are particularlyimportant in light of the possibility,suggested by several commenters, that asingle, high-level beryllium exposuremay have been the cause of CBDoccurring among several workersthought to have had no exposure or onlyincidental, low-level exposures toberyllium.

Proposed section 850.32 would haveestablished broad performance-basedprovisions requiring responsibleemployers to develop procedures forresponding to and alerting workers toberyllium emergencies, to ensure theavailability and use of appropriateprotective equipment during relatedcleanup operations, and to provideemergency response workers withappropriate training on proper responseprocedures.

Two commenters (Exs. 11, 31)responded to the proposed berylliumemergencies section, and both requestedthat DOE provide additional guidanceregarding beryllium emergencyprocedures, training, and personalprotective equipment requirements. Onecommenter (Ex. 31) suggested that thisguidance was needed to ensure aconsistent and coordinated response toberyllium emergencies in cases inwhich workers from different employersrespond to the same event. Bothcommenters suggested that DOEconsider incorporating elements of theemergency response provisions ofOSHA’s Hazardous Waste Operationsand Emergency Response standard (29CFR 1910.120) in the CBDPP rule.

DOE agrees with the commenters, andnotes that the beryllium emergenciesprovisions of the NOPR were notintended to supersede the applicableprovisions of 29 CFR 1910.120.Accordingly, to avoid confusion andduplicative efforts and to ensureconsistent and coordinated responses toberyllium emergencies at DOE facilities,DOE has revised the berylliumemergencies section (renumberedsection 850.33 in the final rule) torequire responsible employers tocomply with 29 CFR 1910.120(l) for



emergency response activities related tohazardous waste cleanup operations,and 29 CFR 1910.120(q) for emergencyresponse activities related to all otheroperations. Also, DOE will providegeneral guidance on preparing for, andresponding to, emergencies involvingberyllium in the DOE implementationguide for this rule.

Section 850.34—Medical SurveillanceSection 850.34 (proposed as section

850.33) establishes the medicalsurveillance provisions of the CBDPP.These provisions are aimed at: (1)Identifying workers at higher risk ofadverse health effects from exposure toberyllium; (2) preventing beryllium-induced disease by linking healthoutcomes to beryllium tasks; and (3)making possible the early treatment ofberyllium-induced disease.

Several changes have been made tothe medical surveillance provisions asproposed. These changes includeenlarging the scope of the coveredpopulation to include former berylliumworkers who are still employed at DOEfacilities in non-beryllium work; addingthe term ‘‘beryllium-associated worker,’’which includes all current workers whohave or had the potential for exposureto beryllium; adding a multiple andalternate physician review process;deleting the requirement that exposurebe at or above the action level beforeinitiating medical surveillance; anddeleting the requirement for Office ofEnvironment, Safety and Health reviewof the written medical surveillanceprogram. In addition, DOE has madeeditorial changes to clarify variousprovisions.

The medical surveillance program isdesigned to ensure the promptidentification, and makes possible theproper treatment, of workers whobecome sensitized to beryllium ordevelop CBD. In addition todetermining the incidence of CBD in theworkforce, the medical surveillanceprogram fulfills a critical informationdevelopment function, includingidentifying the risk factors associatedwith the development of CBD andberyllium sensitization. This rulerequires that medical surveillance begiven to workers who are at the greatestrisk from continued exposure. Thisdetermination should be made on thebasis of the air monitoring results, theSOMD’s recommendation, and anyother relevant information theresponsible employer may possess, suchas past medical or air monitoringrecords, workers’ job tenure, etc.

DOE realizes that some workers mayelect not to participate in the medicalsurveillance program because they

believe that a diagnosis of CBD orberyllium sensitization could have anegative impact on future employmentopportunities or on their healthinsurance. In light of this concern andDOE’s desire to maximize workerparticipation in the medicalsurveillance program, DOE in the NOPRrequested interested parties to commenton the feasibility and utility ofincluding anonymous testing as aprovision in the final rule. In requestingpublic comment, DOE noted twoconcerns it had regarding the use ofanonymous testing; specifically,concern about DOE’s inability tocorrelate collected exposure data tohealth outcomes for workers choosinganonymous testing, and concern aboutthe effect of anonymous testing onDOE’s ability to conduct follow-up teststo confirm positive Be-LPT results.

Eight commenters (Exs. 4, 16, 17, 23,26, 28, 30, 31) responded to DOE’srequest for information regardinganonymous testing. Most commentersstated that anonymous testing wouldnot provide significant additionalbenefits or protection for workers. Inaddition, all of the commenters sharedDOE’s concerns regarding the resultinginability to correlate collected exposuredata to health outcomes, and thedifficulty of tracking employees forfollow-up testing to confirm positiveresults. The commenters believed thatthese two drawbacks overshadow anypotential increase in workerparticipation.

One commenter (Ex. 17) expressedconcern that the use of anonymoustesting would limit the employer’sability to provide support to workersreceiving medical surveillance. Thiscommenter noted that ongoing supportand reassurance is essential for thoseworkers with positive or inconclusivetest results. Three commenters (Exs. 16,23, 26) stated that medical surveillanceshould be used to determine workplaceexposures and evaluate the effectivenessof workplace controls. Thesecommenters believe that anonymoustesting would hamper this effort bypreventing responsible employers fromidentifying specific jobs or tasks thatlead to beryllium-related health effects.

For reasons stated in the NOPR andexpressed by all eight commenters, DOEhas decided against the use ofanonymous testing. However, DOE hastaken steps in the final rule to protectthe privacy of beryllium-associatedworkers, e.g., by requiring the use ofunique identifiers (see discussion ofsection 850.39). DOE cannot responsiblyaccomplish the tasks of ameliorating theeffects of exposure to beryllium anddeveloping needed data on the cause

and development of CDB throughanonymous testing. DOE also believesthat offering anonymous testing as asupplement to identified testing woulddiscourage workers from participatingin identified testing. Accordingly,provisions for anonymous testing arenot included in the final beryllium rule.

Section 850.34(a)(1) requiresresponsible employers to establish andimplement a medical surveillanceprogram for beryllium-associatedworkers. DOE adheres to its view thatparticipation in the medicalsurveillance program should not bemandatory for workers. The responsibleemployer’s obligation is to offer toprovide the medical tests andprocedures as required. DOE expectsthat where worker confidence in themedical program exists, refusal toparticipate will be minimal.

The term ‘‘beryllium-associatedworker’’ is used in the final rule whereDOE has determined that coverage ofprovisions should not be limited tocurrent workers regularly employed inDOE beryllium activities. Use of theterm ‘‘beryllium-associated worker’’ willincrease the population eligible toreceive medical surveillance byincluding current workers with pastberyllium exposures or potential forexposures.

Numerous commenters (Exs. 2, 3, 4,14, 16, 17, 28, 30, 29, 31) maderecommendations regarding the level ofemployee exposure that should triggerworker participation in the medicalsurveillance program. Two of thesecommenters (Exs. 3, 4) objected tooffering medical surveillance to allworkers potentially exposed toberyllium. However, their reasons fornot wanting to include all potentiallyexposed workers differed. Onecommenter (Ex. 3) stated that placing allpotentially exposed employees in themedical surveillance program would beinconsistent with the permissibleexposure limit. The other commenter(Ex. 4) was concerned with the costsassociated with such a strategy, and thepotential for causing worker anxietyfrom false-positive Be-LPT test resultsfor workers with limited exposurepotential. While these commentersagreed that some level of workerberyllium exposure should trigger themedical surveillance program, neitherprovided recommendations for anappropriate trigger level.

One commenter (Ex. 16) suggestedthat DOE use a graded approach to themedical surveillance program whichwould include current berylliumworkers and other workers withexposures or potential exposures at orabove the action level. DOE has



determined that a graded approachlinked to exposure at or above the actionlevel would not ensure the necessarysurveillance of all DOE and contractorworkers who may have had exposure toberyllium, whether current or past.

Several commenters (Exs. 2, 14, 16,17, 28, 29, 30, 31) favored the inclusionof all potentially exposed workers in themedical surveillance program regardlessof the measured exposure level. Thesecommenters argued that medicalsurveillance should not be limited toworkers exposed to levels of berylliumat or above the action level, but rathershould include all workers with thepotential for any beryllium exposure.Three of these commenters stated thatcurrent scientific evidence does notindicate a ‘‘safe’’ level of berylliumexposure, and that CBD has beenidentified in individuals thought tohave only low or incidental exposure toberyllium. Their concern was thatrestricting medical surveillance to‘‘beryllium workers,’’ as defined inproposed section 850.3, would excludesuch workers, who in their view are alsoat risk of contracting CBD. In addition,two of the commenters (Exs. 28, 30)noted that allowing workers exposed atany level to participate in the medicalsurveillance program would act as anincentive for employers to minimize thenumber of individuals who work inberyllium areas.

Similarly, three commenters (Exs. 28,29, 31) argued that current workers withpast beryllium exposures should beoffered the opportunity to participate inthe medical surveillance program. Onecommenter (Ex. 31) noted that, based onthe proposed definition of ‘‘berylliumworker,’’ medical surveillance wouldnot be made available to currentworkers with past beryllium exposureunless they were covered under themedical removal provisions of proposedsection 850.34. Another commenter(Ex.15) suggested that all employees atDOE facilities, even those with noexposure to beryllium, should be giventhe option of participating in themedical surveillance program.

Several commenters (Exs. 2, 16, 28,31, 19) raised the issue of medicalsurveillance for former workers withpast beryllium exposures who no longerwork at a DOE facility. The commentersstated that former DOE workers shouldalso be provided the opportunity toparticipate in medical monitoring. Theyacknowledged DOE’s proposedestablishment of a separate, directlyfunded program that offers medicalexaminations to former workers at riskof developing CBD. However, two of thecommenters (Exs. 16, 31) argued thatthis program should be made available

to former workers at the same time asthe program for current workers.Another commenter argued thatmaintaining two separate databases andprograms was not practical.

DOE has revised the final rule torequire responsible employers toprovide medical surveillance for allberyllium-associated workers. DOEbased this revision on the berylliumcases suggesting that low and evenincidental exposure to beryllium canlead to sensitization or berylliumdisease. This approach will ensure theearly identification of workers at risk ofhealth effects from exposure toberyllium, provide the greatestprotection of worker health, and providea more complete documentation ofberyllium exposures. Beryllium-associated workers eligible for medicalsurveillance include any current workerwho is exposed or was exposed orpotentially exposed to airborneconcentrations of beryllium at a DOEfacility. Thus medical surveillance willbe available to a beryllium worker (asdefined in section 850.3), a currentworker whose work history shows thatthe worker may have been exposed toairborne concentrations of beryllium atDOE facilities, a current worker whoexhibits signs and symptoms ofberyllium exposure, and a worker whois receiving medical removal protectionbenefits.

Section 850.34(a)(2) requiresresponsible employers to designate aSite Occupational Medical Director(SOMD) who will be responsible foradministering the medical surveillanceprogram. One commenter (Ex. 18) statedthat a panel comprised of individualsrepresenting management, labor, thepublic, and the local medicalcommunity should select the SOMD.DOE has not adopted thisrecommendation because DOE believesthat the responsible employer must haveultimate responsibility for ensuringcompliance with this requirement.

A number of commenters (Exs. 12, 14,20, 23) were concerned about thequality of health care for workers withCBD and, more specifically, whether ornot workers would have a choice ofphysicians. One commenter (Ex. 20)pointed out that OSHA no longerrestricts the performance of medicalevaluations to licensed physiciansbecause this requirement is tooprescriptive and fails to recognize therealities of today’s health care system.This commenter suggested adding aprovision to include other licensedhealth care professionals among thosewho may perform medical evaluations.

DOE agrees with this commenter andhas revised section 850.34(a)(3) of the

final rule to require responsibleemployers to ensure that all medicalevaluations and procedures areperformed by or under the supervisionof a licensed physician who is familiarwith the health effects of beryllium.Although a licensed physician is theappropriate person to supervise andevaluate a medical evaluation, certainrequired elements of the evaluation maybe performed by another, appropriatelyqualified person under the supervisionof the physician. The licensed physicianis required to be familiar with the healtheffects of beryllium. DOE expects thatthe medical evaluations and proceduresrequired to diagnose CBD will beperformed or validated by a specialist inpulmonary medicine, occupationalmedicine, or other physician withspecialized equipment and examinationprotocols required to definitivelydifferentiate between CBD and otherlung diseases. DOE believes that this isnecessary due to the unusual nature ofCBD and the fact that not all physiciansare familiar with the evaluation ofberyllium-associated patients.

Three commenters (Exs. 15, 18, 22)expressed concern about certainlanguage in the NOPR preamble thatthey interpreted to mean that workerswould be limited to an evaluationperformed by an employer’s physician.One commenter (Ex. 22) suggested thatDOE adopt OSHA’s Lead Standard as amodel for selecting physicians. DOEnever intended to limit an employee’schoice of physicians. To clarify thispoint, DOE has included in section850.34, paragraphs (c) and (d),provisions for a multiple physician andalternate physician review. Theseprovisions are explained in thediscussion that follows.

DOE views medical surveillance as aprimary tool for determining the extentof CBD risk within the workerpopulation. Therefore, section850.34(a)(4) requires responsibleemployers to maintain and give to theSOMD a list of beryllium-associatedworkers who may be eligible for medicalsurveillance. The list must be based onhazard assessments, exposure records,and any other information that willidentify beryllium-associated workers(section 850.34(a)(4)(i)). In addition,section 850.34(a)(4)(ii) requiresresponsible employers to regularlyupdate the list based on the informationfrom the periodic evaluations performedpursuant to paragraph (b)(2) of thissection.

One commenter (Ex. 16) questionedwhy DOE proposed to give the SOMDthe task of identifying workingconditions that contribute to the risk ofCBD and determining the need for



additional exposure controls. Thiscommenter believed that this taskshould be performed by an industrialhygienist. Similarly, another commenter(Ex. 23) stated that the SOMD shouldnot be responsible for performing dataanalysis to determine which workersshould be included in the medicalsurveillance program, or for maintainingthe list of beryllium workers at a site.The commenter argued that both ofthese tasks are management functionsthat should be carried out by theresponsible employer based ontechnical guidance provided by theindustrial hygiene department and theSOMD. DOE agrees with both of thesecommenters. The responsible employer,not the SOMD, should have the functionof identifying working conditions andevaluating the need for workplacecontrols. Consequently, DOE has revisedthe final rule to require that responsibleemployers identify beryllium-associatedworkers. However, medical judgmentsthat are requisite to managementdecisions are the SOMD’s responsibility.

Section 850.34(a)(5) requires theresponsible employer to provide theSOMD with the information needed tooperate and administer the medicalsurveillance program. This informationincludes, but is not limited to, thebaseline beryllium inventory, hazardassessment results, and exposuremonitoring data, as well as informationregarding the identity and nature ofactivities or operations on the site thatare covered under the CBDPP, therelated duties of beryllium workers, andthe types of personal protectiveequipment employed in theperformance of these duties.

Section 850.34(a)(6) requires theresponsible employer to provide theSOMD and the examining physicianwith (1) A copy of this rule and itspreamble; (2) a description of theworkers’ duties as they pertain toberyllium exposure; (3) records of theworkers’ beryllium exposure; and (4) adescription of personal protective andrespiratory protective equipment incurrent or anticipated use. DOE believesthat this information is necessary toensure that the physician can makeinformed decisions regarding therequired content of the medicalevaluation and the subsequentdevelopment of recommendationsrelated to each beryllium-associatedworker.

Several commenters (Ex. 8, 17, 18, 19)suggested including provisions forproviding beryllium education andtraining programs to physicians andother health care providers in the rule.DOE has not adopted this suggestion,

because it would expand the scope ofthe rule.

Section 850.34(b) requires responsibleemployers to provide, without cost toberyllium-associated workers, allmedical evaluations and proceduresperformed to comply with theseregulations. This section also requiresthat all evaluations and procedures beperformed at a time and place that areconvenient for the worker. Thisprovision is consistent with similarprovisions in OSHA’s expanded healthstandards. This section also requiresresponsible employers to provide theSOMD with a list of beryllium-associated workers who may be eligiblefor protective measures under the rule.

Section 850.34(b)(1) requiresresponsible employers to provide abaseline medical evaluation toberyllium-associated workers. Thepurpose of the baseline medicalevaluation is to: (1) Establish the currenthealth status of the worker anddetermine whether it is appropriate toassign the worker to jobs with berylliumexposure; (2) initially determine whatlevel of medical surveillance theresponsible employer must provide tothe worker; and (3) establish essentialbaseline data for the worker which isused to assess subsequent healthchanges attributable to berylliumexposure.

DOE received a number of commentsregarding baseline medical evaluationsand medical testing. One commenter(Ex. 25) requested clarification as to thedifferences between pre-placementexams, as specified in DOE Notice440.1, ‘‘Interim Chronic BerylliumDisease Prevention Program,’’ and thebaseline exams specified in the NOPR.The final rule will supersede DOENotice 440.1, and the interim medicalsurveillance program requirements willbe replaced with those of the final rule.The final rule does not refer to pre-placement exams. Another commenter(Ex. 23) recommended that the meaningof spirometry be clarified to ensureconsistency. DOE agrees and hasspecified the measurement of forcedvital capacity (FVC) and forcedexpiratory volume at 1 second (FEV 1) insection 850.34(b)(1)(v) of the final rule.

A commenter (Ex. 19) questioned thevalue of baseline pulmonary functiontests and x-rays. This commentersuggested that baseline studies cannotbe used to determine which healthchanges are related to work hazards andwhich are related to other activities ordisease processes. This commenterfavored the approach of followingpatients clinically and using Be-LPTand other studies, to augment clinicalimpressions. Early identification of

CBD, this commenter states, might haveno positive effect on the course of thedisease.

DOE disagrees with this comment.Early identification and intervention areimportant for identifying workers athigher risk of exposure to beryllium,and for preventing and minimizing theeffects of beryllium-induced disease.DOE’s position is supported by acommenter (Ex. 29) who stated thatwhile spirometry and X-rays may not bepredictive, X-rays have in someinstances identified CBD cases inindividuals who had a normal Be-LPT.This commenter stated that these casesare likely to be missed if spirometry andX-rays are not required, and alsorecommended X-ray screening for Be-LPT negative individuals withpersistent chest problems. Anothercommenter (Ex. 19) emphasized thebenefits of good data collection todetermine if early removal of berylliumsensitized workers prevents theprogression to CBD.

One commenter (Ex. 33) suggestedthat, if available, recent chest X-rays beutilized for the baseline medicalevaluation to reduce X-ray exposure.DOE agrees that if previous chest X-rayshave been conducted, for a baselineberyllium evaluation, additional X-raysshould not be used unless specified bya physician. However, to ensure that thechest X-ray correlates with otherdiagnostic and historical information,only those X-rays taken for the purposeof a baseline beryllium evaluation orequivalent evaluation should be used toestablish a baseline.

Section 850.34(b)(1)(vi) requiresresponsible employers to provide a Be-LPT as part of the baseline evaluation.The Be-LPT is the only availablelaboratory test for determiningindividual immune response toberyllium in vitro. Its use in asurveillance program will permitdetection of beryllium-related healtheffects at a pre-clinical stage. A positiveBe-LPT would indicate the need forfurther evaluation to determine thepresence of CBD. The use of the Be-LPTas an evaluation tool provides an earlyopportunity for diagnosis and treatmentof CBD.

Finally, section 850.34(b)(1)(vii)authorizes the examining physician tomake available to the worker anyadditional tests deemed medicallynecessary. DOE believes that it isimportant that the examining physicianhave such discretion becauseindividuals may exhibit differentresponses to beryllium. In this regard,one commenter (Ex. 16) expressedconcern regarding proposed section850.33(i), which provided that workers



would be referred for further diagnosticevaluation if there were two or morepositive Be-LPTs. The commenterinterpreted this provision as amandatory requirement. DOE’s intent isthat workers have the opportunity foradditional testing if recommended bythe examining physician. A worker isnot required by the rule to undergoadditional medical evaluation andtreatment.

One commenter (Ex. 29)recommended clinical referral foradditional diagnostic tests after onepositive Be-LPT, instead of two or moreas proposed by DOE. DOE believes thatthe examining physician is in the bestposition to determine which additionaltests, if any, would be useful inevaluating the health of an individualworker. Therefore, DOE has removedthe requirement for follow-up testingbased on two or more positive Be-LPTtests, relying instead on the examiningphysician’s discretion under section850.34(b)(1)(vii) to order follow-up testswhen appropriate.

Section 850.34(b)(2) requiresresponsible employers to providemedical evaluations to berylliumworkers annually, and to otherberyllium-associated workers every 3years. Responsible employers mustprovide the periodic medical evaluationelements described in section850.34(b)(2)(i) to detect, at an earlystage, any pathological changes thatcould lead to CBD or be aggravated byberyllium exposure. By detectingabnormalities early, workers may bemedically removed to prevent furtherberyllium exposure.

Section 850.34(b)(2)(ii) requiresresponsible employers to provide toberyllium-associated workers a chestradiograph (X-ray) every 5 years. DOEincludes this requirement for periodicX-rays because X-rays have been shownto be effective in the early detection ofberyllium-related health effects (Ex. 29).

Following an emergency in which aworker, who is not already participatingin the beryllium medical surveillanceprogram, is exposed to an elevatedamount of beryllium, the responsibleemployer is required by section850.34(b)(3) to provide a medicalevaluation as soon as possible.

A commenter (Ex. 23) suggested thata standard respiratory symptomquestionnaire, medical work historyform, and physical examination form beused at all DOE sites for consistency.DOE agrees that such standardizedforms may help ensure consistencyacross the DOE complex, but isconcerned that mandating the use ofstandardized forms may limit thediscretion of the SOMD in determining

the appropriate medical surveillance foreach individual. Accordingly, DOE hasdecided to include appropriatestandardized forms as non-mandatoryguidance in an implementation guide toaccompany the final rule. Anothercommenter (Ex. 29) was concerned thatthe NOPR required a respiratorysymptom questionnaire for periodicmedical evaluations, but not for thebaseline evaluation. DOE acknowledgesthis oversight and has included therespiratory symptom questionnaire aspart of both the periodic and baselinemedical evaluations in sections850.34(b)(1)(ii) and (b)(2)(I)(B) of thefinal rule.

Section 850.34(c) requires responsibleemployers to establish a multiplephysician review process for affectedberyllium-associated workers. DOE hasidentified three benefits of providing amultiple physician review process: (1)to strengthen and broaden the bases formedical decisions made pursuant to thisrule when a beryllium-associatedworker questions the findings,recommendations, or determinations ofan initial physician retained by theresponsible employer; (2) to increaseberyllium-associated workers’confidence in the soundness of medicalfindings, recommendations anddeterminations made under this rule;and (3) to increase beryllium-associatedworker’s acceptance of, andparticipation, in the medicalsurveillance program.

Given the shortage of trained andexperienced occupational physicians, itis possible that some physiciansperforming examinations orconsultations under the beryllium rulewill misdiagnose CBD. However, ratherthan requiring multiple medicalopinions in all cases, which would beexpensive and potentially wasteful,DOE is providing to beryllium-associated workers an opportunity toobtain an independent review of thefindings, determinations orrecommendations of the physicianselected by the responsible employer.Over time, this independent review islikely to show either that a perceivedlow level of confidence in the physicianretained by the responsible employer isunwarranted, or that the responsibleemployer should improve the quality ofthe medical surveillance beingprovided. In either case, the multiplephysician review process will haveserved a beneficial purpose.

In section 850.34(c)(1), a beryllium-associated worker may designate asecond physician to review anyfindings, determinations, orrecommendations of the physicianchosen by the responsible employer,

and to conduct such examinations,consultations, and laboratory tests as thesecond physician may deem necessaryto facilitate this review. The responsibleemployer’s obligation to provideinformation to the examining physicianextends to other physicians involved inthe multiple physician review oralternate physician review process sothat all of the physicians involved willhave an equal opportunity to assess theberyllium-associated worker’s healthstatus.

Section 850.34(c)(2) requires that afteran initial physician conducts anexamination or consultation, theresponsible employer must promptlynotify the worker of his or her right toseek a second medical opinion. Thisnotification must be in writing.

Section 850.34(c)(3) requires that afterthe worker is notified of this right, theresponsible employer may condition itsparticipation in, and payment for,multiple physician review upon theworker, within 15 days after receipt ofthe notification or the initial physician’swritten opinion, whichever is later, both(1) informing the responsible employerthat the worker intends to seek a secondmedical opinion, and (2) initiating stepsto make an appointment with a secondphysician.

The rule contains no limitation on aberyllium-associated worker’s choice ofa second physician, except therequirement in section 850.34(a)(3) thatthe second physician must be a licensedphysician who is familiar with thehealth effects of beryllium.

If the second physician’s findings,determinations, and recommendationsare the same as those of the initialphysician, then the multiple physicianreview process comes to an end.However, as provided in section850.34(c)(4), if the opinions of the twophysicians are in conflict, then theresponsible employer and theberyllium-associated worker mustundertake to encourage the twophysicians to resolve any disagreement.DOE expects that the two physicianswill communicate with each other toresolve their differences, but the rulerequires the responsible employer andworker to encourage such a resolution.In most cases, this professionalinteraction should resolve anydifferences of opinion.

In cases where differences remain,these differences of opinion are likely tobe genuine and substantial. If the firsttwo physicians are unable to resolveexpeditiously any differences of opinionwith respect to a beryllium-associatedworker, then it is necessary for a thirdqualified physician to resolve thedispute. It is critical that this third



physician has the confidence of thoseconcerned and is competent to resolvethe dispute. Consequently, section850.34(c)(5) requires that theresponsible employer and theberyllium-associated worker together,through their respective physicians,must designate the third physician.

Under section 850.34(c)(5) the thirdphysician will have a full opportunity toreview the findings, determinations, andrecommendations of the two priorphysicians, and to conduct suchexaminations, consultations andlaboratory tests as the third physiciandeems necessary. DOE’s expects that thethird physician will consult with theother two physicians. The thirdphysician should provide a writtenmedical opinion to the SOMD whichwill be used to resolve the disagreementbetween the other two physicians.Section 850.34(c)(6) requires the SOMDto act in a manner consistent with thefindings, determinations, andrecommendations of the thirdphysician, unless the SOMD and theberyllium-associated worker reach anagreement that is otherwise consistentwith the recommendations of at leastone of the other two physicians.

Since the multiple physician reviewprocess will be a means by whichmedical surveillance is provided to aberyllium-associated worker,responsible employers must bear theexpense of this process when it is used.Based on OSHA’s practice andexperience with multiple physicianreview in its health standards, DOE doesnot expect the costs of this process to beburdensome to the responsibleemployers. If responsible employersestablish and administer medicalsurveillance programs that engenderworker confidence, workers should havelittle or no need to seek second medicalopinions.

The requirement for multiplephysician review is not intended topreclude responsible employers fromestablishing and implementing alternatemedical protocols. DOE has includedlanguage in section 850.34(d) to providefor alternate physician determination.Under that section, the responsibleemployer and beryllium-associatedworker, or the worker’s designatedrepresentative, may agree upon the useof any expeditious alternate physiciandetermination process, instead of themultiple physician review process. Theonly condition is that the alternateprocess be no less protective of theworker’s health than the multiplereview process. For example, a jointlyagreed upon physician might be used inthe first instance without recourse toother physicians. DOE encourages

responsible employers and workers toadopt medical determinationprocedures in which all parties havetrust and confidence.

Section 850.34(e)(1) requires theSOMD to provide to responsibleemployers, within two weeks afterreceipt of results, a written and signedmedical opinion after each medicalevaluation of a beryllium-associatedworker. The purpose of requiring theSOMD to give the responsible employera written opinion is to inform theresponsible employer of the medicalbasis for determining the job placementof the examined worker. This writtenmedical opinion, as described in section850.34(e)(i–iii), must contain anydiagnosis of the worker’s conditionrelated to occupational exposure toberyllium; any other detected medicalconditions relevant to further berylliumexposure; any recommended restrictionson the worker’s exposure to berylliumor on the use of protective clothing orequipment; and a statement indicatingthat the SOMD or the examiningphysician has provided to the workerthe results of the test, the medicalevaluation, including all tests resultsand any medical condition related toberyllium exposure that requires furtherevaluation or treatment.

Section 850.34(e)(2) requires theSOMD to withhold from the responsibleemployer, orally or in the writtenmedical opinion, specific findings ordiagnoses not related to occupationalexposure to beryllium.

Two commenters (Ex. 23, 28)expressed concern regarding proposedsection 850.33(j)(2), which stipulatedthat the physician’s written medicalreports be delivered within 15 calendardays after the completion of a medicalevaluation. The commenters noted thatBe-LPT tests are time-consuming andmay exceed the 15-day time frame, andsuggested that the 15-day period shouldbegin after receipt of the test results.DOE agrees, and has revised section850.34(f) to require the SOMD to giveberyllium-associated workers a writtenmedical opinion containing the resultsof all medical tests or procedures, anexplanation of any abnormal findings,and any recommendation that theworker be referred for additional testingwithin 10 working days after theSOMD’s receipt of test results.

In section 850.34(f)(2), upon requestby the beryllium-associated worker, theresponsible employer is required toprovide the worker with a copy of theinformation the responsible employer isrequired to provide to the examiningphysician.

Section 850.34(g) requires theresponsible employer to report on the

applicable OSHA reporting form(currently OSHA Form No. 200)beryllium sensitization, CBD, or anyother abnormal condition or disorder ofworkers caused or aggravated byoccupational exposure to beryllium.Although not included in the proposedrule, this provision reflects currentpractices and does not impose a newburden on employers. Reportingabnormal conditions and disorders thatare occupationally caused andberyllium-related will contribute to thedevelopment of occupational healthstatistics that eventually may lead toimproved disease prevention andmedical intervention for beryllium-associated workers. It will also provideDOE with information and data helpfulin assessing the effectiveness of theCBDPP rule and in considering what, ifany, modification should be made to therule in the future.

Section 850.34(h)(1) requiresresponsible employers to establish aroutine and systematic analysis ofmedical, job, and exposure data. Thepurpose of this requirement is to collectand analyze information so that theprevalence of disease can be accuratelydescribed and conclusions reached oncauses or risk factors for the disease.This data analysis is an effective meansof measuring performance under theCBDPP, and for correcting andimproving the CBDPP. Section850.34(h)(2) requires the responsibleemployer to use the results of theseanalyses to determine which workersshould be offered medical surveillanceand the need for additional exposurecontrols.

Section 850.35—Medical RemovalSection 850.35 (proposed as section

850.34) requires responsible employersto establish medical removal protection(MRP) and medical removal protectionbenefits (MRPB) as part of the CBDPP.

Medical surveillance can only beeffective in detecting and preventingdisease if beryllium-associated workers:(1) voluntarily seek medical attentionwhen they feel ill; (2) refrain fromefforts to conceal their true healthstatus; and (3) fully cooperate withexamining physicians to facilitateaccurate medical diagnoses andeffective treatment. This sort of workerparticipation and cooperation cannot beevoked by coercion; it will occur onlywhere no major disincentives tomeaningful worker participation exist.Without such participation, it would bemuch more difficult, if not impossible,to adequately monitor workers’ healthand to identify workers who needtemporary or permanent medicalremoval.



MRP is a logical result of medicalsurveillance. Without MRP, responsibleemployers would be free to maintainhigh-risk workers in their current jobs,which would not be sufficientlyprotective of their health. Alternatively,responsible employers could choose toterminate workers or transfer them fromhigher-paying, beryllium-exposed jobsto lower-paying, non-beryllium jobs.This might be protective, but it wouldimpair the workers’ standards of living.In either case, the effectiveness andintegrity of the medical surveillanceprogram would be compromised.

With MRP, beryllium-associatedworkers are assured of being removed tojobs where exposure to beryllium is lowif such removal is determined to benecessary to protect their health. WithMRPB, workers are assured that, if theyfully participate in medical surveillanceand if the results of medicalsurveillance require removal from theirberyllium exposed jobs, their normalearnings and job status will be protectedfor a pre-determined period.

Thirty-two commenters (Ex. 12 is aform letter submitted by 16 berylliumworkers) commented on the proposedMRP and MRPB provisions in theNOPR. They addressed a wide variety ofissues and frequently expressedopposing viewpoints. For instance, twocommenters (Exs. 16, 26) stated that theproposed MRP provisions went too far(e.g., two years of protection is too long;accepted applicants should not beincluded under the provisions), whileothers (Exs. 3, 8, 12, 14, 17, 18, 22, 24,28, 29, 31) stated that the provisions didnot go far enough (e.g., two years ofprotection is not long enough; onefollow-up examination is not enough;the training costs limits are toorestrictive; the rule should provideprovisions for multiple physicianreviews). Several commenters (Exs. 20,22, 31) argued against the voluntarynature of the proposed provisions,stating that it would be unethical toallow a worker with CBD to continue tobe exposed to beryllium, and suggestingthat workers could be wrongfullypressured into staying in beryllium-related jobs. Other commenters (Exs. 29,30) agreed with DOE’s proposal torequire employee consent, andrequested that DOE provide additionalguidance to help workers make moreinformed decisions regarding theirmedical removal. DOE has decided,consistent with some of the comments,to use the provisions of OSHA’sexpanded health standards as the basisfor the MRP and MRPB provisions of thefinal rule. DOE has modeled the MRPand MRPB provisions of this final ruleupon similar provisions in OSHA’s

Cadmium, Lead and Benzene standards,29 CFR 1910.27, 1910.1025 and1910.1028, respectively. DOE’s rationalefor each provision of section 850.35 inthe final rule is discussed below.

Section 850.35(a) requires responsibleemployers to offer a beryllium-associated worker medical removal fromexposure to beryllium on each occasionthat the SOMD determines in a writtenmedical opinion that medical removal isrequired. The SOMD’s determinationmust be based upon one or morepositive Be-LPT results, CBD diagnosis,an examining physician’srecommendation, or any other signs orsymptoms the SOMD deems medicallysufficient to show that the worker has amedical condition that places theworker at increased risk of materialimpairment to health from furtherexposure to beryllium.

Section 850.35(a)(1) deals withtemporary removal. It requires theresponsible employer to offer temporarymedical removal to a beryllium-associated worker whenever the SOMDdetermines in a written medical opinionthat the worker should be removedpending a final medical determinationon the worker’s health. The responsibleemployer must offer to temporarilyremove a worker regardless of whethera job is available into which theremoved worker may be transferred. Ifno such job is available, the responsibleemployer must pay medical removalprotection benefits to the worker for upto one year. Section 850.35(a)(1) (iii)and (iv) require that for each time aberyllium-associated worker istemporarily removed, the responsibleemployer must maintain the worker’stotal normal earnings, seniority andother employment rights as if theworker were not removed, either byproviding an appropriate alternative jobor by paying MRPB, for one year.

If a final medical determination ismade that the worker does not have amedical condition which places theworker at increased risk of materialimpairment to health from exposure toberyllium, the temporary MRP must belifted so that the affected worker mayreturn to his or her normal duties.

Section 850.35(a)(2) requires theresponsible employer to offer beryllium-associated workers permanent medicalremoval whenever the SOMDdetermines in a written medical opinionthat the beryllium-associated workershould be permanently removed fromexposure to beryllium. Once a worker ispermanently removed, the worker willreceive the medical removal protectionbenefits specified in section 850.35(b) ofthis rule.

Section 850.35(a)(3) is intended toensure that beryllium-associatedworkers are given the informationneeded to make an informed decisionon whether to accept temporary orpermanent removal from a job with apotential for beryllium exposure.

Section 850.35(a)(4)(i) prohibits theresponsible employer from returning aberyllium-associated worker who hasbeen permanently removed to theworker’s former job status, unless theSOMD has determined in a writtenmedical opinion that removal is nolonger necessary to protect the worker’shealth, or the exception in section850.35(a)(4)(ii) applies. Under section850.35(a)(4)(ii), if there are specialcircumstances that make medicalremoval an inappropriate remedy, or ifthe SOMD’s professional opinion is thatcontinued exposure will not pose anincreased risk to the worker’s health(e.g., the potential decrements to theworker’s lung function are not projectedto be any greater if the worker werepermitted to continue on the job thanthey would be if the worker wereremoved), the SOMD must fully discussthe matter with the worker and, in awritten medical determination, mayrecommend returning the worker to hisor her former job status. The purpose ofthis exception is to provide someflexibility where it is reasonably clearthat returning the worker to his or hernormal job is unlikely to adverselyaffect the worker’s health. For example,a return to work may be justified if aworker who is not experiencing adecrease in lung function, has been onmedical removal for 2 years and is aboutto retire, and the time that the workerwill continue to be occupationallyexposed at or above the action level isvery limited. If the SOMD recommendsreturn of the worker in such cases, theSOMD may require the responsibleemployer to provide the worker withadditional protection, such as asupplied air respirator operated in apositive pressure mode. In any event, adecision to return the worker should bemade only after the SOMD has fullyexplained the relevant facts andprognoses to the worker.

Section 850.35(b) establishes theMRPB that must be provided toremoved workers. DOE believes that theestablishment of MRPB is critical tominimize the disability associated withCBD. Removal from exposure andeffective job-placement efforts, coupledwith early diagnosis and treatment, willincrease the likelihood that affectedberyllium-associated workers willcontinue as productive members of theDOE workforce. In addition, MRPB willencourage worker participation in the



medical surveillance program byproviding beryllium-associated workerswith a reasonable level of assurance thata finding of sensitization or diagnosis ofCBD will not lead to the loss of theiremployment.

Under section 850.35(b)(1), theresponsible employer is required toprovide up to two years of MRPB to aberyllium-associated worker on eachoccasion that he or she is medicallyremoved from exposure to beryllium inaccordance with this part.

Section 850.35(b)(2) requires theresponsible employer to provide the‘‘total normal earnings, seniority, and allother workers rights and benefits’’ of aremoved beryllium-associated worker asif the worker had not been removed.The purpose of this requirement is toensure that a removed worker does notsuffer economic loss due to the removal.Thus, if a removed worker routinelyearned overtime pay on the job fromwhich he or she was removed andwould have continued to do so duringthe removal period, then MRPB mustinclude the amount of expectedovertime as part of the worker’s ‘‘totalnormal earnings.’’ DOE selected 2 yearsas the maximum period during whichthe responsible employer is required topay MRBP to a worker who acceptsremoval instead of the 18 monthprotection period established in OSHA’sLead and Cadmium standards. DOE hasestablished a different protection periodfor beryllium because of thetoxicological differences betweenberyllium and the two metals covered inthe OSHA standards. Specifically, theearly stages of the health impairmentsassociated with exposure to lead orcadmium will reverse in time with noadditional exposure, but berylliumsensitization and CBD will not. Theobjective of OSHA’s 18 month period isto provide workers with sufficientrecovery time so that they can return totheir job. The objective of DOE’s 24month period, however, is to allowberyllium-associated workers whoaccept permanent medical removalsufficient time to be retrained andplaced in different job. DOE believesthat this period should be long enoughto enable the majority of removedberyllium-associated workers to beretrained and placed in another job or,for those workers who can be returnedto their former job status, to be returnedbefore their MRPB expire.

Under section 850.35(b)(3), if aremoved worker files a claim forworkers’ compensation payments for aberyllium-related disability, theresponsible employer must provideMRPB pending disposition of the claim.The responsible employer receives no

credit for the workers’ compensationpayments received by the worker fortreatment related expenses.

In section 850.35(b)(4), theresponsible employer’s obligation toprovide MRPB is reduced by the amountof any compensation the beryllium-associated worker receives from anyother source for earnings lost during theperiod of removal. This provision isnecessary to ensure that MRPB does notresult in a ‘‘windfall’’ to the worker whocollects other compensation, includingsalary from another job, while theworker is on medical removal fromexposure to beryllium.

Section 850.35(b)(5) provides that therequirement that a responsible employerprovide MRPB is not intended toexpand upon or restrict any rights aworker has or would have had, absentmedical removal, to a specific jobclassification or position under theterms of a collective bargainingagreement.

Section 850.35(b)(6) provides that aresponsible employer may condition theprovision of MRPB upon the beryllium-associated worker’s participation inmedical surveillance. Thus, althoughthe rule does not require workerparticipation in medical surveillance, itpermits the responsible employer todeny economic protection to workerswho are unwilling to participate inmedical surveillance. Since theresponsible employer must bear thefinancial burden of medical removal,the employer has a legitimate interest inminimizing the need for medicalremoval. Unless workers participate inmedical surveillance, the responsibleemployer may not be able to identifyworkers whose exposure to berylliumshould be reduced to avoid the need formedical removal.

In providing the responsible employerthe authority to condition provision ofMPRB upon a beryllium-associatedworker’s participation in medicalsurveillance, DOE does not intend topermit an employer to deny MRPB forinsignificant lapses in suchparticipation. The worker’s actionsshould be assessed reasonably, in lightof the goal of prevention of disease andthe employer’s interest in minimizingthe need for medical removal.

Section 850.36—Medical ConsentSection 850.36 (proposed as section

850.35) establishes the medical consentprovisions of the CBDPP. Becauseworker participation in the medicalsurveillance program established by thisrule is voluntary, this section isnecessary to ensure that beryllium-associated workers receive adequateinformation to make an informed

decision regarding their participation inthe program.

Section 850.36(a) requires responsibleemployers to provide beryllium-associated workers with a summary ofthe medical surveillance program, thetype and purpose of data to be collected,how the data will be maintained, andprotections for ensuring theconfidentiality of medical records.Responsible employers must providethis information at least one week beforeany medical evaluation or tests, or whenrequested by the worker.

Section 850.36(b) requires responsibleemployers to provide beryllium-associated workers with information onthe benefits and risks of the medicaltests and examinations offered as part ofmedical surveillance. This informationmust be provided at least one weekprior to any examination or test. DOEexpects responsible employers to makereasonable efforts to help workersunderstand the material. Accordingly,section 850.36(b) requires responsibleemployers to give beryllium-associatedworkers an opportunity to ask questionsand receive answers before a medicalevaluation is performed.

Section 850.36(c) requires responsibleemployers to have the SOMD obtain theberyllium-associated worker’s signatureon the informed consent form found inAppendix A to this part, before medicalevaluations or tests are performed.

Section 850.37—Training andCounseling

Section 850.37 (proposed as section850.36) establishes requirements fortraining and counseling workersregarding exposure to beryllium, andthe potential health effects associatedwith such exposure. This workertraining is necessary because theappropriate implementation of therequired workplace procedures of theCBDPP ultimately rests upon the front-line workers who will be performingwork on, with, or near beryllium orberyllium-contaminated materials.These workers cannot be expected toimplement the required CBDPPprocedures if they are not aware or fullyappreciative of the significance of theseprocedures.

DOE expects that responsibleemployers will conduct training in amanner that is easy to understand.Training material should be appropriatein content and vocabulary to theeducation level, and languagebackground of affected workers. Thegoal of training is to ensure that allworkers, regardless of cultural oreducational background, have theknowledge necessary to reduce andminimize their exposure to beryllium.



Section 850.37(a)(1) requiresresponsible employers to develop andimplement a worker training programfor beryllium-associated workers and allother individuals who work at a sitewhere beryllium activities areconducted, and ensure theirparticipation in the program. DOErecognizes that OSHA’s HazardCommunication standard (29 CFR1910.1200) already requires thatemployers provide their workers withtraining regarding the risks associatedwith all hazardous materials in theworkplace. DOE does not intend thatemployers would implement separateand redundant training and informationprograms to comply with both this ruleand the Hazard Communicationstandard. Accordingly, sections850.37(b)(1) and (2) require responsibleemployers’ CBDPP training andinformation programs to comply withthe Hazard Communication standard aswell as address the contents of theCBDPP. Through this provision, DOEintends for responsible employers tointegrate their CBDPP training andinformation efforts into their existingHazard Communication trainingprogram. This will minimize the burdenon responsible employers and providefor a consistent approach to workertraining and the communication ofworkplace hazards.

DOE added ‘‘contents of the CBDPP’’to the training requirements in section850.37(b) because this information isessential for a worker to understandhow to effectively participate in theCBDPP. OSHA’s HazardCommunication standard (29 CFR1910.1200) does not explicitly refer toanything like a CBDPP. In the final rule,DOE has removed specific mention ofseveral subjects (beryllium health risk,exposure reduction, and safe handlingof beryllium and medical surveillance)that were specifically identified in theproposed rule. These subjects areadequately covered in the HazardCommunication standard.

One commenter (Ex. 3) recommendeddetailed training for workers who havehad, or are likely to have, exposures toberyllium because their assigned tasksmay have involved beryllium. DOEgenerally agrees with the commenterand in the final rule has used aperformance-based approach toidentifying the workers to be trained.Section 850.37(b), paragraphs (1) and(2), require detailed training forberyllium-associated workers.

In the NOPR (Section V, Request forInformation), DOE stated that it wasconsidering including a requirementthat responsible employers develop andimplement an outreach education

program for family members ofberyllium workers. Commentersgenerally agreed on the need to informworkers’ families about berylliumhazards, but had different views abouthow it should be accomplished. Twocommenters (Exs. 16, 26) recommendedthat an outreach requirement not beincluded in the rule and, instead, thatworkers be relied upon to relayberyllium information to their families.Several other commenters (Exs. 17, 28,30, 31) recommended that DOE includean outreach requirement in the rule, andrequire employers to provide berylliuminformation without relying on theworkers. After considering all of thecomments, DOE has added section850.37(b)(3), which requires theresponsible employer to provide to itsworkers information about risks tofamily members. This section reliesupon the workers to relay the relevantberyllium hazard information to theirfamilies. DOE encourages responsibleemployers to provide beryllium-associated workers with informationabout beryllium risks that is readilyunderstandable to family members andothers, as well as to the workers.

One commenter (Ex. 4) recommendedthat the requirement for outreach not beincluded as part of the rule, but thatDOE provide outreach information froma central point in DOE. The commenterfelt that this approach would be moreefficient than having each responsibleemployer develop and provide its ownoutreach information. DOE disagreeswith this comment, and is of the viewthat more effective outreach will beprovided if responsible employersinclude information about berylliumrisks to families and others as part of thedetailed training provided to beryllium-associated workers and those who useprotective clothing and equipment.

One commenter (Ex. 3) recommendedgeneral awareness training for workerswho are not beryllium-associatedworkers but who, at some time, may beat risk because they work at a site whereberyllium activities are conducted. DOEagrees with this recommendation, andsection 850.37(c) requires theresponsible employer to provide generalawareness training about berylliumhazards and controls to these workers.

Section 850.37(d) requires that theresponsible employer provide trainingto workers prior to initial assignmentand at least every two years thereafter toensure that workers are appropriatelyprepared to deal with the hazards andrisks of working with beryllium. Theinitial training requirement of thisparagraph is important to ensure thatworkers have the information they needto protect themselves before they are

actually subject to exposure or potentialexposure hazards. Periodic training isnecessary to reinforce and update initialtraining, especially with regard to theprotective actions workers must take attheir current jobs to reduce theirpotential for exposure to beryllium.DOE has established the frequency oftwo years as a minimum requirement,rather than the proposed one year.

Section 850.37(e) requires theresponsible employer to provideadditional training when the employerhas reason to believe that a berylliumworker lacks the proficiency,knowledge, or understanding needed towork safely with beryllium. Thissituation could occur because ofchanges in workplace operations,controls, or procedures or theavailability of new or updatedinformation regarding the health riskassociated with exposures to beryllium.Also, a worker’s performance may showthat the worker has not retained therequisite proficiency. DOE used theretraining requirements of the OSHAscaffold standard (29 CFR 1926.454(c))as a model for section 850.37(e).

Section 850.37(f) requires theresponsible employer to develop andimplement a worker counseling programto assist beryllium-sensitized workersand workers diagnosed with CBD. Thepurpose of the counseling program is tocommunicate to workers informationthat may help them make importanthealth-and work-related decisions andperform administrative activities, suchas filing workers’ compensation claims.This section also requires theresponsible employer to communicateinformation concerning the followingtopics: the medical surveillanceprogram; medical treatment options;medical, psychological, and careercounseling; medical benefits;administrative procedures and workerrights under applicable workers’compensation laws and regulations;work practices aimed at limiting workerexposure to beryllium; and the risk ofcontinued exposure after sensitization.

One commenter (Ex. 23) cautionedthat the proposed language dealing withworkers’ compensation counselingcould have been interpreted as imposingobligations that exceed employerobligations under states’ workers’compensation statutes. DOE hasincluded in section 850.37(f) thequalifying language ‘‘administrativeprocedures and worker rights’’ and‘‘under applicable workers’compensation laws and regulations’’ tomake clear that DOE does not intend toestablish any new workers’compensation obligations. DOEunderstands that responsible employers



may develop such counseling programsin consultation with labor organizationsrepresenting covered workers, and thatemployers may wish to advise theworkers to consult their own attorneyson these matters.

Another commenter (Ex. 22)recommended that beryllium training beprovided by organizations or personswho receive grants from DOE. Thiscommenter asserted that it isinappropriate for DOE contractors, whoare responsible employers, to conductberyllium training because theseemployers are not sufficientlyindependent. DOE does not agree withthis comment and has not adopted thisrecommendation. The vast majority ofDOE’s safety and health training iscurrently being conducted adequatelyby responsible employers, and it iscommon outside of DOE for employersto provide safety and health training totheir employees.

One commenter (Ex. 21)recommended that this section berevised to include the adult educationprinciples outlined in Appendix E ofOSHA’s Hazard Communicationstandard (29 CFR 1910.1200) becausethese principles have been effectivewhen applied to training workers. WhileDOE has not explicitly referenced thisadvisory Appendix in the final rule,nothing in the rule prohibits its use.Although the Appendix appears to be agood example of the use of adulteducational principles that an employercould use to train workers on theirhazard communication program, it doesnot expressly identify or describe theseprinciples. Responsible employerswould have to infer the principles fromAppendix E and then apply thoseprinciples to their beryllium trainingprogram. In addition, DOE believes thatan explicit reference to this Appendix inthe rule would be confusing becausethis Appendix is not specificallyapplicable to beryllium training.

Section 850.38—Warning Signs andLabels

Section 850.38 (proposed as section850.37) requires responsible employersto post warning signs and labels toensure that the presence and dangersassociated with beryllium andberyllium-contaminated materials orareas are communicated to workers.Section 850.38(a) requires the posting ofwarning signs at all entranceways toestablished regulated areas and thatthese signs bear the following warning:DANGERBERYLLIUM CAN CAUSE LUNG

DAMAGECANCER HAZARDAUTHORIZED PERSONNEL ONLY

The purpose of these signs is tominimize the number of persons in aregulated area by warning workers priorto entry. The signs alert workers to thefact that they must have the appropriateauthorization from their supervisor toenter the regulated area. This isespecially important when regulatedareas are established on a temporarybasis, such as during cleanupoperations. In such cases, workers whotypically work in or travel through thearea may not be aware of the newpotential for exposures to berylliumand, thus, may not be appropriatelyequipped for or aware of the need toprotect themselves from potentialexposures. Warning signs also serve asa constant reminder to those who workin regulated areas that the potential forexposure to beryllium exists in the areaand that appropriate controls must beused.

Sections 850.38(b)(1) requiresresponsible employers to label withappropriate hazard warnings allcontainers of beryllium, berylliumcompounds, or beryllium-contaminatedclothing, equipment, waste, scrap, ordebris to ensure that individuals whocome in contact with the containers areaware of their contents and the need toimplement special handlingprecautions. Because the effectivenessof the warning labels in achieving theseobjectives is greatly dependent upon thevisibility, accuracy, andunderstandability of the content of thelabels, section 850.38(b)(2) furtherspecifies that labels bear the followinginformation:DANGERCONTAMINATED WITH BERYLLIUMDO NOT REMOVE DUST BY BLOWING

OR SHAKINGCANCER AND LUNG DISEASE

HAZARDSection 850.38(c) clarifies that the

warning signs and labels developed tocomply with the CBDPP must alsocomply with the OSHA HazardCommunication standard, 29 CFR1910.1200. DOE believes thisclarification is needed to avoidduplication of effort. In addition, DOEbelieves that ensuring that the contentand format of warning signs and labelscomply with the HazardCommunication standard will result ina consistent, recognizable, andcomprehensive approach to alertingworkers to beryllium’s potential tocause disease.

One commenter (Ex. 20) asked if DOEhad given consideration to requiringthat warning signs and labels beprovided in languages other thanEnglish or the use of universal symbols

to communicate information. DOE notesthat 29 CFR 1910.1200(f)(9) (OSHA’sHazard Communication standard) statesthat employers with employees whospeak other languages may present theinformation in those other languages, aslong as the information is presented inEnglish as well. DOE agrees with thisapproach. Thus, section 850.38(c)requires that all warning signs andlabels comply with 29 CFR 1910.1200.

Another commenter (Ex. 23) notedthat the warning signs provisionsspecified in the NOPR differed slightlyfrom those in DOE Notice 440.1, andsuggested that DOE retain the NOPRlanguage in the final rule in lieu of thelanguage in the Interim CBDPP. DOEnotes that the warning signs and labelsprovisions of the NOPR were based onthe provisions of the Interim CBDPP,with minor modifications added toclarify the intent of the requirements.DOE has retained these clarifications insection 850.38 of the final rule.

A third commenter (Ex. 9) wasconcerned that references to cancer andcancer hazards in warning signs andlabels may be misleading and deceptive,and, noting that the reference did notrepresent the opinion of a qualifiedmedical professional, recommendedthat DOE obtain a ‘‘qualified medicalopinion’’ to resolve this issue. DOEbelieves that the action of theInternational Agency for Research onCancer (IARC) and ACGIH in classifyingberyllium as a human carcinogenprovides sufficient basis for retainingthe cancer warning on warning signsand labels for beryllium-contaminatedmaterials. DOE further notes that NIOSHhas classified beryllium as a potentialoccupational carcinogen since 1977.

Section 850.39—Recordkeeping and Useof Information

Section 850.39 (proposed as section850.38) requires responsible employersto establish and effectively managerecords that relate to the CBDPP and toperiodically submit to the Office ofEnvironment, Safety and Health aregistry of beryllium-associated workers.

Section 850.39(a) requires theresponsible employer to establish andmaintain up-to-date and accuraterecords of all beryllium inventoryinformation, hazard assessments,exposure measurements, exposurecontrols, and medical surveillance data.DOE believes that up-to-date andaccurate records are essential foreffectively implementing the CBDPP,assessing its adequacy, and studying therelationship between workplaceconditions and CBD. Some of theserecords will be needed to implement the



performance feedback provisions insection 850.40.

One commenter (Ex. 31)recommended that the final ruleexplicitly reference OSHA’s regulationsat 29 CFR 1910.1200 and CFR1910.1020. OSHA regulations at 29 CFR1910.1200 (Hazard Communication)already require employers to keeprecords of beryllium inventoryinformation, and regulations at 29 CFR1910.20 (Access to Employee Exposureand Medical Records) already requireemployers to keep records of berylliumhazard assessments, exposuremeasurements, and medicalsurveillance data. DOE has not,however, included in section 850.39references to these OSHA standards.DOE believes that this rule’srequirements for maintaining andtransferring CBDPP-related records,while ensuring confidentiality ofpersonal information, are stated in clearand concise wording specifically relatedto the CBDPP that is preferable to cross-referenced OSHA standards.Furthermore, one commenter’s (Ex. 31)primary concern was ensuring thatworkers have access to the informationthat relates to their personal exposureand medical status. DOE has addressedthis concern in section 850.24(g), byrequiring responsible employers tonotify affected workers of berylliummonitoring results, and in section850.34(d)(2), by requiring the SOMD toprovide to workers the results ofmedical tests and procedures.

DOE encourages responsibleemployers to take advantage of existingrecordkeeping systems to minimize theburden of implementing section 850.39.Responsible employers also may findthat records that are generated outsidethe CBDPP may be useful inimplementing the CBDPP. Examples arerecords of beryllium training, personneldemographics, beryllium missiondescriptions, and payroll records ofprojects that can be used to link workerswith potential beryllium exposure.

Section 850.39(b) requires Heads ofDOE Departmental Elements todesignate all record series required to begenerated under this rule as federalrecords and, therefore, subject to allapplicable federal records managementand access laws.

One commenter (Ex. 18), incommenting on the baseline inventoryprovisions of the proposed rule,recommended that DOE require fullpublic disclosure of health and safetydocuments related to past berylliumemissions and exposures. In the finalrule, DOE is requiring Heads of DOEDepartmental Elements to designate theCBDPP-required records as federal

records. Federal records, except forrecords containing specific types ofsensitive information, are available tothe public under the Freedom ofInformation Act (FOIA) and relatedfederal policy. The FOIA requires thefederal government to releasegovernment records upon request,except for information that is exemptedfrom disclosure to protect an overridinginterest, such as privacy, nationalsecurity, and trade secrets and otherconfidential business information. TheFOIA exemption for information inpersonnel and medical files (5 U.S.C.552(b)(6)) is especially important forDOE CBDPP-required records, becausemany of these records contain medicalinformation that is protected fromrelease by this FOIA provision and otherfederal laws.

One commenter (Ex. 21)recommended that DOE address theretention of records in this rule. DOEhas added to section 850.39(b) therequirement that Heads of DOEDepartmental Elements ensure that therecord series generated as requiredunder this rule are retained for at least75 years, which is consistent withDOE’s policy on retaining medicalrecords. This requirement will ensurethat required CBDPP records that relateto workplace conditions will beavailable in the future to correlate withthe beryllium-associated workers’medical records. Heads of DOEDepartmental elements will be able toensure that they can comply withsection 850.39(b) if the CBDPP-requiredrecords generated by DOE responsibleemployer contractors are identified inthe relevant contracts as DOE-owneddocuments. Therefore, DOE expects thatHeads of DOE Departmental elementswill direct their DOE contract officers tostipulate DOE ownership of thesedocuments in those contracts.

The same commenter recommendedthat DOE address the transfer of recordsto successive responsible employers.DOE agrees that this information shouldbe covered in the rule, and has addedsection 850.39(c) to require responsibleemployers to convey to DOE, or itsdesignee, all record series generatedunder this rule if the responsibleemployer ceases to be involved in theCBDPP (e.g., ceases to be a DOEcontractor).

Section 850.39(d) requires thatresponsible employers create linksbetween data sets on workplaceconditions and health outcomes to serveas a basis for understanding theberyllium health risk. This linkage ofdata will assist DOE and responsibleemployers in identifying unsafe workpractices and understanding the

relationship between workplaceconditions and CBD.

Section 850.39(e) requires theresponsible employer to ensure theconfidentiality of all records containingpersonal, private information that aregenerated as required by this rule.Protecting the confidentiality of theserecords is required by the Americanswith Disabilities Act (42 U.S.C.12112(d)(4)), the Privacy Act (5 U.S.C.552a) and other applicable laws. Inaddition, DOE recognizes that manyberyllium-associated workers willparticipate in some of the voluntarycomponents of the CBDPP only if theybelieve that their personal informationwill be kept confidential.

Section 850.39(e)(1) explicitlyrequires responsible employers toensure that all records that aretransmitted to other parties do notcontain names, social security numbersor any other variables, or combination ofvariables, that could be used to identifyindividuals. DOE recognizes thatresponsible employers must take theseprecautions to prevent the violation ofconfidentiality laws because personalinformation could be obtained fromtransmitted records, or inferred frominformation other than personalidentifiers in the records, unless theseprecautions are taken.

One commenter (Ex. 4) stated that therule’s confidentiality requirementscould prevent industrial hygienists fromobtaining the health outcomeinformation that is necessary to performthe linkage of site workplace conditionsand health outcomes required by section850.39(d). DOE does not intend healthoutcome information that wouldcompromise confidentiality to beprovided to industrial hygienists. DOEbelieves that the linkage required bysection 850.39(d) could be performedafter personal identifiers are removedfrom the health outcome information,making it consistent with section850.39(e)(1).

Another commenter (Ex. 16)recommended that the final rule requirethe responsible employer to placeberyllium medical records in thecustody of a medical director, asopposed to the proposed requirementthat medical records be held by theresponsible employer. DOE recognizesthat beryllium medical records may bein the custody of physicians involved inCBD studies other than the SOMD. DOEresponds to this commenter’s (Ex. 16)concern in section 850.39(e)(2)(i) byrequiring responsible employers toensure that individual medicalinformation generated by the CBDPP iseither included as part of the worker’ssite medical records and maintained by



the SOMD, or is maintained by anotherphysician designated by the responsibleemployer.

Section 850.39(e)(2)(ii) (proposedsection 850.38(d)) retains the proposedrequirement that responsible employersensure that individual medicalinformation generated by the CBDPP ismaintained separately from otherrecords. A commenter (Ex. 19)recommended that the rule requireresponsible employers to use only onedata system, maintained by the SOMD,to facilitate the analysis of the data andto increase workers’ confidence in theconfidentiality of SOMD-maintainedrecords. DOE retained this requirement,however, because the separation ofmedical and other records is good filemanagement. Further, the Americanswith Disabilities Act (42 U.S.C.12112(d)(4)(C)) requires such separationfor privately-owned medicalinformation. DOE recognizes thatanalysis of the data may be somewhatmore difficult with separatelymaintained medical records, butseparation of these records is requiredby law. There also are practical reasonsto require the separation of theserecords. Personnel officials wouldrequire authorization from medicaldirectors before accessing personnelrecords that were stored with medicalrecords. At the same time, the medicaldirectors would need a system to ensurethat no confidential medicalinformation was mixed in with thepersonnel records that personnelofficials accessed. Employers eliminatethese administrative burdens bymaintaining separate medical andpersonnel records.

Section 850.39(f) requires theresponsible employer to maintain allrecords required by this part in currentand accessible electronic form to permitready retrieval of data in a format thatmaintains confidentiality. Thisrequirement is necessary to facilitatetimely, efficient, and cost-effectivetransfer and analysis of CBDPP-relateddata. DOE has added the phrase ‘‘incurrent and accessible’’ to this sectionbecause DOE’s experience indicates thatthe ability to use information held inelectronic records is severely hamperedif the electronic systems are out-of-dateor the records are difficult to obtain.Similarly, DOE has added the phrase‘‘that maintains confidentiality’’ to thissection because DOE’s experienceindicates that transferring informationwhile maintaining confidentialitycannot practically be accomplishedusing systems that must be modified,converted, or replaced before thetransfer can occur.

A commenter (Ex. 21) recommendedthat the final rule require responsibleemployer contractors to use the samerecord retrieval identifiers that anypredecessor contractor used. This wouldallow current contractors easily to linktheir data to the predecessor contractors’data on the same subject. DOE agreesthat successive contractor’s use of thesame record retrieval identifiers wouldmake exposure-health outcome andepidemiology studies easier to conduct.Therefore, DOE encourages successorcontractors to use the same recordretrieval identifiers as the predecessorcontractor. DOE has not, however, madethis a requirement in the final rulebecause it would be inconsistent withDOE’s commitment to a performance-based rule to mandate this practice.DOE’s goal in developing this rule is toallow the responsible employermaximum flexibility by specifying inthe final rule only those record systemcharacteristics and practices that DOEbelieves are essential for achievingsuccessful CBDPPs.

Section 850.39(g) requires theresponsible employer to transmit allrecords required by this rule, in a formatthat protects the confidentiality ofindividuals, to the DOE AssistantSecretary for Environment, Safety andHealth on request. DOE replaced‘‘Headquarters’’ in the proposed rulewith ‘‘Assistant Secretary forEnvironment, Safety and Health’’ in thefinal rule to clarify that DOE’s Office ofEnvironment, Safety and Health is theDOE organization that is responsible forconducting occupational health studiesthat involve DOE workers.

Section 850.39(h) requires theresponsible employer semi-annually totransmit to the DOE Office ofEpidemiologic Studies, Office ofEnvironment, Safety and Health, anelectronic registry of beryllium-associated workers. The transmittedregistry must protect confidentiality andinclude (but is not limited to) thefollowing information for each workerin the registry: a unique identifier, dateof birth, gender, site, job history,medical screening test results, exposuremeasurements, and results of referralsfor specialized medical evaluations.DOE’s collection of this informationconforms to DOE Record System 88,’’Epidemiologic and Other Studies,Surveys, and Surveillance,’’ establishedas required by the Privacy Act. TheOffice of Epidemiologic Surveillance isresponsible for administrative andpolicy decisions related to the berylliumregistry and provides technical supportto the SOMD.

The medical records generated by theCBDPP will be kept in appropriate

agency Privacy Act systems of records,such as DOE–33, ‘‘Personnel MedicalRecords,’’ and/or DOE–88, and will beafforded the protection provided by thePrivacy Act. Should the agency receivea request for these records, it will useevery argument legally and reasonablyavailable to it, including the authoritygranted under the FOIA and the PrivacyAct and the agency’s regulationsimplementing those statutes, to protectthe privacy of individuals in the recordsgenerated by the CBDPP. DOE’s policyexpressed in 10 CFR 1004.3(e)(ii), tomaximize public disclosure of recordsthat pertain to concerns about theenvironment, public health or safety, oremployee grievances, has never beenapplied to jeopardize the privacyinterests of individuals in their medicalrecords and will not be applied tojeopardize privacy interests in recordsgenerated by the CBDPP.

Section 850.39(h) includes ‘‘exposuremeasurements’’ in the registry asrecommended by a commenter (Ex. 14).DOE had inadvertently omittedexposure measurements in the proposedregistry provision. Also, section850.39(h) includes beryllium-associatedworkers as recommended by acommenter (Ex. 28), rather than thenarrower category of beryllium workersas proposed. DOE accepts thisrecommended change because itrecognizes that some DOE workers whocurrently do not perform tasks involvingberyllium are nonetheless at risk ofcontracting CBD (based on pastpotential exposure to beryllium) andmust be included to complete theregistry.

DOE proposed including beryllium-associated workers’ names and socialsecurity numbers in the data that wouldbe included in the beryllium registry.Several commenters (Exs. 16, 23, 28)argued that including the names andsocial security numbers of theberyllium-associated workers in theregistry would compromise theirprivacy. DOE has responded to thesecommenters’ concerns by replacing theproposed ‘‘names’’ and ‘‘social securitynumbers’’ with ‘‘unique identifier.’’ Theterm ‘‘unique identifier’’ is defined insection 850.3(a) to mean the part of apaired set of labels, used in records thatcontain confidential information, thatdoes not identify individuals except byusing the matching label. Only theSOMD will have the key to match theunique identifier to the individual. Thisapproach allows health and safetyprofessionals and researchers to accessthe registry data and allows the SOMDto inform individuals of relevant studyresults, while maintainingconfidentiality at all times.



The beryllium registry will serve as arepository for information on beryllium-associated workers. DOE will use theregistry to determine the exposureprofile and disease status of beryllium-associated workers, and providefeedback to the responsible employer onthe effectiveness of the CBDPP. Theregistry will give DOE the ability tocombine data from different facilitiesand perform analyses that areimpossible to perform with the smallamount of data that is available fromeach individual facility. The combineddata may help DOE identify risk factorsfor CBD and evaluate the predictivevalue of medical tests such as the Be-LPT. Also, researchers may use theregistry to conduct furtherepidemiological studies to betterunderstand the cause and developmentof CBD and better identify those at risk.

One commenter (Ex. 26)recommended that DOE delete theberyllium registry from the final rulebecause the commenter believes that: (1)DOE has not adequately described theresearch for which it will be used, and(2) implementing the registry will becostly. This commenter suggested, as analternative, that DOE retain theberyllium registry, but include in therule the specific research protocol thatwould be used. DOE does not agree withthe commenter. DOE is confident thatthe registry as provided in the final rulewill support the studies needed to betterunderstand the relationship betweenworkplace conditions and CBD. Thisknowledge should provide the basis forimproved worker protections. DOE alsothinks that the expense of the registry iswell justified by these benefits. DOEalso disagrees with the recommendedalternative of including the researchprotocols in this rule. Stipulatingresearch protocols in regulations thatcould only be changed through notice-and-comment rulemaking could stifleresearch activities.

One commenter (Ex. 19) expressed theconcern that DOE’s Office ofEnvironment, Safety, and Health use ofthe beryllium registry could overshadowimportant site-specific studies. DOEbelieves that studies at both the site andnational level are important forunderstanding the relationship betweenworkplace conditions and CBD. DOEhas included section 850.39(d), whichrequires responsible employers to linkdata on workplace conditions andhealth outcomes, in part to facilitate thesite level studies. The beryllium registryestablished by section 850.39(h) will beused by the Office of EpidemiologicSurveillance to support national levelstudies.

Two commenters (Exs. 19, 23)recommended that the rule require thata university or a university with inputfrom an oversight board, or othersuitably qualified organizations designthe epidemiological analysis of theCBDPP-generated data. Althoughresponsible employers and DOE’s Officeof Environment, Safety and Health mayuse universities or other suitablyqualified organizations to design theseanalyses, DOE thinks it would beinappropriate to specify the use of suchorganizations in the rule. Thisrecommendation is not adopted.

Section 850.40—Performance FeedbackThe final rule requirements for

performance feedback in section 850.40are essentially the same as thoseproposed. Section 850.40(a) requiresthat responsible employers conductperiodic analysis and assessment ofmonitoring results, hazards identified,medical surveillance results, attainmentof exposure reduction and minimizationgoals, and occurrence reporting data.DOE believes that the analysis of thesedata is important for the continuousimprovement of the program.

To ensure that all workers have theinformation needed to safely performtheir assigned tasks, section 850.40(b)requires that results of performanceassessments conducted in accordancewith this rule be provided to linemanagers, planners, worker protectionstaff, workers, medical staff, and others.

LIST OF COMMENTERS

ExhibitNo. Company/Organization

1 Atomic Weapons Establishment(AWE)

2 Oak Ridge Institute for Science andEducation (ORISE)

3 U.S. Department of Navy, Navy En-vironmental Health Center

4 Fluor Daniel Hanford, Incorporated5 Burlin McKinney6 Idaho National Engineering and En-

vironmental Laboratory (INEEL),Operated by Lockheed Martin

7 Freddy D. Marler Jr.8 Alfred Glenn Bell9 Lockheed Martin Idaho Tech-

nologies Company, INEEL10 A Concerned American Citizen11 Robert A. Gadon, CIH12 Daniel R. Roberts, Danny Bush,

Willie James Brooks, C.E. Tilley,Robert Lang Freels, Edna & Er-nest Hugart, Victoria L. O’Sheel,Kenneth L. Moore, Cheryll A.Dyer, James M. Harvey, J. R. Mil-ler, Luis Revilla, Connie Willis,Bruce Lawson, Lynn & Linda Cox,Roy & Debra Jones

13 American Industrial Hygiene Asso-ciation (AIHA)

LIST OF COMMENTERS—Continued


14 Gary Foster15 Darrell Lawson16 University of California, Laboratory

Administration17 Hanford Environmental Health Foun-

dation18 Serious Texans Against Nuclear

Dumping (STAND), Incorporated19 American College of Occupational

and Environmental Medicine20 Occupational Safety and Health Ad-

ministration (OSHA)21 University of Cincinnati Medical

Center22 Paper, Allied Industrial Chemical &

Energy Workers Union (PACE)23 Kaiser-Hill Company, Rocky Flats

Environmental Technology Site24 Lockheed Martin Energy Systems,

Incorporated, (Y–12 Facility)25 Lockheed Martin Energy Research

Corporation (Oak Ridge Labora-tory)

26 Brush Wellman, Incorporated27 James Turner28 National Jewish Medical and Re-

search Center29 National Institute for Occupational

Safety and Health (NIOSH)30 Consortium for Risk Evaluation with

Stakeholder Participation(CRESP)

31 International Chemical WorkersUnion Council of the United Foodand Commercial Workers Inter-national Union (ICWUC/UFCW)

32 Concerned Citizens for NuclearSafety (CCNS)

33 Stanford Linear Accelerator Center(SLAC)

34 Fermi National Accelerator Labora-tory (Fermi Lab)

35 United Steelworkers, Local 803136 U.S. House of Representatives, Van

Hilleary37 National Institute for Occupational

Safety and Health (NIOSH)38 Atomic Weapons Establishment

(AWE)38 Commodore Advance Science, In-

corporated40 Hanford Environmental Health Foun-

dation41 Oak Ridge National Laboratory42 Argonne National Laboratory43 Fluor Daniel Hanford, Incorporated44 University of Cincinnati Medical

Center45 Gary Foster46 Pantex Plant47 Kaiser-Hill, Rocky Flats Environ-

mental Technology Site48 Paper, Allied Industrial Chemical &

Energy Workers Union (PACE)49 Consortium for Risk Evaluation with

Stakeholder Participation(CRESP)

50 Brush Wellman, Incorporated51 University of Cincinnati



LIST OF COMMENTERS—Continued


52 Building & Construction Trades De-partment, AFL–CIO

V. Procedural Requirements

A. Review Under Executive Order 12866

This rulemaking has been determinedto be a significant regulatory actionunder Executive Order 12866,‘‘Regulatory Planning and Review,’’ 58FR 51735 (October 4, 1993).Accordingly, today’s action was subjectto review under the executive order bythe Office of Information and RegulatoryAffairs (OIRA). The assessment of thepotential costs and benefits of theproposed rule, which was madeavailable to the public when the NOPRwas published in the Federal Register,was updated to reflect changes made inthe final rule.

Before conducting the assessment,DOE profiled the sites and activities thatwill be affected by the CBDPP rule andestimated the number of workers thatwill be affected by the rule. DOEestimates that 1,634 workers may beexposed or potentially exposed toairborne concentrations of beryllium inthe DOE complex. Furthermore, DOEestimates that 1,236 of these workers(75.6 percent) are potentially exposedabove the action level or the PELprescribed in the CBDPP rule.

DOE began the cost estimation byreviewing the rule to determine whichrequirements of the rule will imposecosts on affected entities. DOE thendetermined the controls (e.g.,implementation of procedures, purchaseof equipment) necessary for affectedentities to be in compliance with eachrequirement. DOE’s assessment refers tothese determinations as complianceprofiles. Since the goal of thecompliance cost estimation is todetermine the incremental costs ofcompliance (OMB Guidance, 1996), thecompliance profiles were compared tothe procedures and controls that arecurrently in place at DOE facilitiesaffected by the rule (i.e., the baseline).Procedures and controls required by theCBDPP rule that are not currently inplace at DOE facilities were considerednew to the facilities, and thus wouldimpose incremental costs on theaffected entities. The complianceprofiles were then adjusted to reflectonly the required incremental controls.

The next step in DOE’s assessmentwas to estimate the costs for eachcompliance profile. DOE collected dataon the cost of each element contained in

the compliance profiles. The profiles aredesigned to reflect the full opportunitycost of compliance. For example, thecompliance profile for performing a Be-LPT test includes not only the test itself,but also the labor time for the workerand physician to conduct the test,shipping the sample to a lab, andanalyzing and interpreting the results ofthe test. The cost data was obtainedfrom a variety of sources, includingCBDPP plans submitted under DOENotice 440.1, a 1999 Environment,Safety and Health (EH) Cost Survey,contact with DOE facilities subject tothe CBDPP rule, trade publications, theU.S. Office of Personnel Management(OPM) (e.g., for wage rates), andprevious economic analyses of otherregulations (e.g., regulatory impactanalyses of OSHA health standards).This cost data was then applied to thecompliance profiles to determine thecosts associated with each profile,providing an estimate of the incrementalcost for each requirement.

DOE-wide cost estimates for eachrequirement were generated bymultiplying the number of units affectedby each requirement by the incrementalcost for each requirement. Costsestimated in this step were thenannualized using a discount rate.Discount rates are used to translate costs(and benefits) that are incurred in futureyears into a present value. FollowingOMB Guidance (1992), DOE chose a 7percent discount rate. In the analysis,DOE uses the 7 percent discount rate forthree purposes: (1) To annualize thecosts of equipment or other programelements that have a lifetime of morethan one year, (2) to translate the costsincurred in future years into a presentvalue, and (3) to calculate theannualized cost of initial requirementsof DOE N 440.1 and the CBDPP rule.

DOE estimated the total compliancecosts of the CBDPP, including the costsof the interim CBDPP under DOE Notice440.1 and the costs of this final rule.DOE estimates an $8.54 millionannualized cost on DOE contractorsbetween July 1997 and December 1999(compliance with DOE Notice 440.1)and a $31.55 million annualized cost onDOE contractors between December1999 (the assumed effective date of thefinal rule) and December 2009. Thisincludes an initial (i.e., startup) cost of$9.02 million incurred in July 1997 andanother initial cost of $2.22 millionincurred in December 1999.

DOE also assessed the potentialbenefits of the CBDPP for DOE, DOEcontractors, and workers. DOE assessedthe following benefits of the CBDPPrule: (1) Reduced medical costs; (2)reduced mortality; (3) increased quality

of life; (4) increased medicalsurveillance for workers at risk; (5)increased work-life for berylliumworkers; (6) increased productivity; (7)reduced legal costs for DOE and DOEcontractors; and (8) a reduction in theexternality associated with berylliumexposure through a transfer of themedical costs from workers to DOEcontractors. Because sufficientinformation on the dose-responserelationship for beryllium is notavailable within the scientificcommunity, DOE could not relatereduced levels of exposure to a specificreduction in CBD and berylliumsensitization. Nevertheless, DOEestimates that the monetary benefitsfrom reduced lifetime medical costscould range from $10,100 to $16,093 foreach avoided case of berylliumsensitization or CBD.

DOE also assessed the potentialeconomic impacts of the rule on theprovision of public goods that containberyllium and the impact on the marketfor beryllium. DOE assessed each ofthese potential impacts and determinedneither will impose a significanteconomic impact. DOE determined thatthe potential reduction in the provisionof beryllium-containing public goodswill be minimal and, consequently, thereduction in demand for beryllium willalso be small.

DOE’s assessment of the potentialcosts and benefits of the final has beenplaced in the rulemaking file (DocketNumber EH–RM–98–BRYLM). DOE alsohas placed in the rulemaking file adocument that identifies the substantivechanges between the draft final rulesubmitted to the OIRA for review andthe final rule published today, includingidentification of the changes suggestedor recommended by OIRA. Thesedocuments may be reviewed and copiedat the DOE of Information ReadingRoom, Room 1E–190, 1000Independence Avenue, SW,Washington, DC 20585, between thehours of 8:30 a.m. and 4:00 p.m.,Monday through Friday, except Federalholidays.

B. Review Under the RegulatoryFlexibility Act

The Regulatory Flexibility Act, 5U.S.C. 601–612, requires that an agencyprepare a regulatory flexibility analysisand publish it at the time of publicationof general notice of proposedrulemaking for the rule. Thisrequirement does not apply if theagency certifies that the rule will not, ifpromulgated, have a significanteconomic impact on a substantialnumber of small entities (5 U.S.C.605(b)).



Today’s action establishes DOE’sregulations for a CBDPP to reduce thenumber of DOE Federal and contractorworkers exposed to beryllium, minimizethe levels of and potential for exposureto beryllium, and establish medicalsurveillance requirements to ensureearly detection of disease. Thecontractors who manage and operateDOE facilities are principallyresponsible for implementing theCBDPP. DOE has considered whetherthese contractors are ‘‘smallbusinesses,’’ as that term is defined bythe Regulatory Flexibility Act (5 U.S.C.601(3)). The Regulatory Flexibility Act’sdefinition incorporates the definition of‘‘small business concern’’ in the SmallBusiness Act, which the Small BusinessAdministration (SBA) has developedthrough size standards in 13 CFR part121. Small businesses are businessconcerns which, together with theiraffiliates, have no more than 500 to 1500employees, varying by SIC category, andannual receipts of between $0.5 millionto $25 million, again varying by SICcategory. The DOE contractors subject tothe CBDPP requirements exceed theSBA’s size standards for smallbusinesses. In addition, DOE contractorsare reimbursed through their contractswith DOE for the costs of complyingwith DOE health and safety programrequirements. They will not, therefore,be adversely impacted by therequirements in the rule. For thesereasons, DOE certifies that the final rulewill not have a significant economicimpact on a substantial number of smallentities.

C. Review Under the PaperworkReduction Act

DOE submitted the proposedcollections of information in this rule tothe Office of Management and Budgetfor review under section 3507(d) of thePaperwork Reduction Act of 1995 (42U.S.C. 3507(d)). The information thatDOE contractors are required toproduce, maintain and report isnecessary to permit the Department tomanage and oversee the health andsafety programs that control workerexposure to beryllium. The Office ofManagement and Budget has not yetapproved the collections of informationin this rule. An agency may not conductor sponsor, and a person is not requiredto respond to a collection of informationunless it displays a currently valid OMBcontrol number (5 CFR 1320.5(b)).

D. Review Under the NationalEnvironmental Policy Act

DOE has reviewed the promulgationof 10 CFR Part 850 under the NationalEnvironmental Policy Act (NEPA) of

1969 (42 U.S.C. 4321 et seq.), theCouncil on Environmental Qualityregulations for implementing NEPA (40CFR parts 1500–1508), and DOE’s NEPAimplementing procedures (10 CFR Part1021). DOE has completed anEnvironmental Assessment, and on thebasis of that assessment has determinedthat an environmental impact statementis not required and issued a Finding ofNo Significant Impact (FONSI) for thisrule. In the Notice of ProposedRulemaking, the Department announcedthe availability of the draftEnvironmental Assessment andrequested comments on the Assessment.DOE did not receive any comments onthe draft Environmental Assessment.The Environmental Assessment updatesthe draft Environmental Assessment(DOE/EA 1249) to reflect changes in thefinal rule made in response to publiccomments on the rule. TheEnvironmental Assessment and FONSIare available for inspection at the DOEFreedom of Information Reading Room,1E–190, 1000 Independence AvenueSW, Washington, DC 20585, betweenthe hours of 9 a.m. and 4 p.m., Mondaythrough Friday, except Federal holidays.

E. Review Under Executive Order 13132Executive Order 13132 (64 FR 43255,

August 4, 1999), imposes certainrequirements on agencies formulatingand implementing policies orregulations that preempt State law orthat have federalism implications.Agencies are required to examine theconstitutional and statutory authoritysupporting any action that would limitthe policymaking discretion of theStates and carefully assess the necessityfor such actions. DOE has examinedtoday’s rule and has determined that itdoes not preempt State law and does nothave a substantial direct effect on theStates, on the relationship between thenational government and the States, oron the distribution of power andresponsibilities among the variouslevels of government. No further actionis required by Executive Order 13132.

F. Review Under Executive Order 12988Section 3 of Executive Order 12988,

‘‘Civil Justice Reform,’’ 61 FR 4729(February 7, 1996), instructs eachagency to adhere to certain requirementsin promulgating new regulations.Executive agencies are required bysection 3(a) to adhere to the followinggeneral requirements: (1) Eliminatedrafting errors and ambiguity; (2) writeregulations to minimize litigation; and(3) provide a clear legal standard foraffected conduct rather than a generalstandard and promote simplificationand burden reduction. With regard to

the review required by section 3(a),section 3(b) of Executive Order 12988specifically requires that Executiveagencies make every reasonable effort toensure that the regulation: (1) Clearlyspecifies the preemptive effect, if any;(2) clearly specifies any effect onexisting federal law or regulation; (3)provides a clear legal standard foraffected conduct while promotingsimplification and burden reduction; (4)specifies the retroactive effect, if any; (5)adequately defines key terms; and (6)addresses other important issuesaffecting clarity and generaldraftsmanship under any guidelinesissued by the Attorney General. Section3(c) of Executive Order 12988 requiresExecutive agencies to review regulationsin light of applicable standards insection 3(a) and section 3(b) todetermine whether they are met or it isunreasonable to meet one or more ofthem. DOE has completed the requiredreview and determined that this finalrule meets the relevant standards ofExecutive Order 12988.

G. Review Under the UnfundedMandates Reform Act of 1995

Title II of the Unfunded MandatesReform Act of 1995 (Pub. L. 104–4)requires each federal agency, to theextent permitted by law, to prepare awritten assessment of the effects of anyFederal mandate in an agency rule thatmay result in the expenditure by State,local, and tribal governments, in theaggregate, or by the private sector, of$100 million in any one year. It alsorequires a federal agency to develop aneffective process to permit timely inputby elected officers of State, local, andtribal governments on a proposed‘‘significant Federal intergovernmentalmandate,’’ and requires an agency planfor giving notice and an opportunity fortimely input to potentially affectedsmall governments before establishingany requirements that mightsignificantly or uniquely affect smallgovernments. The final rule publishedtoday applies only to activitiesconducted by or for DOE, and itsimplementation will not result in anexpenditure of $100 million in any yearby State, local or tribal governments orthe private sector. Therefore, therequirements of Title II UnfundedMandates Reform Act of 1995 do notapply.

H. Review Under Small BusinessRegulatory Enforcement Fairness Act of1996

As required by 5 U.S.C. 801, DOE willreport to Congress promulgation of thisrule prior to its effective date. Thereport will state that it has been



determined that the rule is not a ‘‘majorrule’’ as defined by 5 U.S.C. 804(2).

Appendix A to the Preamble References

1. ‘‘Beryllium Disease: Reducing the Risks.’’National Jewish Medical and ResearchCenter Website (http://www.nationaljewish.org/beryllium/). 1999.

2. Green DM et al. ‘‘Agency for ToxicSubstances and Disease Registry (ASTDR)Case Studies in Environmental Medicine,No.19.’’ U.S. Department of Health andHuman Services. 1992.

3. Hardy HL, Tabershaw IR. ‘‘DelayedChemical Pneumonitis Occurring inWorkers Exposed to BerylliumCompounds.’’ Journal of Industrial HygieneToxicology, Volume 28:197 (1946).

4. Powers MB. ‘‘History of Beryllium.’’ InBeryllium Biomedical and EnvironmentalAspects. Rossman MD, Preuss OP, andPowers MB, eds. Baltimore: Williams andWilkins, 1991.

5. Eisenbud M et al. ‘‘Non-occupationalBerylliosis.’’ Journal of Industrial HygieneToxicology, Volume 31:282–294 (1949).

6. Eisenbud M, Lisson J. ‘‘EpidemiologicAspects of Beryllium-InducedNonmalignant Lung Disease: A 30–YearUpdate.’’ Journal of OccupationalMedicine, Volume 25:196–202 (1983).

7. Sterner JH, Eisenbud M. ‘‘Epidemiology ofBeryllium Intoxication.’’ Archives ofIndustrial Hygiene and OccupationalMedicine, Volume 4:123–157 (1951).

8. Newman LS, Kreiss K. ‘‘NonoccupationalBeryllium Disease Masquerading asSarcoidosis: Identification by BloodLymphocyte Proliferative Response toBeryllium.’’ American Review ofRespiratory Disease, Volume 145:1212–1214 (1992).

9. Tepper LB. ‘‘Introduction.’’ In: BerylliumBiomedical and Environmental Aspects.Rossman MD, Preuss OP, and Powers MB,eds. Baltimore: Williams and Wilkins,1991.

10. Sprince NL, Kazemi H. ‘‘BerylliumDisease.’’ In: Environmental andOccupational Medicine, 2nd ed. Room W,ed. Boston: Little, Brown, 1992.

11. Newman LS et al. ‘‘Pathologic andImmunologic Alterations in Early Stages ofBeryllium Disease. Reexamination ofDisease Definition and Natural History.’’American Review of Respiratory Disease,Volume 139:1479–11486, (1989).

12. Kreiss K, Newman LS, Mroz MM,Campbell, PA. ‘‘Screening Blood TestIdentifies Subclinical Beryllium Disease.’’Journal of Occupational Medicine, Volume31:603–608 (1989).

13. Rossman MD, Kern JA, Elias JA et al.‘‘Proliferative Response of BronchoalveolarLymphocytes to Beryllium: A Test ForChronic Beryllium Disease.’’ Annals ofInternal Medicine, Volume 108:687–693(1988).

14. Saltini C, Winestock K, Kirby M et al.‘‘Maintenance of Alveolitis in Patients withChronic Beryllium Disease by BerylliumSpecific Helper T-Cells.’’ New EnglandJournal of Medicine, Volume 320:103–1109(1989).

15. Cullen MR et al. ‘‘Chronic BerylliumDisease in a Metal Refinery. Clinical

Epidemiologic and Immunologic Evidencefor Continuing Risk from Exposure to LowLevel Beryllium Fume.’’ American Reviewof Respiratory Disease, Volume135(1):201–208 (1987).

16. Kreiss K, Mroz MM, Zhen B et al.‘‘Epidemiology of Beryllium Sensitizationand Disease in Nuclear Workers.’’American Review of Respiratory Disease,Volume 148:985–991 (1993).

17. Kreiss K et al. ‘‘Beryllium DiseaseScreening in the Ceramics Industry.’’Journal of Occupational Medicine, Volume35:267–274 (1993).

18. Health Assessment Document forBeryllium [Publication No. EPA/600/8–84/026F] U.S. Environmental ProtectionAgency. (1987).

19. Stange AW et al. ‘‘Possible Health Risksfrom Low Level Exposure to Beryllium.’’Toxicology, Volume 111:213–224 (1996).

20. Barnard AE, et al. ‘‘RetrospectiveBeryllium Exposure Assessment at theRocky Flats Environmental TechnologySite.’’ American Industrial HygieneAssociation Journal, Volume 57:804–808(1996).

21. Kreiss K et al. ‘‘Machining Risk ofBeryllium Disease and Sensitization withMedian Exposures Below 2 µg/m3,’’American Journal of Industrial Medicine,Volume 30:16–25 (1996).

22. Kreiss K, Mroz M, Zhen B, WiedemannH, Barna B. Risks of beryllium diseaserelated to work processes at a metal, alloy,and oxide production plant. Occupationaland Environmental Medicine, Volume54:605–612 (1997).

23. Cohen BS. ‘‘Air Sampling.’’ In: BerylliumBiomedical and Environmental Aspects.Rossman MD, Preuss OP, and Powers MB,eds. Baltimore: Williams and Wilkins,1991.

24. Finch GL. ‘‘In Vitro DissolutionCharacteristics of Beryllium Oxide andBeryllium Metal Aerosols.’’ Journal ofAerosols Science, Volume 19:333–342(1988).

25. Newman LS. ‘‘To Be2∂ or Not to Be2∂ :Immunogenetics and OccupationalExposure.’’ Science, Volume 262:197–198(8 October 1993).

26. Haley PJ. ‘‘Mechanisms of GranulomatousLung Disease from Inhaled Beryllium: TheRole of Antigenicity in GranulomaFormation.’’ Toxicologic Pathology,Volume 19:514–525 (1991).

27. Finch GL. ‘‘Clearance, Translocation, andExcretion of Beryllium FollowingInhalation of Beryllium Oxide by BeagleDogs.’’ Fundamentals of AppliedToxicology, Volume 15:231–241 (1990).

28. Richeldi L et al. ‘‘HLA-DPB1 Glutamate69: A Genetic Marker of BerylliumDisease.’’ Science, Volume 262:242–244 (8October 1993).

29. Eisenbud M. ‘‘The Standard for Controlof Chronic Beryllium Disease.’’ AppliedOccupational Environmental Hygiene,Volume 13(1):25–31 (January 1998).

30. Pappas GP et al. ‘‘Early PulmonaryPhysiologic Abnormalities in BerylliumDisease.’’ American Review of RespiratoryDisease, Volume 148:661–666 (1993).

31. Yoshida T et. al. ‘‘A Study on theBeryllium Lymphocyte Transformation

Test and the Beryllium Levels in WorkingEnvironment.’’ Industrial Health, Volume35(3):374–9 (Jul 1997).

32. Threshold Limit Value for ChemicalSubstances and Physical Agents andBiological Exposure Indices, Notice ofIntended Change (1999).

33. U.S. Environmental Protection Agency:Integrated Risk Information System,Substance File—Beryllium andCompounds, CASRN 7440–41; U.S.Environmental Protection Agency,Washington, DC (1998).

34. Epstein WL. ‘‘Cutaneous Effects ofBeryllium.’’ In: Beryllium Biomedical andEnvironmental Aspects. Rossman MD,Preuss OP, and Powers MB, eds. Baltimore:Williams and Wilkins, 1991.

35. Sanderson WT et. al. ‘‘BerylliumContamination Inside Vehicles of MachineShop Workers.’’ Applied OccupationalEnvironmental Hygiene, Volume 14:223–230 (1999).

Appendix B to the Preamble—Questions and Answers Concerning theBeryllium-Induced LymphocyteProliferation Test (Be-LPT), MedicalRecords, and the Department of Energy(DOE) Beryllium Registry

What Is the Be-LPT Blood Test?In the Be-LPTs, disease-fighting blood

cells that are normally found in thebody, called lymphocytes, are examinedin the laboratory and separated fromyour blood. Beryllium and other testagents are then added to small groups ofthese lymphocytes. If these lymphocytesreact to the beryllium in a specific way,the test results are ‘‘positive.’’ If they donot react to beryllium, the test is‘‘negative.’’

Experts believe that the Be-LPT showspositive results in individuals who havebecome sensitive or allergic toberyllium. It is unclear what thissensitivity means. Studies have shownit to be an early sign of chronicberyllium disease (CBD) in manyindividuals. In others, sensitivity mightsimply mean that the person wasexposed to beryllium and that his or herbody has reacted. It might mean that anindividual is more likely than others toget CBD. You are being offered the Be-LPT because doctors believe it is usefulin detecting cases of CBD early or casesthat might otherwise be missed ordiagnosed as another type of lungproblem. Once CBD is identified,doctors can determine the treatment thatis needed to minimize the lung damagethat CBD causes.

As in any other medical test, the Be-LPT sometimes fails or provides unclearresults. The laboratory calls theseresults ‘‘uninterpretable.’’ Even whenthe test appears successful, it mayappear positive when a person is notsensitive or allergic to beryllium. This iscalled a ‘‘false positive’’ result. It is also



possible that the test will show‘‘negative’’ results when a person isactually ‘‘sensitized’’ to beryllium. Thisis a ‘‘false negative’’ result. If you havea ‘‘uninterpretable’’ blood Be-LPTresult, you will be asked to provideanother blood sample so the test can berepeated. If you have ‘‘positive’’ results,you will be offered further medical teststo confirm or rule out CBD. Rememberthat you may refuse further tests at thispoint or at any point during yourmedical evaluations.

It is important for you to know thatif the physical examination or theresults from other tests you are receivingsuggest that you have CBD, you may beoffered further medical tests. Thesemedical tests may be offered even ifyour Be-LPT is ‘‘negative.’’

Some individuals with confirmed‘‘positive’’ Be-LPTs but no other signs ofCBD have developed the disease. Thelikelihood of this happening will onlybe known after large groups ofpotentially exposed individuals havehad their blood tested, have had furthermedical tests, and are studied for manyyears.

Do I Have To Have the Be-LPT Done?No. Your participation in the medical

surveillance program is strictlyvoluntary. You may refuse any of thetests offered to you, including the Be-LPT. If you change your mind, you arefree to participate in the program at anytime. Talking with your family, yourdoctor, or other people you trust mayhelp you decide. The physicians in theclinic that provide the tests can alsohelp answer any questions that youmight have.

What Will Happen if I Decide To Havethe Be-LPT Blood Test?

A small amount of your blood will bedrawn from a vein in your arm and sentto a laboratory. There is little physicalrisk in drawing blood. Slight pain andbruising may occur in a few individuals.Rarely, the needle puncture will becomeinfected. Other routine medicalevaluation tests may be offered whenyou have the Be-LPTs including aphysical examination, a chest X-ray, andbreathing tests that help find signs ofCBD, if they exist.

Other diseases may resemble CBD.Different medical tests can help aphysician decide if a person has CBD oranother disease. If the examiningphysician suspects that you have CBD,he or she will recommend additionalmedical tests to help confirm adiagnosis. Separate informationregarding these additional medical testswill be given to you if they arerecommended. Your consent will be

requested when the extra tests are given.You can always refuse additional tests,if you so choose. Your employer willpay for all tests.

When Will I Receive the Results of MyBe-LPT Blood Test?

It could take 2 to 4 weeks for you toreceive a letter informing you of yourtest results. The test itself usually takes8 days to perform. The testing laboratoryreports results to the physician whoexamined you and he or she will notifyyou.

Could a Positive Be-LPT Blood TestAffect My Job Assignment?

Yes. If you have a positive Be-LPT orhave been diagnosed with CBD, youremployer may inform you that theSOMD has recommended that you betemporarily or permanently removedfrom working with beryllium. You willbe given information and counseling tohelp you decide whether to acceptmedical removal. If you agree to medicalremoval, every effort will be made tooffer you another job that you arequalified (or can be trained for in a shortperiod) to perform and where theberyllium exposures will be as low aspossible, but in no case above the actionlevel.

If you are temporarily removed, youwill maintain your total normalearnings, seniority, and other benefitsuntil you are placed in another job for1 year, whichever comes first. If you arepermanently removed, you willmaintain your total normal earnings,seniority, and other benefits until youare placed in another job or for 2 years,whichever comes first. If you becomephysically unable to continue working,you may be eligible for workers’compensation and other benefits.

Will I Lose Any Pay or Any OtherBenefits by Having the ExaminationDuring Normal Working Hours?

No. Your examination will bescheduled during normal work hours.You will not be required to take leaveto have the examination, nor will youlose pay or any other benefits.

What Will Happen to the Records of theMedical Examination Results?

The results of your Be-LPT and otherscreening tests will be made available toyou and, with your consent, to yourphysician. The information also willbecome part of your medical record,which the clinic keeps.

The results of tests and examinationsin your medical record will be availableto the physicians and nurses in thisclinic, and possibly to scientistsconducting health studies. The test

results in your medical records will bekept in specially secured files under thesupervision of physicians and nurses inthe clinic, separate from other personnelrecords. Your test results will bemedically confidential data and will notbe released to anyone other than thoselisted in the following, unless youprovide written permission. Thefollowing groups will have direct accessto this information:

1. Clinic staff members;2. Medical specialists who will

provide or arrange for additionalmedical treatment or tests, if necessary;

3. U.S. Department of EnergyBeryllium Registry staff; and

4. The Centers for Disease Control andPrevention and the National Institute forOccupational Safety and Health officialsmay require direct access to records thatidentify you by name for health studies.

If information about you is used inreports or a published health study,your identity will be disguised. You willnot be identified in any publishedreport or presentation.

What Laws Protect Me if I Consent ToParticipate in the Blood Be-LPT TestingProgram?

State medical and nursing licensingboards enforce codes of ethics thatrequire doctors and nurses to keepmedical information confidential. ThePrivacy Act prevents unauthorizedaccess to your DOE records withoutyour permission. The information inrecords kept by your employer must behandled in accordance with theAmericans with Disabilities Act and thePrivacy Act of 1974. The consent formyou sign also provides additionalprotection.

Can My Privacy and the Confidentialityof My Medical Records Be Guaranteed?

No. Access to or release of recordscould be required under court order, orDOE directive, but it is unlikely. Itwould also be available as the Freedomof Information Act or Privacy Actprovide, such as to Congress, to anindividual upon a showing ofcompelling circumstances affecting thehealth and safety of an individual, etc.If you apply for another job or forinsurance, you may be requested torelease the records to a future employeror an insurance company. If, for medicalreasons, it is recommended that youtransfer to an area where you will notcontact beryllium, and you elect to doso, the personnel department and yoursupervisor will be notified. They willnot be told the specific results of yourtests but, because of the restrictions,they may assume that your Be-LPTresults were positive.



What Is the DOE Beryllium Registry?

Your health and the health of allworkers is a major concern to DOE.There is a need to learn more aboutchronic beryllium disease and whatcauses some individuals to react morestrongly than others do. A DOEberyllium registry has been establishedto collect and maintain information onworkers who are exposed to beryllium.This registry is a tool that will be usedin health studies to better understandthe nature of the disease. With it we canmeasure the burden of health effectsrelated to beryllium exposure. Theregistry will also be used to evaluate theeffectiveness of exposure controlprograms.

In addition to information about yourberyllium-related exposures, the resultsof beryllium sensitization testing and/orCBD status collected by your employerwill be added to the registry. Youremployer must treat this information asconfidential medical information andcan only use or disclose thisinformation in conformance with thePrivacy Act of 1974, the Americans withDisabilities Act, and other applicablelaws. Your employer will establish aunique identifier for you that will beincluded in the registry instead of yourpersonal identifying information (suchas your name and social securitynumber). The unique identifier will beused to inform your employer of anystudy results that you and youremployer’s Site Occupational MedicalDirector (SOMD) should know about.The SOMD will know to whom theunique identifier refers and will notifyyou of these results. At no time willyour name or other personal identifyinginformation be included in any report.The confidentiality of personalinformation in DOE records is protectedunder the Privacy Act of 1974.

List of Subjects in 10 CFR Part 850

Beryllium, Chronic beryllium disease,Hazardous substances, Lung diseases,Occupational safety and health,Reporting and recordkeepingrequirements.

Issued in Washington, D.C., on November24, 1999.

Bill Richardson,Secretary of Energy.

For the reason set forth in thepreamble, Title 10, Chapter III of theCode of Federal Regulations is amendedby adding a new part 850 as set forthbelow.

PART 850—CHRONIC BERYLLIUMDISEASE PREVENTION PROGRAM

Subpart A—General Provisions

Sec.850.1 Scope.850.2 Applicability.850.3 Definitions.850.4 Enforcement.850.5 Dispute resolution.

Subpart B—Administrative Requirements

850.10 Development and approval of theCBDPP.

850.11 General CBDPP requirements.850.12 Implementation.850.13 Compliance.

Subpart C—Specific Program Requirements

850.20 Baseline beryllium inventory.850.21 Hazard assessment.850.22 Permissible exposure limit.850.23 Action level.850.24 Exposure monitoring.850.25 Exposure reduction and

minimization.850.26 Regulated areas.850.27 Hygiene facilities and practices.850.28 Respiratory protection.850.29 Protective clothing and equipment.850.30 Housekeeping.850.31 Release criteria.850.32 Waste disposal.850.33 Beryllium emergencies.850.34 Medical surveillance.850.35 Medical removal.850.36 Medical consent.850.37 Training and counseling.850.38 Warning signs and labels.850.39 Recordkeeping and use of

information.850.40 Performance feedback.

Appendix A to Part 850—Chronic BerylliumDisease Prevention Program InformedConsent Form.

Authority: 42 U.S.C. 2201(i)(3), (p); 29U.S.C. 668; E.O. 12196, 3 CFR 1981 comp.,p. 145 as amended.

Subpart A—General Provisions

§ 850.1 Scope.

This part establishes a chronicberyllium disease prevention program(CBDPP) that supplements and isintegrated into existing workerprotection programs that are establishedfor Department of Energy (DOE)employees and DOE contractoremployees.

§ 850.2 Applicability.

(a) This part applies to:(1) DOE offices responsible for

operations or activities that involvepresent or past exposure, or thepotential for exposure, to beryllium atDOE facilities;

(2) DOE contractors with operationsor activities that involve present or pastexposure, or the potential for exposure,to beryllium at DOE facilities; and

(3) Any current DOE employee, DOEcontractor employee, or other worker ata DOE facility who is or was exposed orpotentially exposed to beryllium at aDOE facility.

(b) This part does not apply to:(1) Beryllium articles; and(2) DOE laboratory operations that

meet the definition of laboratory use ofhazardous chemicals in 29 CFR1910.1450, Occupational Exposure toHazardous Chemical in Laboratories.

§ 850.3 Definitions.(a) As used in this part:Action level means the level of

airborne concentration of berylliumestablished pursuant to section 850.23of this part that, if met or exceeded,requires the implementation of workerprotection provisions specified in thatsection.

Authorized person means any personrequired by work duties to be in aregulated area.

Beryllium means elemental berylliumand any insoluble beryllium compoundor alloy containing 0.1 percentberyllium or greater that may bereleased as an airborne particulate.

Beryllium activity means an activitytaken for, or by, DOE at a DOE facilitythat can expose workers to airborneberyllium, including but not limited todesign, construction, operation,maintenance, or decommissioning, andwhich may involve one DOE facility oroperation or a combination of facilitiesand operations.

Beryllium article means amanufactured item that is formed to aspecific shape or design duringmanufacture, that has end-use functionsthat depend in whole or in part on itsshape or design during end use, and thatdoes not release beryllium or otherwiseresult in exposure to airborneconcentrations of beryllium undernormal conditions of use.

Beryllium-associated worker means acurrent worker who is or was exposedor potentially exposed to airborneconcentrations of beryllium at a DOEfacility, including:

(1) A beryllium worker;(2) A current worker whose work

history shows that the worker may havebeen exposed to airborne concentrationsof beryllium at a DOE facility;

(3) A current worker who exhibitssigns or symptoms of berylliumexposure; and

(4) A current worker who is receivingmedical removal protection benefits.

Beryllium emergency means anyoccurrence such as, but not limited to,equipment failure, container rupture, orfailure of control equipment oroperations that results in an unexpected



and significant release of beryllium at aDOE facility.

Beryllium-induced lymphocyteproliferation test (Be-LPT) is an in vitromeasure of the beryllium antigen-specific, cell-mediated immuneresponse.

Beryllium worker means a currentworker who is regularly employed in aDOE beryllium activity.

Breathing zone is defined as ahemisphere forward of the shoulders,centered on the mouth and nose, witha radius of 6 to 9 inches.

DOE means the U.S. Department ofEnergy.

DOE contractor means any entityunder contract with DOE (or itssubcontractor) that has responsibility forperforming beryllium activities at DOEfacilities.

DOE facility means any facilityoperated by or for DOE.

Head of DOE Field Element means anindividual who is the manager or headof the DOE operations office or fieldoffice, or any official to whom the Headof DOE Field Element delegates his orher functions under this part.

High-efficiency particulate air (HEPA)filter means a filter capable of trappingand retaining at least 99.97 percent of0.3 micrometer monodispersedparticles.

Immune response refers to the seriesof cellular events by which the immunesystem reacts to challenge by an antigen.

Medical removal protection benefitsmeans the employment rightsestablished by section 850.35 of thispart for beryllium-associated workerswho voluntarily accept temporary orpermanent medical removal fromberyllium areas following arecommendation by the SiteOccupational Medicine Director.

Operational area means an area whereworkers are routinely in the presence ofberyllium as part of their work activity.

Regulated area means an areademarcated by the responsible employerin which the airborne concentration ofberyllium exceeds, or can reasonably beexpected to exceed, the action level.

Removable contamination meansberyllium contamination that can beremoved from surfaces bynondestructive means, such as casualcontact, wiping, brushing or washing.

Responsible employer means:(1) For DOE contractor employees, the

DOE contractor office that is directlyresponsible for the safety and health ofDOE contractor employees whileperforming a beryllium activity or otheractivity at a DOE facility; or

(2) For DOE employees, the DOEoffice that is directly responsible for thesafety and health of DOE Federal

employees while performing aberyllium activity or other activity at aDOE facility; and

(3) Any person acting directly orindirectly for such office with respect toterms and conditions of employment ofberyllium-associated workers.

Site Occupational Medical Director(SOMD) means the physicianresponsible for the overall direction andoperation of the site occupationalmedicine program.

Unique identifier means the part of apaired set of labels, used in records thatcontain confidential information, thatdoes not identify individuals except byusing the matching label.

Worker means a person who performswork for or on behalf of DOE, includinga DOE employee, an independentcontractor, a DOE contractor orsubcontractor employee, or any otherperson who performs work at a DOEfacility.

Worker exposure means the exposureof a worker to airborne beryllium thatwould occur if the worker were notusing respiratory protective equipment.

(b) Terms undefined in this part thatare defined in the Atomic Energy Act of1954 shall have the same meaning asunder that Act.

§ 850.4 Enforcement.DOE may take appropriate steps

under its contracts with DOEcontractors to ensure compliance withthis part. These steps include, but arenot limited to, contract termination orreduction in fee.

§ 850.5 Dispute resolution.(a) Subject to paragraphs (b) and (c) of

this section, any worker who isadversely affected by an action taken, orfailure to act, under this part maypetition the Office of Hearings andAppeals for relief in accordance with 10CFR part 1003, Subpart G.

(b) The Office of Hearings andAppeals may not accept a petition froma worker unless the worker requestedthe responsible employer to correct theviolation, and the responsible employerrefused or failed to take correctiveaction within a reasonable time.

(c) If the dispute relates to a term orcondition of employment that is coveredby a grievance-arbitration provision in acollective bargaining agreement, theworker must exhaust all applicablegrievance-arbitration procedures beforefiling a petition for relief with the Officeof Hearings and Appeals. A worker isdeemed to have exhausted all applicablegrievance-arbitration procedures if 150days have passed since the filing of agrievance and a final decision on it hasnot been issued.

Subpart B—AdministrativeRequirements

§ 850.10 Development and approval of theCBDPP.

(a) Preparation and submission ofinitial CBDPP to DOE. (1) Theresponsible employer at a DOE facilitymust ensure that a CBDPP is preparedfor the facility and submitted to theappropriate Head of DOE Field Elementbefore beginning beryllium activities,but no later than April 6, 2000 of thispart.

(2) If the CBDPP has separate sectionsaddressing the activities of multiplecontractors at the facility, the Head ofDOE Field Element will designate asingle DOE contractor to review andapprove the sections prepared by othercontractors, so that a single consolidatedCBDPP for the facility is submitted tothe Head of DOE Field Element forreview and approval.

(b) DOE review and approval. Theappropriate Head of DOE Field Elementmust review and approve the CBDPP.

(1) The initial CBDPP and anyupdates are deemed approved 90 daysafter submission if they are notspecifically approved or rejected byDOE earlier.

(2) The responsible employer mustfurnish a copy of the approved CBDPP,upon request, to the DOE AssistantSecretary for Environment, Safety andHealth or designee, DOE programoffices, and affected workers or theirdesignated representatives.

(c) Update. The responsible employermust submit an update of the CBDPP tothe appropriate Head of DOE FieldElement for review and approvalwhenever a significant change orsignificant addition to the CBDPP ismade or a change in contractors occurs.The Head of DOE Field Element mustreview the CBDPP at least annually and,if necessary, require the responsibleemployer to update the CBDPP.

(d) Labor Organizations. If aresponsible employer employs orsupervises beryllium-associated workerswho are represented for collectivebargaining by a labor organization, theresponsible employer must:

(1) Give the labor organization timelynotice of the development andimplementation of the CBDPP and anyupdates thereto; and

(2) Upon timely request, bargainconcerning implementation of this part,consistent with the Federal labor laws.

§ 850.11 General CBDPP requirements.(a) The CBDPP must specify the

existing and planned operational tasksthat are within the scope of the CBDPP.The CBDPP must augment and, to the



extent feasible, be integrated into theexisting worker protection programsthat cover activities at the facility.

(b) The detail, scope, and content ofthe CBDPP must be commensurate withthe hazard of the activities performed,but in all cases the CBDPP must:

(1) Include formal plans and measuresfor maintaining exposures to berylliumat or below the permissible exposurelevel prescribed in § 850.22;

(2) Satisfy each requirement insubpart C of this part;

(3) Contain provisions for:(i) Minimizing the number of workers

exposed and potentially exposed toberyllium;

(ii) Minimizing the number ofopportunities for workers to be exposedto beryllium;

(iii) Minimizing the disability and lostwork time of workers due to chronicberyllium disease, berylliumsensitization and associated medicalcare; and

(iv) Setting specific exposurereduction and minimization goals thatare appropriate for the berylliumactivities covered by the CBDPP tofurther reduce exposure below thepermissible exposure limit prescribed in§ 850.22.

§ 850.12 Implementation.

(a) The responsible employer mustmanage and control berylliumexposures in all DOE berylliumactivities consistent with the approvedCBDPP.

(b) No person employed by DOE or aDOE contractor may take or cause anyaction inconsistent with therequirements of:

(1) This part,(2) An approved CBDPP, and(3) Any other Federal statute or

regulation concerning the exposure ofworkers to beryllium at DOE facilities.

(c) No task involving potentialexposure to airborne beryllium that isoutside the scope of the existing CBDPPmay be initiated until an update of theCBDPP is approved by the Head of DOEField Element, except in an unexpectedsituation and, then, only upon approvalof the Head of DOE Field Element.

(d) Nothing in this part precludes aresponsible employer from taking anyadditional protective action that itdetermines to be necessary to protectthe health and safety of workers.

(e) Nothing in this part affects theresponsibilities of DOE officials underthe Federal Employee OccupationalSafety and Health Program (29 CFR part1960) and related DOE directives.

§ 850.13 Compliance.(a) The responsible employer must

conduct activities in compliance withits CBDPP.

(b) The responsible employer mustachieve compliance with all elements ofits CBDPP no later than January 7, 2002.

(c) With respect to a particularberyllium activity, the contractor incharge of the activity is responsible forcomplying with this part. If nocontractor is responsible for a berylliumactivity, DOE must ensureimplementation of, and compliancewith, this part.

Subpart C—Specific ProgramRequirements

§ 850.20 Baseline beryllium inventory.(a) The responsible employer must

develop a baseline inventory of thelocations of beryllium operations andother locations of potential berylliumcontamination, and identify the workersexposed or potentially exposed toberyllium at those locations.

(b) In conducting the baselineinventory, the responsible employermust:

(1) Review current and historicalrecords;

(2) Interview workers;(3) Document the characteristics and

locations of beryllium at the facility;and

(4) Conduct air, surface, and bulksampling.

(c) The responsible employer mustensure that:

(1) The baseline beryllium inventoryis managed by a qualified individual(e.g., a certified industrial hygienist);and

(2) The individuals assigned to thistask have sufficient knowledge andexperience to perform such activitiesproperly.

§ 850.21 Hazard assessment.(a) If the baseline inventory

establishes the presence of beryllium,the responsible employer must conducta beryllium hazard assessment thatincludes an analysis of existingconditions, exposure data, medicalsurveillance trends, and the exposurepotential of planned activities. Theexposure determinants, characteristicsand exposure potential of activitiesmust be prioritized so that the activitieswith the greatest risks of exposure areevaluated first.

(b) The responsible employer mustensure that:

(1) The hazard assessment is managedby a qualified individual (e.g., acertified industrial hygienist); and

(2) The individuals assigned to thistask have sufficient knowledge and

experience to perform such activitiesproperly.

§ 850.22 Permissible exposure limit.The responsible employer must assure

that no worker is exposed to an airborneconcentration of beryllium greater thanthe permissible exposure limitestablished in 29 CFR 1910.1000, asmeasured in the worker’s breathing zoneby personal monitoring, or a morestringent TWA PEL that may bepromulgated by the Occupational Safetyand Health Administration as a healthstandard.

§ 850.23 Action level.(a) The responsible employer must

include in its CBDPP an action levelthat is no greater than 0.2 µg/m3,calculated as an 8-hour TWA exposure,as measured in the worker’s breathingzone by personal monitoring.

(b) If an airborne concentration ofberyllium is at or above the action level,the responsible employer mustimplement §§ 850.24(c) (periodicmonitoring), 850.25 (exposure reductionand minimization), 850.26 (regulatedareas), 850.27 (hygiene facilities andpractices), 850.28 (respiratoryprotection), 850.29 (protective clothingand equipment), and 850.38 (warningsigns) of this part.

§ 850.24 Exposure monitoring.(a) General. The responsible employer

must ensure that:(1) Exposure monitoring is managed

by a qualified individual (e.g., acertified industrial hygienist); and

(2) The individuals assigned to thistask have sufficient industrial hygieneknowledge and experience to performsuch activities properly.

(b) Initial monitoring. The responsibleemployer must perform initialmonitoring in areas that may haveairborne beryllium, as shown by thebaseline inventory and hazardassessment. The responsible employermust apply statistically-basedmonitoring strategies to obtain asufficient number of sample results toadequately characterize exposures,before reducing or terminatingmonitoring.

(1) The responsible employer mustdetermine workers’ 8-hour TWAexposure levels by conducting personalbreathing zone sampling.

(2) Exposure monitoring resultsobtained within the 12 monthspreceding the effective date of this partmay be used to satisfy this requirementif the measurements were made asprovided in paragraph (b)(1) of thissection.

(c) Periodic exposure monitoring. Theresponsible employer must conduct



periodic monitoring of workers whowork in areas where airborneconcentrations of beryllium are at orabove the action level. The monitoringmust be conducted in a manner and ata frequency necessary to representworkers’ exposure, as specified in theCBDPP. This periodic exposuremonitoring must be performed at leastevery 3 months (quarterly).

(d) Additional exposure monitoring.The responsible employer must performadditional monitoring if operations,maintenance or procedures change, orwhen the responsible employer has anyreason to suspect such a change hasoccurred.

(e) Accuracy of monitoring. Theresponsible employer must use amethod of monitoring and analysis thathas an accuracy of not less than plus orminus 25 percent, with a confidencelevel of 95 percent, for airborneconcentrations of beryllium at the actionlevel.

(f) Analysis. The responsibleemployer must have all samplescollected to satisfy the monitoringrequirements of this part analyzed in alaboratory accredited for metals by theAmerican Industrial HygieneAssociation (AIHA) or a laboratory thatdemonstrates quality assurance formetals analysis that is equivalent toAIHA accreditation.

(g) Notification of monitoring results.(1) The responsible employer must,within 10 working days after receipt ofany monitoring results, notify theaffected workers of monitoring results inwriting. This notification of monitoringresults must be:

(i) Made personally to the affectedworker; or

(ii) Posted in location(s) that is readilyaccessible to the affected worker, but ina manner that does not identify theindividual to other workers.

(2) If the monitoring results indicatethat a worker’s exposure is at or abovethe action level, the responsibleemployer must include in the notice:

(i) A statement that the action levelhas been met or exceeded; and

(ii) A description of the correctiveaction being taken by the responsibleemployer to reduce the worker’sexposure to below the action level, ifpracticable.

(3) If the monitoring results indicatethat worker exposure is at or above theaction level, the responsible employermust also notify DOE and the SOMD ofthese results within 10 working daysafter receipt.

§ 850. 25 Exposure reduction andminimization.

(a) The responsible employer mustensure that no worker is exposed abovethe exposure limit prescribed in§ 850.22.

(b) The responsible employer must, inaddition:

(1) Where exposure levels are at orabove the action level, establish a formalexposure reduction and minimizationprogram to reduce exposure levels tobelow the action level, if practicable.This program must be described in theresponsible employer’s CBDPP andmust include:

(i) Annual goals for exposurereduction and minimization;

(ii) A rationale for and a strategy formeeting the goals;

(iii) Actions that will be taken toachieve the goals; and

(iv) A means of tracking progresstowards meeting the goals ordemonstrating that the goals have beenmet.

(2) Where exposure levels are belowthe action level, implement actions forreducing and minimizing exposures, ifpracticable. The responsible employermust include in the CBDPP adescription of the steps to be taken forexposure reduction and minimizationand a rationale for those steps.

(c) The responsible employer mustimplement exposure reduction andminimization actions using theconventional hierarchy of industrialhygiene controls (i.e., engineeringcontrols, administrative controls, andpersonal protective equipment in thatorder).

§ 850.26 Regulated areas.(a) If airborne concentrations of

beryllium in areas in DOE facilities aremeasured at or above the action level,the responsible employer must establishregulated areas for those areas.

(b) The responsible employer mustdemarcate regulated areas from the restof the workplace in a manner thatadequately alerts workers to theboundaries of such areas.

(c) The responsible employer mustlimit access to regulated areas toauthorized persons.

(d) The responsible employer mustkeep records of all individuals whoenter regulated areas. These recordsmust include the name, date, time inand time out, and work activity.

§ 850.27 Hygiene facilities and practices.(a) General. The responsible employer

must assure that in areas where workersare exposed to beryllium at or above theaction level, without regard to the useof respirators:

(1) Food or beverage and tobaccoproducts are not used;

(2) Cosmetics are not applied, exceptin change rooms or areas and showerfacilities required under paragraphs (b)and (c) of this section; and

(3) Beryllium workers are preventedfrom exiting areas that containberyllium with contamination on theirbodies or their personal clothing.

(b) Change rooms or areas. Theresponsible employer must provideclean change rooms or areas forberyllium workers who work inregulated areas.

(1) Separate facilities free of berylliummust be provided for beryllium workersto change into, and store, personalclothing, and clean protective clothingand equipment to prevent cross-contamination;

(2) The change rooms or areas that areused to remove beryllium-contaminatedclothing and protective equipment mustbe maintained under negative pressureor located so as to minimize dispersionof beryllium into clean areas; and

(c) Showers and handwashingfacilities. (1) The responsible employermust provide handwashing and showerfacilities for beryllium workers whowork in regulated areas.

(2) The responsible employer mustassure that beryllium workers who workin regulated areas shower at the end ofthe work shift.

(d) Lunchroom facilities. (1) Theresponsible employer must providelunchroom facilities that are readilyaccessible to beryllium workers, andensure that tables for eating are free ofberyllium, and that no worker in alunchroom facility is exposed at anytime to beryllium at or above the actionlevel.

(2) The responsible employer mustassure that beryllium workers do notenter lunchroom facilities withprotective work clothing or equipmentunless the surface beryllium has beenremoved from clothing and equipmentby HEPA vacuuming or other methodthat removes beryllium withoutdispersing it.

(e) The change rooms or areas, showerand handwashing facilities, andlunchroom facilities must comply with29 CFR 1910.141, Sanitation.

§ 850.28 Respiratory protection.(a) The responsible employer must

establish a respiratory protectionprogram that complies with therespiratory protection programrequirements of 29 CFR 1910.134,Respiratory Protection.

(b) The responsible employer mustprovide respirators to, and ensure thatthey are used by, all workers who:



(1) Are exposed to an airborneconcentration of beryllium at or abovethe action level, or

(2) Are performing tasks for whichanalyses indicate the potential forexposures at or above the action level.

(c) The responsible employer mustinclude in the respiratory protectionprogram any beryllium-associatedworker who requests to use a respiratorfor protection against airborneberyllium, regardless of measuredexposure levels.

(d) The responsible employer mustselect for use by workers:

(1) Respirators approved by theNational Institute for OccupationalSafety and Health (NIOSH) if NIOSH-approved respirators exist for a specificDOE task; or

(2) Respirators that DOE has acceptedunder the DOE Respiratory ProtectionAcceptance Program if NIOSH-approvedrespirators do not exist for specific DOEtasks.

§ 850.29 Protective clothing andequipment.

(a) The responsible employer mustprovide protective clothing andequipment to beryllium workers andensure its appropriate use andmaintenance, where dispersible forms ofberyllium may contact worker’s skin,enter openings in workers’ skin, orcontact workers’ eyes, including where:

(1) Exposure monitoring hasestablished that airborne concentrationsof beryllium are at or above the actionlevel;

(2) Surface contamination levelsmeasured or presumed prior toinitiating work are above the levelprescribed in § 850.30;

(3) Surface contamination levelsresults obtained to confirmhousekeeping efforts are above the levelprescribed in § 850.30; and

(4) Any beryllium-associated workerwho requests the use of protectiveclothing and equipment for protectionagainst airborne beryllium, regardless ofmeasured exposure levels.

(b) The responsible employer mustcomply with 29 CFR 1910.132, PersonalProtective Equipment GeneralRequirements, when workers usepersonal protective clothing andequipment.

(c) The responsible employer mustestablish procedures for donning,doffing, handling, and storing protectiveclothing and equipment that:

(1) Prevent beryllium workers fromexiting areas that contain berylliumwith contamination on their bodies ortheir personal clothing; and

(2) Include beryllium workersexchanging their personal clothing for

full-body protective clothing andfootwear before they begin work inregulated areas.

(d) The responsible employer mustensure that no worker removesberyllium-contaminated protectiveclothing and equipment from areas thatcontain beryllium, except for workersauthorized to launder, clean, maintain,or dispose of the clothing andequipment.

(e) The responsible employer mustprohibit the removal of beryllium fromprotective clothing and equipment byblowing, shaking, or other means thatmay disperse beryllium into the air.

(f) The responsible employer mustensure that protective clothing andequipment is cleaned, laundered,repaired, or replaced as needed tomaintain effectiveness. The responsibleemployer must:

(1) Ensure that beryllium-contaminated protective clothing andequipment, when removed forlaundering, cleaning, maintenance, ordisposal, is placed in containers thatprevent the dispersion of beryllium dustand that are labeled in accordance with§ 850.38 of this part; and

(2) Inform organizations that launderor clean DOE beryllium-contaminatedprotective clothing or equipment thatexposure to beryllium is potentiallyharmful, and that clothing andequipment should be laundered orcleaned in a manner prescribed by theresponsible employer to prevent therelease of airborne beryllium.

§ 850.30 Housekeeping.

(a) Where beryllium is present inoperational areas of DOE facilities, theresponsible employer must conductroutine surface sampling to determinehousekeeping conditions. Surfacescontaminated with beryllium dusts andwaste must not exceed a removablecontamination level of 3 µg/100 cm2

during non-operational periods. Thissampling would not include the interiorof installed closed systems such asenclosures, glove boxes, chambers, orventilation systems.

(b) When cleaning floors and surfacesin areas where beryllium is present atDOE facilities, the responsible employermust clean beryllium-contaminatedfloors and surfaces using a wet method,vacuuming or other cleaning methods,such as sticky tack cloths, that avoid theproduction of airborne dust.Compressed air or dry methods mustnot be used for such cleaning.

(c) The responsible employer mustequip the portable or mobile vacuumunits that are used to clean beryllium-contaminated areas with HEPA filters,

and change the filters as often as neededto maintain their capture efficiency.

(d) The responsible employer mustensure that the cleaning equipment thatis used to clean beryllium-contaminatedsurfaces is labeled, controlled, and notused for non-hazardous materials.

§ 850.31 Release criteria.(a) The responsible employer must

clean beryllium-contaminatedequipment and other items to the lowestcontamination level practicable, but notto exceed the levels established inparagraphs (b) and (c) of this section,and label the equipment or other items,before releasing them to the generalpublic or a DOE facility for non-beryllium use, or to another facility forwork involving beryllium.

(b) Before releasing beryllium-contaminated equipment or other itemsto the general public or for use in a non-beryllium area of a DOE facility, theresponsible employer must ensure that:

(1) The removable contaminationlevel of equipment or item surfaces doesnot exceed the higher of 0.2 µg/100 cm 2

or the concentration level of berylliumin soil at the point or release, whicheveris greater;

(2) The equipment or item is labeledin accordance with § 850.38(b); and

(3) The release is conditioned on therecipient’s commitment to implementcontrols that will prevent foreseeableberyllium exposure, considering thenature of the equipment or item and itsfuture use and the nature of theberyllium contamination.

(c) Before releasing beryllium-contaminated equipment or other itemsto another facility performing work withberyllium, the responsible employermust ensure that:

(1) The removable contaminationlevel of equipment or item surfaces doesnot exceed 3 µg/100 cm 2;

(2) The equipment or item is labeledin accordance with § 850.38(b); and

(3) The equipment or item is enclosedor placed in sealed, impermeable bagsor containers to prevent the release ofberyllium dust during handling andtransportation.

§ 850.32 Waste disposal.(a) The responsible employer must

control the generation of beryllium-containing waste, and beryllium-contaminated equipment and otheritems that are disposed of as waste,through the application of wasteminimization principles.

(b) Beryllium-containing waste, andberyllium-contaminated equipment andother items that are disposed of aswaste, must be disposed of in sealed,impermeable bags, containers, or



enclosures to prevent the release ofberyllium dust during handling andtransportation. The bags, containers,and enclosures that are used fordisposal of beryllium waste must belabeled according to § 850.38.

§ 850.33 Beryllium emergencies.(a) The responsible employer must

comply with 29 CFR 1910.120(l) forhandling beryllium emergencies relatedto decontamination anddecommissioning operations.

(b) The responsible employer mustcomply with 29 CFR 1910.120(q) forhandling beryllium emergencies relatedto all other operations.

§ 850.34 Medical surveillance.(a) General. (1) The responsible

employer must establish and implementa medical surveillance program forberyllium-associated workers whovoluntarily participate in the program.

(2) The responsible employer mustdesignate a Site Occupational MedicalDirector (SOMD) who is responsible foradministering the medical surveillanceprogram.

(3) The responsible employer mustensure that the medical evaluations andprocedures required by this section areperformed by, or under the supervisionof, a licensed physician who is familiarwith the health effects of beryllium.

(4) The responsible employer mustestablish, and maintain, a list ofberyllium-associated workers who maybe eligible for protective measuresunder this part. The list must be:

(i) Based on the hazard assessment,exposure records, and other informationregarding the identity of beryllium-associated workers; and

(ii) Adjusted at regular intervals basedon periodic evaluations of beryllium-associated workers performed underparagraph (b)(2) of this section;

(5) The responsible employer mustprovide the SOMD with the informationneeded to operate and administer themedical surveillance program, includingthe:

(i) List of beryllium-associatedworkers required by paragraph (a)(4) ofthis section;

(ii) Baseline inventory;(iii) Hazard assessment and exposure

monitoring data;(iv) Identity and nature of activities or

operations on the site that are coveredunder the CBDPP, related duties ofberyllium-associated workers; and

(v) Type of personal protectiveequipment used.

(6) The responsible employer mustprovide the following information to theSOMD and the examining physician:

(i) A copy of this rule and itspreamble;

(ii) A description of the worker’sduties as they pertain to berylliumexposure;

(iii) Records of the worker’s berylliumexposure; and

(iv) A description of the personalprotective and respiratory protectiveequipment used by the worker in thepast, present, or anticipated future use.

(b) Medical evaluations andprocedures. The responsible employermust provide, to beryllium-associatedworkers who voluntarily participate inthe medical surveillance program, themedical evaluations and proceduresrequired by this section at no cost andat a time and place that is reasonableand convenient to the worker.

(1) Baseline medical evaluation. Theresponsible employer must provide abaseline medical evaluation toberyllium-associated workers. Thisevaluation must include:

(i) A detailed medical and workhistory with emphasis on past, present,and anticipated future exposure toberyllium;

(ii) A respiratory symptomsquestionnaire;

(iii) A physical examination withspecial emphasis on the respiratorysystem, skin and eyes;

(iv) A chest radiograph (posterior-anterior, 14 x 17 inches) interpreted bya National Institute for OccupationalSafety and Health (NIOSH) B-reader ofpneumoconiosis or a board-certifiedradiologist (unless a baseline chestradiograph is already on file);

(v) Spirometry consisting of forcedvital capacity (FVC) and forcedexpiratory volume at 1 second (FEV1);

(vi) A Be-LPT; and(vii) Any other tests deemed

appropriate by the examining physicianfor evaluating beryllium-related healtheffects.

(2) Periodic evaluation. (i) Theresponsible employer must provide toberyllium workers a medical evaluationannually, and to other beryllium-associated workers a medical evaluationevery three years. The periodic medicalevaluation must include:

(A) A detailed medical and workhistory with emphasis on past, present,and anticipated future exposure toberyllium;

(B) A respiratory symptomsquestionnaire;

(C) A physical examination withemphasis on the respiratory system;

(D) A Be-LPT; and(E) Any other medical evaluations

deemed appropriate by the examiningphysician for evaluating beryllium-related health effects.

(ii) The responsible employer mustprovide to beryllium-associated workersa chest radiograph every five years.

(3) Emergency evaluation. Theresponsible employer must provide amedical evaluation as soon as possibleto any worker who may have beenexposed to beryllium because of aberyllium emergency. The medicalevaluation must include therequirements of paragraph (b)(2) of thissection.

(c) Multiple physician review. Theresponsible employer must establish amultiple physician review process forberyllium-associated workers thatallows for the review of initial medicalfindings, determinations, orrecommendations from any medicalevaluation conducted pursuant toparagraph (b) of this section.

(1) If the responsible employer selectsthe initial physician to conduct anymedical examination or consultationprovided to a beryllium-associatedworker, the worker may designate asecond physician to:

(i) Review any findings,determinations, or recommendations ofthe initial physician; and

(ii) Conduct such examinations,consultations and laboratory tests, as thesecond physician deems necessary tofacilitate this review.

(2) The responsible employer mustpromptly notify a beryllium-associatedworker in writing of the right to seek asecond medical opinion after the initialphysician provided by the responsibleemployer conducts a medicalexamination or consultation.

(3) The responsible employer maycondition its participation in, andpayment for, multiple physician reviewupon the beryllium-associated workerdoing the following within fifteen (15)days after receipt of the notice, orreceipt of the initial physician’s writtenopinion, whichever is later:

(i) Informing the responsibleemployer in writing that he or sheintends to seek a second medicalopinion; and

(ii) Initiating steps to make anappointment with a second physician.

(4) If the findings, determinations, orrecommendations of the secondphysician differ from those of the initialphysician, then the responsibleemployer and the beryllium-associatedworker must make efforts to encourageand assist the two physicians to resolveany disagreement.

(5) If, despite the efforts of theresponsible employer and theberyllium-associated worker, the twophysicians are unable to resolve theirdisagreement, then the responsibleemployer and the worker, through theirrespective physicians, must designate athird physician to:



(i) Review any findings,determinations, or recommendations ofthe other two physicians; and

(ii) Conduct such examinations,consultations, laboratory tests, andconsultations with the other twophysicians, as the third physiciandeems necessary to resolve thedisagreement among them.

(6) The SOMD must act consistentlywith the findings, determinations, andrecommendations of the thirdphysician, unless the SOMD and theberyllium-associated worker reach anagreement that is consistent with therecommendations of at least one of theother two physicians.

(d) Alternate physician determination.The responsible employer and theberyllium-associated worker or theworker’s designated representative mayagree upon the use of any alternate formof physician determination in lieu of themultiple physician review processprovided by paragraph (c) of thissection, so long as the alternative isexpeditious and at least as protective ofthe worker.

(e) Written medical opinion andrecommendation. (1) Within two weeksof receipt of results, the SOMD mustprovide to the responsible employer awritten, signed medical opinion for eachmedical evaluation performed on eachberyllium-associated worker. Thewritten opinion must take into accountthe findings, determinations andrecommendations of the otherexamining physicians who may haveexamined the beryllium-associatedworker. The SOMD’s opinion mustcontain:

(i) The diagnosis of the worker’scondition relevant to occupationalexposure to beryllium, and any othermedical condition that would place theworker at increased risk of materialimpairment to health from furtherexposure to beryllium;

(ii) Any recommendation for removalof the worker from DOE berylliumactivities, or limitation on the worker’sactivities or duties or use of personalprotective equipment, such as arespirator; and

(iii) A statement that the SOMD orexamining physician has clearlyexplained to the worker the results ofthe medical evaluation, including alltests results and any medical conditionrelated to beryllium exposure thatrequires further evaluation or treatment.

(2) The SOMD’s written medicalopinion must not reveal specificrecords, findings, and diagnoses that arenot related to medical conditions thatmay be affected by beryllium exposure.

(f) Information provided to theberyllium-associated worker. (1) The

SOMD must provide each beryllium-associated worker with a writtenmedical opinion containing the resultsof all medical tests or procedures, anexplanation of any abnormal findings,and any recommendation that theworker be referred for additional testingfor evidence of CBD, within 10 workingdays after the SOMD’s receipt of theresults of the medical tests orprocedures.

(2) The responsible employer must,within 30 days after a request by aberyllium-associated worker, providethe worker with the information theresponsible employer is required toprovide the examining physician underparagraph (a)(6) of this section.

(g) Reporting. The responsibleemployer must report on the applicableOSHA reporting form berylliumsensitization, CBD, or any otherabnormal condition or disorder ofworkers caused or aggravated byoccupational exposure to beryllium.

(h) Data analysis. (1) The responsibleemployer must routinely andsystematically analyze medical, job, andexposure data with the aim ofidentifying individuals or groups ofindividuals potentially at risk for CBDand working conditions that arecontributing to that risk.

(2) The responsible employer mustuse the results of these analyses toidentify additional workers to whom theresponsible employer must providemedical surveillance and to determinethe need for additional exposurecontrols.

§ 850.35 Medical removal.(a) Medical removal protection. The

responsible employer must offer aberyllium-associated worker medicalremoval from exposure to beryllium ifthe SOMD determines in a writtenmedical opinion that it is medicallyappropriate to remove the worker fromsuch exposure. The SOMD’sdetermination must be based on one ormore positive Be-LPT results, chronicberyllium disease diagnosis, anexamining physician’s recommendation,or any other signs or symptoms that theSOMD deems medically sufficient toremove a worker.

(1) Temporary removal pending finalmedical determination. The responsibleemployer must offer a beryllium-associated worker temporary medicalremoval from exposure to beryllium oneach occasion that the SOMDdetermines in a written medical opinionthat the worker should be temporarilyremoved from such exposure pending afinal medical determination of whetherthe worker should be removedpermanently.

(i) In this section, ‘‘final medicaldetermination’’ means the outcome ofthe multiple physician review processor the alternate medical determinationprocess provided for in paragraphs (c)and (d) of § 850.34.

(ii) If a beryllium-associated worker istemporarily removed from berylliumexposure pursuant to this section, theresponsible employer must transfer theworker to a comparable job for whichthe worker is qualified (or for which theworker can be trained in a short period)and where beryllium exposures are aslow as possible, but in no event at orabove the action level.

(iii) The responsible employer mustmaintain the beryllium-associatedworker’s total normal earnings,seniority, and other worker rights andbenefits as if the worker had not beenremoved.

(iv) If there is no such job available,the responsible employer must provideto the beryllium-associated worker themedical removal protection benefitsspecified in paragraph (b)(2) of thissection, until a job becomes available orfor one year, whichever comes first.

(2) Permanent medical removal. (i)The responsible employer must offer aberyllium-associated worker permanentmedical removal from exposure toberyllium if the SOMD determines in awritten medical opinion that the workershould be permanently removed fromexposure to beryllium.

(ii) If a beryllium-associated worker isremoved permanently from berylliumexposure based on the SOMD’srecommendation pursuant to thissection, the responsible employer mustprovide the worker the medical removalprotection benefits specified inparagraph (b) of this section.

(3) Worker consultation beforetemporary or permanent medicalremoval. If the SOMD determines that aberyllium-associated worker should betemporarily or permanently removedfrom exposure to beryllium, the SOMDmust:

(i) Advise the beryllium-associatedworker of the determination thatmedical removal is necessary to protectthe worker’s health;

(ii) Provide the beryllium-associatedworker with a copy of this rule and itspreamble, and any other information theSOMD deems necessary on the risks ofcontinued exposure to beryllium andthe benefits of removal;

(iii) Provide the beryllium-associatedworker the opportunity to have anyquestions concerning medical removalanswered; and

(iv) Obtain the beryllium-associatedworker’s signature acknowledging thatthe worker has been advised to accept



medical removal from berylliumexposure as provided in this section,and has been provided with theinformation specified in this paragraph,on the benefits of removal and the risksof continued exposure to beryllium.

(4) Return to work after medicalremoval. (i) The responsible employer,subject to paragraph (a)(4)(ii) of thissection, must not return a beryllium-associated worker who has beenpermanently removed under this sectionto the worker’s former job status unlessthe SOMD first determines in a writtenmedical opinion that continued medicalremoval is no longer necessary toprotect the worker’s health.

(ii) Not withstanding paragraph (a)(4)(i) of this section, if, in the SOMD’sopinion, continued exposure toberyllium will not pose an increasedrisk to the beryllium-associated worker’shealth, and medical removal is aninappropriate remedy in thecircumstances, the SOMD must fullydiscuss these matters with the workerand then, in a written determination,may authorize the responsible employerto return the worker to his or her formerjob status. Thereafter, the returnedberyllium-associated worker mustcontinue to be provided with medicalsurveillance under § 850.34 of this part.

(b) Medical removal protectionbenefits. (1) If a beryllium-associatedworker has been permanently removedfrom beryllium exposure pursuant toparagraph (a)(2) of this section, theresponsible employer must provide theberyllium-associated worker:

(i) The opportunity to transfer toanother position which is available, orlater becomes available, for which theberyllium-associated worker is qualified(or for which the worker can be trainedin a short period) and where berylliumexposures are as low as possible, but inno event at or above the action level; or

(ii) If the beryllium-associated workercannot be transferred to a comparablejob where beryllium exposures arebelow the action level, a maximum of 2years of permanent medical removalprotection benefits (specified inparagraph (b)(2) of this section).

(2) If required by this section toprovide medical removal protectionbenefits, the responsible employer mustmaintain the removed worker’s totalnormal earnings, seniority and otherworker rights and benefits, as thoughthe worker had not been removed.

(3) If a removed beryllium-associatedworker files a claim for workers’compensation payments for a beryllium-related disability, then the responsibleemployer must continue to providemedical removal protection benefitspending disposition of the claim. The

responsible employer must receive nocredit for the workers’ compensationpayments received by the worker fortreatment related expenses.

(4) The responsible employer’sobligation to provide medical removalprotection benefits to a removedberyllium-associated worker is reducedto the extent that the worker receivescompensation for earnings lost duringthe period of removal either from apublicly- or employer-fundedcompensation program, or fromemployment with another employermade possible by virtue of the worker’sremoval.

(5) For the purposes of this section,the requirement that a responsibleemployer provide medical removalprotection benefits is not intended toexpand upon, restrict, or change anyrights to a specific job classification orposition under the terms of anapplicable collective bargainingagreement.

(6) The responsible employer maycondition the provision of medicalremoval protection benefits upon theberyllium-associated worker’sparticipation in medical surveillanceprovided in accordance with § 850.34 ofthis part.

§ 850.36 Medical consent.

(a) The responsible employer mustprovide each beryllium-associatedworker with a summary of the medicalsurveillance program established in§ 850.34 at least one week before thefirst medical evaluation or procedure orat any time requested by the worker.This summary must include:

(1) The type of data that will becollected in the medical surveillanceprogram;

(2) How the data will be collected andmaintained;

(3) The purpose for which the datawill be used; and

(4) A description of how confidentialdata will be protected.

(b) Responsible employers must alsoprovide each beryllium-associatedworker with information on the benefitsand risks of the medical tests andexaminations available to the worker atleast one week prior to any suchexamination or test, and an opportunityto have the worker’s questionsanswered.

(c) The responsible employer musthave the SOMD obtain a beryllium-associated worker’s signature on theinformed consent form found inAppendix A to this part, beforeperforming medical evaluations or anytests.

§ 850.37 Training and counseling.(a) The responsible employer must

develop and implement a berylliumtraining program and ensureparticipation for:

(1) Beryllium-associated workers;(2) All other individuals who work at

a site where beryllium activities areconducted.

(b) The training provided for workersidentified in paragraph (a)(1) of thissection, must:

(1) Be in accordance with 29 CFR1910.1200, Hazard Communication;

(2) Include the contents of the CBDPP;and

(3) Include potential health risks toberyllium worker family members andothers who may come in contact withberyllium on beryllium workers orberyllium workers’ personal clothing orother personal items as the result of aberyllium control failure at a DOEfacility.

(c) The training provided for workersidentified in paragraph (a)(2) of thissection must consist of generalawareness about beryllium hazards andcontrols.

(d) The responsible employer mustprovide the training required by thissection before or at the time of initialassignment and at least every two yearsthereafter.

(e) The employer must provideretraining when the employer hasreason to believe that a berylliumworker lacks the proficiency,knowledge, or understanding needed towork safely with beryllium, including atleast the following situations:

(1) To address any new berylliumhazards resulting from a change tooperations, procedures, or berylliumcontrols about which the berylliumworker was not previously trained; and

(2) If a beryllium worker’sperformance involving beryllium workindicates that the worker has notretained the requisite proficiency.

(f) The responsible employer mustdevelop and implement a counselingprogram to assist beryllium-associatedworkers who are diagnosed by theSOMD to be sensitized to beryllium orto have CBD. This counseling programmust include communicating withberyllium-associated workersconcerning:

(1) The medical surveillance programprovisions and procedures;

(2) Medical treatment options;(3) Medical, psychological, and career

counseling;(4) Medical benefits;(5) Administrative procedures and

workers rights under applicableWorkers’ Compensation laws andregulations;



(6) Work practice procedures limitingberyllium-associated worker exposure toberyllium; and

(7) The risk of continued berylliumexposure after sensitization.

§ 850.38 Warning signs and labels.(a) Warning signs. The responsible

employer must post warning signs ateach access point to a regulated areawith the following information:DANGERBERYLLIUM CAN CAUSE LUNG

DAMAGECANCER HAZARDAUTHORIZED PERSONNEL ONLY

(b) Warning labels. (1) Theresponsible employer must affixwarning labels to all containers ofberyllium, beryllium compounds, orberyllium-contaminated clothing,equipment, waste, scrap, or debris.

(2) Warning labels must contain thefollowing information:DANGERCONTAMINATED WITH BERYLLIUMDO NOT REMOVE DUST BY BLOWING

OR SHAKINGCANCER AND LUNG DISEASE

HAZARD(c) Warning signs and labels must be

in accordance with 29 CFR 1910.1200,Hazard Communication.

§ 850. 39 Recordkeeping and use ofinformation.

(a) The responsible employer mustestablish and maintain accurate recordsof all beryllium inventory information,hazard assessments, exposuremeasurements, exposure controls, andmedical surveillance.

(b) Heads of DOE DepartmentalElements must:

(1) Designate all record series asrequired under this rule as agencyrecords and, therefore, subject to allapplicable agency records managementand access laws; and

(2) Ensure that these record series areretained for a minimum of seventy-fiveyears.

(c) The responsible employer mustconvey to DOE or its designee all recordseries required under this rule if theemployer ceases to be involved in theCBDPP.

(d) The responsible employer mustlink data on workplace conditions andhealth outcomes in order to establish abasis for understanding the berylliumhealth risk.

(e) The responsible employer mustensure the confidentiality of all work-related records generated under this ruleby ensuring that:

(1) All records that are transmitted toother parties do not contain names,social security numbers or any other

variables, or combination of variables,that could be used to identify particularindividuals; and

(2) Individual medical informationgenerated by the CBDPP is:

(i) Either included as part of theworker’s site medical records andmaintained by the SOMD, or ismaintained by another physiciandesignated by the responsible employer;

(ii) Maintained separately from otherrecords; and

(iii) Used or disclosed by theresponsible employer only inconformance with any applicablerequirements imposed by the Americanswith Disabilities Act, the Privacy Act of1974, the Freedom of Information Act,and any other applicable law.

(f) The responsible employer mustmaintain all records required by thispart in current and accessible electronicsystems, which include the abilityreadily to retrieve data in a format thatmaintains confidentiality.

(g) The responsible employer musttransmit all records generated asrequired by this rule, in a format thatprotects the confidentiality ofindividuals, to the DOE AssistantSecretary for Environment, Safety andHealth on request.

(h) The responsible employer mustsemi-annually transmit to the DOEOffice of Epidemiologic Studies withinthe Office of Environment, Safety andHealth an electronic registry ofberyllium-associated workers thatprotects confidentiality, and the registrymust include, but is not limited to, aunique identifier, date of birth, gender,site, job history, medical screening testresults, exposure measurements, andresults of referrals for specializedmedical evaluations.

§ 850.40 Performance feedback.

(a) The responsible employer mustconduct periodic analyses andassessments of monitoring activities,hazards, medical surveillance, exposurereduction and minimization, andoccurrence reporting data.

(b) To ensure that information isavailable to maintain and improve allelements of the CBDPP continuously,the responsible employer must giveresults of periodic analyses andassessments to the line managers,planners, worker protection staff,workers, medical staff, and labororganizations representing beryllium-associated workers who request suchinformation.

Appendix A to Part 850—ChronicBeryllium Disease Prevention ProgramInformed Consent Form

I, lllllll have carefully read andunderstand the attached information aboutthe Be-LPT and other medical tests. I havehad the opportunity to ask any questions thatI may have had concerning these tests.

I understand that this program is voluntaryand I am free to withdraw at any time fromall or any part of the medical surveillanceprogram. I understand that the tests areconfidential, but not anonymous. Iunderstand that if the results of any testsuggest a health problem, the examiningphysician will discuss the matter with me,whether or not the result is related to mywork with beryllium. I understand that myemployer will be notified of my diagnosisonly if I have a beryllium sensitization orchronic beryllium disease. My employer willnot receive the results or diagnoses of anyhealth conditions not related to berylliumexposure.

I understand that, if the results of one ormore of these tests indicate that I have ahealth problem that is related to beryllium,additional examinations will berecommended. If additional tests indicate Ido have a beryllium sensitization or CBD, theSite Occupational Medical Director mayrecommend that I be removed from workingwith beryllium. If I agree to be removed, Iunderstand that I may be transferred toanother job for which I am qualified (or canbe trained for in a short period) and wheremy beryllium exposures will be as low aspossible, but in no case above the actionlevel. I will maintain my total normalearnings, seniority, and other benefits for upto two years if I agree to be permanentlyremoved.

I understand that if I apply for another jobor for insurance, I may be requested torelease my medical records to a futureemployer or an insurance company.

I understand that my employer willmaintain all medical information relative tothe tests performed on me in segregatedmedical files separate from my personnelfiles, treated as confidential medical records,and used or disclosed only as provided bythe Americans with Disability Act, thePrivacy Act of 1974, or as required by a courtorder or under other law.

I understand that the results of my medicaltests for beryllium will be included in theBeryllium Registry maintained by DOE, andthat a unique identifier will be used tomaintain the confidentiality of my medicalinformation. Personal identifiers will not beincluded in any reports generated from theDOE Beryllium Registry. I understand thatthe results of my tests and examinations maybe published in reports or presented atmeetings, but that I will not be identified.

I consent to having the following medicalevaluations:/ / Physical examination concentrating on

my lungs and breathing/ / Chest X-ray/ / Spirometry (a breathing test)/ / Blood test called the beryllium-induced

lymphocyte proliferation test or Be-LPT/ / Other test(s). Specify:



lllllllllllllllllllllSignature of Participant:lllllllllllllllllllllDate: llllll

I have explained and discussed anyquestions that the employee expressed

concerning the Be-LPT, physicalexamination, and other medical testing aswell as the implications of those tests.Name of Examining Physician:lllllllllllllllllllllSignature of Examining Physician:

lllllllllllllllllllll

Dated: llllll

[FR Doc. 99–31181 Filed 12–6–99; 8:45 am]

BILLING CODE 6450–01–P


Documents

Title 10 CFR Part 850, Chronic Beryllium Disease ...Inhalation of beryllium dust or particles can cause chronic beryllium disease (CBD) or beryllium sensitization. CBD is a chronic,