federal register - UNITARcwm.unitar.org/publications/publications/cbl/prtr/pdf/... · 2005. 9. 13. · federal register 42221 Tuesday August 3, 1999 Part IV Environmental Protection

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TuesdayAugust 3, 1999

Part IV

EnvironmentalProtection Agency40 CFR Part 372Lead and Lead Compounds; Lowering ofReporting Thresholds; Community Right-to-Know Toxic Chemical ReleaseReporting; Proposed Rule

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42222 Federal Register / Vol. 64, No. 148 / Tuesday, August 3, 1999 / Proposed Rules

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 372

[OPPTS–400140; FRL–6081–4]

RIN 2070–AD38

Lead and Lead Compounds; Loweringof Reporting Thresholds; CommunityRight-to-Know Toxic Chemical ReleaseReporting

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Proposed rule.

SUMMARY: EPA is proposing to lower thereporting thresholds for lead and leadcompounds which are subject toreporting under section 313 of theEmergency Planning and CommunityRight-to-Know Act of 1986 (EPCRA) andsection 6607 of the Pollution PreventionAct of 1990 (PPA). EPA believes thatlead and lead compounds are persistent,bioaccumulative toxic (PBT) chemicalsthat warrant lower reporting thresholdsthan those currently established underEPCRA section 313. Today’s proposedaction also includes a limitation on thereporting of lead when contained incertain alloys and proposedmodifications to certain reportingexemptions and requirements for leadand lead compounds.DATES: Written comments, identified bythe docket control number OPPTS–400140, must be received by EPA on orbefore September 17, 1999.ADDRESSES: Comments may besubmitted by mail, electronically, or inperson. Please follow the detailedinstructions for each method asprovided in Unit I. of theSUPPLEMENTARY INFORMATIONsection of this document.FOR FURTHER INFORMATION CONTACT:Daniel R. Bushman, PetitionsCoordinator, 202–260–3882, e-mail:[email protected], forspecific information on this proposedrule, or for more information on EPCRAsection 313, the Emergency Planningand Community Right-to-Know Hotline,Environmental Protection Agency, MailCode 5101, 401 M St., SW., Washington,DC 20460, Toll free: 1–800–535–0202,in Virginia and Alaska: 703–412–9877or Toll free TDD: 1–800–553–7672.SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

You may be potentially affected bythis notice if you manufacture, process,or otherwise use lead or leadcompounds. Potentially affected

categories and entities may include, butare not limited to:

Category Examples of Potentially Af-fected Entities

Industry Facilities that: process cop-per ores, lead and zincores; operate pulp mills,petroleum refineries, pri-mary copper smelters,primary and secondarynonferrous metal smelt-ers, gray/ductile ironfoundries, steel found-ries, blast furnaces, steelmills, petroleum bulk sta-tions and terminals, in-dustrial boilers that burncoal, wood, petroleumproducts, and electricutilities that combust coaland/or oil for distributionof electricity in com-merce; facilities thatmanufacture, process, oruse inorganic pigments,small arms ammunition,asphalt paving mixturesand blocks, storage bat-teries, motor vehiclesand motor vehicle equip-ment; manufacture elec-tronic components andaccessories.

Federal Gov-ernment

Federal facilities that: man-ufacture, process, or uselead or lead compounds;burn coal or petroleumproducts.

This table is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beaffected by this action. Other types ofentities not listed in the table could alsobe affected. To determine whether yourfacility would be affected by this action,you should carefully examine theapplicability criteria in part 372, subpartB of Title 40 of the Code of FederalRegulations. If you have questionsregarding the applicability of this actionto a particular entity, consult the personlisted in the preceding ‘‘FOR FURTHERINFORMATION CONTACT’’ section.

B. How Can I Get AdditionalInformation or Copies of this Documentor Other Support Documents?

1. Electronically. You may obtainelectronic copies of this document fromthe EPA internet Home Page at http://www.epa.gov/. On the Home Page select‘‘Laws and Regulations’’ and then lookup the entry for this document underthe ‘‘Federal Register - EnvironmentalDocuments.’’ You can also go directly to

the ‘‘Federal Register’’ listings at http://www.epa.gov/homepage/fedrgstr/.

2. In person. The Agency hasestablished an official record for thisaction under docket control numberOPPTS–400140. The official recordconsists of the documents specificallyreferenced in this action, any publiccomments received during an applicablecomment period, and other informationrelated to this action, including anyinformation claimed as confidentialbusiness information (CBI). This officialrecord includes the documents that arephysically located in the docket, as wellas the documents that are referenced inthose documents. The public version ofthe official record does not include anyinformation claimed as CBI. The publicversion of the official record, whichincludes printed, paper versions of anyelectronic comments submitted duringan applicable comment period, isavailable for inspection in the TSCANonconfidential Information Center,North East Mall Rm. B-607, WatersideMall, 401 M St., SW., Washington, DC.The Center is open from 12 noon to 4p.m., Monday through Friday, excludinglegal holidays. The telephone number ofthe Center is (202) 260–7099.

C. How and to Whom Do I SubmitComments?

You may submit comments throughthe mail, in person, or electronically. Besure to identify the appropriate docketcontrol number (i.e., ‘‘OPPTS–400140’’)in your correspondence.

1. By mail. Submit written commentsto: Document Control Office (7407),Office of Pollution Prevention andToxics (OPPT), EnvironmentalProtection Agency, 401 M St., SW.,Washington, DC 20460.

2. In person or by courier. Deliveryour comments to: OPPT DocumentControl Office (DCO) in East Tower Rm.G-099, Waterside Mall, 401 M St., SW.,Washington, DC. The DCO is open from8 a.m. to 4 p.m., Monday throughFriday, excluding legal holidays. Thetelephone number for the DCO is: 202–260–7093.

3. Electronically. Submit yourcomments electronically by E-mail to:‘‘[email protected].’’ Pleasenote that you should not submit anyinformation electronically that youconsider to be CBI. Electronic commentsmust be submitted as an ASCII fileavoiding the use of special charactersand any form of encryption. Commentsand data will also be accepted onstandard computer disks in WordPerfect5.1/6.1 or ASCII file format. Allcomments and data in electronic formmust be identified by the docket controlnumber OPPTS–400140. Electronic


42223Federal Register / Vol. 64, No. 148 / Tuesday, August 3, 1999 / Proposed Rules

comments on this proposal may also befiled online at many Federal DepositoryLibraries.

D. How Should I Handle CBIInformation that I Want to Submit to theAgency?

You may claim information that yousubmit in response to this document asCBI by marking any part or all of thatinformation as CBI. Information somarked will not be disclosed except inaccordance with procedures set forth in40 CFR part 2. A copy of the commentthat does not contain CBI must besubmitted for inclusion in the publicrecord. Information not markedconfidential will be included in thepublic docket by EPA without priornotice. If you have any questions aboutCBI or the procedures for claiming CBI,please consult with the technical personidentified in the ‘‘FOR FURTHERINFORMATION CONTACT’’ section.

II. What is EPA’s Statutory Authorityfor Taking These Actions?

These actions are proposed undersections 313(f)(2) and 328 of EPCRA, 42U.S.C. 11023(f)(2) and 11048.

Section 313 of EPCRA requires certainfacilities manufacturing, processing, orotherwise using a listed toxic chemicalin amounts above reporting thresholdlevels, to report their environmentalreleases of each chemical annually.These reports must be filed by July 1 ofeach year for the previous calendar year.Facilities also must report pollutionprevention and recycling data for suchchemicals, pursuant to section 6607 ofPPA.

A. What is EPA’s Statutory Authority toLower EPCRA Reporting Thresholds?

Section 313 contains default reportingthresholds, which are set forth insection 313(f)(1). Section 313(f)(2),however, provides that EPA ‘‘mayestablish a threshold amount for a toxicchemical different from the amountestablished by paragraph (1).’’ Theamounts established by EPA may, at theAdministrator’s discretion, be based onclasses of chemicals or categories offacilities.

This provision provides EPA withbroad authority to establish thresholdsfor particular chemicals, classes ofchemicals, or categories of facilities, andcommits to EPA’s discretion thedetermination that a different thresholdis warranted. Congress has alsocommitted the determination of thelevels at which to establish an alternatethreshold to EPA’s discretion, requiringonly that any ‘‘revised threshold shallobtain reporting on a substantialmajority of total releases of the chemical

at all facilities subject to therequirements’’ of section 313 (42 U.S.C.11023(f)(2)). For purposes ofdetermining what constitutes a‘‘substantial majority of total releases,’’EPA interprets ‘‘facilities subject to therequirements’’ of section 313 as thefacilities currently reporting, in partbecause section 313(b)(1)(A) providesthat ‘‘the requirements of [section 313]shall apply’’ to facilities that meet allthe reporting criteria and hence arerequired to file reports. Thus, in revisingthe reporting thresholds, EPA mustensure that under the new thresholds asubstantial majority of releases currentlybeing reported will continue to bereported. No further guidance forexercising this authority appears in thestatute.

While the ‘‘substantial majority’’requirement of section 313(f)(2) applieswhether EPA is raising or loweringthresholds, EPA believes that as apractical matter this standard canoperate to constrain EPA’s action onlywhen the Agency is raising thethresholds and thereby reducingreporting. Under those circumstances,the releases reported under the newthreshold would be lower than thosebeing reported under the currentthreshold, and EPA would be requiredto determine that the reduction inreporting would not be so great as to failthe ‘‘substantial majority’’ test. WhenEPA lowers thresholds, however, thesubstantial majority test is met as amatter of logical necessity, because thelower thresholds are almost alwayslikely to result in increased, rather thandecreased, reporting. The requiredfindings therefore can be made withoutthe need for quantitative support. Thus,EPA has found that the revisedreporting thresholds contained intoday’s proposed action meet the‘‘substantial majority’’ test in section313(f)(2).

Because Congress provided noprerequisites to the exercise of EPA’sauthority to lower the thresholds, andlittle explicit guidance, EPA looked tothe purposes of section 313 to helpguide the exercise of its discretion.EPCRA section 313(h) indicates that thedata collected under EPCRA section 313are intended:

. . . to inform persons about the releases oftoxic chemicals to the environment; to assistgovernmental agencies, researchers, andother persons in the conduct of research anddata gathering; to aid in the development ofappropriate regulations, guidelines andstandards, and for other similar purposes. (42U.S.C. 11023(h)).

EPA has identified several purposes ofthe EPCRA section 313 program, asenvisioned by Congress, including: (1)

Providing a complete profile of toxicchemical releases and other wastemanagement activities; (2) compiling abroad-based national data base fordetermining the success ofenvironmental regulations; and (3)ensuring that the public has easy accessto these data on releases of toxicchemicals to the environment. (See 62FR 23834, 23836, May 1, 1997). EPAconsidered these purposes in exercisingits discretion to establish lowerreporting thresholds under EPCRAsection 313 for lead and leadcompounds, which the Agency hasdetermined are persistent,bioaccumulative chemicals.

B. What is EPA’s Statutory Authority forMaking Modifications to Other EPCRASection 313 Reporting Requirements?

Congress granted EPA extremelybroad rulemaking authority to allow theAgency to fully implement the statute.EPCRA section 328 provides that the‘‘Administrator may prescribe suchregulations as may be necessary to carryout this chapter’’ (28 U.S.C. 11048).

III. How Did EPA Develop this Proposaland What is the Scope of the CommentsBeing Solicited?

A. Why Was Lead Not Addressed in theRecently Proposed PBT Rule?

In EPA’s recent proposed rule tolower the EPCRA section 313 reportingthresholds for certain PBT chemicals (64FR 688, January 5, 1999) (FRL–6032–3),EPA reviewed the bioaccumulation datafor two lead compounds: tetramethyland tetraethyl lead. However, theanalysis was limited to the data for theintact compounds and did not addressthe potential availability of lead fromthese compounds or other leadcompounds or the potential for lead tobioaccumulate. In the January 5, 1999proposed rule for PBT chemicals, EPAmade the following statements aboutlead and lead compounds:

EPA is aware of additional available datathat may indicate that lead and/or leadcompounds meet the bioaccumulationcriteria discussed in this proposed rule. EPAintends to review these additional data todetermine if lead and/or lead compoundsshould be considered PBT chemicals andwhether it would be appropriate to establishlower reporting thresholds for thesechemicals. Any such determination will bemade part of an additional rulemakingactivity. (See 64 FR 717, column 1).

Since development of the January 5,1999 proposed rule, EPA has receivednumerous comments requesting that theAgency include lead and leadcompounds as PBT chemicals underEPCRA section 313 and set lowerreporting thresholds (see the docket



support for the proposed rule (docketcontrol number OPPTS–400132)). Manyof these comments were received wellinto the comment period on the January5, 1999 proposed rule. Rather than delaymovement on the January 5, 1999proposed rule until EPA was ready toproceed with lead and lead compounds,the Agency elected to address lowerreporting thresholds for lead and leadcompounds as a separate proposal. EPAbelieves that such an approach willallow both the Agency and thosecommenters especially interested inlead and lead compounds to focus onthe issues specifically related to thesesubstances. Accordingly, today’sproposed rule is the result of EPA’sreview of the available information onlead and lead compounds, and is theAgency’s response to the requests forlower reporting thresholds for lead andlead compounds based on theirpersistence and bioaccumulation.

B. What is the Scope of Comments BeingSolicited on this Proposed Rule?

EPA recognizes that this proposal forlead and lead compounds may raisesimilar issues to those raised in theJanuary 5, 1999 proposed rule. For thepurposes of this proposal, however, EPAis only soliciting comments on howthese proposed actions would affectEPCRA section 313 reporting on leadand lead compounds, the impacts theseproposed changes would have on theburden of section 313 reporting for leadand lead compounds, and the benefitssuch reporting would provide thepublic. Comments of a more genericnature were solicited in the January 5,1999 proposed rule, and should havebeen submitted during the commentperiod for that proposal, which closedApril 7, 1999. EPA will respond totimely comments on these genericissues in the final PBT chemicals rule.The Agency will limit its considerationof and responses to commentssubmitted in the comment period forthis proposal to those that relate tosection 313 reporting of lead and leadcompounds. To the extent thatcomments were submitted on theJanuary 5, 1999 proposed rule that acommenter believes are relevant to thisproposal, the commenter must resubmitor reference those comments forinclusion in the docket for thisproposal, along with an explanation ofwhy the comments are relevant to leadand lead compounds.

C. What are the Issues on Which EPA isInterested in Receiving Comment?

The Agency is particularly interestedin receiving comments on the generalpolicy issues, as they apply to lead and

lead compounds, that were discussedand raised for comment in Unit IX. ofthe preamble to the PBT proposed rule(see 64 FR 688, at 717). It is importantfor EPA to clarify that this proposal doesnot introduce any new issues beyondthose associated with lead and leadcompounds (e.g., persistence data forlead, bioaccumulation data for lead,estimated number of reports). TheAgency is therefore only seekingcomments on the generic issues thatrelate specifically to the proposal tolower the reporting threshold for leadand lead compounds. The changes thatEPA is proposing to make to thereporting requirements for lead and leadcompounds are discussed in detail inUnit VI. of this preamble, including theapplicability to lead and leadcompounds of the general amendmentsto EPCRA section 313 reportingrequirements for PBT chemicalspresented in the proposed PBT rule.Accordingly, comments on thefollowing issues, which were previouslyidentified and for which comment wassought in Unit IX. of the preamble to theproposed PBT rule (see 64 FR 688, at717), are only requested on thisproposal insofar as the comments relateparticularly to lead and leadcompounds: (1) Whether EPA shouldattempt to estimate the releases thatwould be reported at an ‘‘average’’facility at each of the identified optionsfor a lowered threshold, the appropriatemethodology for estimating releasesfrom all affected industry sectors, andwhether EPA should then use thoseestimates to select the loweredthreshold that would capture someoverall percentage of releases, e.g., 75 -80%; (2) whether EPA should considerlowering the reporting thresholds forlead and lead compounds based oneither persistence or bioaccumulation(rather than both); (3) whether EPAshould consider other mechanisms forfurther minimizing the potentialimpacts associated with lowering thereporting thresholds for lead and leadcompounds (i.e., it was suggested thatEPA develop a modified Form A withthresholds more appropriate for leadand lead compounds, retain de minimisthresholds for lead and lead compounds(perhaps at a lower level), retain wholenumber reporting, the half-pound rule,and range reporting for lead and leadcompounds, establish an activityqualifier restricting the lower reportingthreshold to the manufacture of leadand lead compounds, retaining thehigher current thresholds with respectto import, process or use activities, andthat EPA modulate the frequency ofreporting).

D. What Other Comments Should thePublic Submit?

EPA believes that the additionalinformation provided by lowering theTRI reporting thresholds for PBTchemicals, including lead and leadcompounds, will be valuable tocommunities and will significantlyenhance their knowledge about toxicchemical releases and other wastemanagement activities that may be ofconcern to them. At the same time, EPArecognizes that today’s proposal, alongwith its earlier proposal to lowerreporting thresholds for various otherPBT chemicals (64 FR 688), willincrease the burden imposed by the TRIprogram on facilities that must provideinformation. EPA is mindful of theimportance of minimizing reportingburden, while continuing to providecommunities with high quality right-to-know information. EPA is genuinelyinterested in reducing TRI reportingburden, while assuring that the goalsand objectives of EPCRA section 313continue to be met.

EPA has already initiated a number ofburden reducing activities in the TRIprogram. For example, EPA is currentlyreviewing the original list of EPCRAsection 313 chemicals in response tosuggestions that EPA evaluate thosechemicals against the EPCRA section313(d) criteria. EPA is also developingreporting guidance, including guidancespecifically for small businesses, whichwill simplify and ease reportingburdens. These efforts include thedevelopment of intelligent reportingsoftware with built-in error checkingroutines and calculation methodologies;the development of a single facilityidentification program for facilities thatreport to EPA; and the development ofguidance to facilitate more consistentuse of chemical nomenclature, reportingunits, and time frames across differentprograms.

As a means of identifying otherpotential areas for reducing TRIreporting burden, EPA initiated anintensive stakeholder process tocomprehensively evaluate current TRIreporting. An important part of thisstakeholder process was a reviewconducted by the Toxics Data Reporting(TDR) Committee of the NationalAdvisory Council on EnvironmentalPolicy and Technology (NACEPT). EPAasked the TDR Committee to developrecommendations to improve the right-to-know information available tocommunities and to help streamlinereporting to ease the paperwork burdenfor facilities affected by therequirements. Specifically, theCommittee was asked to examine the



format of and nomenclature in the FormR, seek opportunities for burdenreduction, and evaluate EPA’spresentation of the data in publicinformation documents. The TDRCommittee met eight times betweenSeptember 1997 and October 1998, andissued its final report in May 1999. TheTDR Committee report is available onthe Internet at www.epa.gov/opptintr/tri, and a copy of the report is alsoavailable in the public version of theofficial record for this proposed rule.

In their final report to the Agency,after noting that the TDR Committee didnot reach final consensus on mostissues, the TDR Committee presentedthe various suggestions raised duringthe discussions as ‘‘ideas’’ without anyindication of the level of support forthem. These ideas fall under the broadcategories of burden reduction, thepublic data release (PDR), and the FormR. Some of the burden reduction ideaspresented by the TDR Committeeinclude the creation of an intelligentsoftware program for reporters, theintegration of reporting across programs,the provision of industry specificguidance, the expansion of the EPCRAsection 313 exemptions, and options forincreasing eligibility for the alternatethreshold as certified by Form A. Withregard to the Form R, most of theCommittee’s suggestions involved theaddition of data elements intended tofurther clarify the information currentlycollected, particularly on the wastemanagement data. The Committee alsooffered ideas for improving the PDR,including adding information to thePDR that would provide additionalcontext for the TRI data.

The TDR Committee report alsomentions a more general approach forburden reduction that involvesestablishing, either through regulationor guidance, limitations on the level ofeffort and data accuracy required for TRIreports. For example, this approachmight include greater use of defaultparameters and standardized estimationmethods based on best engineeringpractices, and/or a percentage rule inwhich a facility would be required tocollect information and report onlysome fixed percentage of releases (e.g.,90%). This latter approach could allowfacilities to focus their reporting effortson larger sources of releases and ignoresome smaller sources, as long as theyreported at least the specifiedpercentage of total releases. Theabsolute quantity not reported wouldvary from toxic chemical to toxicchemical and from facility to facility.EPA requests comments on thesubstance of this approach, includingmechanisms that would allow

implementation consistent with EPCRAsection 313. In particular, EPA isinterested in comments regarding thepotential impacts of this approach onthe facility reporting burden and on theintegrity of the TRI data and communityright-to-know.

In addition to the TDR Committeereport, EPA has received othersuggestions for burden reduction in theTRI program. Although EPA has alreadyrequested comment on the suggestionthat EPA effectively modify thefrequency of reporting for PBTchemicals (see 64 FR 688, at 718), andlead and lead compounds (see UnitIII.C. of this preamble), it has beensuggested that EPA consider changingthe frequency of reporting under EPCRAsection 313 in general, i.e., requirebiennial reporting. EPA is requestingcomment on the utility of biennialreporting and whether that approachwould provide for significant burdenreduction for affected facilities. EPAwelcomes comment on the availabilityof information that would allow theAgency to make the requisite findingsunder EPCRA section 313(i)(3)(B),especially how consideration ofalternate reporting requirements shouldpertain to the facilities in the recentlyadded industry sectors for which firstreports have just recently been received,the lack of readily available informationon EPCRA section 313 chemicals fromexisting sources, and what availableinformation may exist to allow EPA toaddress the requirements of the law.

EPA places great importance onreducing burden on the public and iscurrently considering the varioussuggestions it has received, includingthe ideas in the TDR Committee report,and others received from industry andother agencies. EPA welcomesadditional suggestions, and specificallyrequests comment on the ideaspresented in the TDR Committee report,particularly those that relate to burdenreduction.

IV. Explanation for Lowering ReportingThresholds

A. What is the General Background forthis Rulemaking?

In 1986, Congress passed EPCRA.This new law recognized the uniquerole that communities can play inassuring environmental protection at thelocal level. Just prior to the passage ofEPCRA, fatal chemical releases from achemical manufacturing facility inBhopal, India highlighted the need fordeveloping and sharing both emergencyplanning information and routinerelease information with the public. Theidentification of United States facilities,

chemicals, and processes identical tothe Bhopal situation brought home thepotential for similar accidents in theUnited States as well as a recognitionthat routine releases of toxic chemicalsassociated with routine facilityprocesses could pose significant risks tocommunities. These routine, annualreleases, if assessed at all, were knownonly to the facilities themselves.Communities however, were unaware ofthe magnitude and potentialconsequences of such releases.

Section 313 of EPCRA resulted in thecreation of the Toxics Release Inventory(TRI). TRI is a publicly available database that provides quantitativeinformation on toxic chemical releasesand other waste management activities.With the collection of this informationfor the first time in 1987, came theability for the public, government, andthe regulated community to understandthe magnitude of chemical emissions inthe United States; to compare chemicalreleases among facilities and transfers ofchemical wastes among States,industries, and facilities; and perhapsmost importantly, to assess the need toreduce and where possible, eliminatethese releases and other wastemanagement activities. TRI enables allparties interested in environmentalprogress to establish credible baselines,to set realistic goals, and to measureprogress over time, in meeting thosegoals. The TRI system provides a neutralyardstick by which progress can bemeasured by all interested parties. TRIis an important tool in empowering theFederal government, State governments,industry, environmental groups, and thegeneral public, to fully participate in aninformed dialogue about theenvironmental and human healthimpacts of toxic chemical releases andother waste management activities.

Prior to EPCRA, the kind ofinformation contained in the TRIgenerally was nonexistent orunavailable to the Federal government,State governments, emergencypreparedness teams or the generalpublic, and often was not discloseduntil after major impacts on humanhealth and the environment wereevident. This ‘‘after the fact’’ disclosureof information did little to help plan foror prevent such serious health andenvironmental impacts. While permitdata are generally cited as a publicsource of environmental data, they areoften difficult to obtain, are not multi-media, and present only a limitedperspective on a facility’s overallenvironmental performance. Whileother sources of data are sometimescited as substitutes for TRI data, basedon its own research, EPA is unaware of



any other publicly available, nationwidedata base that provides multi-media,facility-specific release and other wastemanagement information to the publicin a readily accessible form. With TRI,and the real gains in understanding ithas produced, communities now knowwhich industrial facilities in their arearelease or otherwise manage as wastelisted toxic chemicals.

Under EPCRA section 313, Congressset the initial parameters of TRI, but alsogave EPA clear authority to modify TRIin various ways, including to change thetoxic chemicals subject to reporting, thefacilities required to report, and thethreshold quantities that triggerreporting. By providing this authority,Congress recognized that the TRIprogram would need to evolve to meetthe needs of a better informed publicand to refine existing information. EPAhas, therefore, undertaken a number ofactions to expand and enhance TRI.These actions include expanding thenumber of reportable toxic chemicals byadding 286 toxic chemicals andchemical categories to the EPCRAsection 313 list in 1994 (59 FR 61432,November 30, 1994) (FRL–4922–2).Further, a new category of facilities wasadded to EPCRA section 313 on August3, 1993, through Executive Order 12856(58 FR 41981, August 6, 1993), whichrequires Federal facilities meetingthreshold requirements to file annualTRI reports. In addition, in 1997 EPAexpanded the number of private sectorfacilities that are required to reportunder EPCRA section 313 by addingseven new industrial groups to the listof covered facilities (62 FR 23834, May1, 1997) (FRL–5578–3). At the sametime, EPA has sought to reduce theburden of EPCRA section 313 reportingby actions such as delisting chemicalsthat were determined not to meet thestatutory listing criteria and establishingan alternate reporting threshold of 1million pounds for facilities with 500pounds or less of production-relatedreleases and other wastes. Facilitiesmeeting the requirements of thisalternate threshold may file acertification statement (Form A) insteadof reporting on the standard TRI report,the Form R.

In today’s action, EPA is proposingenhanced reporting requirements forlead and lead compounds. Lead andlead compounds are toxic chemicalsthat persist and bioaccumulate in theenvironment. To date, with theexception of facilities subject to thealternate threshold exemption, EPA hasnot altered the statutory reportingthreshold for all listed chemicals.However, as the TRI program hasevolved over time and as communities

identify areas of special concern,thresholds and other aspects of theEPCRA section 313 reportingrequirements may need to be modifiedto assure the collection anddissemination of relevant, topicalinformation and data. Towards that end,EPA is proposing to increase the utilityof TRI to the public by lowering thereporting thresholds for lead and leadcompounds. Lead and lead compounds,being PBT chemicals, are of particularconcern because they remain in theenvironment for significant periods oftime and concentrate in the organismsexposed to them. EPA believes it isimportant that the public understandthat these PBT chemicals can haveserious human health andenvironmental effects resulting fromlow levels of release and exposure.Lowering the reporting thresholds forlead and lead compounds would ensurethat the public has importantinformation on the quantities of thesePBT chemicals released or otherwisemanaged as waste, that would not bereported under the current thresholds.

B. Why Should EPCRA Section 313 beUsed to Focus on Chemicals that Persistand Bioaccumulate?

As discussed in Unit VI.A. of thispreamble, EPA is proposing to lower theEPCRA section 313 reporting thresholdsfor lead and lead compounds becausethese substances persist andbioaccumulate in the environment. Achemical’s persistence refers to thelength of time the chemical can exist inthe environment before being destroyedby natural processes. Bioaccumulationis a general term that is used to describethe process by which organisms mayaccumulate certain chemicals in theirbodies. The term refers to both uptakeof chemicals from water(bioconcentration) and from ingestedfood and sediment residues. PBTchemicals, such as lead and leadcompounds, are therefore toxicchemicals that partition to water,sediment, or soil and are not removedat rates adequate to prevent theirbioaccumulation in aquatic or terrestrialspecies. Chemicals that persist andbioaccumulate have been found inshellfish, birds, human adipose tissue,and other mammals. See Unit V. of thispreamble for a more detailed discussionof and definitions for the termspersistence and bioaccumulation andthe data for lead and lead compounds.

Review of existing data leads EPA tobelieve that, as a general matter, therelease to the environment of toxicchemicals that persist andbioaccumulate is of greater concern thanthe release of toxic chemicals that do

not persist or bioaccumulate. Since PBTchemicals can remain in theenvironment for a significant amount oftime and can bioaccumulate in animaltissues, even relatively small releases ofsuch chemicals from individualfacilities have the potential toaccumulate over time to higher levelsand cause significant adverse impactson human health and the environment.EPA believes that the availability ofinformation on PBT chemicals, andspecifically lead and lead compounds,is a critical component of acommunity’s right-to-know. Therefore,it is particularly important to gather anddisseminate to the public relevantinformation on the releases and otherwaste management activities of PBTchemicals.

Thus, for PBT chemicals, releases andother waste management activities thatoccur at facilities that manufacture,process, or otherwise use suchchemicals even in relatively smallamounts are of concern. Under currentreporting thresholds, a significantamount of the releases and other wastemanagement activities involving leadand lead compounds are not beingcaptured. The public, therefore, doesnot have the information needed todetermine if lead and lead compoundsare present in their communities atlevels that may pose a significant risk.By lowering the section 313 reportingthresholds for lead and leadcompounds, EPA would be providingcommunities across the United Stateswith access to data that may help themin making this determination. Thisinformation could also be used bygovernment agencies and others toidentify potential problems, setpriorities, and take appropriate steps toreduce any potential risks to humanhealth and the environment.

Several EPA offices have ongoingprojects and programs that are dealingwith issues concerning PBT chemicals,such as lead and lead compounds. EPAhas established the PBT planning groupwhich is a coordinating body consistingof representatives from various programoffices throughout EPA that are dealingwith PBT chemicals. This group hasdeveloped a strategy to reduce pollutionfrom PBT chemicals through theapplication of regulatory and non-regulatory authorities, with a strongemphasis on pollution prevention.Under this initiative, the reporting ofPBT chemicals at lower thresholdsunder EPCRA section 313 wouldprovide data on PBT chemicals to EPA,industry, and the public. Theavailability of that data can allow allparties to identify and track releases ofPBT chemicals and monitor the progress



of the programs designed to reduce theamount of PBT chemicals entering theenvironment. The data would also allowEPA and others to design preventionstrategies that are focused and effective.

EPA is also participating in severalinternational efforts to reduce oreliminate pollution from PBTchemicals. These efforts include: theCommission for EnvironmentalCooperation (CEC) Process forIdentifying Candidate Substances forRegional Action Under the SoundManagement of Chemicals Initiative, theUnited Nations EnvironmentProgramme Persistent OrganicPollutants (POPs) Negotiations, and theCanada-United States Strategy for theVirtual Elimination of Persistent ToxicSubstances in the Great Lakes Basin.

The program between the UnitedStates and Canada focuses on pollutionof the Great Lakes by PBT chemicals,which has been a matter of greatconcern for both countries. However,the Canada-United States Strategy forVirtual Elimination of Persistent ToxicSubstances in the Great Lakes Basincontains commitments that applynationwide, including those for alkyllead. EPA has established the GreatLakes National Program Office (GLNPO)to develop and implement programs toreduce pollution of the Great Lakes.GLNPO works in cooperation withcounterpart organizations in Canada,most notably Environment Canada, tocarry out its mission. The ‘‘Final WaterQuality Guidance for the Great LakesSystem’’ (60 FR 15366, March 23, 1995)(FRL–5173–7) identified ‘‘Pollutantsthat are Bioaccumulative Chemicals ofConcern (BCCs)’’ among the ‘‘Pollutantsof Initial Focus in the Great Lakes WaterQuality Initiative.’’ Working with thatlist, Canada and the United Statesagreed on an initial list of chemicalsidentified as ‘‘Substances Targeted bythe Canada-United States Strategy forthe Virtual Elimination of PersistentToxic Substances in the Great LakesBasin’’ (Ref. 1). A subset of the targetedsubstances is often referred to as the‘‘Binational Level 1 List,’’ and includeschemicals both countries havecommitted to ‘‘virtually eliminate’’ fromthe Great Lakes, through meeting aseries of interim reduction goals, someof which are national in scope. Virtualelimination is to be attained byprograms implemented voluntarily byeach country. The Binational Level 1List includes alkyl lead, and theassociated commitment reads: ‘‘USChallenge: Confirm by 1998, that thereis no longer use of alkyl lead inautomotive gasoline. Support andencourage stakeholder efforts to reducealkyl lead releases from other sources.’’

The information that would be reportedunder this proposed rule regarding alkyllead would directly contribute to theAgency’s ability to ‘‘support andencourage stakeholder efforts to reducereleases’’ as agreed to in the BinationalStrategy.

EPA discussed the issue of reportingon PBT chemicals under section 313 inits January 12, 1994 chemical expansionproposed rule (59 FR 1788) (FRL–4645–6). In the preamble to the proposed rule,EPA specifically requested comment onwhether PBT chemicals should beadded to the section 313 list. EPA alsoasked for comments on whatmodifications to reporting requirements,such as lowering reporting thresholds ormodifying the de minimis exemption,would need to be made in order toensure that release and transferinformation would be collected for suchchemicals. In response to EPA’s requestfor comments on the reporting of PBTchemicals, 39 commenters responded,with 35 of these commenters fullysupporting such reporting under section313. In addition, of the over 620comments EPA received on its 1997proposal to add a dioxin and dioxin-likecompounds category, over 520commenters supported lowering thereporting thresholds for the proposedcategory. Many commenters alsosuggested that EPA lower the reportingthreshold for all toxic chemicals thatpersist and bioaccumulate. EPA willprovide specific responses to thesecomments as part of any final ruledeveloped to add the dioxin and dioxin-like compounds category to the section313 list and lower the reportingthresholds. EPA has recently addressedthe issue of lower reporting thresholdsfor certain other PBT chemicals in aproposed rule that was published onJanuary 5, 1999 (64 FR 688) (FRL–6032–3).

V. Review of Persistence,Environmental Fate, andBioaccumulation Data for Lead andLead Compounds

A. What are Persistence andEnvironmental Fate and What Data areAvailable for Lead and LeadCompounds?

A chemical’s persistence refers to thelength of time the chemical can exist inthe environment before being destroyed(i.e., transformed) by natural processes.The environmental media for whichpersistence is measured or estimatedinclude air, water, soil, and sediment;however, water is the medium for whichpersistence values are most frequentlyavailable. It is important to distinguishbetween persistence in a single medium

(air, water, soil, or sediment) and overallenvironmental persistence. Persistencein an individual medium is controlledby transport of the chemical to othermedia, as well as transformation toother chemical species. Persistence inthe environment as a whole is a distinctconcept. It is based on the observationsthat the environment behaves as a set ofinterconnected media, and that achemical substance released to theenvironment will become distributed inthese media in accordance with thechemical’s intrinsic (physical/chemical)properties and reactivity. For overallpersistence, only irreversibletransformation contributes to net loss ofa chemical substance.

Although metals and metalcompounds, including lead and leadcompounds, may be converted from themetal to a metal compound or from onemetal compound to another in theenvironment, the metal cannot bedestroyed. Thus, metals are obviouslypersistent in the environment in someform. The form of the metal that existsin the environment depends on itsenvironmental fate. Environmental faterefers to the ultimate result of physical,chemical, and biological processesacting upon a metal or metal compoundonce released into the environment. Theenvironmental fate determines whetherthe metal or the metal from a metalcompound will be available forexposure to organisms once releasedinto the environment. Theenvironmental fate of a metal or metalcompound varies depending on theenvironmental conditions and thephysical/chemical properties of themetal in question.

The information summarized belowfor the environmental fate of lead ineach environmental medium representsthe key elements influencing thetransport, transformation, andbioavailability of lead in air, soil, waterand sediments. Commenters shouldconsult the support documents andreview the studies contained andreferenced therein for furtherinformation. The informationsummarized below as well as a moreextensive review of the existing data onthe environmental fate of lead iscontained in The Environmental Fate ofLead and Lead Compounds (Ref. 2) andin the references contained therein.

Most lead released to air eventuallysettles back to ground level by drydeposition or washout by rain. Thus,airborne lead is either returned to soilsurfaces by deposition or to surfacewater by deposition or surface runoff.However, while airborne, some leadcompounds (e.g., lead halides) can



undergo reactions to produce leadsulfates and carbonates.

After deposition in the soilenvironment, lead may bind strongly bymechanisms such as the formation ofinsoluble complexes with organicmaterial, clay minerals, phosphate, andiron-manganese oxides common inmany soils. These mechanisms canlower the levels of soluble lead in soils.However, some of the lead in the soilenvironment (0.2 to 1%) may be watersoluble. The extent of sorption appearsto increase with increasing pH. Underacidic conditions, levels of lead in soilwater can increase significantly. Thesolubility of lead increases linearly inthe pH range of 6 to 3. At a pH of 5 to9, heavy metals such as lead may bindto the surface of clay minerals. Cationexchange capacity (CEC, related to soilclay content) and pH also influence thecapacity of soil to immobilize lead.Generally, as the CEC and pH increase,the capacity of a soil to sorb leadincreases. Conversely, soils with lowerCEC and pH tend to have a lowercapacity to sorb lead. Using organicchelation as a model, the total capacityof soil to immobilize lead can bepredicted by the linear relationshipdeveloped by Zimdahl and Skogerboe(Ref. 3). Using this equation to predictsaturation capacity from CEC and pH, itcan be shown that a pH drop from 5.5to 4.0 would reduce estimated soilabsorption capacity 1.5 times, therebyincreasing the concentration of availablelead in soil water.

A number of field studies demonstratethe effect of environmental conditionson the mobility of lead in soils. In allof these studies, variables including pH,soil organic matter content and thechemical species of lead present, had asignificant influence on soil leadmobility. Data indicate that when thepH and soil organic matter content arelow and conditions favor the formationof soluble forms of lead, the mobility oflead increases. Therefore, decreasing pHcan lead to increasing concentrations oflead in soil water. Other studiesdemonstrate that when pH and soilorganic matter are high, lead mobility insoils is decreased. Limited data indicatethat organolead compounds may beconverted into water-soluble leadcompounds in some soil. Degradationproducts of tetramethyl and tetraethyllead, the trialkyl lead oxides, areexpected to be significantly more mobilein soils than the parent tetraalkyl leadcompounds would be.

The levels of soluble lead in surfacewaters depend on the pH of the waterand the dissolved salt content.Equilibrium calculations show that at apH greater than 5.4, the total solubility

of lead is approximately 30 microgramsper liter (µg/L) in hard water andapproximately 500 µg/L in soft water. Insoft water, sulfate ions limit the leadconcentration in solution through theformation of lead sulfate. The leadcarbonates limit lead in solution at a pHgreater than 5.4 (Ref. 4). Concentrationsas high as 330 µg/L could be stable inwater at a pH near 6.5 and an alkalinityof about 25 milligrams (mg) bicarbonateion per liter. Water having theseproperties is common, for example, inrunoff areas of New York State and NewEngland. In other waters, wherealkalinity and pH are higher, the relativeconcentrations of soluble lead may belower.

Lead also forms complexes withorganic matter in water. The organicmatter includes humic and fulvic acidsthat are the primary complexing agentsin soils and widely distributed insurface waters. The presence of fulvicacid in water has been shown toincrease the rate of solution of leadsulfide 10 to 60 times (Refs. 5 and 6).At pH levels near neutral (i.e., about7.0), soluble lead-fulvic acid complexesare present in solution. As pH levelsincrease, the complexes are partiallydecomposed, and lead hydroxide andcarbonate are precipitated, and mayeither remain suspended or fall to thesediment. Other studies have shownthat humic acid in freshwater andmarine sediments, and in the aqueousphases, are capable of complexingvarious amounts of metals. In somecircumstances, this process couldpotentially reduce the levels of solublelead present.

At neutral pH, lead generally movesfrom the dissolved to the particulateform with ultimate deposition insediments. There is evidence that inanaerobic sediments, lead can undergobiological or chemical methylation. Thisprocess could result in theremobilization and reintroduction oftransformed lead into the water columnwhere it could be available for uptakeby biota, and volatilization to theatmosphere. However, tetramethyl leadmay be degraded in aerobic water beforereaching the atmosphere.

In conclusion, EPA believes thatprocesses commonly observed in theenvironment can result in the release ofbioavailable (ionic) lead where it can bebioaccumulated by organisms. Theseprocesses may occur in soil and aquaticenvironments with low pH and lowlevels of clay and organic matter. Underthese conditions, the solubility of leadis enhanced and if there are no sorbingsurfaces and colloids, lead ion canremain in solution for a sufficientperiod to be taken up by biota. Lead

sorption to soil organic matter has beenshown to be pH dependent. DecreasingpH can lead to increasingconcentrations of lead in soil water;while increasing pH can lead todecreasing concentrations of lead in soilwater.

The Agency’s analysis of theenvironmental fate of lead and leadcompounds, therefore, shows that undermany environmental conditions lead isavailable to express its toxicity and tobioaccumulate. The bioavailability ofmetals such as lead has been raised asan issue at recent public meetings onEPA’s January 5, 1999 proposed rule onPBT chemicals (64 FR 688). It has beensuggested that metals will not bebioavailable from certain metalcompounds that may be released intothe environment and that therefore theyshould not be considered PBTchemicals. The issue of thebioavailability of metals from metalcompounds is broader than just itsimplications for whether a chemical isa PBT. The issue of bioavailability hasbeen addressed for EPCRA section 313chemical assessments through EPA’spolicy and guidance concerningpetitions to delist individual membersof the metal compound categories listedunder EPCRA section 313 (May 23,1991, 56 FR 23703). This policy statesthat if the metal in a metal compoundcannot become available as a result ofbiotic or abiotic processes then themetal will not be available to express itstoxicity. If the intact metal compound isnot toxic and the metal is not availablefrom the metal compound then such achemical is a potential candidate fordelisting. EPA developed this petitionprocess specifically to address suchcircumstances.

EPA requests comment on itsdiscussion of the scientific informationconcerning the fate, transport, and theavailability of lead in the environment,and on how this information should beconsidered in classifying lead as a PBTchemical.

B. What is Bioaccumulation and WhatAquatic Bioaccumulation Data areAvailable for Lead and LeadCompounds?

Bioaccumulation is a general termthat is used to describe the process bywhich organisms may accumulatechemical substances in their bodies. Thediscussions and data onbioaccumulation in this unit (i.e., UnitV.B.) deal strictly with aquaticorganisms. This is not to imply thatbioaccumulation cannot occur in non-aqueous environments and in fact UnitV.C. of this preamble discusses thebioaccumulation of lead in humans,



including bioaccumulation from non-aqueous media. The termbioaccumulation refers to uptake ofchemicals by organisms both directlyfrom water and through their diet (Ref.7). EPA has defined bioaccumulation asthe net accumulation of a substance byan organism as a result of uptake fromall environmental sources (60 FR15366). The nondietary accumulation ofchemicals in aquatic organisms isreferred to as bioconcentration, and maybe described as the process throughwhich a chemical is distributed betweenthe organism and environment based onthe chemical’s properties,environmental conditions, andbiological factors such as an organism’sability to metabolize the chemical (Ref.8). EPA has defined bioconcentration asthe net accumulation of a substance byan aquatic organism as a result of uptakedirectly from the ambient water throughgill membranes or other external bodysurfaces (60 FR 15366). A chemical’spotential to bioaccumulate can bequantified by measuring or predictingthe chemical’s bioaccumulation factor(BAF). EPA has defined the BAF as theratio of a substance’s concentration in

tissue of an aquatic organism to itsconcentration in the ambient water, insituations where both the organism andits food are exposed and the ratio doesnot change substantially over time (60FR 15366). A chemical’s potential tobioaccumulate can also be quantified bymeasuring or predicting the chemical’sbioconcentration factor (BCF). EPA hasdefined the BCF as the ratio of asubstance’s concentration in tissue of anaquatic organism to its concentration inthe ambient water, in situations wherethe organism is exposed through wateronly and the ratio does not changesubstantially over time (60 FR 15366).

A review of the ecotoxicologicalliterature indicates thatbioconcentration values of lead and leadcompounds (lead salts) in aquatic plantsand animals are often above abioconcentration/bioaccumulationfactor of 1,000. Lead is bioaccumulatedby aquatic organisms such as plants,bacteria, invertebrates, and fish. Theprincipal form that is believed to beaccumulated is divalent lead (i.e., leadin its plus 2 oxidation state (Pb∂2)). Ithas been shown that fish held in waterat a pH of 6.0 accumulate three times as

much lead as fish held in water at a pHof 7.5 (Ref. 9), thus as pH decreases theavailability of divalent lead increases.Older organisms usually have thehighest body burdens, and leadaccumulates in bony tissues to thegreatest extent.

Table 1 below summarizes some ofthe data reviewed concerning the extent(magnitude) of lead bioaccumulationfound to occur in many aquatic plantsand animals and the leadbioconcentration factors (BCF)determined or measured from laboratorystudies conducted for certain durationsusing BCF test methods. Only some ofthe laboratory calculated values ormonitored field values near or above abioaccumulation factor of 1,000 areincluded in Table 1; additional data canbe found in the bioaccumulationsupport document (Ref. 10).Concentrations of lead monitored invarious organisms listed in Table 1 weredetermined by comparingconcentrations in the environment(water) with concentrations measured inthe organisms.



Table 1.—Bioaccumulation/Bioconcentration Data for Lead and Lead Compounds in Aquatic Organisms.

Test SpeciesChemical Tested/Monitored (con-

centration)BCF Value1 Field Concentration

Factor2 Reference

Freshwater SpeciesSnail (Lymnaea palustris) Lead nitrate (12 µg/

L)1,700; 3,100 (soft tis-

sue); 2,500 (wholeanimal)

NA Ref. 11

Phytoplankton, 13 species(Melosira italica andAsterionella formosa weredominants)

Lead (0.4-2.5 µg/dm3 NA 10,000x or greater(3) Ref. 12

Green alga (Selenastrumcapricornutum)

Lead nitrate (5 µg/L) 10,000(3) NA Ref. 13

Green alga (Selenastrumcapricornutum)

Lead nitrate (50 µg/L)

2,900(3) NA Ref. 13

Green alga (Cladophora sp.) Lead NA 390x(3); 690x(3); and1,695x(3)

Ref. 14

Pondweed (Pontamogeton sp.) Lead NA 525x(3) and 1,695x(3) Ref. 15

Rainbow trout (Salmo gairdneri) Lead (3.5 µg/L; 24µg/L)

726 (whole fish);12,540 and 17,300(intestinal lipids)

NA Ref. 16

Marine SpeciesBlue mussel (Mytius edulis) Lead nitrate; Lead

(10 µg/L); Lead(500 µg/L)

2,570 and 2,800(soft parts);2,427(3) (kidney)and 306(3) (softparts); 4,985(3)

(soft parts)

NA Refs. 17 and 18

Eastern oyster (Crassostreavirginica)

Lead (1, 3.3 µg/L) 1,320(3) and 691(3)

(soft parts)NA Ref. 19

Brown alga (Fucus vesiculosus) Lead (1-7.5 µg/L) NA 570x-3,600x(3) Ref. 20

Algae (Ulva sp.) Lead (1-7.5 µg/L) NA 1,140x-7,350x(3) Ref. 20

Algae (Enteromorpha linza) Lead (1-7.5 µg/L) NA 1,020x-6,750x(3) Ref. 20

Algae (Blidingia minima) Lead (1-7.5 µg/L) NA 900x-12,300x(3) Ref. 20

American Lobster (Homarusamericanus)

Lead (50 µg/L) 2,760 (antennalgland)

NA Ref. 21

1BCF values are calculated from laboratory studies.2Field concentrations are estimated from water:organism sample comparisons.3Value was converted from a dry weight value to a wet weight value using appropriate conversion factors.

Additional information concerninglead’s bioaccumulation potential issummarized in the bioaccumulationsupport document for this proposed rule(Ref. 10). In general, bioconcentrationvalues for four freshwater invertebratespecies ranged from 499 to 1,700 (Ref22). BCFs for two species of freshwaterfish were much lower, 42 and 45.However, certain fish tissues have muchhigher BCF values, e.g., the BCF valuefor the intestinal lipids in rainbow troutwere as high as 17,300. Freshwaterphytoplankton and both marine andfreshwater algae accumulate orconcentrate lead to very high levels

(e.g., greater than 10,000x). BCF valuesfor marine bivalve organisms were ashigh as 4,985 for blue mussels. Easternoysters also have BCF values greaterthan 1,000. These data indicate thatmany of the BCF values and measuredenvironmental concentration factors forlead are above 1,000 with severalspecies having BCF or observedconcentration factors above 5,000. Thereferences cited for blue musselsinclude a range of values, the upper endof which is very close to 5,000 (i.e.,4,985). There are also a few fish tissuesthat have BCFs greater than 10,000,

though most of the available fish dataare below 5,000.

EPA requests comment on itsdiscussion of the scientific informationconcerning the bioaccumulation of leadin aquatic organisms, and on how thisinformation should be evaluated inassessing the bioaccumulative potentialof lead and lead compounds.

C. What Data are Available on theHuman Bioaccumulation of Lead andLead Compounds?

There is a great deal of informationavailable on the bioaccumulation of leadin humans and the effects that such



accumulation can have. Much of thisinformation is summarized and cited inthe following documents, The Agencyfor Toxic Substances and DiseaseRegistry Toxicological Profile on Lead(Ref. 23), EPA’s Risk Analysis toSupport Standards for Lead in Paint,Dust, and Soil (Ref. 24), and EPA’s AirQuality Criteria for Lead (Ref. 25). EPA’sOffice of International Affairs has alsoestablished an Internet site that providesinformation on lead including lists ofvarious EPA documents on lead that areavailable as well as links to other EPAprograms and agencies that haveinformation on lead and its hazards(Ref. 26). This unit provides a summaryof some of the information from thesesources that relates to the ability of leadto accumulate in humans.

The bioaccumulation and persistenceof lead in humans is well documented.Although lead has no known biologicalfunction in humans, it is readilyabsorbed through the gut and can beabsorbed by inhalation and, to someextent by dermal contact. Absorption oflead can occur as a result of exposureto air-borne forms of lead, as well asingestion or contact with contaminatedsoil and dust. Children and developingfetuses are known to absorb lead morereadily than adults and to excrete it ata lower total rate. These findings areespecially significant since youngchildren are most susceptible to theadverse effects associated with leadexposure. Lead absorption varies fromvery low levels (e.g., 5%) up toessentially 100%. Lead absorptionappears to be linked to particle size, thechemical composition, and other factors(Refs. 27 and 28). Long-lasting impactson intelligence, motor control, hearing,and neurobehavioral development ofchildren have been documented atlevels of lead that are not associatedwith clinical intoxication and were oncethought to be safe. An analysis ofhuman blood-lead level data collectedfrom most recent National Health andNutrition Examination Surveys (see Ref.24), showed that approximately 4.4% ofthe nation’s children aged 1-5 yearshave blood-lead concentrations at orabove 10 micrograms per deciliter (µg/dL), which is the current action levelestablished by the Centers for DiseaseControl. While this is a significantimprovement over the 88% of childrenwho had blood lead levels above thisthreshold in 1976, before the phase-outof lead in gasoline, it is still cause forconcern because it leaves nearly 900,000children aged 1-5 with unacceptablyhigh blood-lead levels.

Once lead is absorbed in the body, itis primarily distributed to the blood,

soft tissues (kidney, bone marrow, liver,and brain) and to the mineralizing tissue(bones and teeth). In one study it wasshown that in adults, following a singledose of lead, one-half of the leadabsorbed from the original exposureremained in the blood for approximately25 days after exposure, in soft tissues forabout 40 days, and in bone for morethan 25 years (Ref. 29). Once in thebone, lead can re-enter the blood andsoft tissues. Under certaincircumstances, such as pregnancy andlactation, lead can more readily re-enterblood and soft tissues. Thus,accumulation of lead in bone can serveto maintain elevated blood lead levelsyears after exposure. The total amountof lead in long-term bone retention canapproach 200 mg for adult males 60-70years old (and even higher withoccupational exposure). For adults, upto 94% of the total amount of lead in thebody is contained in the bones and teethbut for children only about 73% isstored in their bones. While the increasein bone lead level across childhood ismodest, the total accumulation rate isactually 80-fold when the 40-foldincrease in skeletal mass that childrenundergo is taken into account. Whilelead absorption rates are influenced byseveral parameters, including route ofexposure, chemical speciation, thephysical/chemical characteristics of thelead and the exposure medium, as wellas the age and physiological states of theexposed individual, there is substantialdocumentation that a significant amountof lead can be absorbed andaccumulated in humans.

EPA requests comments on itsdiscussion of the scientific informationconcerning the bioaccumulation of leadin humans and on how this informationshould be considered in classifying leadand lead compounds as ‘‘highlybioaccumulative.’’

D. What are EPA’s Conclusions from theReview of the Available Data on Leadand Lead Compounds?

EPA’s review of the availableinformation on lead and leadcompounds has led EPA to concludethat lead and lead compounds arehighly persistent and highlybioaccumulative. The persistence oflead in the environment is not inquestion since, as a metal, lead cannotbe destroyed in the environment. Withrespect to whether lead or leadcompounds released to the environmentwill result in lead that is bioavailable,the data indicate that under manyenvironmental conditions lead doesbecome available. The conclusion thatlead is bioavailable in the environment

is confirmed by the data on thebioaccumulation of lead in aquaticorganisms and in humans as a result ofenvironmental exposures. As for lead’sbioaccumulation potential, lead hasbeen shown to bioaccumulate inlaboratory studies and has been found tobioaccumulate in organisms observed inthe environment. These data indicatethat many of the BCF values andmeasured environmental concentrationfactors for lead are above 1,000 withseveral species having BCF or observedconcentration factors above 5,000. Thereferences cited for blue musselsinclude a range of values, the upper endof which is very close to 5,000 (i.e.,4,985). There are also a few fish tissuesthat have BCFs greater than 10,000,though most of the available fish dataare below 5,000.

A high concern for thebioaccumulation potential for chemicalswith BCF values above 1,000 isconsistent with the discussion of BCFvalues in the recent proposed rule onPBT chemicals (January 5, 1999, 64 FR688). In addition, there is considerableinformation on the accumulation of leadin humans, including children who arethe most susceptible to the toxic effectsof lead. The data on lead’s persistenceand availability in the environment, theobserved high bioaccumulation valuesin aquatic organisms, and lead’s abilityto accumulate in humans, are the basisfor EPA’s conclusion that lead and leadcompounds are highly persistent andhighly bioaccumulative.

E. Are There Particular Issues on WhichEPA is Interested in ReceivingComment?

The Agency recognizes that there areseveral complex technical issuessurrounding the availability andbioaccumulation of lead and leadcompounds. For example, during theinter-agency review process it wassuggested that the bioavailability of leadin the environment could beconstrained by many abiotic factorssuch that lead is not available in certainenvironments. These abiotic factorsinclude: Soils have a high capacity toimmobilize lead and therefore limit itsavailability; high pH levels may reducelead bioavailability; organic matter candecrease lead bioavailability; inorganicconstituents can reduce lead availabilityin aqueous environments; and,increasing water hardness can alsoreduce lead availability. The Agencyspecifically requests comments on theseissues.



VI. What Changes are EPA Proposing toMake to the Reporting Requirementsfor Lead and Lead Compounds?

A. What Changes are EPA Proposing forthe Reporting Thresholds for Lead andLead Compounds?

EPA is proposing to lower thereporting thresholds for lead and leadcompounds.

1. What was considered in theselection of lower reporting thresholds?In selecting potential lower reportingthresholds for lead and leadcompounds, EPA considered not onlytheir persistence and bioaccumulationbut also the potential burden that mightbe imposed on the regulated communityby lower reporting thresholds. Each ofthese important considerations isdiscussed below.

a. How was persistence andbioaccumulation considered inthreshold selection? Because lead andlead compounds persist andbioaccumulate in the environment, theyhave the potential to pose human healthand environmental risks over a longerperiod of time. Thus, even smallamounts that enter the environment canlead to elevated concentrations in theenvironment and in organisms whichcan result in adverse effects on humanhealth and the environment. The natureof lead and lead compounds indicatesthat small quantities of such chemicalsare of concern, which provides strongsupport for setting lower reportingthresholds than the current section 313thresholds of 25,000 and 10,000 pounds.

For determining how low reportingthresholds should be set for PBTchemicals, including lead and leadcompounds, EPA has adopted a two-tiered approach. Under this approach,EPA identifies PBT chemicals thatshould have a lower reporting thresholdas those chemicals with half-lives of atleast 2 months and BAF/BCF values ofat least 1,000. This approach alsorecognizes that toxic chemicals thathave very high persistence andbioaccumulation potentials (e.g.,chemicals with half-lives of 6 months ormore and BAF/BCF values of 5,000 ormore), like those that have been widelyrecognized as PBT chemicals, are ofgreatest concern and should have aneven lower reporting threshold. EPAbelieves that for toxic chemicals that arehighly persistent and bioaccumulative,any release of the toxic chemical canresult in elevated concentrations in theenvironment and organisms because oftheir very high persistence andbioaccumulation potentials. As a result,consideration of persistence andbioaccumulation alone would lead EPAto set a reporting threshold for the

subset of highly persistentbioaccumulative chemicals thatapproaches zero in order to provide themost relevant data to communities.However, EPA believes that it isappropriate to set a low threshold fortoxic chemicals that persist andbioaccumulate and to set a lowerthreshold for toxic chemicals that arehighly persistent and bioaccumulative.

Because lead cannot be destroyed inthe environment and because lead isavailable in the environment, EPAbelieves that lead and lead compoundsare highly persistent. Thebioaccumulation data for lead and leadcompounds includes many BCF orconcentration values well above 5,000,and there is additional data that showthat lead bioaccumulates in humans.Given this data, EPA considers lead andlead compounds to be highlybioaccumulative. Thus, EPA believesthat based solely on the degree ofpersistence and bioaccumulation, itwould be appropriate to set section 313manufacture, process, and otherwise usethresholds of 1 pound for lead and leadcompounds. This approach is consistentwith the general approach that EPA hastaken for setting reporting thresholds forPBT chemicals that are highly persistentand highly bioaccumulative asdiscussed in the recent proposed rule onPBT chemicals (64 FR 688).

As EPA stated in the January 5, 1999proposed rule, EPA believes thatcommunities have a greater right-to-know about chemicals which canreasonably be anticipated to be presentin the community at higher levels (64FR 688). This is particularly the case forlead which, as a metal, cannot bedestroyed in the environment. Releasesof lead and lead compounds fromfacilities subject to section 313 reportingrequirements, therefore, can increase thepotential exposure to lead withincommunities relative to a chemical thatcan be destroyed.

The increased exposure potential alsoapplies to chemicals with differentBCFs. The identical amount of twodifferent chemicals, chemical A with aBCF of 1,000 to fish and chemical Bwith a fish BCF of 5,000, will result indifferent exposures to fish that consumeother organisms lower in the food chainthat have been exposed to thesechemicals. For example, organisms thatconsume the fish exposed to chemical Bwill usually be exposed to greaterquantities of the chemical thanorganisms that consume the fishexposed to chemical A, assumingidentical feeding rates and otherconditions. Due to concerns for itshigher accumulation potential, a lower

threshold would be set for Chemical Bthan for Chemical A.

b. Was burden considered inthreshold selection and what is theproposed threshold for lead and leadcompounds? As discussed above, indetermining the appropriate reportingthresholds to propose for lead and leadcompounds, EPA started with thepremise that very low reportingthresholds may be appropriate for leadand lead compounds based solely ontheir persistence and bioaccumulationpotential. EPA then considered theburden that would be imposed by foursets of reporting thresholds. Thethresholds considered were: (1) The 1pound threshold discussed above; (2) 10pounds; (3) 100 pounds; and (4) 1,000pounds. For each threshold, EPAestimated the number of additionalreports that facilities might be requiredto file and the costs associated with thefiling of those additional reports (seeTables 3 and 4 in Unit VII.E.4. of thispreamble). Based on the potentialburdens, EPA believes it is appropriateto lower the reporting thresholds to alevel that would capture significantlymore information about lead and leadcompounds than current thresholds butthat would not be unduly burdensomeon industry. Therefore, EPA isproposing to lower the manufacture,process, and otherwise use thresholds to10 pounds for lead and leadcompounds. This consideration ofburden is consistent with the approachEPA used in the January 5, 1999proposed rule (64 FR 688), in which thepreferred thresholds were set an order ofmagnitude higher than EPA would haveproposed based solely on the degree ofpersistence and bioaccumulation.

EPA requests comment on itsconsideration of industry burden inestablishing lower reporting thresholdsfor lead and lead compounds, includingcomments on the extent to whichburden should be considered in EPA’sdecision. EPA requests comment onwhether the Agency should lower thereporting threshold to 1 pound for leadand lead compounds rather than the 10pound reporting threshold proposed inthis document. EPA requests commenton whether there are any policy reasonsfor selecting the 1 pound reportingthreshold rather than the 10 poundreporting threshold. Such policy reasonscould include the fact that the 10 poundreporting threshold for lead and leadcompounds, which are highly persistentand bioaccumulative, may not captureall releases that are of concern to localcommunities. Alternatively, EPA alsoseeks comment on reasons for selectingreporting thresholds of 100 pounds and1,000 pounds.



c. What is the relationship of theEPCRA section 313 reporting thresholdsto other statutory thresholds? Forpurposes of establishing EPCRA section313 reporting thresholds, Congress hasexpressed a clear intent to obtainreporting on a substantial majority oftotal releases of the chemical at allfacilities subject to the requirements ofthe section, and to assure that thisinformation is reported to EPA and thestates and provided to the usercommunity. In this action, by proposingto lower the reporting thresholds forlead and lead compounds, EPA isworking to assure that communities areprovided with data on these toxicchemicals, which are frequentlymanufactured, processed, or otherwiseused in quantities well below theexisting reporting thresholds of 25,000pounds and 10,000 pounds andconsequently are not reported to EPAand the states. In choosing the proposedEPCRA section 313 thresholds for leadand lead compounds, EPA took intoconsideration a number of factorsincluding small business impacts,overall reporting burden, and reportgeneration in addition to utility of theinformation. It has been EPA’s goal,under the EPCRA section 313 program,to maintain a balance betweencommunity right-to-know and overallreporting burden for the affectedindustry.

EPCRA section 313 provides one ofseveral authorities through which EPAcollects data. Each of these authoritieshas different criteria and differentpurposes. Many are aimed at supportingenvironmental decisionmaking andstandard setting with communityinvolvement in these processes. Thethresholds established under EPCRAsection 313 are designed to meet thestatutory requirements of the Act as wellas the overarching goal of informing thepublic about chemical releases andother waste management practices intheir communities. Other EPA statutessuch as the Clean Water Act (CWA), theClean Air Act (CAA), and ResourceConservation and Recovery Act (RCRA)also have information collectionprovisions, whose criteria, coverage,scope and purpose may be differentfrom that of EPCRA section 313. Thethresholds proposed here, for purposesof EPCRA section 313, should not beconstrued to limit or expand the datacollection goals or authorities of otherEPA programs.

B. What is the de minimis Exemptionand What Changes is EPA Proposing toMake to the Use of the de minimisExemption for Lead and LeadCompounds?

As part of the final rule implementingthe reporting provisions of EPCRAsection 313 (53 FR 4500, February 16,1988), EPA adopted a limited deminimis exemption for listed toxicchemicals in mixtures. The de minimisexemption allows facilities to disregardcertain concentrations of chemicals inmixtures or other trade name productsthey import, process, or otherwise usein making threshold calculations andrelease and other waste managementdeterminations for section 313reporting. This exemption does notapply to the manufacture of a toxicchemical unless the toxic chemical ismanufactured as an impurity or isimported.

EPA adopted this exemption inresponse to comments requesting sometype of concentration limitation forlisted toxic chemicals in mixtures orother trade name products as a burdenreducing measure. Commenterscontended that it would be extremelyburdensome for suppliers, processors,and other users of mixtures or tradename products to have to account forquantities below a de minimis level.Most of these commenters requestedthat EPA adopt a de minimisconcentration limitation consistent withthe Occupational Safety and HealthAdministration (OSHA) HazardCommunication Standard (HCS)requirement. The HCS provides that asupplier does not have to list a‘‘hazardous chemical’’ component in amixture if that chemical comprises lessthan 1.0% of the mixture or 0.1% wherethe chemical is a carcinogen as definedin 29 CFR 1910.1200(d)(4). OSHA chosethe 1% and 0.1% limits because theagency believed that they generallyappeared to be protective of workersand were considered reasonable by anumber of commenters (48 FR 53280,November 25, 1983).

EPA adopted the de minimisexemption primarily as a means ofreducing burden associated with thenew (at the time) EPCRA section 313reporting requirements. The Agencychose the HCS levels because: (1) Theywere consistent with the existing OSHArequirements for developing MaterialSafety Data Sheet (MSDS) informationand with other requirements underEPCRA sections 311 and 312; (2)suppliers of products were familiar withthese levels; (3) for the first 2 years ofreporting, users of these mixtures wereonly likely to be able to rely on the

product MSDS for information about thecontent and percentage composition ofcovered toxic chemicals in theseproducts; and (4) EPA did not expectthat the processing and otherwise use oftoxic chemicals at less than the deminimis concentration in mixtureswould, in most instances, contributesignificantly to the thresholddeterminations or releases of listed toxicchemicals from any given facility.

When determining whether the deminimis exemption applies to a listedtoxic chemical, the facility mustconsider only the concentration of thetoxic chemical in mixtures and tradename products in process streams inwhich the toxic chemical is involved ina reportable activity. If the toxicchemical in a process stream ismanufactured as an impurity, imported,processed, or otherwise used and isbelow the appropriate de minimisconcentration level, then the quantity ofthe toxic chemical in that processstream does not have to be applied tothreshold determinations nor includedin release or other waste managementdeterminations. If a toxic chemical in aprocess stream is below the appropriatede minimis level, all releases and otherwaste management activities associatedwith the toxic chemical in that streamare exempt from EPCRA section 313reporting. It is possible to meet anactivity (e.g., processing) threshold for atoxic chemical on a facility-wide basis,but not be required to calculate releasesor other waste management quantitiesassociated with a particular processbecause that process involves onlymixtures or trade name productscontaining the toxic chemical below thede minimis level.

As stated above, the intent of the deminimis exemption was primarilyburden reduction. The de minimisexemption was not intended to be ageneral small quantity exemption, butrather an exemption based on thelimited information likely to be readilyavailable to facilities newly affected byEPCRA section 313. EPA did not expectin 1988 that ‘‘the processing and[otherwise] use of mixtures containingless than the de minimis concentrationwould, in most instances, contributesignificantly to the thresholddeterminations or releases of listed toxicchemicals from any given facility’’ (53FR 4509). However, given 10 years ofexperience with the program, EPAbelieves that there are many instanceswhere a PBT chemical, including leador a lead compound, may exist in amixture at a concentration below the1% (or 0.1% for OSHA carcinogens) deminimis level, but where themanufacture, process, or otherwise use



of the PBT chemical in that mixturewould otherwise contributesignificantly to, or exceed, the lowerreporting threshold proposed in thisdocument.

For example, a raw material isprocessed that contains less than the deminimis level of lead. The quantity ofraw material processed results insignificantly more than the thresholdquantity of lead being processed. Also,during the processing of lead, itsconcentration in the process streamremains below the de minimis level.However, the concentration of lead inthe wastestream that results from thatprocessing activity is above the deminimis concentration level for lead andthe wastestream containing lead isreleased to the land. In this example,because the concentration of lead in theprocess stream is below the de minimisconcentration, the de minimisexemption can be taken. As a result, (1)The quantities processed do not have tobe applied to the processing thresholdfor lead at the facility, and (2) quantitiesof lead that are released or otherwisemanaged as waste as a result of thisspecific processing activity are exemptfrom release and other wastemanagement determinations. Theexemption applies even though lead isconcentrated above the de minimis levelin the wastestream. This informationwould not be included in that facility’sForm R.

In addition, EPA believes that theinformation available to the typicalEPCRA section 313 reporter is generallygreater than it was 10 years ago. Since1987, the Air Pollution Emission Factors(AP-42) guidance document has beenrepeatedly updated and expanded. Forexample, several new sections wereadded in 1996, including a sectionspecific to electroplating. In the early1990s, the Factor Information Retrievaldata base (FIRE) was developed. EPAhas developed several additionalguidance documents and softwareprograms, including Air CHIEF CD-ROM, to aid facilities in estimatingreleases. Facilities also have access toguidance from trade associations.

EPA believes that there may besignificant releases of lead and leadcompounds in mixtures when thesechemicals exist below the de minimislimit and that even minimal releases ofpersistent bioaccumulative chemicalsmay result in elevated concentrations inthe environment or in an organism thatreasonably can be anticipated to resultin significant adverse effects. Therefore,EPA believes that allowing facilities tocontinue to take the de minimisexemption for lead and leadcompounds, would deprive

communities of important information.While these chemicals may exist inmixtures below the de minimis levelsthey will concentrate in theenvironment and in organisms. Further,lead and lead compounds have beenshown to cause adverse effects atconcentrations far less than the deminimis levels. For example, EPA hasstated that it appears that some of thehealth effects of lead, particularlychanges in the levels of certain bloodenzymes and in aspects of children’sneurobehavioral development, mayoccur at blood lead levels so low as tobe essentially without a threshold (Ref.30). Thus, because lead and leadcompounds can cause adverse effects atconcentrations well below de minimislevels, EPA believes that the de minimisprinciple may no longer apply. SeeEnvironmental Defense Fund v. EPA, 82F.3d 451, 466 (D.C. Cir. 1996); AlabamaPower Co. v. Costle, 636 F. 2d 323, 360(D.C. Cir 1979). In addition, for thereasons articulated above, EPA isconcerned about whether other similarregulatory exemptions continue to besupportable for lead and leadcompounds. See e.g., 40 CFR 372.38(c).

Further, EPA believes that loweringthe reporting thresholds for lead andlead compounds, while leaving the deminimis exemption in place may resultin very limited reporting and underminethe very purpose of this action. Withouta concomitant change in the de minimisexemption, lowering the reportingthresholds would not increase reportingfor lead and lead compounds from someindustry sectors due to the lowconcentrations in mixtures or othertrade name products that are processedor otherwise used. A facility may exceedthe reporting threshold based on someprocesses that involve lead or leadcompounds in a mixture where the leador lead compound is above the deminimis level or on activities for whichthe de minimis exemption is notapplicable. However, EPA expects therewill be significant numbers of activitiesthat occur for which the de minimisexemption could otherwise be taken. Allreleases and other waste managementactivities associated with these activitieswould therefore be exempt.

Given that use of the de minimisexemption could significantly limit theamount of reporting on lead and leadcompounds under the lower reportingthreshold being proposed in today’saction, EPA is proposing to eliminatethe de minimis exemption for lead andlead compounds.

Therefore, EPA is proposing to modify40 CFR 372.38(a) to add the followingsentence to the end thereof:

This exemption does not apply to toxicchemicals listed in § 372.28 (i.e., thechemicals for which thresholds have beenlowered), except for purposes of§ 372.45(d)(1).

As indicated in the proposed regulatorytext, EPA is proposing to list lead andlead compounds in § 372.28.

EPA is not proposing to extend thismodification to 40 CFR 372.45(d)(1)because the Agency believes that thereis sufficient information available onlead and lead compounds. Requirementof additional information in this casewould result in redundancies.

In past expansion actions, EPA hastried to retain burden reducing optionswherever feasible. However, as the TRIprogram evolves to meet emergingcommunity needs, EPA will need toreassess these exemptions and modifythem as appropriate. EPA notes that theincrease in burden resulting fromeliminating the de minimis exemptionfor lead and lead compounds would belimited to facilities that import, process,otherwise use or manufacture asimpurities lead and lead compounds.Many facilities may engage in activitiesthat result in the manufacturing of leadand lead compounds as byproducts. Inthe preamble to the 1988 final ruleimplementing the reporting provisionsof EPCRA section 313 (53 FR 4500), EPAexplained, that the ‘‘de minimislimitation does not apply to thebyproducts produced coincidentally asa result of manufacturing, processing,use, waste treatment, or disposal’’ (see53 FR 4501, column 1). EPA furtherexplains on page 4504, column 3, itsdecision about the application of the deminimis exemption to impurities andbyproducts:

EPA has distinguished between toxicchemicals which are impurities that remainwith another chemical that is processed,distributed, or used, from toxic chemicalsthat are byproducts either sent to disposal orprocessed, distributed, or used in their ownright. EPA also considers that it would bereasonable to apply a de minimisconcentration limitation to toxic chemicalsthat are impurities in another chemical ormixture. . . .Because the covered toxicchemical as an impurity ends up in aproduct, most producers of the product willfrequently know whether the chemical ispresent in concentrations that exceed the deminimis level, and, thus may be listed on theMaterial Safety Data Sheet (MSDS) for thatproduct under the OSHA HCS.

This final rule does not adopt a de minimisconcentration limitation in connection withthe production of a byproduct. EPA believesthat the facility should be able to quantify theannual aggregate pounds of production of abyproduct which is not an impurity becausethe substance is separated from theproduction stream and used, sold, or



disposed of, unlike an impurity whichremains in the product. (53 FR 4500).

Because many facilities may engage inactivities that manufacture lead or leadcompounds as byproducts and since thede minimis exemption does not apply tosuch activities, eliminating it wouldhave no effect on the reporting of leadand lead compounds from thosefacilities.

For lead and lead compounds inmixtures that are imported, processed,or otherwise used, the increase inburden resulting from the elimination ofthe de minimis exemption would belimited because EPCRA does not requireadditional monitoring or sampling inorder to comply with the reportingrequirements under EPCRA section 313.EPCRA section 313(g)(2) states:

In order to provide the informationrequired under this section, the owner oroperator of a facility may use readilyavailable data (including monitoring data)collected pursuant to other provisions of law,or, where such data are not readily available,reasonable estimates of the amountsinvolved. Nothing in this section requires themonitoring or measurement of the quantities,concentration, or frequency of any toxicchemical released in the environment beyondthe monitoring and measurement requiredunder other provisions of law or regulation.

Information used should be based onproduction records, monitoring, oranalytical data, guidance documentsprovided by EPA and trade associations,and reasonable judgement on the part ofthe facility’s management. No furthermonitoring or analysis of production,process, or use is required.

EPA requests comment on itsproposed modification of the deminimis exemption for lead and leadcompounds. EPA also requestscomments on whether the Agencyshould modify the exemptions at 40CFR 372.38(c) (e.g., the otherwise useexemptions, including the structuralcomponent exemption, the routinejanitorial or facility groundsmaintenance exemption; the personaluse exemption, the motor vehiclemaintenance exemption, and the intakeair and water exemption) such that theywill not apply to lead or leadcompounds. The legal authority forthese exemptions is also the de minimisprinciple, and as noted above, EPA isconcerned that this doctrine may not beapplicable to PBT chemicals, such aslead and lead compounds.

C. What is the Alternative Thresholdand Form A, and is EPA Proposing AnyChanges to the Use of the AlternateThreshold and Form A?

On November 30, 1994, EPApublished a final rule (59 FR 61488) that

provides that facilities that have 500pounds or less of production-relatedwaste (the sum of sections 8.1 through8.7 of Form R) may apply an alternatemanufacture, process, and otherwise usereporting threshold of 1 million pounds.Facilities that have less than 500pounds of production-related waste of alisted toxic chemical and that do notmanufacture, process, or otherwise usemore than 1 million pounds of thatlisted toxic chemical may file a Form Acertification statement certifying thatthey do not exceed either of thesequantities for the toxic chemical. Thiscertification statement includes facilityidentification information and chemicalidentification information. EPA adoptedthe alternate threshold and the Form Aas a means of reducing the burdenassociated with EPCRA section 313.

EPA believes that use of the existingalternate threshold and reportablequantity for Form A would beinconsistent with the intent of expandedreporting for PBT chemicals such asproposed for lead and lead compoundsin this proposed rule. While the FormA does provide some generalinformation on the quantities of thechemical that the facility manages aswaste, this information is insufficientfor conducting analyses on PBTchemicals, such as lead and leadcompounds and would be virtuallyuseless for communities interested inassessing risk from releases of lead andlead compounds. First, the thresholdcategory for amounts managed as wastedoes not include quantities released tothe environment as a result of remedialactions or catastrophic events notassociated with production processes(section 8.8 of Form R). Thus, the wastethreshold category will not include allreleases. Given that even smallquantities of lead or lead compoundsmay result in elevated concentrations inthe environment or in an organism, thatreasonably can be anticipated to resultin significant adverse effects, EPAbelieves it would be inappropriate toallow an option that would excludeinformation on some releases. Second,the 500 pound waste threshold categorycould be interpreted by some users, asa worst-case, to mean that greater than500 pounds of the lead and leadcompounds has been released into theenvironment (i.e., 500 pounds ofproduction-related waste as release andsome quantity of catastrophic release).Other users may assume that the facilityhad no catastrophic releases and all ofthe lead or lead compounds in wastewas managed in a manner other than asrelease, e.g., the lead and leadcompounds in waste were recycled. For

those chemicals, such as lead and leadcompounds, where any release is aconcern, an uncertainty level of 500pounds will result in data that arevirtually unusable. As a result, EPA isproposing to exclude lead and leadcompounds from the alternate thresholdof 1 million pounds. Therefore, EPAproposes to modify 40 CFR 372.27 toadd a new paragraph (e) to read asfollows:

(e) The provisions of this section do notapply to any toxic chemicals listed in§ 372.28. As indicated above, EPA isproposing to list lead and lead compounds in§ 372.28.

EPA requests comment on thislimitation to the use of the Form Acertification statement.

D. What is Range Reporting and WhatChanges is EPA Proposing to Make tothe Use of Range Reporting?

For releases and off-site transfers forfurther waste management of less than1,000 pounds of the toxic chemical, EPAallows facilities to report the amounteither as a whole number or by usingrange codes. The reporting ranges are: 1-10 pounds; 11-499 pounds; and 500-999pounds. For larger releases and off-sitetransfers for further waste managementof the toxic chemical, the facility mayreport only the whole number. WhileEPA provided range reporting primarilyas a burden reducing measure focusedon small businesses, the Agency notes anumber of drawbacks. Use of rangescould misrepresent data accuracybecause the low or the high end rangenumbers may not really be that close tothe estimated value, even taking intoaccount its inherent error (i.e., errors inmeasurements and developingestimates). The user of the data mustmake a determination on whether to usethe low end of the range, the mid-point,or the upper end. For example, a releaseof 501 pounds could be misinterpretedas 999 pounds if reported as a range of500 to 999. This represents a 100%error. This uncertainty severely limitsthe utility of release information wherethe majority of a facility’s releases arewithin the amounts eligible for rangereporting. Given that the largeuncertainty that would be part of thesedata would severely limit their utility,EPA believes that facilities shouldreport numerical values, not ranges, forlead and lead compounds. EPA,therefore, proposes to modify 40 CFR372.85(b)(16)(i) to read as follows:

An estimate of the total releases in poundsper year (releases of toxic chemicals of lessthan 1,000 pounds per year may be indicatedin ranges, except for toxic chemicals set forthin § 372.28) from the facility plus anindication of the basis of estimate:



EPA also proposes to modify 40 CFR372.85(b)(16)(ii)(B) to read as follows:

An estimate of the amount of the chemicalin waste transferred in pounds per year(transfers of toxic chemicals of less than1,000 pounds per year may be indicated inranges, except for toxic chemicals set forth in§ 372.28) to each off-site location, and anindication of the basis for the estimate andan indication of the type of treatment ordisposal used.

EPA requests comment on itsproposal to discontinue the use of rangereporting in Form Rs for lead and leadcompounds.

E. What is the Half-Pound Rule andWhole Numbers and What Change isEPA Proposing to Make to the Use of theHalf-Pound Rule and Whole Numbers?

EPA requires that facilities reportnumerical quantities in sections 5, 6,and 8 of Form R as whole numbers anddoes not require more than twosignificant digits (except where theAgency allows range reporting; see UnitVI.D. of this preamble). EPA currentlyallows facilities to round releases of 0.5pounds or less to zero (see ToxicChemical Release Inventory ReportingForms and Instructions: Revised 1997Version (EPA 745-K-98-001), p. 27). Thecombination of requiring the reportingof whole numbers and allowingrounding to zero would result in asignificant number of facilities reportingtheir releases of lead and leadcompounds as zero. EPA, therefore, isproposing that all releases or otherwaste management quantities greaterthan a tenth of a pound of lead or leadcompounds be reported, provided thatthe appropriate activity threshold hasbeen exceeded. Releases and otherwaste management activities wouldcontinue to be reported to twosignificant digits. For quantities of 10pounds or greater, only whole numberswould be required to be reported. Forquantities less than 10 pounds,fractional quantities, e.g., 6.2 pounds,rather than whole numbers would berequired. Remember, EPCRA onlyrequires reporting to be based on thebest readily available information orreasonable estimates.

EPA requests comment on theproposed requirement that all non-zeroreleases of lead and lead compoundsgreater than one tenth of a pound bereported. EPA also requests comment onusing fractional quantities for reportsunder 10 pounds.

F. What Limitation is EPA Proposing forthe Reporting of Lead in Certain Alloys?

Lead can be found in various types ofalloys and is subject to reporting undersection 313 when contained in these

alloys. In response to several petitionsthat EPA has received, the Agency hasbeen reviewing the issue of how metalscontained in alloys, specificallystainless steel, brass, and bronze alloys,should be reported under section 313.Because this issue is currently beingreviewed and no final decisionsconcerning the reporting of lead or othermetals in alloys have been made, EPAdoes not believe that, at this time, itwould be appropriate to increasereporting for those facilities that mustsubmit reports for lead when containedin these alloys. Thus, EPA is notproposing to make any changes,including lowering thresholds, to thecurrent reporting requirements for leadwhen contained in stainless steel, brass,and bronze alloys. EPA is thereforeproposing to exclude lead contained instainless steel, brass, and bronze alloysfrom the lower reporting threshold andretain the current reporting thresholdsfor lead when contained in stainlesssteel, brass, and bronze alloys. Thiswould result in no changes to thereporting requirements for leadcontained in stainless steel, brass, andbronze alloys until EPA makes a finaldetermination on whether there shouldbe any changes to the reportingrequirements for lead and other metalscontained in stainless steel, brass, andbronze alloys. Lead contained instainless steel, brass, and bronze alloyswould still be reportable, but only underthe current reporting thresholds. EPAwould make this distinction at 40 CFR372.28, which is the new section of theCFR that will set forth the lower section313 reporting threshold being proposedin this action. This section wouldindicate that only lead not contained ina stainless steel, brass, or bronze alloywould be subject to the lower reportingthreshold. EPA would also make thisdistinction clear in the section 313 FormR and Form A reporting instructionsand other documents.

Under this proposed limitation forlead in stainless steel, brass, and bronzealloys, reporting facilities that use leadto make stainless steel, brass, andbronze alloys would report for leadunder the lower reporting thresholdsince lead is being used to manufacturean alloy. However, once incorporatedinto the stainless steel, brass, andbronze alloy, lead would not be subjectto the lower reporting threshold. Forpurposes of section 313 reporting, EPAconsiders metal compounds that areused to make alloys to exist as theparent metal in the alloys. Thus, thelimitation on stainless steel, brass, andbronze alloy reporting for lead wouldapply to lead compounds once they are

incorporated into an alloy. The cutting,grinding, shaving, etc. of a stainlesssteel, brass, or bronze alloy does notnegate the reporting limitations forstainless steel, brass, and bronze alloyscontaining lead.

VII. What are the results of EPA’sEconomic Analysis?

EPA has prepared an economicanalysis of the impact of this proposedaction, which is contained in adocument entitled Economic Analysis ofthe Proposed Rule to Modify Reportingof Lead and Lead Compounds underEPCRA Section 313 (Ref. 31). Thisdocument is available in the publicdocket for this rulemaking. The analysisassesses the costs, benefits, andassociated impacts of the proposed rule,including potential effects on smallentities. The major findings of theanalysis are briefly summarized here.

A. What is the Need for the Rule?This proposed rule is intended to

address the market failures arising fromprivate choices about lead and leadcompounds that have societal costs, andthe market failures created by thelimited information available to thepublic about the release and other wastemanagement activities involving leadand lead compounds. Through thecollection and distribution of facility-specific data on toxic chemicals, TRIovercomes firms’ lack of incentive toprovide certain information, andthereby serves to inform the public ofreleases and other waste management oflead and lead compounds. Thisinformation enables individuals to makechoices that enhance their overall well-being. Choices made by a moreinformed public, including consumers,corporate lenders, and communities,may lead firms to internalize into theirbusiness decisions at least some of thecosts to society relating to their releasesand other waste management activitiesinvolving lead and lead compounds. Inaddition, by helping to identify areas ofconcern, set priorities and monitortrends, TRI data can also be used tomake more informed decisionsregarding the design of more efficientregulations and voluntary programs,which also moves society towards anoptimal allocation of resources.

Certain facilities currently report TRIdata on lead and lead compounds underthe existing 10,000 and 25,000 poundreporting thresholds. In 1996, EPAreceived TRI data on the release andother waste management of over abillion pounds of lead and leadcompounds from approximately 1,600facilities. The industry groups reportingthe largest amounts of release or other



waste management of lead and leadcompounds in 1996 were: Electronicand Other Electrical Equipment andComponents (SIC 36); Primary MetalIndustries (SIC 33); Rubber andMiscellaneous Plastics Products (SIC30); Stone, Clay, Glass, and ConcreteProducts (SIC 32); and Fabricated MetalProducts (SIC 34) (Ref. 31). EPA believesthat there are additional facilities inthese and other industry groups that donot currently report lead and leadcompounds to TRI because they do notexceed current reporting thresholds forlead and lead compounds, and/orbecause the lead-containing materialsthey handle are currently covered by thede minimis exemption. EPA is not ableto quantify the total multi-mediareleases or other waste managementfrom these additional facilities withoutTRI reporting. Since even small releasesof lead and lead compounds are ofconcern, EPA believes that there is aneed for reporting from these additionalfacilities.

If EPA were not to take this proposedaction to lower the reporting thresholds,the market failure (and the associatedsocial costs) resulting from the limitedinformation on the release anddisposition of lead and lead compoundswould continue. EPA believes thattoday’s action will improve the scope ofmulti-media data on releases and otherwaste management of lead and leadcompounds. This, in turn, will provideinformation to the public, empowercommunities to play a meaningful rolein environmental decision-making, andimprove the quality of environmentaldecision-making by governmentofficials. In addition, this action willserve to generate information thatreporting facilities themselves may finduseful in such areas as highlightingopportunities to reduce chemical use orrelease and thereby lower costs ofproduction and/or waste management.EPA believes that these are soundrationales for lowering reportingthresholds for lead and leadcompounds.

B. What Regulatory Options WereConsidered?

EPA evaluated four regulatory optionsfor lower reporting thresholds in thedevelopment of this proposed rule. Theoptions were created by varying thereporting thresholds for lead and leadcompounds from their current levels of25,000 pounds for manufacture andprocessing, and 10,000 pounds forotherwise use of EPCRA section 313chemicals. The options in Table 2 belowsummarize the scope of EPA’s analysis.

Table 2.—Summary of OptionsConsidered

RegulatoryOption

Description of ReportingThreshold for Lead and Lead

Compounds

Option 1 1 pound manufactured, proc-essed, or otherwise used

Option 2 10 pounds manufactured,processed, or otherwiseused

Option 3 100 pounds manufactured,processed, or otherwiseused

Option 4 1,000 pounds manufactured,processed, or otherwiseused

Reporting under all four options isaffected by other proposed changes inreporting requirements for lead and leadcompounds. These proposed changesinclude the elimination of the deminimis exemption for lead and leadcompounds, and a requirement for allfacilities to report on lead and leadcompounds using the Form R. The effectof these other proposed changes onreporting is addressed in the economicanalysis of the proposed rule (Ref. 31).

Table 3 following section E.4. of thisunit displays, for each option, theestimated number of additional reportsfor lead and lead compounds expectedfrom various industry groups underEPCRA section 313. This table is notexhaustive. While EPA believes that ithas addressed the industry groups mostlikely to submit additional reports ineconomic analysis of the proposed rule(Ref. 31), other industry groups may alsofile additional reports on lead and leadcompounds. EPA requests thatcommenters provide any availableinformation on other categories offacilities that may be affected by thisproposal, as well as any data on thenumber of facilities in the category thatwould be affected, and the quantity oflead and lead compoundsmanufactured, processed, or otherwiseused by facilities in the category.

In proposing this rule, EPA has soughtto balance the public’s right to knowabout toxic chemical releases and otherwaste management practices in theirneighborhoods and the benefitsprovided by this expanded knowledgewith the costs the rule will likelyimpose on industry, including theimpact on small entities.

C. What are the Potential Costs of thisProposal?

The proposed rule would result in theexpenditure of resources that, in theabsence of the regulation, could be used

for other purposes. The cost of theproposed rule is the value of theseresources in their best alternative use.Most of the costs of the proposed rulewould result from requirements onindustry. Table 4 following section E.4.of this unit displays the industry costsfor each option based on the estimatednumber of facilities affected by thisproposal. Under the option presented inthe regulatory text (Option 2),approximately 15,000 facilities wouldsubmit additional Form R reportsannually. As shown, aggregate industrycosts in the first year for the proposedalternative are estimated to be $116million; in subsequent years they areestimated to be $60 million per year.Industry costs are lower after the firstyear because facilities will be familiarwith the reporting requirements, andmany will be able to update or modifyinformation from the previous year’sreport.

Some of the facilities potentiallyaffected by this proposed rule may alsobe affected by the proposed PBT rule (64FR 688). If these rules are finalized asproposed, certain facilities may fileadditional reports on lead or leadcompounds, as well as on one or moreof the PBT chemicals from the earlierproposal. The ultimate outcome of theseseparate proposals is, however,uncertain at present. Therefore, certainfacility-specific reporting costs havebeen included in the economic analysisfor this proposal and in the economicanalysis of the PBT proposal eventhough these costs would be incurredonly once per facility. Uponfinalization, the aggregate cost of thetwo proposals may be less than the sumof the industry costs shown in theeconomic analyses of these proposalsdue to this potential double-counting ofreporting costs. Under the preferredoptions presented in the regulatory textof this and the previous proposal, thepotential double-counting of industrycosts amounts to approximately $4million in the first year of reporting.EPA plans to estimate the cost of thefinal rules for these proposals using theregulatory framework that exists at thetime of finalization as a baseline.Further information on the extent ofpotential double-counting of costs in theanalyses of the two proposals ispresented in the economic analysis ofthis proposal (Ref. 31).

EPA is expected to expend $1.6million in the first year, and $1.2million in subsequent years forprogrammatic, compliance assistance,and enforcement activities as a result ofthe proposed rule.



D. What are the Potential Benefits of thisProposal?

In enacting EPCRA and PPA, Congressrecognized the significant benefits ofproviding the public with informationon toxic chemical releases and otherwaste management practices. TRI hasempowered the Federal government,State governments, industry,environmental groups and the generalpublic to participate in a fully informeddialogue about the environmentalimpacts of toxic chemicals in the UnitedStates. TRI’s publicly available data baseprovides quantitative information ontoxic chemical releases and other wastemanagement practices. Since TRI’sinception in 1987, the public,government, and the regulatedcommunity have had the ability tounderstand the magnitude of chemicalreleases in the United States and toassess the need to reduce the uses andreleases of toxic chemicals. TRI enablesall interested parties to establishcredible baselines, to set realistic goalsfor environmental progress over time,and to measure progress in meetingthese goals over time. The TRI system isa neutral yardstick by which progresscan be measured by all stakeholders.

The information reported to TRIincreases knowledge of the amount oftoxic chemicals released to theenvironment and the potential pathwaysof exposure, improving scientificunderstanding of the health andenvironmental risks of toxic chemicals;allows the public to make informeddecisions on where to work and live;enhances the ability of corporate leadersand purchasers to more accurately gaugea facility’s potential environmentalliabilities; provides reporting facilitieswith information that can be used tosave money as well as reduce emissions;and assists Federal, State, and localauthorities in making better decisionson acceptable levels of toxic chemicalsin the environment.

There are two types of benefitsassociated with TRI reporting: thoseresulting from the actions required bythe rule (such as reporting andrecordkeeping), and those derived fromfollow-on activities that are not requiredby the rule. Benefits of activitiesrequired by the rule include the valueof improved knowledge about therelease and waste management of toxicchemicals, which leads toimprovements in understanding,awareness and decision-making. It isexpected that this rulemaking willgenerate such benefits by providingreadily accessible information thatotherwise would not be available to thepublic. The proposed rule will benefit

ongoing research efforts to understandthe risks posed by lead and leadcompounds and to evaluate policystrategies that address the risks.

The second type of benefits derivefrom changes in behavior that mayresult from the information reported toEPCRA section 313. These changes inbehavior, including reductions inreleases of and changes in the wastemanagement practices for toxicchemicals may yield health andenvironmental benefits. These changesin behavior come at some cost, and thenet benefits of the follow-on activitiesare the difference between the benefitsof decreased chemical releases andtransfers and the costs of the actionsneeded to achieve the decreases.

Because the state of knowledge of theeconomics of information is not highlydeveloped, EPA has not attempted toquantify the benefits of changingreporting thresholds for lead and leadcompounds. Furthermore, because ofthe inherent uncertainty in thesubsequent chain of events, EPA hasalso not attempted to predict thechanges in behavior that result from theinformation, or the resultant netbenefits, (i.e., the difference betweenbenefits and costs of follow-onactivities). EPA does not believe thatthere are adequate methodologies tomake reasonable monetary estimates ofeither the benefits of the activitiesrequired by the proposed rule, or thefollow-on activities. The economicanalysis of the proposed rule, however,provides illustrative examples of howthe proposed rule will improve theavailability of information on the releaseand other waste management of leadand lead compounds (Ref. 31).

E. What are the Potential Impacts onSmall Entities of this Proposal?

In accordance with the RegulatoryFlexibility Act (RFA) and the Agency’slongstanding policy of alwaysconsidering whether there may be apotential for adverse impacts on smallentities, the Agency has also evaluatedthe potential impacts of this proposedrule on small entities. The Agency’sanalysis of potentially adverse economicimpacts is included in the economicanalysis for this proposed rule (Ref. 31).The following is a brief overview ofEPA’s findings.

1. What was the overall methodologyfor assessing potential small entityimpacts? This proposed rule may affectboth small businesses and smallgovernments. For the purpose of itsanalysis for the proposed rule, EPAdefined a small business using the smallbusiness size standards established bythe Small Business Administration

(SBA). For example, the SBA sizestandard is 500 employees forapproximately 75% of themanufacturing industries, and either750, 1,000 or 1,500 for the remainingmanufacturing industries, which wouldmean that more than 98.5% of allmanufacturing firms are classified assmall businesses (Ref. 32 ). EPA definedsmall governments using the RFAdefinition of jurisdictions with apopulation of less than 50,000. No smallorganizations are expected to be affectedby the proposed rule.

Potential small entity impacts werecalculated for both the first year ofreporting and subsequent years underOption 2 (the option presented in theproposed regulatory text). Only thosesmall entities that are expected tosubmit at least one report are consideredto be ‘‘affected’’ for the purpose of thesmall entity analysis, although EPArecognizes that other small entities willconduct compliance determinationsunder lower thresholds. The number ofaffected entities will be smaller than thenumber of affected facilities, becausemany entities operate more than onefacility. First year costs are typicallyhigher than continuing costs becausefirms must familiarize themselves withthe requirements. Once firms havebecome familiar with how the reportingrequirements apply to their operations,costs fall. EPA believes that subsequentyear impacts are the best measure of theimpact on small entities because thesecontinuing costs are more representativeof the costs firms face to comply withthe proposed rule.

EPA analyzed the potential costimpact of the proposed rule on smallbusinesses and governments for themanufacturing sector and in each of therecently added industry sectorsseparately in order to obtain the mostaccurate assessment for each. EPA thenaggregated the analyses for the purposeof determining whether it could certifythat the proposed rule will not, ifpromulgated, have a ‘‘significanteconomic impact on a substantialnumber of small entities.’’ RFA section605(b) provides an exemption from therequirement to prepare a regulatoryflexibility analysis for a rule where anagency makes and supports thecertification statement quoted above.EPA believes that the statutory test forcertifying a rule and the statutoryconsequences of not certifying a rule allindicate that certificationdeterminations may be based on anaggregated analysis of the rule’s impacton all of the small entities subject to it.

2. What are the potential impacts onsmall businesses? EPA used annualcompliance costs as a percentage of



annual company sales to assess thepotential impacts on small businesses ofthis proposed rule. EPA believes thatthis is a good measure of a firm’s abilityto afford the costs attributable to aregulatory requirement, becausecomparing compliance costs to revenuesprovides a reasonable indication of themagnitude of the regulatory burdenrelative to a commonly availablemeasure of a company’s businessvolume. Where regulatory costsrepresent a small fraction of a typicalfirm’s revenue (for example, less than1%, or not greater than 3%), EPAbelieves that the financial impacts of theregulation may be considered notsignificant.

Based on its estimates for Option 2 ofthe proposed rule, the Agency estimatesthat approximately 8,100 businesseswill be affected by the proposed rule,and that approximately 5,600 of these

businesses are classified as small basedon the applicable SBA size standards.EPA estimates that no small businesseswill bear costs greater than 1% ofrevenues in the first or subsequentreporting years.

3. What are the potential impacts onsmall governments? To assess thepotential impacts on small governments,EPA used annual compliance costs as apercentage of annual governmentrevenues to measure potential impacts.Similar to the methodology for smallbusinesses, this measure was usedbecause EPA believes it provides areasonable indication of the magnitudeof the regulatory burden relative to agovernment’s ability to pay for the costs,and is based on readily available data.

EPA estimates that 36 publicly ownedelectric utility facilities, operated by atotal of 34 municipalities, may beaffected under Option 2 of the proposed

rule. Of these, an estimated 18 areoperated by small governments (i.e.,those with populations under 50,000). Itis estimated that none of these smallgovernments will bear annual costsgreater than 1% of annual governmentrevenues in the first or subsequentreporting years.

4. What are the potential impacts forall small entities? As discussed above,no small businesses are expected to bearannual costs over 1% of annualrevenues. None of the affected smallgovernments are estimated to bearannual costs greater than 1% of annualrevenues. No small organizations areexpected to be affected by the proposedrule. Thus, the total number of smallentities with impacts above 1% ofrevenues does not change when theresults are aggregated for all smallentities (i.e., small businesses, smallgovernments, and small organizations).

Table 3.—Summary of Reporting Under Regulatory Options

SIC Code - Industry GroupEstimated Number of Additional Reports (Annual)

Option 1 Option 2 Option 3 Option 4

12 - Coal mining 321 321 321 321

29 - Petroleum refining and related industries 1,033 117 91 90

3241 - Cement, hydraulic 123 123 123 123

33 - Primary metal industries 1,130 1,130 1,109 842

367 - Electronic components and accessories 4,033 4,033 3,109 405

371 - Motor vehicles and motor vehicle equipment 2,862 2,862 1,485 201

4911/4931/4939 - Electric services 414 378 319 248

4953 - Refuse systems (RCRA subtitle C only) 80 74 64 36

5171 - Petroleum bulk stations and terminals 2,459 980 621 55

7389 - Solvent recovery services 26 24 22 14

20-39 - Other manufacturing; industrial combustion 10,142 5,001 1,498 570

Total 22,623 15,043 8,762 2,905

Table 4.—Summary of Reporting and Industry Cost of Regulatory Options

Regulatory Options for Lead and Lead Compounds Annual Number ofReports

Estimated Industry Costs ($ million peryear)

First Year Subsequent Years

Opion 1—Reporting threshold of 1 lb 22,623 $174 $91

Option 2—Reporting threshold of 10 lb 15,043 $116 $60

Option 3—Reporting threshold of 100 lb 8,762 $67 $35

Option 4—Reporting threshold of 1,000 lb 2,905 $22 $12



VIII. What are the References Cited inthis Proposed Rule?

1. The Great Lakes Binational ToxicsStrategy, Canada — United StatesStrategy for the Virtual Elimination ofPersistent Toxic Substances in the GreatLakes, signed by Carol Browner,Administrator U.S. EnvironmentalProtection Agency and Sergio Marchi,Minister of the EnvironmentGovernment of Canada. 1997.

2. Syracuse Research Corporation.The Environmental Fate of Lead andLead Compounds. Prepared for David G.Lynch, U.S. Environmental ProtectionAgency, under contract number SRC 68-D5-0012, March 1999.

3. Zimdahl, R.L., Skogerboe, R.K.1977. Behavior of Lead in Soil. Environ.Sci Technol. 11:1202-1207.

4. USEPA/ORD. Air Quality Criteriafor Lead. Research Triangle Park, NC.EPA, Office of Research andDevelopment, Office of Health andEnvironmental Assessment. 1986.EPA600/8-83-028bF

5. Bondarenko, G.P. 1968. Anexperimental study of the solubility ofgalena in the presence of fulvic acids.Geochem. Int. 5: 525-531.

6. Lovering, T.G. ed. 1976. Lead in theEnvironment. Washington, DC: USDepartment of the Interior, GeologicalSurvey; Geological Survey professionalpaper no. 957. S/N 024-001-02911-1

7. Rand, G.M., Fundamentals ofAquatic Toxicology, 2nd. Ed. TaylorFrancis, Washington, DC, (1995), 1125pp.

8. Meylan, W.M., Howard, P.H., andBoethling, R.S. 1999. ‘‘ImprovedMethod for Estimating BioconcentrationFactor from Octanol/Water PartitionCoefficient.’’ Environ. Toxicol. Chem.18:664-672.

9. Merlini, M. and A. Pozzi. 1977.Lead and freshwater fishes. Part 1. Leadaccumulation and water pH. Environ.Pollut. 12:167-172.

10. USEPA/OPPT. Bioaccumulation/Bioconcentration Assessment For Leadand Lead Compounds. Jerry Smrchek,Ph.D., Biologist, Existing ChemicalsAssessment Branch, Risk AssessmentDivision, March 31, 1999.

11. Borgmann, U., Kramer, O. and C.Loveridge. 1978. Rates of mortality,growth, and biomass production ofLymnaea palustris during chronicexposure to lead. J. Fish. Res. BoardCanada. 35:1109-1115.

12. Denny, P. and R.P. Welsh. 1979.Lead accumulation in plankton bloomsfrom Ullswater, the English LakeDistrict. Environ. Pollut. 18:1-9.

13. Vighi, M. 1981. Lead uptake andrelease in a experimental trophic chain.Ecotoxicol. Environ. Safety. 5:177-193.

14. Eisler, R. 1988. Lead hazards tofish, wildlife, and invertebrates: asynoptic review. Biological Report85(1.14), Contaminant Hazard ReviewsReport No. 14, U.S. Fish and WildlifeService, U.S. Department of the Interior,Laurel, MD, 134 pp.

15. USEPA. Jenkins, D.W. 1980.Biological monitoring of trace metals.Vol. 2. Toxic trace metals in plants andanimals of the world. Part II. EPA 600/3-80-091, U.S. Environmental ProtectionAgency, Washington, DC, pp. 619-778.

16. Wong, P.T.S., Chau, Y.K., Kramer,O. and G.A. Bengert. 1981.Accumulation and depuration oftetramethyllead by rainbow trout. WaterRes. 15:621-625.

17. Schulz-Baldes, M. 1972. Toxicityand accumulation of lead in thecommon mussel Mytilus edulis inlaboratory experiment. Mar. Biol.16:226-229.

18. Schulz-Baldes, M. 1974. Leaduptake from sea water and food, andlead loss in the common mussel, Mytilusedulis. Mar. Biol. 25:177-193.

19. Zaroogian, G.E., Morrison, G. andJ.F. Heltshe. 1979. Crassostrea virginicaas an indicator of lead pollution. Mar.Biol. 52:189-196.

20. Seeliger, U. and P. Edwards. 1977.Correlation coefficients andconcentration factors of copper and leadin seawater and benthic algae. Mar.Pollut. Bull. 8:16-19.

21. Gould, E. And R.A. Greig. 1983.Short-term low-salinity response inlead-exposed lobsters, Homarusamericanus (Milne Edwards). J. Exp.Mar. Biol. Ecol. 69:283-295.

22. USEPA. Ambient Water QualityCriteria for Lead. 1984. EPA 440/5-84-027, Office of Water, U.S.Environmental Protection Agency,Washington, DC, 1985, 81 pp.

23. ATSDR. Draft ToxicologicalProfile for Lead. U.S. Department ofHealth and Human Services, PublicHealth Service, Agency for ToxicSubstances and Disease Registry. August1997.

24. USEPA/OPPT. Risk Analysis toSupport Standards for Lead in Paint,Dust, and Soil - Volume 1. U.S.Environmental Protection Agency,Office of Pollution Prevention andToxics, Washington DC, EPA 747-R-97-006, June 1998.

25. USEPA/ECAO. Air QualityCriteria for Lead - Volume 1 of IV. U.S.Environmental Protection Agency,Environmental Criteria and AssessmentOffice, Research Triangle Park, NC,EPA-600/8-83/028aF, June 1986.

26. USEPA/OIA. TechnicalInformation Package for Lead. Internetsite: http://www.epa.gov/oiamount/tips/lead2.htm. Maintained by the U.S.

Environmental Protection Agency,Office of International Affairs.Downloaded March 1999.

27. Davis A., Ruby M., and BergstromP. Factors controlling leadbioavailability in the Butte miningdistrict, Montana, USA EnvironmentalGeochemistry and Health 1994; 16(3/4):147-157

28. Davis A., Drexler J., Ruby M., andNicholson A. Micromineralogy of MineWastes in Relation to LeadBioavailability, Butte, Montana EnvironSci Technology 1993 Mar 16;27(7):1415-1425

29. Rabinowitz, M.B., et. al., KineticAnalysis of Lead Metabolism in HealthyHumans. Journal of ClinicalInvestigation. 1976. 58:260-270.

30. IRIS 1999. U.S. EnvironmentalProtection Agency’s Integrated RiskInformation System Profile pertaining tolead and lead compounds.

31. USEPA, OPPT. Economic Analysisof the Proposed Rule to Modify theReporting Requirements for Lead andLead Compounds under EPCRA Section313, (1999).

32. USSBA. Office of Advocacy -Statistics - Major Industry, Firms,Establishment, Employment, Payrolland Receipts, 1995. Information fromthe Small Business Administration onthe Internet. http://www.sba.gov/advo/stats/us—ind95.html. Downloaded onDecember 10, 1998.

33. USEPA, OPPT. UnfundedMandates Reform Act (UMRA)Statement for the Proposed Rule toModify the Reporting Requirements forLead and Lead Compounds underEPCRA Section 313, April 1999.

IX. Regulatory AssessmentRequirements

A. What is the Determination UnderExecutive Order 12866?

Under Executive Order 12866,entitled Regulatory Planning andReview (58 FR 51735, October 4, 1993),it has been determined that this is aneconomically ‘‘significant regulatoryaction’’ subject to review by the Officeof Management and Budget (OMB)because it is likely to have an annualeffect on the economy of $100 millionor more. This action was thereforesubmitted to OMB for review, and anysubstantive comments or changes madeduring that review have beendocumented in the public record.

In addition, EPA has prepared aneconomic analysis of the impact of thisaction, which is contained in adocument entitled Economic Analysis ofthe Proposed Rule to Modify Reportingof Lead and Lead Compounds underEPCRA Section 313 (Ref. 31). This



document is available as part of thepublic record for this action, and isbriefly summarized in Unit VII. of thispreamble.

B. What is the Determination Under theRegulatory Flexibility Act?

For the reasons explained in Unit VII.of this preamble, pursuant to section605(b) of the Regulatory Flexibility Act(RFA) (5 U.S.C. 601 et seq.), the Agencyhereby certifies that this proposed rulewill not have a significant economicimpact on a substantial number of smallentities. In brief, the factual basis of thisdetermination is as follows: none of theapproximately 5,600 small businessespotentially affected by the proposed rulewill experience annual compliancecosts above 1% of annual sales. Inaddition, EPA estimates that there are18 small governments that may beaffected by the proposed rule (i.e., willhave to file reports under the proposedrule), none of which will bear annualcosts greater than 1% of annualgovernment revenues. Given theserelatively small estimated impacts, forpurposes of the RFA, EPA believes thatthe proposed rule will not have asignificant economic impact on asubstantial number of small entities.EPA’s estimates are based on theeconomic analysis (Ref. 31), and are alsodiscussed in Unit VII. of this preamble.This determination is for the entirepopulation of small entities potentiallyaffected by this proposed rule, since thetest for certification is whether the ruleas a whole has a significant economicimpact on a substantial number of smallentities.

Notwithstanding the Agency’scertification of this proposed rule undersection 605(b) of the RFA, EPA remainscommitted to minimizing real impactson small entities where this does notunacceptably compromise theinformational benefits of the rule. TheAgency is always interested in anycomments regarding the economicimpacts that this regulatory actionwould impose on small entities,particularly suggestions for minimizingthat impact. Such comments may besubmitted to the Agency at any time, tothe address listed in Unit I.C. of thispreamble. To ensure considerationduring the development of the finalrule, comments must be received by thedate indicated in the ‘‘DATES’’ section.

Information relating to thisdetermination has been provided to theChief Counsel for Advocacy of the SmallBusiness Administration, and isincluded in the docket for thisrulemaking.

C. What is the Determination Under thePaperwork Reduction Act?

The information collectionrequirements contained in this proposedrule have been submitted to OMB underthe Paperwork Reduction Act (PRA), 44U.S.C. 3501 et seq., and in accordancewith the procedures at 5 CFR 1320.11.An amended Information CollectionRequest (ICR) document has beenprepared by EPA (EPA ICR No. 1363)and a copy may be obtained from SandyFarmer, OP Regulatory InformationDivision; U.S. Environmental ProtectionAgency (2137); 401 M St., SW.;Washington, DC 20460, by calling (202)260-2740, or electronically by sendingan e-mail message to‘‘[email protected].’’ Theinformation requirements contained inthis proposal are not effective untilOMB approves them. An Agency maynot conduct or sponsor, and a person isnot required to respond to a collectionof information subject to OMB approvalunder the PRA unless it displays acurrently valid OMB control number.The OMB control numbers for EPA’sregulations, after initial publication inthe Federal Register, are maintained ina list at 40 CFR part 9.

Provision of this information ismandatory, upon promulgation of afinal rule, pursuant to EPCRA section313 (42 U.S.C. 11023) and PPA section6607 (42 U.S.C. 13106). EPCRA section313 requires owners or operators ofcertain facilities manufacturing,processing, or otherwise using any ofover 600 listed toxic chemicals andchemical categories (hereinafter toxicchemicals) in excess of the applicablethreshold quantities, and meetingcertain requirements (i.e., at least 10FTEs or the equivalent), to reportenvironmental releases and transfers ofand waste management activities forsuch chemicals annually. Under section6607 of the PPA, facilities must alsoprovide information on the quantities ofthe toxic chemicals in waste streamsand the efforts made to manage thosewaste quantities. The regulationscodifying the EPCRA section 313reporting requirements appear at 40 CFRpart 372. Respondents may designatethe specific chemical identity of asubstance as a trade secret, pursuant toEPCRA section 322 (42 U.S.C. 11042).Regulations codifying the trade secretprovisions can be found at 40 CFR part350.

Under the proposed rule, all facilitiesreporting to TRI on lead and leadcompounds would have to use the EPAToxic Chemical Release Inventory FormR (EPA Form No. 9350-1). OMB hasapproved the existing reporting and

recordkeeping requirements related toForm R, supplier notification, andpetitions under OMB Control No. 2070–0093 (EPA ICR No. 1363).

For Form R, EPA estimates theindustry reporting burden for collectingthis information (includingrecordkeeping) to average 74 hours perreport in the first year, at an estimatedcost of $5,079 per Form R. Insubsequent years, the burden isestimated to average 52.1 hours perreport, at an estimated cost of $3,557 perForm R. These estimates include thetime needed to review instructions;search existing data sources; gather andmaintain the data needed; complete andreview the collection of information;and transmit or otherwise disclose theinformation. The actual burden on anyspecific facility may be different fromthis estimate depending on thecomplexity of the facility’s operationsand the profile of the releases at thefacility.

This proposed rule is estimated toresult in additional reports fromapproximately 15,000 respondents. Ofthese, approximately 5,100 facilities areestimated to be reporting to TRI for thefirst time as a result of the rule, whileapproximately 9,900 are currentlyreporting facilities that will besubmitting additional reports. These15,000 facilities will submit anestimated additional 15,000 Form Rs.This proposed rule therefore results inan estimated total burden of 1.7 millionhours in the first year, and 0.9 millionhours in subsequent years, at a totalestimated industry cost of $116 millionin the first year and $60 million insubsequent years.

Under PRA, ‘‘burden’’ means the totaltime, effort, or financial resourcesexpended by persons to generate,maintain, retain, or disclose or provideinformation to or for a Federal agency.This includes, where applicable, thetime needed to review instructions;develop, acquire, install, and utilizetechnology and systems for the purposesof collecting, validating, and verifyinginformation, processing andmaintaining information, and disclosingand providing information; adjust theexisting ways to comply with anypreviously applicable instructions andrequirements; train personnel to be ableto respond to a collection ofinformation; search data sources;complete and review the collection ofinformation; and transmit or otherwisedisclose the information. EPA’s burdenestimates for the rule take into accountall of the above elements, consideringthat under section 313, no additionalmeasurement or monitoring may beimposed for purposes of reporting.



Comments are requested on theAgency’s need for this information, theaccuracy of the provided burdenestimates, and any suggested methodsfor minimizing respondent burden,including through the use of automatedcollection techniques. Send commentson the ICR to EPA at the addressprovided above, with a copy to theOffice of Information and RegulatoryAffairs, Office of Management andBudget, 725 17th St., NW., Washington,DC 20503, marked ‘‘Attention: DeskOfficer for EPA.’’ Please remember toinclude the ICR number in anycorrespondence. The final rule willrespond to any comments on theinformation collection requirementscontained in this proposal.

D. What are the Determinations Underthe Unfunded Mandates Reform Actand Executive Orders 12875 and 13084?

Pursuant to Title II of the UnfundedMandates Reform Act of 1995 (UMRA)(Pub. L. 104-4), EPA has determinedthat this action contains a ‘‘Federalmandate’’ that may result inexpenditures of $100 million or morefor the private sector in any 1 year, butthat it will not result in suchexpenditures for State, local, and tribalgovernments in the aggregate.Accordingly, EPA has prepared awritten statement for this proposed ruleas required by section 202 of UMRA,and that statement is available in thepublic docket for this rulemaking (Ref.33). The costs associated with thisaction are estimated in the economicanalysis prepared for this proposed rule(Ref. 31), which is included in thepublic docket and summarized in UnitVII. of this preamble. The following isa brief summary of the UMRA statementfor the proposed rule.

This proposed rule is beingpromulgated pursuant to sections313(f)(2) of EPCRA, 42 U.S.C. section11023(f)(2), and section 6607 of thePollution Prevention Act, 42 U.S.C.section 13106. The economic analysisestimates that the total industry costs ofthe proposed rule will be $116 millionin the first year and $60 million per yearthereafter, and concludes that thebenefits will be significant but cannot beassigned a dollar value due to the lackof adequate methodologies. Thisinformation is also summarized abovein Unit VII. of this preamble. EPAbelieves that the benefits provided bythe information to be reported underthis proposed rule will outweigh thecosts imposed by today’s action. Thebenefits of the information will in turnhave positive effects on health, safety,and the natural environment through

the behavioral changes that may resultfrom that information.

EPA has not identified any Federalfinancial resources that are available tocover the costs of this proposed rule. Asset forth in the economic analysis, EPAhas estimated the future industrycompliance costs (after the first year) ofthis proposed rule to be $60 millionannually. Of those entities affected bytoday’s action, EPA has not identifiedany disproportionate budgetary impacton any particular region, government, orcommunity, or on any segment of theprivate sector. Based on the economicanalysis, EPA has concluded that it ishighly unlikely that this proposed rulewill have an appreciable effect on thenational economy.

EPA has determined that theproposed rule will not significantly oruniquely affect small governments anddoes not contain a significant Federalintergovernmental mandate, so noaction is needed under section 203 or204 of UMRA.

Finally, EPA believes this proposedrule complies with section 205(a) ofUMRA. The objective of this proposedrule is to expand the public benefits ofthe TRI program by exercising EPA’sdiscretionary authority to add chemicalsto the program and to lower reportingthresholds, thereby increasing theamount of information available to thepublic regarding the use, management,and disposition of listed toxicchemicals. In making additionalinformation available through TRI, theAgency increases the utility of TRI dataas an effective tool for empowering localcommunities, the public sector,industry, other agencies, and State andlocal governments to better evaluaterisks to public health and theenvironment, particularly at the locallevel.

As described in Unit VI. of thispreamble, EPA considered burden in thethreshold selection. The proposed rulealso contains reporting requirementsthat will limit burden (e.g., reportinglimitations for lead and lead compoundsin certain alloys). In addition, existingburden-reducing measures (e.g., thelaboratory exemption, and the otherwiseuse exemptions, which include theroutine janitorial or facility groundsmaintenance exemption, motor vehiclemaintenance exemption, structuralcomponent exemption, intake air andwater exemption and the personal useexemption) will apply to the facilitiesthat file new reports as a result of thisproposed rule. EPA also will beassisting small entities subject to theproposed rule, by such means asproviding meetings, training, andcompliance guides in the future, which

also will ease the burdens ofcompliance.

Many steps have been and will betaken to further reduce the burdenassociated with this proposed rule, andto EPA’s knowledge there is no availablealternative to the proposed rule thatwould obtain the equivalent informationin a less burdensome manner. For all ofthese reasons, EPA believes the rulecomplies with UMRA section 205(a).

In addition, today’s rule does notcreate a mandate on State, local or tribalgovernments, nor does it significantly oruniquely affect the communities ofIndian tribal governments. Accordingly,the requirements of section 1(a) ofExecutive Order 12875, entitledEnhancing the IntergovernmentalPartnership (58 FR 58093, October 28,1993), and section 3(b) of ExecutiveOrder 13084, entitled Consultation andCoordination with Indian TribalGovernments (63 FR 27655, May 19,1998), do not apply to this proposedrule.

E. What are the Determinations UnderExecutive Orders 12898 and 13045

Pursuant to Executive Order 12898,entitled Federal Actions to AddressEnvironmental Justice in MinorityPopulations and Low-IncomePopulations (59 FR 7629, February 16,1994), the Agency has consideredenvironmental justice related issueswith regard to the potential impacts ofthis action on environmental and healthconditions in low-income populationsand minority populations. Since this isan economically significant action (i.e.,it is expected to have an annual adverseimpact of $100 million or more),additional OMB review is requiredunder Executive Order 13045, entitledProtection of Children fromEnvironmental Health Risks and SafetyRisks (62 FR 19885, April 23, 1997). TheAgency has, to the extent permitted bylaw and consistent with the agency’smission, identified and assessed theenvironmental health risks and safetyrisks that may disproportionately affectchildren.

By lowering the section 313 reportingthresholds for lead and leadcompounds, EPA is providingcommunities across the United States(including low-income populations andminority populations) with access todata that may assist them in loweringexposures and consequently reducingchemical risks for themselves and theirchildren. This information can also beused by government agencies and othersto identify potential problems, setpriorities, and take appropriate steps toreduce any potential risks to humanhealth and the environment. Therefore,



the informational benefits of theproposed rule will have a positiveimpact on the human health andenvironmental impacts of minoritypopulations, low-income populations,and children.

List of Subjects in 40 CFR Part 372

Environmental protection, Chemicals,Community right-to-know, Hazardoussubstances, Intergovernmental relations,Reporting and recordkeepingrequirements, Superfund.

Dated: July 23, 1999.Carol M. Browner,Administrator.

Therefore, it is proposed that 40 CFRpart 372 be amended as follows:

PART 372—[AMENDED]

1. The authority citation for part 372would continue to read as follows:

Authority: 42 U.S.C. 11023 and 11048.

§ 372.22 [Amended]

2. In § 372.22(c), by removing thephrase ‘‘§ 372.25 or § 372.27’’ andadding in its place ‘‘§ 372.25, § 372.27,or § 372.28’’.

§ 372.25 [Amended]

3. In the introductory text of § 372.25,by removing the first clause ‘‘Except asprovided in § 372.27,’’ and adding in itsplace ‘‘Except as provided in §§ 372.27and 372.28,’’.

4. In § 372.27, by adding a newparagraph (e) to read as follows:

§ 372.27 Alternate threshold andcertification.

* * * * *(e) The provisions of this section do

not apply to any chemicals listed in§ 372.28.

5. By adding a new § 372.28 tosubpart B to read as follows:

§ 372.28 Lower thresholds for chemicalsof special concern.

(a) Notwithstanding § 372.25 or§ 372.27, for the toxic chemicals setforth in this section, the thresholdamounts for manufacturing (includingimporting), processing, and otherwiseusing such toxic chemicals are as setforth in this section.

(1) Chemical listing in alphabeticorder:

Chemical name CAS no.Report-

ingthreshold

Lead (this lowerthreshold does notapply to lead whencontained in a stain-less steel, brass orbronze alloy)

7439-92-1

10

(2) Chemical categories in alphabeticorder:

Category name Reporting threshold

Lead Compounds 10

(b) The threshold determinationprovisions at § 372.25(c) through (h) andthe exemptions at § 372.38(b) through(h) are applicable to the toxic chemicalslisted in paragraph (a) of this section.

§ 372.30 [Amended]

6. In § 372.30(a), by removing thephrase ‘‘in § 372.25 at’’ and adding in itsplace ‘‘in § 372.25, § 372.27, or § 372.28at’’.

7. In § 372.38(a), by adding thefollowing sentence at the end of theparagraph to read as follows:

§ 372.38 Exemptions.

(a) * * * This exemption does notapply to toxic chemicals listed in§ 372.28, except for purposes of§ 372.45(d)(1).

* * * * *

§ 372.85 [Amended]

8. Amend § 372.85 as follows:i. By removing in paragraphs (b)(15)(i)

introductory text and (b)(16)(ii)(B) thephrase ‘‘may be indicated in ranges’’and adding in its place ‘‘may beindicated in ranges, except forchemicals set forth in § 372.28’’.

ii. By removing in paragraph(b)(16)(i)(B) the phrase ‘‘may beindicated as a range’’ and adding in itsplace ‘‘may be indicated as a range,except for chemicals set forth in§ 372.28’’.

[FR Doc. 99–19729 Filed 8–2–99; 8:45 am]BILLING CODE 6560–50–F
