CFC SUBSTITVIES HUMAN HEALTH AND ENVIRONMENTAL EFFECTS PROGRAM

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OCTOBER 10,1989

STRATEGY FOR HUMAN HEALTH AND ENVIR0"TAL EFECTS REVIEW

OF CFC SUBSTITUTES

INTRODUCTION

Pumose

The purpose of this paper is to provide the interested members of the public with an opportunity to review a strategy which is intended to guide the Environmental Protection Agency (EPA) in its review of the health and environmental effects of substitutes for fully halogenated chlorofluorocarbons (CFCs) and halons. The strategy represents the joint efforts of the Office of Toxic Substances (OTS), the Office of Air and Radiation ( O A R ) , and the Office of Water (OW). OAR has lead responsibility within the Agency for activities related to the Montreal Protocol and its domestic implementation. human and environmental toxicity of CFC substitutes. OAR and OTS

EPA to ensure that all relevant factors are considered in decisions concerning the acceptability of CFC substitutes.

In the past, CFCs were often selected for high volume/high exposure uses because their low toxicity kept risk low, in spite of high exposure. chlorine in these chemicals contributes to the depletion of the stratospheric dzone layer. The major substitutes will be used in similar high volume/high exposure situations. Substitutes Human Health and Environmental Effects Program is a program of the Office of Toxic Substances that selects chemicals for expedited review/assessment which is based on the high exposure potential of the substitutes. The Agency intends to review all potential CFC substitutes including new chemicals, those now in commercial use (if their production may increase o r their use change), and those already on the EPA's inventory of existing chemicals, but not yet in commercial production.

OTS has the lead for reviewing

.will coordinate efforts with OW and other program offices within

CFCs are now being phased out because the

The CFC

phase-out of CFCQ

Chlorofluorocarbons are highly stable compounds which remain intact when they are released into the air, breaking apart only when they reach the stratosphere. There they release chlorine, which destroys ozone molecules that serve as the earth's natural barrier to harmful ultraviolet radiation. Growing concern f o r CFCs climaxed with the September 1987 signing of the Montreal Protocol on Substances That Deplete The Ozone Layer. The agreement went into effect in January 1989, and has been ratified

production and consumption of CFC-11, CFC-12, CFC-113, CFC-114, ~ by 41 countries. The Protocol calls for a freeze in the

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and CFC-115, at 1986 levels by mid-1989 and reduces production of these CFCo to 80 percent of 1986 levels beginning in mid-1993 and to 5 0 percent beginning in mid-1998. The agreement a l so calls for a freeze in the production and consumption of halons 1211, 1301, and 2402 at 1986 levels, by 1992.

Since the agreement was ratified, the United States, Canada, the European Community, the Nordic nations and many others have called for a complete phase-out, rather than a reduction in use of these fully-halogenated CFCs and halons by the year 2000. The Parties to the Protocol are expected to reconvene in June 1990 to discuss changes to the Protocol's control measures (as provided for in Article 2). It is likely that the complete phase-out of CFCs and halons will be suggested for inclusion under the Protocol at that time. In addition, EPA has issued an Advance Notice of Proposed Rulemaking (ANPRM) to notify the public that methyl chloroform and carbon tetrachloride will be among the chemicals suggested for inclusion in the Protocol. This dynamic situation makes the search for new chemical substitutes a more

.demanding challenge.

According to Article 6 of the Montreal Protocol, beginning in 1990, and at least every four years thereafter, the ratifying parties shall assess CFC control measures on the basis of available scientific, environmental, technical, and economic information. The experts chosen to prepare these documents will issue four assessment reports: a technical assessment on the feasibility of#substitution; an economic assessment analyzing the rates and costs of substitution; a scientific assessment confirming and reanalyzing new data on the rate and level of ozone depletion: and an environmental assessment focusing on the impacts of ozone depletion on human health and the environment. These assessments will be completed a6 final documents in August 1989. The Partiem to the Protocol will begin meeting in September 1989 to recommend changes in the language and controls of the current Protocol agreement. The Agency has been actively contributing to these technical assessments which will be used during renegotiation of the Protocol tentatively scheduled for June 1990.

The chemical industry is now engaged in a major effort to develop subatituteo for the CFCs limited under the Protocol. While toxicologic studies are underway for many chericals which are likely substitute8 for the CFCo, progreoe toward co~ercialization of substitutes is likoly to occur before all - toxicologic studie8 are completed, particularly in the case of

~ cancer bioassays which require a 4-5 year tineframe to complete. The Agency ha8 taken thi8 into account in the strategy. intend8 to (1) amsure that the appropriate toxicologic, environmental, and release/exposure data on the major CFC

EPA

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substituteo aro obtained as soon as possiblo, (2) assess these data as t h e y B e c o m a available, and (3) publicly communicate its interim assessments of the data to industry and other interested parties.

By providing a near-term interim review of the health and environmental impacts of major CFC substitutes, the Agency will be in a better position to more effectively evaluate and, if necessary, intervene to prevent any use of a substitute for CFCs which poses an unreasonable risk to human health and the environment. problematic substitute/use combinations at tho earliest possible stage while also identifying data needs for more comprehensive analysis later.

This process should identify potentially

The Agency will complete an initial interim assessment of chemicals identified as likely major CFC substitutes and will communicate the results in early 1990. The interim assessment will be based on available data. As new data are developed on the substitutes, the Agency will adjust the interim assessments, as

a appropriate, until an adequate data base is developed to enable the Agency to make a final assessment regarding each major substitute. The Agency is conscious of the need for industry to make decisions about the manufacture and use of suitable CFC substitute. ae soon as possible, and believe6 that generation and review of all necessary information about the effects of these chemicals on human health and the environment at the earliest possible time will facilitate these decisions. EPA intends to conduct its review of substitutes in a manner that will minimize delays or interference in the development and commercialization of substitutes, while at the same time ensuring that new health or environmental problems do not result from their introduction.

The strategy for review of CFC substitutes presented in the remainder of this paper provides a comprehensive framework for (1) identifying major CFC substitutes, (2) assesoing their health and environmental risks, and (3) preventing any unreasonable risk8 from occurring. Human Health and Environmental Effects Program is on high volume/high exposuro uses.

environrrnt.1 roloaso of the major substitutes, the Agency believes that an adequate data base must be developed on an expedited basi8 (if not currently available) for each of the major substitutes. Sufficient data must be available in order to assess the human health effects, environmental effects, and exposures during manufacturing, processing, distribution in

. commercr, us., and disposal of those chemic818 usrd a8 CFC substitutes. If the Agency finds that the data are not available, it will ensure that the producers of the chemical conduct the necessary studies on an expedited bash, either

The primary focus of our CPC Substitutes

In view of the extent of production, human exposure, and

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voluntarily or in compliance with an Agency regulation which would be promulgated under the Toxic Substances Control Act (TSCA) .

Minor CFC substitutes, which are used in smaller volumes resulting in more limited exposures will be examined in the context of the standard OTS existing chemical screening process. In the screening process, they will be reviewed on the basis of readily available data. The Agency will review the data in light of expected use patterns. If the Agency finds that insufficient data are available to assess risks associated with the projected use, it may place the chemical on a test rule. determine the appropriate level of testing after reviewing the extent of environmental release, human exposure, and/or the chemical's expected potential to cause adverse human health or environmental effects. As production levels and exposure increase, the Agency will require additional testing as necessary.

EPA will

If significant concerns are raised on the basis of available data, the Agency will take appropriate risk management actions to control environmental release or human exposure pending development of information necessary to fully address the concerns raised during the initial review of the chemical.

In addition, a possible s'cenario is that environmental or human health concerns about a CFC substitute may be also appropriately addressed through the regulatory programs administered by the EPA Offices of Air and Radiation, Water, or Solid Waste, than through TSCA, administered by the Office of Toxic Substances. Appropriate BPA program offices will address these issues when they arise and take necessary action.

This paper contains a description of the process which OTS would use to identify and assess major substitutes and the proposed criteria used to make decisions within the process.

CFC SllBSTlTUTES REVIEW STRATEGY DECISION PROCESS

, INouNlEAsoNAaE I t

t

L t

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CFC SUBSTITUTES REVIEW PROCESS

The review of each CFC substitute will occur in four phases (see the diagram at p.5). In Phase 1, the Agency will gather information concerning the potential CFC substitute and identify whether it is likely to become a major substitute. In Phase 2, the Agency will gather existing exposure and hazard data to determine whether there are sufficient data to support an assessment of the risks presented by the substitute. If sufficient data are available, the chemical moves directly to Phase 4 where a final risk assessment is developed. If at the end of Phase 2, an adequate data base is unavailable, the chemical will proceed to Phase 3 where the Agency will perform and provide industry and other interested parties with an Interim Assessment of the toxicity and environmental effects of the chemical. In Phase 3, the Agency will take whatever steps are necessary, including issuance of TSCA section 4 and section 8 rules to obtain the information it needs to adequately assess the risks from the CFC substitute. The Agency could also issue a *significant new use rule (SNUR) under section 5 of TSCA where applicable, if restrictions are warranted until additional data becomes available. When adequate data are available, the chemical will move to Phase 4 of the process in which the risks posed by use of the chemical as a CFC substitute are assessed, and the Agency takes appropriate action.

The ultimate goal of the CFC Substitutes Human Health and Environmental Effects Program is to reach a final conclusion regarding the potential risks posed by chemicals replacing the CFCs restricted under the Montreal Protocol. However, as toxicologic and environmental tests are developed for the substitutes, Interim Assessments will be completed and made available to the public. The Interh Assessments will include: 1) the results of tests, 2) the judgment of Agency scientists regarding the potential for toxicity of the substitutes, and 3) reports on the status of toxicologic and environmental tests which are underway or planned. The Agency cannot reach a final conclusion until it has a full set of data. In cases where available toxicologic and environmental data are insufficient to support a final conclusion, even if the data indicate that the chemical will not pose adverse effects, the Interim Assessment will describe the existing data base and indicate what testing is required to confirm this interim assessment of the effects of the substitute.

Review of CFC substitutes will be an iterative process. Data submission, interim assessment, and public communication will be continuously occurring. Interim Assessments of toxicity

. and environmental effects of any particular chemical may change over time as more comprehensive data for chemicals under review are developed and submitted to the Agency. Steps will be taken to control unreasonable risks identified throughout the process.

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PEASE 1: IDENTIFICATION OF MAJOR CFC SUBSTITUTES (BOXES 1-5)

The first phase of the regulatory strategy involves identification of major CFC substitutes. The major substitutes would be identified through three major paths: the known list of ma] or substitutes, TSCA section 8(a) notification, and TSCA section 5 premanufacture notification (PMN)

PHASE 1 ' IDENTIFICATION OF n A J O R CFC SUBSTITUTES

m rOfIFICATIOW

bikelv Major Substitutes maul- The chemical industry has identified 8 chemicals and two

groups of chemicals that it considers most likely to become major CFC substitutes. Those chemicals are HCFC-22, HCFC-123, HCFC- 124, HFC-125, HFC-l34a, HCFC-lllb, HCFC-l42b, and HFC-152a. In addition, aqueous and terpene cleaners appear to be leading candidates to replace CPC-113. An additional chemical which may become a major CFC substitute is RFC-32. OTS proposes to pursue the development of an adequate set of toxicity and exposure data on these chemicals in order to support an assessment of any risk arising from their use as CFC substitutes.

An international industry consortium, the Program for Alternate Fluorocarbon Toxicity Testing (PAFT), has recognized the need to develop data and initiated testing agreements on five substitutes. PAPT toxicologic tests will provide valuable information regarding the potential human health effects of these chemicals for the regulatory decision-making process. The remaining three are already widely used in commerce and the Agency is now reviewing the available human health and environmental data on these three chemicals in order to determine what additional data, if any, will be needed for their assessment. If warranted, EPA will then ask industry to develop

. additional toxicity and/or environmental test data either voluntarily or in compliance with a TSCA Section 4 Test Rule.

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Section Notification to IdeDtifv CFC Substitutes (*ox * )

In addition to the eight likely major fluorocarbon substitutes (and aqueous and terpene cleaners) identified above, EPA expects other chemical8 to be amployod as substitutes for the CFCs controlled under the Montreal Protocol. Most of these will be minor substitutes, however some may become major substitutes.

The Agency is considering using its authority under section 8(a) of TSCA to monitor the development of CFC substitutes. Section 8(a) authorizes the Administrator to request information such as production, use, and exposure data from manufacturers (including importers) and processors of both new and existing chemicals.

Section 8(a) notification will enable the Agency to be alerted whenever a chemical is being developed for use as a CFC substitute. EPA will probably also request related information concerning production levels and use category for each chemical. Information will be requested through section 8(a) so that the Agency can determine whether a chemical io likely to become a major CFC substitute.

require reporting from small businesses. All companies with sales under $4 million and companies under $40 million, except for specific chemicals which they produce in quantities of 100,000 pounds'or more are exempt from reporting under 8(a), unless the chemical is the subject of certain actions under TSCA sections 4, 5, 6, and 7. The Agency believes the small business exemption will not affect a large number of companies.

The Agency is considering a number of alternatives for identifying chemicals subject to reporting under section 8 ( a ) . EPA is considering issuing a reporting rule that names specific chemicals that have been identified by industry and the Agency as likely CFC substitutes. Alternatively, EPA io con8idering gathering information on substitutes through us8 of a rule that specifies categories of uses rather than individual chemicals. Use categorfer could be developed to correspond with major CFC uses. EPA is soliciting advice in identifying how to structure an 8(a) notification rule based on use of a chemical and the advantageo/dimadvantage8 of a use rule versu8 a chemical specific rule .

Hovever, section 8(a) does not authorize the Agency to

EPA must also decide when individuals must report the requested information. for 8(a) notification: 1) periodic reporting, 2) triggered

reporting.

The Agency is considering three options

~ reporting, and 3) a combination of triggered and periodic

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A rule could be developed which will require companies producing or processing chemicals for use as CFC substitutes to submit a periodic report indicating the amount of each chemical likely to be produced and used as a CFC substitute broken down by critical use categories. The Agency is considering a 12 month reporting cycle, but others would also bo considered. Our belief is that periodic reporting is administratively simpler than the other two options for both the Agency and persons who must report.

establish reporting thresholds based on tho volume of CFC substitutes produced or percent increase in production for each specifiod use category. Once a manufacturer or processor surpasses a production threshold, it would have to comply with the reporting requirements developed under section 8(a). triggered rule could also require manufacturers to report requested information when a business decision has been reached to increase production of a CFC substitute in the future. A

earlier notification and evaluation of CFC substitutes.

Alternatively, for triggered 8(a) reporting, EPA could

A

. business decision trigger is advantageous because it allows

A combination of triggered and periodic reporting would include the same elements of annual reporting with the addition of a requirement to report if a special event occurred, such as exceeding a volume threshold. ~

Comments dre solicited on the three options under consideration and on other suitable options.

(Box 31

Under section 5(a) of TSCA, anyone who intends to manufacture a substance that is not on the TSCA section 8(b) inventory must submit a premanufacture notice to the Agency at least 90 days in advance. In the notice, tho submitter must describo the intendod use of the substanco and must provide an estimate of production levels for the first three years of production. In reviewing PMNs, the Agency will become aware of new substances being developed as CFC substitutes.

Information obtained during the review of individual PMNs may also increase the Agency's knowledge of uses of CFC substitutes in general, particularly with respect to exposure and environmental release patterns associated with various uses. The Agency intendo to review all new CFC sub.titutes, however, only thooo eubstitutes which are determined to be "ajorW will be

~ carried through the process described in this paper.

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pecidina Whether a Chem ical I s a Maqor CFC Substitute (B ox 4 1

In the past, CFCs have been used in high volumes resulting in substantial releases and high numbers of people exposed. The CFC substitutes may be used in a similar manner. The Agency has determined that major substitutes should b8 reviewed to ensure that they do not present an unreasonable risk to human health or the environment. Th8refore, EPA will s8lect chemical8 for expedited review/assessnent based on potential for high exposure.

To separate major CFC substitutes from other CFC substitutes, EPA is proposing to use a screen related to the production volume necessary to result in exposure to 100,000 persons in the workplace or through widespread consumer or general population exposure for the use in which it will substitute. Anticipated production of any chemical for use as a CFC substitute in excess of this threshold would qualify it as a major CFC substitute for purposes of expedited review/assessment.

In order to determine what production volume of a CFC substitute would be an indication of exposure to 100,000 persons in the workplace or through widespread consumer or general population exposure, the Agency will evaluate the extent of exposure expected in a CFC replacement us8 from a given volume of a chemical substitute. The volume required to result in exposure to high numbers of people will'then be established as the production volume threshold that selects chemicals for special review. 4

Some uses of substitutes may result in higher levels of exposure than others. production volume thresholds for some useo. If use-specific thresholds are established, the Agency will develop a scoring mechanism for substitutes that have more than one use and do not exceed any of the uoe-specific thresholds.

EPA is considering development of separate

EPA intends to identify chemicals for expedited review/assesnment based on projections of production volumes and uses. In other words, the Agency will not wait for production of a CFC substitute to actually meet the production VOlUaa threshold before it initiates the special review process. EPA will initiate the process as soon as the Agency determines that a substitute io likely to exceed the production volume threshold at some point within the next several years. Thi8 approach will ensure that the Agency will be able to evaluate the substitute while under development and/or in the early stages of commercialization for the CFC replacement markets.

In selecting chemicals for expedited review/assessment, EPA will aggregate information from all companies reporting section 8(a ) data. The Agency must aggregate data becausr companies will report individually, but a finding of "aJorm will b8 baned on

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industry-vide use patterns. Any chemical identified as a major substituto will then enter Phase 2 of the process. Others will go to the existing chemical screening program (box 5).

criteria for determining what is a major substitute. At what level should the threshold values for making the major determination be set? Should the threshold values vary with use? In other words, should the production threshold value be lower for chemicals likely to be used for applications involving higher exposure (both in terms of numbers of people exposed, as well as higher individual dooes/exposures)?

EPA is soliciting comments on how it should structure its

Peferral to C h d c a l Screeninu P r o w (Box 5L

Chemicals not identified as major CFC substitutes will be referred to the existing chemical screening process for further consideration. In the existing chemical screening process, they will be reviewed on the basis of readily available data. The Agency will review the data in light of expected use patterns. If the Agency finds that insufficient data are available to assess risks associated with the projected use, it may place the chemical on a test rule. EPA will determine the appropriate level of testing after reviewing the extent of environmental release, human exposure, and/or the chemical's expected potential to cause adverse human health or environmental effects. As production levels and exposure increase, the Agency will require additional testing as necessary.

If significant concerns are raised on the basis of available data, the Agency will take appropriate risk management actions to control environmental release or human exposure pending development of information necessary to fully address the concerns raised during the initial review of the chemical.

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PBASE 2: EVALUATING ADEQUACY OF DATA ON CEXMIcALs IDENTIFIED AS MAJOR CFC SUBSTITIJTES

(BOXES 6-7)

In the second phase, readily available data will be reviewed. EPA will then judge whether the exposure and hazard data base are sufficient to support a risk assessment for the endpoints of concern.

PHASE 2 : EVALUATING ADEQUACY OF DATA ON CHEXICXSZ IDEllTIFIED AS RAJOR CFC SUBSTITUTES I

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G a t u a v A v a e Data '(Box 6 )

The Agency will obtain data on each major substitute through a variety of methods. gather all information in its files. Also, when appropriate, relevant data will be obtained under section 114 of the Clean Air Act or other regulatory authorities. under section 8(d) of TSCA requiring mubrission of all health and safety studies for 3 of the fluorocarbons identified as likely major substitutes. Similar 8(d) rules are under development for the remaining 5 fluorocarbons.

It will conduct literature searches and

EPA has promulgated rules

E v a l E o H a z a r d u r e Information m x 71

In order to make a final decision regarding potential risk associated with the manufacture, processing, distribution in commerce, use or disposal of the substitute chemicals, data from health and environmental tests will be required for major CFC substitutes. Aft8r chemicals are identified as major CFC substitutes, the Agency will review available information to determine whether it is adequate to support a risk assessment f o r the toxicologic and environmental endpoints of concern.

13 -- EPA will be flexible in terms of the precise data

requirements and chemical review will occur on a case-by-case basis. In general, the Agency considers the results of the following toxicity and safety tests as being illustrative of the data set needed to assess risks:

Pharmacokinetics (absorption, distribution, metabolism, kinetics, excretion)

Acute toxicity (high exposure-short duration studies)

Mutagenicity

Subchronic toxicity

Neurotoxicity (functional observation battery, neuropathology, motor activity, etc.)

Developmental toxicity

2-generation reproductive effects

Chronic toxicity

Oncogenicity

combustion toxicity (effects of combustion/pyrolysis products )

Safety considerations (flammability, volatility, reactivity, etc.)

Environmental effects (acute and chronic testing on aquatic and terrestrial species, including plants)

Environmental fate (transport, transformation, bioaccumulation, physical chemical properties, etc.)

Tho above tests are routinely required under TSCA section 4 ( a ) ( l ) ( B ) for chemicals produced in substantial quantities.

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The following tests have been identified as those proposed as necessary for substitutes where significant releases to water are a concern. The tests are those routinely used by the Office of Water to develop water quality criteria.

Acute tests in at least eight different fro-shwater families such that all of the following are included:

a.

b.

C.

d.

e.

f.

9.

h.

the family Salmonidae in the class Osteichthyes

a second family in the class Osteichthyes, preferably a commercially or recreationally important warm water species (e.g., bluegill, channel catfish, etc.)

a third family in the phylum Chordata (may be in the class Osteichthyes or may be an amphibian, etc.)

a planktonic crustacean (e.g., cladoceran, copepod, etc.)

a benthic crustacean (e.g., ostracod, isopod, amphipod, crayfish, etc. )

an insect (e.g., mayfly, dragonfly, damselfly, a tonefly, caddisfly, mosquito, midge, etc.)

a family in a phylum other than Arthropoda or Chordata (e.g:, Rotifera, Annelida, Mollusca, etc.)

a family in any order of insect or any phylum not already represented.

Acute-chronic ratios with species of aquatic animals in at least three different families provided that of the three species :

--at least one is a fish

--at least one is an invertebrate

--at least one is an acutely sensitive freshwater species (the other two may be saltwater species).

Results of at least one test with a freshwater alga or vascular plant. If plants are among the aquatic organisms that are most sensitive to the material, results of a test with a plant in another phylum (dividon) should also be available.

At least one bioconcentration factor determined with an appropriate freshwater species.

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Acute testa in at least eight different saltwater families such that all of the following are included:

a. two families in the phylum Chordata

b.

c.

a family in a phylum other than Arthropoda or Chordata

either the Mysidae or Penaeida8 family

d. three other families not in the phylum Chordata (may include Mysidae or Penaeidae, whichever was not used above)

e. any other family

Acute-chronic ratios with species of aquat i c animals in at least three different families provided that of the three species :

--at least one is a fish

--at least one is an invertebrate

--at least one is an acutely sensitive saltwater species

At least ?ne test with a saltwater alga or a vascular plant. If plants are among the aquatic organisms most sensitive to the material, results of a test with a plant in another phylum (division) should also be available.

At least one bioconcentration factor determined with an appropriate saltwater species.

Octanol-watar partition coefficient

(the other two may be freshwater species).

Water solubility

Boiling point

Henry'. law coefficient

Half-life in water

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Additional studies may be required for the major chemical substitutes if, upon review of the test data, significant toxicity or exposure concerns are discovered. endpoints beyond those specified above may be required as needed to identify and characterize hazards from these high exposure chemicals.

In addition,

The studies outlined above cover potential hazards associated with the manufacture, processing, distribution in commerce, use or disposal of the CFC substitutes. In addition, many Agency statutes provide for waste treatment per technoloqy- based standards and/or call €or waste reduction strategies. This testing plan does not address these issues. Further work by other program offices may be needed to address treatability and pollution prevention issues.

toxicologic concerns, OTS has initiated discussions with U.S. PAFT members concerning the adequacy of th8 PAFT testing program 'in providing the data base needed to assess the toxicologic effects of the CFC substitutes included in that effort. OTS has requested that PAFT prepare a description and discussion of the rationale used by PAFT in developing its planned testing scheme, including a discussion of the basis for including or excluding certain teats. In addition, PAFT was requested to provide an explanation of how the results'obtained from the planned tests will trigger other tests. response, the Xgency position regarding toxicity tests required for the major fluorocarbon substitutes will be determined. This decision will serve as a general toxicity testing guideline, but each major CFC substitute will be examined on a case-by-case basis. Environmental testing of the fluorocarbons may also be required, depending on the existing data bas8.

In the particular case of the fluorocarbons, due to specific

Upon receipt and review of a PAFT

In order ts conduct a risk assessment for CFC substitutes, estimates must be mad8 of exposure/releases which occur during manufacturing, processing, distribution in commerce, use, and disposal of CFC oubstitutes. developed for each of the above categories, as well as specific use categories (e.g., consumer exposure from home insulation, automobih air conditioning, home refrigeration, etc.). Suggestions are solicited for how such exposure data for use in

Exposure scenarioo need to be

risk aSS88Sm8nt Of -0 CFC substitutes can b8 d8V810m.

EPA is also seeking comments on the testing and exposure information that would constitute an adequate data set for major CFC substitutes and the timing of testing 8nd exposure data requirementa along vith any suggestions for a process to resolve

. and implement such requirements.

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If the necessary data for the endpoints of concern are available, the chemical will move directly to Phase 4 where a final risk assessment can be developed. If an adequate data base is unavailable at the end of Phase 2, the chemical will move into Phase 3.

PEASE 3: INTERM ASSESSHENT AND R I S K )IIANAGEHENT/DATA COLLECTION (BO= 8-10)

Phase three of the process for reviewing major CFC substitutes will be activated only if the Agency determines that available data are insufficient for an adequate evaluation of th- ilsks that may arise from use of the chemical as a CFC substitute. If the data are insufficient, the Agency will conduct an Interim Assessment and take action to collect the necessary data. Ordinarily, the action will be the issuance of a section 4 test rule unless other enforceable mechanisms such as' section 4 or section 5 consent agreements to donduct testing can be put into place. The Agency is also considering using section 8(a) to gather relevant exposure data.

PEASE 3 : IllTERIll ASSESSHENT AND RISK llANAGEHENT/DATA COLLECTION

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The Agency will review available data for indications of significant risk. to the extent that the statutory authority can be legally exercised, the Agency will issue a significant new use rule (SNUR) under section 5 of TSCA to control exposures and manage the potential risk until data necessary for a risk assessment have been obtained.

If an indication of significant risk is found,

If the necessary data for some endpoints of concern are unavailable, an Interim Assessment vi11 be completed on the basis of the information that is available. E a c h Interim Assessment will include: 1) results of completed tests, 2) the judgment of Agency scientisto regarding the potential for toxicity of the substitute, and 3) reports on the status of toxicologic and environmental tests which are underway or planned. made publicly available and adjusted as new data are submitted.

.

It will be

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The Agency will consider issuing a SNUR if it determines that the Interim Assessment supports a concern about the chemical's health or environmental effects, and that this concern cannot be resolved until further toxicologic, environmental, or exposure data are developed. Section 5 of TSCA gives the Administrator discretion in promulgating significant new use rules. SNURs prohibit the significant new use defined in the rule until after a prospective user has notified EPA of its intent to begin the use. A SNUR will be promulgated by the Agency to the extent that the legal authority exists.

are outlined in 40 CFR Sec. 721.170. These criteria are repeated in Appendix A. EPA is seeking comments on whether any additional factors specific to CFC substitutes should also be considered.

The Agency's general criteria for issuing a risk-based SNUR

The Agency will obtain whatever data are necessary to complete the risk assessment and, if needed, ri8k management of the CFC substitute. EPA has a number of way8 to obtain data and will use non-regulatory means, whenever practical, to gather exposure and/or hazard data. In addition, EPA will gather voluntary studies such as those conducted by PAFT and government sponsored studies by NTP and NIOSH.

The Agenc3 is considering using its authority under TSCA section 8(a) to gather relevant exposure data. Producers and processors of major CFC substitutes would be required to provide data and information on the extent of exposure, including populations exposed, estimates of number exposed, exposure routes, and duration and levels of exposure.

Section 4(a)(l)(B) of TSCA could also be used to require toxicity, environmental, and exposure studies. The Agency is considering promulgation of test rules to requiro testing when essential toxicity or environmental data are unavailable for major 8ub8titut.8. Tho Agency could US. ita authority under section 4 (a) (2) (B) to issue lgexpu~~re-basedn te8t rules. The test rules could be issued on the basis of tho h-igh levels of production, e~p08ur0, and environmental releaso associated with the major CIC subatitutos.

In other word8, if there are insufficient d8ta on a chemical substance or rixturo to dotermine ita offoct8 on health or the enviro~ent, the statutory language states that EPA can make a section 4 ( a ) ( l ) ( B ) finding based solely on oithor aubotantial

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production and substantial release p~ substantial production and significant p~ subatantfal human exposure.

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In contrast with the requirements for issuing "risk-basedtt test rules under section 4 ( a ) (1) ( A ) of TSCA, EPA is not required to demonstrate potential or actual risk to human health or the environment to issue an "exposure-based" test rule.

The Agency proposes to require that producers of the major CFC substitutes provide the Agency with any essential information that it determined was not available in the review of data discussed above (box 7).

The Agency will conduct a risk assessment in Phase 4 to determine whether any of the major CFC substitutes present or will present a significant risk. After completion of the risk assessment, if significant risk, is identified, the Agency will conduct a risk management evaluation to analyze costs and benefits of the CFC substitute and its alternatives. Appropriate regulatory activities will follow the analysis to control risk, if necessary.

PHASE 4: XAKING A REGULATORY DECISIOh (BOXES 11-18)

dr c

rb I c

I I

After the necessary hazard and exposure data have been obtained, the Agency will conduct a risk assessment to determine whether any use of a chemical presents or will present a significant risk. regulatory procedures, if needed.

The results will enable EPA to initiate proper

If the Agency determines that a major CFC substitute does not present or will not present a significant risk to human

~ health or the environment, then no further action will occur.

2 0

Sianificant Risk [Boxes 13 - 15) . .

If the Agency determines that a significant risk exists, risk management evaluation will take place. OTS will evaluate the results to determine if any aspect of manufacture, processing, distribution in commerce, use, or disposal of any of the major CFC substitutes presents or will present an unreasonable risk of injury to health or the environment.

A CFC substitute may present a ri8k which is more appropriately addressed through other statutes administered by EPA, than through the Toxic Substances Control Act, administered by the Office of Toxic Substances. program offices will ensure that significant risks are adequately addressed.

Coordinating efforts with

No Unreasonable Risk Determination (Boxes 16-17]

If it is determined that no unreasonable risk exists or will exist, then no additional regulatory activities will take place in the Office of Toxic Substances.

tion (Boxes 18 ..) 20L

If EPA concludes that a major CFC substitute presents or will present an' unreasonable risk, the Agency will regulate the chemical under TSCA section 6 or employ a section 9(a) referral.

Section 6 of TSCA authorizes EPA to take actions to control the use of chemical8 that present an unreasonable risk to human health or the environment (box 19). These actions range from labeling to a complete ban.

The Administrator is authorized to refer chemicals which present an unreasonable risk to human health or the environment to another agency under TSCA section 9(a) (box 20). The Agency will use a section 9(a) referral if it concludes that another agency administers a law which can be used to prevent or reduce the risk "to a sufficient extent". If another agency could not act to prevent or reduce the risk to a sufficient extent, or if the agency refers the matter back to EPA, EPA would act using its authority. 9(b) of TSCA to protect against such risk by actions taking action under TSCA, if the Administrator d8temines it is in the public interest to us8 TSCA rather than oth8r statutes.

The Admlinistrator has the authority under section

21

TIHE LINES POR REVIEW OF HAJOR KNOWN CFC SUBSTI- (HCFC-22, HCFC-123, HCFC-124, HFC-125, FiPC-l34a, HCFC-14lb8 HCFC-142b8 HFC-152a8 and aqueous and terpene cleaners)

At this time, 8 fluorocarbons, along with aqueous and terpene cleaners have been identified as major substitutes f o r the CFCs regulated under the Montreal Protocol. These chemicals include existing chemicals, as well as new chemicals subject to TSCA Section 5 notification requirements. Of the fluorocarbons, 5 are included in PAFT testing programs, and 3 are existing chemicals currently under production. review process, Identification of CFC Substitutes, is complete for each of these chemicals. The Agency io in the process of gathering readily available data (Phase 2).

HCFC-l4lb) have not been commercially produced and have a limited toxicologic and environmental data base: however, testing is underway for a number of the chemicals and will be initiated soon for the remainder of the chemicals. Discussions are underway between Agency scientists and PAFT members regarding the adequacy of the battery of tests which PAFT has committed to complete. Upon conclusion of this discussion, a decision will be made regarding the required testing for the fluorocarbons, and the mechanism used to establish the TSCA regulatory requirements for the submission of test results (e.g., section 4 test rule, or consent orders under either section 4 or 5, as appropriate). It is expected th6t a fluorocarbon test rule can be promulgated in approximately 15 months after the test requirements are identified.

Phase 1 of the substitutes

The PAFT chemicals (HCFC-123, HCFC-124, HFC-125, HFC-l34a,

While a limited data base presently exists for the PAFT chemicals, results from a number of studies are available on the 3 chemicals on the commercial market (XCFC-22, XCFC-l42b, and HFC-152a). These studies are currently under review by OTS. While the decision reached regarding the required battery of tests for the PAFT fluorocarbons will also be used as a general N l e for the 3 commercialized fluorocarbons, each chemical will be considered on an individual basis. To the extent that the toxicologic endpoints of concern have not been addressed for the 3 chemicals, further testing may be required.

companies regarding particular fluorocarbons, an Interim Aooessment for each of the 8 fluorocarbons, along with aqueous and terpene cleaners vi11 be publicly released in early 1990 (Phase 3). Each Interim Assessment will susurize the studies available to the Agency as of September 1989 (including the reoults of the PAFT studies completed at that tima) and the Agency scientists' judgments regarding the potential human health and environmental effects of the chemical. identify the environmental and toxicologic endpoints of concern

While discussions will be ongoing with PAFT and specific

Each assessment will

22

for which testing has not been completed and the status of testing requirements.

In addition, if the available data suggest that the potential severity of adveroe effects asoociated with manufacture, processing, distribution in commerce, use or disposal of a chemical warrant exposure controls, the Agency would initiate rulemaking to establish a SNUR. SNUR is expected to take approximately 12 months.

Promulgation of a

A 8 additional tests are completed and data are submitted to the Agency on the aqueous and terpene cleaners and on the fluorocarbon substitutes, amended Interim Assessrents will be issued by the Agency to reflect the avail8ble information on the CFC substitutes.

Over the long-term, the chemicals will enter Phase 4 of the process. As the battery of toxicologic and environmental tests are completed for each of the chemicals, a final assessment of 'the potential risk will be completed and the Agency's findings will be announced. This final step would occur over a period of 3-7 years as toxicity and/or environmental tooting is completed.

ADDITIONAL =OR SUBSTITUTES IDENTIFIED T H R O U ~ ~ u ( a ) NOTIFICATION (i-e., existing chemicals moving into the CpC rarlcet)

It will take approximately one year from initiation of rulemaking to promulgate an 8(a) rule requiring notification by manufacturers producing chemicals to be used as CFC substitutes. Once the rule is effective, and a notification is received for any particular chemical, completion of Phase 1 (Identification of CFC Hajor Substitutes) and Phase 2 (Evaluating Adequacy of Data of Chemicals Idontified as Major CFC Submtitutes), will take approximately 6-10 months. The timeframe for completion of these activitie8 i8 dependent upon the nechani8r used to collect existing data (e.g., whether CAA 114 letters are issued, literature searches are performed, or if previous Agency actions have required the submission of toxicologic and environmental data), and the volume of test data available for Agency review.

8

At the completion of Phase 2, if adequate data have been developed to allow the Agency to complete a risk assessment, the chemical will movo directly to Phase 4. i8 unavailable, tho chemical will move into Pham 3, and an Interim Assessment will be completed. rule to requira development of additional data (if necessary),

If an adequate data base

Promulgation of a test

~ will take approximately 15 months.

23

If the available data suggest that the potential severity of adverse effects associated with manufacture, processing, distribution in commerce, use or disposal of the chemical warrant exposure controls, pending development of all required test data, rulemaking would be initiated to establish a SNUR (to the extent that such a rule would be appropriate f o r th8 existing chemical). Promulgation of a SNUR is expected to take approximately 12 months.

A s additional tests are completed and data are submitted to the Agency on the chemical, the Interim Assrssment will be amended to reflect the available information on the CFC SubStitUt8.

Over the long-term the chemical will enter Phase 4 of the process. As the battery of toxicologic and environmental tests is completed for the chemical, a final assessment of the potential risk vi11 be completed and the Agency's finding will be . announced.

SUESTITUTES IDENTIFIED THROUGH THE PMN PROCESS

Phase 1 (Identification 02 CFC Substitutes) and Phase 2 (Evaluating Adequacy of Chemicals Identified as Major CFC Substitutes) wduld be completed during the PMN review process. Phase 3 (Interim Assessment and Risk Management/Data Collection) can occur through consent orders issued through section 5(e) or through promulgation of a section 4 test rule depending upon the specifics of the case. When adequate data are developed, the chemical would move to Phase 4 and a risk assessment would be completed.

Action8 throughout the process, such a8 rel8ase of Interim Adsessrents, would have to conform w i t h applicable confidential businerr information procedures.

24

APPENDIX A

SNUR CRITERIA

EPA may determine that the data support a concern about a

(1) The substance may cause carcinogenic effects because the

substance's health or environmental effects if EPA makes any one of the following findings:

substance:

(A) Has been shown by valid test data to cause carcinogenic

(B) Has been shown to be a possible carcinogen based on the

(C) Is closely analogous, based on toxicologically relevant

effect8 in humans or in at least one species of laboratory animal.

weight of the evidence in short-term tests indicative of the potential to cause carcinogenic effects.

.similarities in molecular structure and physical properties, to another substance that has been shown by test data to cause carcinogenic effects in humans or in at least one species of laboratory animal, provided that if there is more than one such analogue, the greatest weight vi11 be given to the relevant data for the most appropriate analogues.

valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause carcinogenic effects under the criteria in paragraphs A, B, or C above.

The substance has been shown by valid test data to cause acutely toxic effects in at least one species of laboratory animal or is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause acutely toxic effect. in at least one species of laboratory animal, provided that if there is more than one 8uch analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

The subrtance may cause serious chronic effects, serious .cute effects, or developmentally toxic effects under reasonably anticipated conditions of exposure because the substance:

H a 8 been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic affects in humans or in at least one specie8 of labor8tory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure.

(D) Is known or can reasonably be anticipated, based on

( 2 )

(3)

(A)

25

(B) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another chemical substance that has been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic effects in humans or in at least one species of laboratory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(C) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause serious chronic effects, serious acute effects, or developmentally toxic effects under the criteria in paragraph A and B above.

-toxic effects based on the weight of the evidence in short-term tests indicative of the potential to cause developmentally toxic effects.

(4) The substance may cause significant adverse environmental effects under reasonably anticipated exposures because the substance:

(A) adverse environmental effects at dose levels that could be of concern under r'easonably anticipated exposures.

(B) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(C) Ha8 been determined, based on calculations using the substance's physical and chemical properties, to be potentially able to cauae significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated exposures.

valid scientific data or established scientific principles, to be environmentally transformed to a substance which may havo the potential to cause dgnificant adverse environmental effects under the criteria in paragraph A, B, or C above.

effects of one or more impurities or byproducts of the substance

criteria discussed above and either:

(D) Has been shown to potentially cause developmentally

Has been shown by valid test data to cause significant

(D) Is known or can reasonably be anticipated, based on

( 5 ) Concern exists about the health or environmental

-because the impurity or byproduct meets one or more of the

2 6

(A ) The impurity or byproduct is a new chemical substance [not on the TSCA section 8(b) inventory] and may be present in concentrations that could cause adverse health or environmental effects under reasonably anticipated exposures.

activities involving the CFC substitute may result in significantly increased human exposure to or anvironmental release of the impurity or byproduct compared to exposure or release levels resulting from existing activitims involving the impurity or byproduct.

(B) Reasonably anticipated manufacturm, processing, or use

EPA will designate as a significant new use only those activities that may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified in 1 through 5 above.

. _ _ ---

Hydro, SolventsTM

Solvent Engineering has developed a matrix of solvent replacements to

meet CFC replacement needs throughout industry. This matrix is called

H y d r 0 x Solven t sm. The H y d r 0 S o l v e n t s m blends have different

characteristics to suit a user's application and needs, such as desired

solvent characteristics, no-residue, semi-aqueous, desired flashpoint,

recoverability, reuse, and cost.

H y d r 0 x SolventsTM is a matrix of solvent based products which are

formulated specifically for various user applications in industry. H y d r o

Solventsm are hydrocarbon and oxygenated solvent blends and do N O T

contain any halogenated materials. H y d r o , SolventsTM are designed to

be non-toxic, easily recoverable, and reasonable in costs.

It is not possible to duplicate all the aspects of any specific FreonTM solvent

blend by using a blend of other solvents. Because of this, each H y d r o ,

SolventsTM product contains a different combination of substitutes for the

target blend (such as FreonTM TMC). This gives H y d r o , Solventsm the

ability to specifically target the optimum substitute blend for a particular

application or product need.

Solvent Engineering is now working with various companies to present the

end user with a TOTAL SYSTEM SOLUTION to their cleaning operations.

We have begun various projects with companies to address user issues.

We encourage your participation and input in these projects and issues.

Team in P Pr 0-i ec t s

Solvent Engineering is now working with various equipment cleaning,

reclamation and recycling companies to produce a S Y S T E M solution for

your solvent needs.

We are presently establishing BETA test locations for various applications

using the H y d r o , Solventsmsystem. The goal of the program is to

provide information so that we can assist you in solving your cleaning

requirements at a systems level.

Solvent Engineering staff can assist you in the determination of the proper

cleaning materials needed to suit your application. This includes working

with process engineers, and environmental and safety personnel to

determine and resolve these issues.

Preliminarv Evaluation and Test ing - Proiects

Solvent Engineering can provide samples for preliminary testing and

evaluation. We will work with your staff to determine the proper solvent

formulation required for your application and we will reformulate the

y d r 0 S o l v e n t s m to your specific needs. We provide you

comprehensive Material Safety Data Sheets for your review.

Samples and small quantities are available NOW,

Solvent Engineering, Inc. Hydrox Solventsm Product Matrix

Target Blends FreonTM TMS FreonN TA

TMCR - 50NR TMCR - 105SA TMSR - 50NR TMSR - 105SA TNR - 52NR TNR - 105SA

TMCR - 80NR TMCR - 140SA TMSR - 80NR TMSR 140SA TNR - 80NR TNR - 140SA

TMCR-1O1NR TMCR-200SA TMSR-101NR TMSR-200SA TNR- 101NR TNR-200SA

HydrO,Solvents~

Replacement Matrix

METHY LENE CHLOROFORM ACETONE 1 ,I 9 1 TRICHLOROETHANE CHLORIDE

TCAR - 94NR MECL2R -50 NR CCL4R - 50NR HydrOxSolventsTM

Replacement Matrix

TCAR - 105SA MECL2R -90 NR MECL2R-101 NR MECL2R -1 05SA

CCL4R -1 01 NR ACER -50NR ACER -90NR ACER -101 NR

General Degreasing Solvent Blends

SOLVENT ENGINEERING SPECIALTY SOLVENTS

Specialty Water Based Cleaners --Tailored to your specific application.

Hydro, Solventsm 50NR N-Methyl-2-Pyrrolidone Repalcement

Non-Methylene Chloride StripperCleaners -- GI 200 Urethane Stripper -- EN 12 Enamel Stripper -- PR-101 Photoresist Stripper --Tailored to your specific application.

Citrisafe XDM --Terpene based general parts cleaner

FreonN is a registered trademark of duPont

NR NO RESIDUE

NUMERATION DENOTES FLASHPOINT

Hydrox SolventsTM

Is a registered trademark of SA = SEMI-AQUEOUS

Solvent Engineering, Inc.