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32294 Federal Register / Vol . 56 . No . 135 / Monday, July 15, 1991 / Notice s ENVIRONMENTAL PROTECTION TSCA section 4(a)[1)(B) policy substantial human exposure to such 3ENCY definitions should be submitted to : substance or mixture , TSCA Public Docket Office (TS-793), (2) There are insufficient data and ~TS-47002J ; FRL 3847-21 Office Toxic Substances, Environmental experience upon which the effects of the rtiN 2070-AC31 Protection Agency . Rm . NE-G004, 401 M manufacture, distribution in commerce , St ., SW

. . Washington, DC 20460 . A processing, use, or disposal of such TSCA Section 4(a)(1)(B) P roposed public version of the administrative substance or mixture or an y Statement of Policy record supporting this action is combination of such activities on health available for inspection at the above or the environment can reasonably be AGENCY : Environmental Protection address from 8 a .m . to 12 noon . and 1 determined or predicted, an d Agency (EPA) . p .m . to 4 p .m ., Monday through Friday, (3) Testing of such substance or ACTION : Proposed Statement of Policy . except legal holidays . mixture with respect to such effects is Information submitted in an y SUMMARY : EPA is proposing standards comment on this notice may be claimed necessary to develop such data . and criteria it intends to use in These are known as "release or interpreting its legal authority to make as "Confidential Business Information ." exposure-based" findings as opposed to findings under the Toxic Substances Information so marked will not be the "risk-based" findings of TSCA Control Act (TSCA) section 4(a)(i)(B)(i) disclosed except in accordance with section 4(a)(1)(A)

. for determining substantial production, procedures set forth in 40 CFR part 2 . A copy of the comment that does not On April 12,1990, the Court remande d release to the environment in to EPA the TSCA section 4 test rule for substantial quantities, and substantial contain CBI must be submitted for cumene in response to a challenge to the or significant human exposure . This inclusion in the public record

. rule by the Chemical Manufacturers is not intended to address how Information not marked confidential wil l policy be disclosed publicly by EPA by placing Association (CMA) . The Court generally EPA establishes priorities for testing or upheld EPA's factual findings in the rule whether any individual chemical should it in the public record without prior as being supported by substantia l be tested . Further, EPA does not intend notice to the submitter . evidence but instructed EPA to ""' to require testing of every chemical that FOR FURTHER INFORMATION CONTACT : articulate the standards or criteria on meets the criteria under TSCA section David Kling, Acting Director . the basis of which it found the quantities 4(a)(1)(B)(i) as articulated in this notice Environmental Assistance Division (TS- of cumene entering the environment because EPA must also find under 799) . Office of Toxic Substances, rm . E- from the facilities in question to be TSCA section 4(a)(1)(B)(ii) and (iii) that 543B, 401 M St ., SW ., Washington, DC 'substantial' and potentially resulting data are inadequate to determine or 20460, (202) 554-1404 . TDD (202) 554- human exposure to be 'substantial' ." predict the effects of the chemical and 0551 . EPA decided to use the opportunity to 'hat testing of such chemical is SUPPLEMENTARY INFORMATION : EPA is explain its criteria for making all lega l -essary . This notice is not intended to proposing to establish quantitative findings under section 4(a)(1)(B)(i) of Aress the policy issues related to how criteria (numerical thresholds) and other TSCA . This notice is not intended to A identifies candidates for testing . factors for evaluating "substantial address EPA's policy decisions fo r or the reasons articulated in this production," "substantial" and selecting chemicals as potential notice . EPA is proposing that in cases "significant" exposure, and candidates for testing . Afte r where the actual numbers for "substantial" release findings as set consideration of public comments . EPA production, re)ease, or exposure are forth in test rules developed under will publish a final notice on this policy

. above certain quantitative numerical TSCA section 4(a)(1)(B) . In Chemica l thresholds, these numbers are per se Manufacturers Association et al ., V . TSCA provides EPA with little substantial . Furthermore, EPA guidance on what criteria and standards proposes Environmental Protection Agency, 899 should be used in making sectio n that such findings are also appropriate F .2d . 344, (5th Cir .1990), the Fifth Circuit 4(a)(1)(B) findings . The statute does not in situations where the quantitative Court of Appeals (the "Court" ) numerical thresholds are not met, if define the terms "significant" or remanded to EPA the rule requiring "substantial ." It is usefu), however, to "additional factors" exist . EPA will cumene testing and required EPA to understand EPA's legal authority in continue to develop and refine the articulate criteria for the findings EP A criteria as its experience with chemicals TSCA section 4 in the context of th e made in the cumene test rule (53 FR entire statute . The general of considered for testing evolves, 28195) . EPA has decided to use this purposes

with red to the findings are set forth in TSCA section 2(b) : particularly gar opportunity to propose criteria fo r of significant human exposure, for which 'making all findings under section (b) Policy .-It is the policy of the Unite d EPA is not proposing a minimum cut-off 4(a)(1)(B)(i) of TSCA . States thatin this notice . If EPA needs to provide (1) adequate data should be developed further rationale for its findings beyond I . Introduction with respect to the effect of chemica l the explanation resented in this substances and mixtures on health and the

P Under section 4(a)(1)(B) of TSCA, EPA environment and that the development of proposal . EPA will articulate the criteria must require testing of a chemical such data should be the responsibility of used in making such findings in the substance or mixture (chemical) to those who manufacture and those who proposal for that individual test rule . develop health effects, environmental process such chemical substances and This notice also addresses the effects, or chemical fate data, or other mixtures ; application of the proposed criteria to data relevant to determining risk, if it (2) adequate authority should exist to EPA's existing cumene test rule (July 27, finds that : regulate chemical substances and mixtures 1988, 53 FR 28195) . (1) The chemical substance or mixture which present an unreasonable risk of injury DATES : Submit written comments on or is or will be produced in substantial to health or the environment . an .i to take `?efore September 13 . 1991
. action with respect to chemical substance s quantities, and (a) it enters or may and mixtures which are imminent hazards : )DRESSES : Written comments, in reasonably be anticipated to enter the an d 1plicate, identified by the docket environment in substantial quantities, or (3) authority over chemical substances e• d imber (OPTS-47002J) for the proposed (b) there is or may be significant or mixtures should be exercised in such a 

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Federal Register / Vol . 56, No . 135 / Monday, July 15, 1991 / Notices 32295

manner as not to impede unduly or create number of people exposed, or the extent of knowledge on the vast majo ri ty, it is unnecessary economic barriers to of environmental exposure are among reasonable to interpret TSCA section technological innovation while fulfilling the the considerations which may be 4(a)(1)(B) as autho rizing EPA to require prima ry purpose of this Act to assure that relevant in particular circumstances .- testing for eve ry chemical that presents such innovation and commerce in such (Legislative History at 425) . a scena ri o of environmental or human chemical substances and mixtures do no t present an unreasonable risk of injury to For example, the benefits of testing a exposure which may need to be health or the environment chemical in the absence of hazard data addressed on the basis of test data . ( 1 5 U .S .C .2em(b)li)) . is demonstrated by testing conducted EPA is proposing qu antitative criteria As explained in section 2 of TSC under the cumene rule . The sponsors of ( numerical thresholds) and other factors A, the cumene testing conducted under the testing is only a first step . Once test that will generally be used to make rule found effects of cumene that wer e data are obtained, EPA can then those determinations while reserving the consider whether any regulatory important enough to submit to EPA ability to consider other factors on a restrictions on the manufacturing . under TSCA section 8(e), Notice to case-by-case basis . As a matter of p ro cessing, distribution in commerce, Administrator of Substantial Risks, prior course, EPA has reviewed past test rules use, and disposal of the chemical are to the time they were required to report mul ated under section 4(a)(1)(B) of necessary . If EPA decides that the the data under the test rule . Also, test ~ A, ghreshoids embraced in both EPA t chemical presents an unreasonable risk sponsors indicated to EPA that they and non-EPA regulatory ams, and of injury, EPA may then initiate intended to notify workers and apro~ rulemaking under section 6 of TSCA . consumers about these results, reduce economic indices in developing these Since tes ti ng is only a first step in worker exposure to cumene, provide crite ria. EPA believes that these protecting the public from unreasonable employee training. and re vise their proposed c ri teria and factors are both risk of injury to health and the material safety data sheets for cumene appropriate and reasonable for environment, Congress gave EPA broad (Ref. 1) . implementing the congressional authority to require tes ti ng of chemicals EPA recogr .izes that it should not mandate of requiring testing o f not only when there is some preliminary i nterpret the words "significant" and chemicals under TSCA sec tion
conce rn about the chemical (TSCA "substantial" in ways that would require 4(a)(1)(B) . section 4(a)(1)(A)), but also in the case it to make findings for eve ry chemical in EPA has implemented a po li cy of chemicals wi th large production (and commerce, or the statute would have designed to routinely seek data on new release or exposure), even in the simply re quired testing for all chemicals

. chemical substances which may present absence of any information that the Nevertheless, TSCA section 4(a)(1)(B) is widespread human or environmenta l designed to support ri sk managemen t chemical may be hazardous t o health or the environment . This human activiti es under the other provisions of for the e dthat provides a evelopment

of a policy f~or~tn t

sense because in the case of "large" TSCA, including sec tion 6 . TSCA is existing chemicals . Section 5(e) of TSCA production volume chemicals, it is most different from most other environmenta l statutes in that it is intended to be provides EPA with the authority to likely that these chemicals may have preventa tive . To a ll ow the continued regulate new substances pending either the release or human exposure widespread exposure to chemicals with development of health and scenarios that EPA may wish to restrict unknown hazards would be contra ry to environmental effects data based on based on the results of testing . the preventative goal of TSCA . which either the poten tial risk presented by the The legislative history of TSC A provides some guidance on criteria to be was expressed in the legislative history substance (section 5(e)(1)(A)(ii)(1 1 ) or the potenti al for substantial production used in making secti on 4(a)(1)(B) as follows : findings : "The condi tions speci fi ed in This vast volume of chemicals have, for the volume and substantial or significant (TSCA) secti on 4(aKi)(B) re fl ect the most part . been released into the human exposure or substantial Committee's recogni ti on that the re are environment with little or no knowledge of environmental release (sec tion certain situations in which tes ting is their long-term health or environmental 5(e )( 1)(A)(ii)(II))

_ desirable even though there is an effects . As a result, chemicals currently in In ini tiating the section 5(e ) policy, commercial and household use are now being EPA developed crite ri a (guidelines) to absence of information indicating that found to cause or contribute to health or , the substance or mixture may be environmental hazards unknown at the time define the terms , 'substantial' and harmful" ( H . Conf. Rept . 2341 . 94th commercial use of the chemical begaa "significant" in the sectio n Cong ., 2d sess . (1976), at 18 reprinted in, • • • • • 5(e)(1)(A)(ii)(I) and 5(e)(1)(A )( ii)(II) A Legisla ti ve History of the Toxic [I)t is often many years after exposure to a findings . These guidelines are illustrated Substances Control Act (Comm . Print harmful chemical before the effects of its in Unit 1V . A . of this no tice . Because the 1976) (" Legislative Histo ry ") at 425) and harm become visible . By that time it ma y be produc tion volumes of new substances "•' * the re are certain situations in too late to reverse those effects . are typically sma ll er until they have which testing should be c onducted even ' ' ' • • been in p roduc tion for sometime and though there is an absence of Because of the lack of ► eatiag by because of the greater uncertainty in manufacturers and processors of chemicals to information indicating that the , determine their health and environmental accurately predicting the exposures substance or mixture per se may be effects, the general popula ti on and the which may result to humans and the hazardous" (H . Conf. Rept.1679, 94th environment now se rve as the laboratory for environment from the manufactnring
. Cong ., 2d sess . ( 1976), at 61 reprinted in, discovering adverse health and p ro cessing, distribu tion in commerce, Legislative Histo ry at 674) . The environmental effects . Aside from inequities use, and/or disposal of these new legislative histo ry also indicates that in relying on human experience to indicate substances, EPA has adopted threshold "" • the Administrator is not limited to when a chemical is harmful, such a method is values for new substances which are consideration of sheer volume of also a grossly inefficient way to iden ti fy lower than those which are being production or exposu re at a specific p ro blems . point in time . The duration of the (Legislative History at 411 -41 3) . proposed in this notice for the testing of

existing chenucab under TSCA section exposure, the level . of or intensity of With greater than 80,000 chemical 4(a)(1)(B}

. exposure at various periods of time, the substances in commerce and a scarcity

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32296 Federal Register / Vol . 56, No . 135 / Monday, July 15, 1991 j Notice s
II . Proposed Approach production volume is at least 1 million by volume released . However . the TRI is iubstantial Production pounds, would not disclose sufficient comprised only of the releases of a information to be considered a select group of chemicals . and therefore ae first finding under TSCA section disclosure of information which might may not be representative of the ata)(1)(B) is whether the chemical "is or be entitled to confidential treatment . In releases of all chemicals in commerce

. will be produced in substantial any event . TSCA section 14(a)(4) EPA believes that because in actuality

. quantities," referred to as "substantial authorizes the disclosure of information only 11 percent of all chemicals are production ." EPA is proposing that a which otherwise might be entitled to produced in quantities that exceed I threshold value of I million pounds confidential treatment when relevant in million pounds, the percentage of those (lbs .), 454,000 kilograms (kgs .), be any proceeding, including rulemaking, chemicals that are released in this established as the substantial provided that disclosure is made in such quantity will be much smaller . Although production threshold . EPA believes it is manner as to preserve confidentiality to EPA believes TSCA allows it the reasonable to interpret production in the extent practicable without impairing discretion to interpret substantial substantial quantities to mean large the proceeding . By disclosing only that a release at amounts lower than 1 million production, and that 1 million pounds is chemical is or will be produced in pounds per year, EPA believes it i s a large amount of production . The TSCA volumes of 1 million pounds per year or reasonable to interpret the term section 8(b) inventory of the chemical greater, EPA would preserve "substantial release" to include this substances in commerce shows that confidentiality to the extent practicable limited group of chemicals (i .e . . less than only about 11 percent of the listed while still making findings under section 11 percent)

. substances have production volumes 4(a)(1)(B) . The alternative of at least 10 percent over I million pounds, together B . Substantial Release of production volume threshold is accounting for over 95 percent of the incorporated into this criterion to allow total production volume of all If tfie criterion for substantial EPA some flexibility to require testing of substances produced in the United production under section 4(a)(1)(B)(i)(I) chemicals that are produced i n States (Ref. 2) . EPA believes that'TSCA is met, then at least one of the following quantities equal to or greater than I section 4(a)(1)(B) gives EPA sufficient three separate findings under section million pounds per year, but that are discretion to set the level of substantial 4(a)(1)(B)(i)(II) would also have to be released in amounts less than I million production lower than I million pounds met to legally require testing : (1) There pounds per year . Although few per year, however, it is well within is or may be substantial release, (2) chemicals with production volumes reason to find that this small number of there is or may be substantial human between 1 and 10 million pounds will chemicals (i .e ., the top il percent exposure, or (3) there is or may be have releases of greater than 10 percent according to production volume), which significant human exposure . Substantial of production volume, EPA believes it is account for the vast majority of all release is discussed in this Unit II .B, reasonable to require testing of suc h ~duction, clearly are chemicals with while both human exposure components chemicals because a release of 10 stantial production as that term is are discussed together in Unit II .C . of percent of production means that a -i in TSCA section 4(a)(1)(B) . this notice . sizable amount of what is being .owever . some may feel that a EPA believes that the intent of produced is escaping into th e substantial production threshold value Congress was that the phrase "enter the environment . Given the results of the of 1 million pounds per year is too low a environment in substantial quantities" testing, EPA may want to act to limit value ; others may feel it is too high . (referred to as "substantial release" ) Therefore, EPA is soliciting comments captures chemicals for which there is or such releases . Again, by setting the level on adoption of a different threshold may be extensive release to the at 10 percent of production, EPA value and the supporting rationale for environment which, in itself, would be, believes that this is a reasonabl e such choice . sufficient to require testing even in the interpretation of EPA's authority under Some manufacturers of chemicals for absence of any information that the TSCA section 4(a)(1)(B) . which TSCA section 4(a)(1)(B) findings chemical may be hazardous to human However, some may feel that the 1 would be made may claim that their health or the environment because such million pounds of release or 10 percent individual production volumes of a releases might be amenable to risk of production volume threshold may particular chemical are confidential management . In other words, as with lead to inconsistent results . For business information . EPA recognizes substantial production, release of instance, under these criteria a chemical that whenever it makes a finding under substantial quantities means large with 1 million pounds of production and TSCA section 4(a)(1)(B) based on the release . EPA is proposing that, a value 100,000 pounds of release would met the numerical threshold for substantial of I million pounds per year release or criteria for substantial release, while a production (i .e ., l million pounds per release of at least 10 percent of total chemical with 2 million pounds o f year), it would be publicly production volume, whichever is lower, production and 100,000 pounds of acknowledging that the chemical is or be established as the threshold . EPA release would not met the criteria for will be produced in the aggregate in believes that 1 million pounds of release substantial release . Therefore, EPA quantities exceeding I million pounds to the environment each year is a solicits comments on the adoption of a per year . EPA does not believe that sufficiently large amount of release fixed threshold, such as 100 .000 pounds disclosing to the public the fact that a where testing could be required even in or i million pounds

. chemical is produced in at least 1 the absence of any hazard information

. C . Substantial and Significant Human million pounds per year would be a The Toxics Release Inventory (TRI) F-xposur e disclosure of CBI . In making such a (Ref. 3) established under section 313 o f finding, EPA would be relying on the the Emergency Planning and Community The TSCA section 4(a)(1)(B) findings aggregate production volume of the Right-to-Know Act . 42 U .S .C .11023, for human exposure have two bases : 'npmical for all manufacturers . Thus, shows that 37 percent of the listed substantial or significant . Because a ~ would not be disclosing specific chemicals have releases over 1 million basic principle of statutory construction .,rmation regarding any particular pounds, accounting for over 99 percent is that when Congress used tw o duct . Moreover, a statement that a of the total reported releases on the TRI different words, it intended them to

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Federal Register / Vol . 58, No . 135 / Monday, July 15, 1991 / Notices 32297

have two different meanings, EPA these terms within the bounds threshold set forth in the policy and the believes that interpreting the two words established in TSCA and in its nature of the exposure is also significant to have different meanings is a legislative history . Note that EPA can as set forth in this policy . The following reasonable interpretation of the statute . make a finding that there is or may be Table I compares the proposed criteria United States v . Johnson, 462 F .2d 463 both significant human exposure and for "substantial" and "significant " 

### (3rd Cir . 1972) . cert . denied, 410 U- S (1093) . EPA has attempted to define 937 nmsbert exposure : of people exposed exceeds th e
TABLE 1 .-PROPOSED TSCA SECTION 4(A)(1)(B) HUMAN EXPOSURE CRITERIA
Cat egory Substan ti al Significant General popula ti on 100,000 people < 1 00

. 000 people exposed more directly or on a rou ti ne or episodic bas i s Consumers 10,000 people < 10,000 people exposed more direc tl y or on a rou ti ne or episodic basis Workers 1,000 workers < 1 .000 workers exposed more direc tl y or on a routine or episodic basis
.
While there was little guidance data on that chemical . EPA believes that requiring testing . Further, EPA rejects provided by the statute itself or the the different numerical thresholds for this approach because TSCA section 4 legislative histo ry , under TSCA EPA has workers, consumers, and the general requires only that EPA find that there traditionally interpreted the word population are necessary to re flect the "is or may be significant or substantial "substantial" as a quantitative measure, inherent differences in each probable human exposure" ( emphasis added) to a referring in this case to widespread exposure scenario ( e .g ., workers chemical, not that EPA definitively exposure-large numbers of people . EPA generally are exposed on a more routine prove exposure at a part icular level . believes that it is reasonable to interpret or direct basis than consumers, and A finding of significant exposur e the term "substantial human exposure" consumers are generally exposed on a would generally be made where the to mean widespread human exposure, or more direct basis than the general numerical threshold for numbers of in other words, exposure to large public) . persons exposed for substantial numbers of people . This is reasonable As a general matter, EPA has found exposure is not met, but the nature of because where large numbers of people that workers tend to be subject to the exposure is more direct than that are exposed to a chemical, EPA and routine or episodic exposure over a long which usually characte ri zes general others should have data indicating pe ri od of time . Thus, exposure, to be population exposure, consumer whether the chemical presents an considered substantial, does not have to exposure, or worker exposure . For unreasonable risk, to decide whether be as widespread for workers as for example, if there is general population actions are necessary to protect the consumers or the general popula ti on . exposure to fewer than 100 .000 people, public against such unreasonable risk . Similarly, TSCA and its legislative but the nature of the exposure is quite EPA does not rely on levels of exposure history provide little guidance about direct, e .g ., via drinking water, EPA may in determining substantial exposure, what constitutes significant human find that there is significant exposure for because the risk presented by a level of exposure . Under TSCA . EPA has purposes of requiring testing under exposure cannot be determined unless generally interpreted the term TSCA section 4 . An example o f the toxici ty of the chemical is known . "significant" as relating to the nature or significant consumer exposure might be Further, EPA can also require testing importance of exposure . EPA therefore where fewer than 10,000 consumers are under TSCA section 4(a)(1)(B) to is proposing to interpret "significant" as exposed, but the consumers use the determine the level of exposure to a referring to the nature of the exposure . product near their food, or are likely to particular chemical . EPA believes that if the nature of some inhale it or dermally contact th e EPA believes this is a reasonable exposure is sufficiently direct, large or substance . interpretation of the word "substantial" prolonged, even if the number of people EPA recognizes that the approach because Congress made it clear that exposed is not "substantial", there is a explained in this proposal integrates to EPA should require testing under TSCA need to develop data on the chemical some extent the concepts o f section 4(a)(1)(B) even in the absence of because, on the basis . of the data, EPA "substantial" and "significant" in information that the chemical may be may take some risk management action defining what constitutes "substantial hazardous, if the other findings could be to control the exposure . human exposure" by distinguishing made . In ri sk assessment, it is necessa ry By its interpretation of "significant between the nature of the exposure to to take into account both the toxicity human exposure," EPA does not adopt workers, consumers, and the general and the exposure to determine the ri sk . the approach suggested by CMA in the population . The Court in CM A Under TSCA section 4(a)(1)(B), where cumene litigation to require testing only recognized that there could be some there is or may be a substantial number if EPA demonstrates that people are overlap between substantial an d of people exposed and toxicity is not exposed to levels that would be significant human exposure : " it is characte ri zed, EPA believes it is considered toxic if the chemical were not necessa ri ly clear that 'significant' appropriate to obtain data on those found to be hazardous . EPA rejects this and 'substantial' as used in clause (II) chemicals for which EPA might consider approach because it cannot know what must be understood in a way that further assessment . EPA believes that level of exposure is hazardous until the prevents any overlap in their respective when there may be tens of thousands of chemical's toxici ty has been fully tested . meanings or requires that any factor people exposed to a chemical, Currently, EPA and the scientific relevant to one be necessa rily irrelevant thousands of consumers exposed to a community do not have sufficient data to the other ." CMA at 356, note 17 . chemical, or 1,000 workers exposed to a about the universe of chemicals to set Finally, EPA believes its approach is a chemical, it is reasonable to require test such an absolute cutoff level for reasonable interpretation of its lega l

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322,qg Federal Register / Vol . 56 . No . 135 / Monday . July 15, 1991 / Notice s ~-uthority because there must be pound or 10 percent threshold for therefore, cumene is p ro duced in tistan tial producti on before EPA even substantial release is not met . substantial quantities . siders whether there is or may be Further, existence of a chemical in Based on release estimates, EPA _astantial release or significant or human adipose tissue may indicate found that cumene is released to the substantial human exposure . Thus the widespread human exposu re to the environment in substantial quantities . criteria listed above for release and chemical, if the tissue survey represents EPA has found, and the Court in CMA exposure will not result in testing any a large popula ti on. Therefore , for upheld EPA's finding that the fugitive chemicals other than those in the - example, exposure as demonstrated by emissions of cumene to the atmosphere highest 11 percent of all chemicals existence of a chemical in the Na ti onal from manufacturing, processing . and use produced
. Human Adipose Tissue Survey may be acti vities are estimated to be 3 million D. Additional Factors the basis for making a finding of pounds per year . For the reason s substantial human exposure to the discussed elsewhere in this notice, I EPA would apply the generic chemical
. million pounds of release to the numerical thresholds for most chemicals Finally, in some cases, EPA may e nvironment is substantial release, and considered for action under TSCA consider a category of chemicals for therefore cumene may be released into section 4(a)(1)(B) . In some cases, testing where it does not have the environment in substantial however, where the thresholds are not information for each chemical within the quantities . met, it may be more appropriate to use a catego ry that shows that each chemical EPA also found that there may be case-by-case approach for making meets the thresholds established in this substantial human exposure to cumene . findings by applying other policy . In these cases, EPA believes it is The indust ri al re leases of cumene are considerations . That is to say, EPA may reasonable to use the thresholds concentrated in a few large metropolitan consider "additional factors" for making articulated in this no tice for making areas where the majority of cumene findings for chemicals which do not findings on the entire catego ry , rather manufacturing and pro ce ssing faciliti es meet the numerical thresholds proposed than requiring EPA to show that each are located . The Court in CMA found herein for evaluating existing chemicals individual within the catego ry meets the that the record adequately supported under TSCA section 4(a)(1)(B) . EPA's criteria set forth in this notice . EPA's finding that approximately'13 .5 authority to use this fl exible approach On the other hand, there may be some million people living in

- the vicini ty of was recognized by the Court in its instances when a chemical meets the cumene manufacturing and processing decision re garding the cimiene test rule . criteria proposed in this notice under facilities may be exposed to thi s The Court stated that EPA's definition TSCA section 4(a)(i)(B)(i), but EPA chemical . need not be precise

- it need not decides not to propose tes ting under When CMA b riefed its case, it "functi on like a mathematical formula." TSCA secti on 4(a)(1)(B) because EPA submi tt ed a monito ring study not Further, the Court stated EPA need not finds that data are sufficienYto submitted as comments on the rule that en adopt a definition applicable to al l ses, but may proceed on a case-by- reasonably determine or predict the relates to the presence of man y e interpretation, if it ra tionally effects of the manufacture, process, chemicals in the Houston Ship Channel

, , .plains its exercise of disc reti on . (CMA distribu ti on, use and disposal of the area ; including cumene . CMA submitted at 359 .) chemical and/or that testing is not the study in support of its argument that An example of an "additional factor" necessary . there was not substantial exposure to is bioaccumulation . Bioaccumulation cumene . The Court in CMA said . "The M

. Appli cation of Proposed Criteria to extent to which this information may b e refers to the tendency of ce rtain the Final Test Rule for Cumene material may significantly depend on chemicals to con centrate in anima l tissue in increasing levels as it EPA issued a fina l test rule under the c rite ri a a rticulated or developed by progresses up the food chain . The term TSCA section 4(a)(1)(B), requiring EPA on remand . We direct that EPA on refers to both uptake from water manufacturers an d processors of remand afford CMA an oppo rtunity to (bioconce ntrati on) and uptake from cumene to, perform health effects testing . p re sent such studies ( and any o th ers ingested food and sediment residues Based on the available data an c unene that EPA deems approp ri ate) unless (Ref . 4) . Chemicals that bioaccumulate dis cussed in Unit II . of the preamble to they would not be mate ri al to any of have been found in shellfish . birds, the final rule (Jul y 27 .19M13 FR 28295) EP A's criteria relied on -for the testing" mammals, and human adipose tissue . As (Ref .5) .and Unit II . of the p re amble to (CMA at 360-361)
. a general matter . EPA believes that

- the th e proposed rule (November 6, 1 98 5, 50 EPA's preliminary review of the study release to the environment of a chemical FR 46UH ) . EPAfound that cumene .is indicates that the study presents the that bioaccumulates is of greater produced in substanti al quantities, that level of cumene found at certain times in concern than the release of a substance the re is or may be substantial human the Houston Ship Channel a re a, rather that does not bioaccumulate . EPA exposure from its man .ufactur e, than the number of people exposed . believes that the persistence of a procesaing, use, and disposaL and that it Because the crite ria for finding that chemical in the environment, the is released in substan ti al quantiti es to there is or may be substan tial human subsequent storage of a chemical in the environment based on estimates of exposure is based on the number of animal tissue, and the likelihood for release . people which are or may be exposed, concentration of a chemical in the food EPA found that cumene is produced in rather than the levels of exposure , the chain are factors that could indicate that substantial quantifies
. EPA has found, study does not relate to whether EP A a chemical should be tested to and the Cou rt in CMA upheld EPA's could make a substantial human determine if risk management measu res finding that U .S .-production of cumene exposu re finding . However, because the
are necessary even at release levels in 1 .984 was reported to-be 3 .35 bi ll ion finding that the re is substanti a l below those specified in the general pounds, and an additional 339 mi llion produc ti on and that there is or may be teria . Thus, release to the pounds was imported . For the reasons substantial release to the environment vironment of a chemical that discussed elsewhere in this notice . EPA a re legally sufficient to suppo rt the test ) accumulates may be considered to be finds

- that 1 .milli on ;pounds of producti on rule and the testing of cumene has been ,stantial re lease even,if the S .million per year is substantialproduction-and completed It is not ,necessary for4?FA'to

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. 6

Federal Regi s ter / V ol . 56, N o . 135 / Monday, July 15, 1991 / No tices 32299 give further consideration to the is unreasonable and inappropriate for established in interpreting each of the question of whether there is or may be determining release into the same statutory terms for the review of substantial human exposure to cumene environment of "substantial quantities" new substances pursuant to EPA' s at this time . of chemicals . A fixed threshold of 1 TSCA section 5(e) authority . In general

. Therefore, for the reasons set forth million pounds would, in essence, the guidelines used for evaluating new elsewhere in this notice proposing the exclude almost all chemicals with substances under section 5(e) have minimum criteria for testing under production volumes of between I and 10 lower threshold values than those TSCA section 4(a)(1)(B), and because million pounds from testing under TSCA proposed herein for section 4(a)(1)(B)

. cumene exceeded these thresholds . EPA section 4(a)(1)(B), based on release Therefore, EPA encourages publi c finds that there is substantial production volume ; rendering the 1 million pound comment of the adoption of the section of cumene and there is or may be "substantial production" threshold 5(e) guidelines for evaluating chemicals substantial release of cumene based on meaningless . This is because few under section 4(a)(1)(B) . If comments its manufacture, processing, use, and chemicals with production volumes indicate to EPA that there is a disposal . between I and 10 million pounds have sufficiently strong basis for adopting releases which exceed I million pounds

. IV . Alternatives to Proposed Criteria Finally, EPA rejected the section 5(e) guidelines, or some other y' percentage criteria, than the criteria propose d 4 . Substantial Production only approach because in the absence of herein by EPA, EPA will conside r EPA considered other options for data similar to TRI for all chemicals, it adopting those criteria . The section 5(e) interpreting "substantial production" : may be difficult for EPA to determine •~substantial" and "significant" human First, the 220,000 pound (100,000 kg .) precisely what percentage of a exposure guidelines for all substances substantial production threshold (Ref . 6) chemical's production volume i s released to the environment having annual production volumes of a t used by EPA under its TSCA section . least 220,000 pounds are as follows : 5(e) authority ; and second, a production Furthermore, even when releases ar e volume threshold based on the less than 10 percent of production TABLE 2 .-TSCA SECTION 5(e) HUMAN uppermost quartile of chemicals volume, they may be large in quantit y for extremely high production volume EXPOSURE GUIDELINES produced . These two options would substance s capture essentially the same chemicals . and therefore they merit testing . For these reasons, EPA believes Substantial ~lo r That is to say, chemicals with that these options are less appropriate s'9"~'~'t~Expoaure Description of Criteria production volumes in or near the than the proposed criteria . EPA als o 220,000 pound range and above . EPA solicits comment on whether a higher Worker : .. .. . . .. . .. .. .. .. . . . . . ... . .. .. . thinks that 220,000 pounds, while threshold should be used and th e appropriate for new substances which high number of ~ 1,000 workers inherently have smaller production supporting rationale for using such a workers exposed . exposed (substantial) higher threshold

. volumes early in their commercial life, acute worker exposure
. . r~_ 100 workers exposed may be an unreasonably low production C. Substantial And Significant Human by inhalation to 2 10 threshold for an existing chemical . For Exposure '"g/dsy(subst`'"t'a l and ~nificant) these reasons, EPA thinks that these EPA considered other options for chronic worke r options are less appropriate than the interpreting "substantial" and exposure : proposed criterion . EPA also solicits "significant" human exposure : First, inhalation

. . . . . .. . . . . . . . . . . . .. . = 100 workers exposed comment on whether a higher threshold define the terms "substantial" and to 1-10 mg/day for ~ 100 days/year should be used and the supporting "significant" solely on the basis of (substantial and rationale for using such a higher numbers of people exposed without sigrificanU threshold . regard to whether the persons are ~rrrW Z 2 50 workers exposed B. Substantial Release workers, consumers, or members of the to by routine derma l general population, and base contact for a 100 EPA considered other options for "significant" human exposure on the daya/yea . (substantiai interpreting "substantial release" : First, nature of exposure ; or second, adopt the and significant ) the 22,000 pound (10,000 kg .) substantial "substantial" and "significant" human Consumer : release (all environmental media) exposure thresholds used by EPA unde r threshold used by EPA under its TSCA its TSCA section 5(e) authority (see consumer exposure . . . . ., . Presence of the section 5(e) authority ; second, a set Table 2 .) . EPA believes that the first substance in any product where (1) th e threshold of I million pounds of release ; option may not adequately address the physical state of the and third, release greater than 10 inherent differences in magnitude and substance in the percent of a chemical's production duration of exposures to workers, product and (2) the volume . consumers, and the general """"°` of use woul d population . make exposures likely EPA believes that 22,000 pounds of Option 2 was rejected because new (Significant ) release, while appropriate for new chemicals are more likely to have lower General Population : substances which inherently have levels of exposure or less widesprea d smaller production and release volumes exposure than existing chemicals and ambient surface water j .* 70 mg/year of early in their commercial life, could therefore the levels and numbers of exposure . exposure via surface include the release volumes of most persons exposed used by EPA in water (significant) existing commercial chemicals, and is implementing TSCA section 5(e) may be ambient a ir exposure . . ., . j- . 70 mg/year of therefore not indicative of the term more appropriate for new chemicals . For exposure via air "substantial release" as it relates to these reasons, EPA thinks these options (significant ) TSCA section 4(a)(1)(13) . are less appropriate than the propose d Also, EPA believes that assigning a approach . ambient yroundwater

. . . . . ~ 70 mg/year of release threshold based solely on a As discussed above, quantitative and e7PO""e via fixed release volume of 1 million pounds qualitative guidelines have been (significant)p . 7

323 00 Federal Register / Vol . 56, No . 135 / Monday, July 15, 1991 / Notice s
TABLE 2 .-TSCA SECTION 5(e) HUMAN policy under TSCA section 4 . docket (2) USEPA . Chemicals in Commerce :XPOSURE GUlDELtNEs-Continued number OPTS-47002J, which is available In fo rmation Systems Search (CICIS )
. Office for inspection Monday through Friday, of Toxic Substances . USEPA (1977)

. Substantial and/or excluding legal holidays, in rm
. NT- (3) USEPA . Toxic Release Inventory (TRI)

. Significant Exposure Description of Criteria G004,401 M St ., SW ., Washington, DC

. . Office of Toxic Substances . USEPA (1988)

. Crnena (4) Casarett, I ., and )- 7ou11 . Toxicology : 20460 from 8 a .m . to 12 noon and from I The Basic Science of Po ; tons . Macmillian p .m . to 4 p .m . This record includes basic Publishing Company

. ttie v York . (1986)

. aggregate ambient 22 .000 tbs .tyear information considered by EPA in (5) USEPA . Cumene ; Fi-A Test Rul e exposure through release to all developing this policy . This record (OPTS-4207A ; FRL 342t11-7 . Office of Toxic surface water• or . enwonarensat media includes the following information : Substances . USEPA ()idy z

. .198c)

. (6) USEPA . tmplementatio~- Proposal ; "New and groundwater (substantial) (1) Interagency memoranda

. (where +Be~

~ from landfill is comments, and proposals . Chemicals Exposure-Based Fi :iding," letter expected) . from Charles L . Elkins to Geraidine V . Cox (2) Reports - published an d ' unpublished data . (Chemical Manufacturers Ass, iation)
. uOffice of Toxic Substances, t1'-x'DA EPA also solicits cnmment on whether (3) Chemical Manufacturers (September 22 .19 8 8)

. a higher threshold should be used and Association v . EPA . 899 F .2d R44 the supporting rationale for using such a (5th Cir . 1990)

. P s op ri• 1 11 1 V5, 1001 . higher threshold

. B . References Victor ) . Kimm , V . Record Acting Assistant Administrator !or PNStrcides (1) USEPA . Section 8(e) Notice . Public and Toxic Substances

. A . Supporting Documentation Docket Control No . W -900000018

. 8EHQ0190-0646 FLWP, Office of Toxic Substances . (FR Doc . 91-16747 Filed 7-12-91- .8 .45 amj EPA has established a record for this USEPA (January 2a . 1990)
. OILUNG CODE 61560404



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