### P
.

Frida y 

## May 14, 1993

~



# Part III ! 

## F 

# Environmental

Protection Agenc y L TSCA Section 4( a)( 1 

# x B 

# } Final Statement a of Policy ; Criteria for Evaluating

Substantial Production, 

## Substantial Release, and 

## ' Substantiai or Significant Human Exposure ; Notic e

= 

# S

### p . 2

28736 Federal Register / Vol
. .58, No . 92 / Friday, May .14, 1993 / Notice s ENVIRONMENTAL PROTECTION Association v . Environmental Protection "adeqtiate deta shoald be developed AGENCY . Agency, 899 F .2d 344 (5th C 'rr .19W) . with respect to the effect of chemical the Fifth Circuit Court of A peals ;(the substances and mixtures on health and (OPPTS-47002K ; FRL4W9-9] "Court") remanded to EPA the sule the environment and that the ° RIN 2070-AC31 issued pursuant to 4(a)(1)(B) for cumene development of such data ahould be the testing and required EPA to articulate' responsibility of 

## those who manufacture TSCA 

## Section 4taxixB) Final crite 

## ri a for the 

## findings EPA made in 

## the and those .who process such chemJcBl Statement of 

## Policy ; Criteria for cumene test rule (53 FR 28195, July 27, substances and mixtures ." 15 U .S .C . . 

## Evaluating Substantial Pr 

## b duction, 1988) . EPA has decided 

## to-use this . 2601(b)(1) . See Chemical 

## Manufacturer s Substantial Release, and 

## Substantial opportunity to articulate c 

## ri teria-for
. 

## Association v . EPA, 859 F .2d 977, 98 0 or Significant Human Exposure making all findings under section ' (D .C . Cir . i988) (hereinafter "EHA - 4(a)(1)(B)(i) of TSCA . decision") . To accomplish this goal ; AGENCY : Environmental Protection This notice does not addnasshow)PA EPA has established a program for the Agency (EPA) . will set priorities for testing oi•how EPA testing of chemicals
. 

### AcztoN ; Final Statement of Policy
. will determine the speciiictests to be' EPA must make findings under either performed . Rather, this notice addreases section 4(a)(1)(A) ("A" finding) or SUMMARY : EPA is articulating standards one element in EPA's process for- 4(a)(1)(B) ("B" finding) of TSCA before and criteria for making findings it will selecting appropriate candidates foi tasting may be required of a ' use in Implementing its authority under testing - Le, how EPA will determine - manufacturer or processor . Both the " A " the Toxic Substances Control Act whether the chemical is or will be and "B' .' findings under TSCA section- • (TSCA) section 4(a)(1)(B)(i) . Under this "produced in substantial quantities ;' 4(a)(1) require the Administrator to find policy, EPA will use as guidance ' whether it "enters ortnay reasonably be that "there are insufficient data and threshold amounts to make anticipated to enter the environment in experience upon which the effects of the "substantial" production, release, and' . substantial quantities," and whether manufacture, distribution in commerce . human exposure findings under TSCA there is or may be "significant or' =' processing, use, or disposal of such section 4(a)(1)(B) . However . EPA may substantial human exposure," as used in substance or mixture or an y also make such findings in situations : TSCA section 4(a)(1)(B)(i) . combination of such activities on healthwhere the quantitative numerical Introduction or the environment can reasonably be thresholds are not met if additional I . . determined or predicted," and that factors exist . EPA will continue to A . Remand "testing of such substance or mixture develop and refine the criteria as its On April 12 . 1990, the Fifth Circuit with e elo~su cto suc h h dataef 1 S effects necessary experience with chemical substances ~~ofAppeals remanded to EPA the 2603(a)(1j(Aj(ii}-(iii) an d and mixtures (chemicals) considered for TSCA section 4 test rule forcvmene to the findings of particularly humand based on a challenge to the rule by the 2 To( arequire testing)under section exposure, for which EPA is not Chemical Manufacturers Association 4(a)(1)(A) of TSCA the Administrator establishing a minimum numerical ( CM A)• CMA v. EPA
. 899 F .2d 344 (5th mum find that "the manufacture, threshold in this notice, This notice also Ciz• 1990) (hereinafter "cumene distribution in commerce, processing, addresses specific issues related to decision"), The Court generally upheld use, or disposal of a chemical substance EPA's existing cumene test rule (July 27, EPA's factual findings in the rule as or mixture, or that any combination . of 1988, 53 FR 28195) being supported by substantial evidence such activities, may present a n

. 

### but instructed the Agency to "articulate unreasonable risk of injury to health or FOR FURTHER NdFORMATiON COKTACT : The standards or criteria on the basis of the environment" (emphasis added) .'In Susan B . Hazen, Director . which it found the quantities of cum8ne the ERA decision, the Court found this Environmental Assistance Division 't'S- emtering the environment from the ' provision to require EPA to establish a 799), Office of Pollution Prevention and facilities in question to be 'substantial' ." . . more than 

## theoretical basis!' for finding To 

## xics, rm E-543B 

### . 401 M St, SW ., 899 F .2d at 360 . In this notice, EPA 

## Is that the chemical may present an 

## Washington', DC 20460, telephone : (202) articulating 

## standards and 

## criteria It will un 

## re asonable 

## ri sk, but that 

## EPA could 554-1404, TDD (202) 554 

## -0 551 . use in making findings under section establish existence and amount of 

## SUPPLEMENTARY IN FORitAT

## M : 4(a)(1)(B)(i) of TSCA
. 

## Additionally, EPA human exposure to the chemical on the Electronic AvailabElity : This document is responding to the instructions by the basis of inference drawn fio m 

### is available as an electronic file on The 

## Court regarding the applica

## ti on of 

## such circumstances under which the Fede 

## ra l Bulletin Boa 

## rd at 9 a .m . on the 

## criteria to the cumene rule
. 

## ch emical is manufactured and date of publication in 

## the Federal 

### Register . 859 F .2d at 991 . This ter. By modem dial (202) 512-1387 B . Backgroun d y interpretation of the statute "prevents a or call (202) 512-1530 for disks•or paper Congress enacted TSCA to give EPA testing rule based on little more tban' copies, This file is also available in the authority to assess and prevent scientific curiosity, yet allows the Postscript . Wordperfect and ASCII . unreasonable risks associated with the, _Agency to act when an existin g EPA Is articulating guidelines for manufacture, processing, distribution In possibility of harm raises reasonable finding that "a chemical substance or commerce, use, or disposal of chemicals and legitimate cause for concern ." mixture is or will be'produced in through a variety of regulatory means
. Ausimont U .S .A . v ; EPA, 838 F . 2 d 93, substantial quantities, and (I) it enters or 15 ;J . ° . C 2601 . at seq . This authority 97 (3rd Cir . 1988) . may reasonably be anticipated to enter includes, among other things, the In contrast to TSCA section 4(a)(i)(A)

. the environment in substantial authority to require chemical testing to under TSCA section 4(a)(1)(B), there is quantities, or (Il) there Is or may be develop data for risk assessment, 15 no risk-based criterion to satisfy . See significant or substantial human U .S .C . 2603, and the authority to ban 899 F .2d at 347, n .4 (cumene•decision)
. exposure to such a substance or chemicals If necessary to prevent According to the legislative history, the mixture," under TSCA section unreasonable risks, 15 U .S .C . 2605, A provisions of TSCA section 4(a)(1)(B)(i) 4(a)(1)(B)(i), In Chemical Manufacturers principal tenet underlying TSCA is that reflect the "Conferoes' recngnition that

### p . 3
Federal Reg i ster / Vol . 58, No . 92 / Friday, May 14, 1993 / No ti ces 287 3 7 there are ce rt ain situati ons in which statute is silent or ambiguous on a developing adequate data with respect tes ti ng should be conducted even pa rticular issue, deference is accorded to chemicals and making th e though there is an absence of to any reasonable interpreta ti on development of that data the information indicating that the consistent with the statuto ry purpose . responsibility of chemical substance or mixture per se may be Chevron USA, Inc . v . EPA, 487 U .S . 837, manufacturers and processors, hazardous ." H . Conf

. Rapt . 1679, 94th 842-844, (1984) : NRDC v . EPA . 907 F .2 d Cong ., 2d Sass . ( 1976), at 61, rep ri nted 1146, 1153 ( D .C . Cir . 1990) . The Fifth II . R esponse to Pub lic Comments in A Legislative History of the Toxic Circuit Court of Appeals recognized this A
. Summar y Substances Control Act (Comm . P ri nt princi p le when reviewing the cumen e 1976) ("Leg . Hist .") at 674 ; and H . Conf . test rule . Accordin g to the Cou rt , where EP A received written comments on kept
. 1341, 94th Cong ., 2d Sass . (1976), TSCA and its legislative histo ry provide the proposed statement of po li cy fro m at 18, reprinted in Leg . Hist ., at 425 . no defini ti on of a term such as the Chemical Manufacturers Associa tion Thus, under section 4(a)(1)(B) of TSCA, "substan tial," "Congress is deemed to (CMA), the Epoxy Resin Systems Task EPA can act even in the absence of have implicitly delegated to the EPA the Group of The Society of the Plas tics informati on that the chemical may be power to define or inte rp ret Industry, Inc
. (SPD , the Monsanto hazardous . Section 4(a)(1)(B)(i) requires 'substantial, "and we will sustain the Company, the Ecological an d the Administrator to find that "a Agency's interpretation as long as It Is Toxi cological Associa ti on of the chemical substance or mixture is or will rational and consistent with the Dyestuffs Manufacturing Indust ry be produced in substan ti al quan titi es, statuto ry scheme and legislative ( ETAD ), the Calle ry Chemical Company ,' and (I) it enters or may reasonably be histo ry " 899 F .2d at 354 . the Halogenated Solvents Indus try an ticipated to enter the environment in (S)ubstantial Is an inherently Imprecise Alliance (HSIA), the GAF Chemicals substan ti al quanti ti es, or (11) there is or word . ••• no definition or group of Corpora tion (GAF), the BAS F may be significant or substan ti al human criteria can be esta blished which will Corpora ti on ( BASF), the Arco Chemical ex p osure to such substance or mixture ." function like a mathematical formula, so that Company (ACC), the U .S . Depa rtment of This policy statement sets out EPA's for eve ry given set of facts a specific, Labor's Occupa ti onal Safety and Healt h interpreta ti on of section 4(a)(1)(B)(i) of predictable answer will always be Administration (DOIJOSHA L and the TSCA . This no ti ce is not intended to forthcoming
. exerc . Room must be left for the U .S . Department of Health and Huma n address EPA's preliminary policy Id . at 359 . Service's Na tional Institute for decisions for selectin g chemicals as Occupa tional Safety and Health MS/ potential candidates for testing
. Clearly, there is nothing in the NIOSH) (Refs . 1-9) . Likewise, it is not intended to address statuto ry language or legisla tive histo ry CMA's Acetone and Ketones Panels, findings made under TSCA sections that restricts the Agency's a llowed Oxo Process Panel, Cumene Panel, 4(a)(1)(B)(ii) or ( iii), or the scope of interpretation of "substantial" or Cydohexane Panel, and Hexamethylene testing that may eventually be imposed " significant" to consideration of Diiosocyanate Panel, and the Diethy l by EPA
. It is only intended to articulate particular quantiti es of or other Ether Manufacturers Task Group (Refs . the standards and crite ri a EPA will use evidence relating to production, release, 10-15) also submitted comments which in implemen ti ng its authority to make or exposure . In fact, Congress p ro vided supported, in general, the comments findings under TSCA section a list of factors which may or may not submitted by CMA
. These commenters 4(a)(1)(B)(i) . To this and, EPA pub lished be considered by EPA in making TSCA are co llectively referred to as'•CMA " in the Federal Register on July 15, 1991 secti on 4(a)(1)(B)(i) findings . H . Rept. hereafter in this notice . Comments (56 FR 32294), its p ro posed statement of 1341, 94th Cong ., 2d Sess . (1978), at 18, submitted by them groups which are po licy regarding section 4(a)(1)(B)(i) of rep ri nted in Leg. Hist ., at 425 . See also specific to a proposed test rule for a TSCA . EPA requested comments on its cumene decision, 899 F .2d at 356, n .18 speci fic chemical will be addressed, as construction of the phrases "produced ( "Moreover, the quoted language in H . app ro priate, in the final rule for tha t in substan tial quan tities," "enters or Rept . 1341 '•• is permissive and specific chemical . Those rules will be may reasonably be an ticipated to enter
. expansive in respect to what the EPA published in the future . The comment the environment in substan ti al may consider and when it may require periods were reopened for p ro posed test quan tities," and "is or may be tes ti ng under section 4(a)(1)(B) •••"), rules for Office of Drinking Water significant or substantial human In this statement of policy, EPA is Chemicals ( 5 5 FR 21393, May 24, 1990), exposure" as used in section exercising its discretion by a rticulating Cydohexane (52 FR 19096, May 20, 4(a)(1)(B)(i) of TSCA . quan ti tati ve thresholds to se rv e as 1987) .1,6-Hexamethylene, Diisocyanate C. The "B" Policy guidance in making findings of (54 FR 21240, May 17, 1989), and 1 V substantial" producti on, release, and methylpyrrolidone ( 55 FR 11398, March Secti on 4(a)(1)(B)( 1 ) of TSCA requires human exposure . " Significant" human 28, 1990) ; See 56 FR 32292 . (July 15 , the Administrator to find th at a exposure findings will be made on a 1991) . A summary of the comments chemical substance or mixture is or will case-by-case basis . As explained In the received on the TSCA section 4(a)(1)(B) be produced in substan tial quanti ti es, proposed policy statement (56 FR proposed statement of policy i s and "(I) it enters or may reasonably be 32294), it is EPA's belief that EPA may included in the fo ll owing Units II .B . anti cipated to enter the environment in make findings under section 4(a)(1)(B)(i)

- II .G ., along with EP A's responses to substantial quan tities, or ( II ) there is or of TSCA based on quan tita ti ve comments . may be signi ficant or substan tial human thresholds . However, EPA does no t exposure to such substance or mixture," intend to limit itself to the use of these B . Scope of Testing to impose tes ting requirements . criteria in making "B" findings and ( M A and other commenters have However, TSCA does not define the reserves the ability to consider other expressed the concern that, given the crite ri a or standards to be used, or the factors on a case-by-case basis . Such an c ri teria a rticulated in this no ti ce, meanings of the words "significant" or interpretation is consistent with the " nearly 8,000 substances will require "substan tial ." Additionally, the legisla ti ve history of TSCA and [ EPA] review under section 4(a)(1)(B)" legisla ti ve history of TSCA p ro vides no effectuates the policy objectives ( Refs . 1 and 5) . These comments elucidati on of these terms . Where a described in section 2 of TSCA of indicate that many commenters havep . 4

28738 Federal Register / Vol . 58, No . 92 / Friday, May 14, 1993 / Notice s misinterpreted the intended and actual environmental releases, the Agency sections 4(a )( 1 XA git) and (iii) and (B)(ii) scope of this policy . The "B" policy is should limit rules supported by such and (iiir it bears-no dependence on or not intended to be, nor will it used findings to chemical fate and other relationship to the findings under as an automa ti c trigger to testing
. environmental effects testing" (Ref
. 1) . either subsec tion 4(a )( 1xA)(i) or (B)(i) . Nothing in this policy will require EPA EPA believes that any linkage Thus, once the Administrator ha s to immediately review any of the between the particular numerical made a finding under TSCA sec tion chemical substances currently in threshold criteria articulated in this 4(a)(i )( A)(i) that a substance may commerce . Rather, this po licy statement policy statement, or the particular present an unreasonable ri sk, or under sets out EPA's interpretation of the findings made under TSCA sectfon TSCA sec tion 4(a)(1)(B)(i) that a findings it must make under section 4(a)(1)(B)(i), and the nature and scope of substance is or will be 'produced in 4(a)(1)(B)(i) and the general factors EPA testing to be required once such a substanti al quantities and may either will consider in evaluating section finding has been made, is misplaced, enter the environment in substan ti al 4(a)(1 )( Bxi)'s app li cabili ty in specific and indeed, based on a quan titi es or that there may b e cases . This policy statement is not misinterpreta ti on of the scope of EPA's substantial or signifi ca nt human intended to function as a tool for set ti ng tes ti ng authority under section 4 of ex p osure to the substance, th e testing p ri oriti es . Testing priori ti es will 'l'S( ',A
. Administrator may require any type of be set by EPA's ongoing efforts in . TSCA section 4(a) states : tes ting necessary to address unanswered developing a Master Testing List . This ( a) TESTING REQUIR>E3MENTS .-If the ques ti ons about the effects of th e list was made available to the public in Administrator finds that- substance . EPA need not limit the scope EPA's Chemicals-in-Progress Bulletin (1)(Al(i) the menufactun , distribution in of testing required to the factual bases (June, 1990) . See also 56 FR 42055 (Aug . commerce . procesdn & use, Or disposal ofa for the section 4(a ) (1)(A)(i) or (B)(i ) 26, 1991) for fu rther informa ti on . chemical substance or mbcture, or that any findings . Many respondents . including CMA , co mbination of such actMties, may peesent Essentially . under TSCA section have indicated their tacit support for the an unreasonable risk of injury to health or the 4(axl)(B)

. EPA may require health ted 

### threshold criteria arti cula in this environment . (ii) there are Insufficient data and effects testing even it it has only mad e policy notice , so long as "B" fi ndings experience upon which the offs rim of such a finding that there is or may b e are made only in support of rules manufechus, distribution in commerce . su b stantial entr y into the envi ro nment requiring only ti ered screening level or pr oces s ing , use , or dis p osal of such substance of a substance, or require environmental "baseline testing" of chemical or mixture or of any combination of such effects testing even if it has only made substances ( Ref. 1) . CMA opposes activities on health or the environment can a finding that there Is or may be utilization of the "B" policy criteria, reasonably be determined or predicted . and substantial or si p ficent huma n and indeed, use of EPA's section ( iii) testing of such substance or mixture exposure to a substance . Clauses (I) and 4(a)(1)(B) testing autho rity for any other with respect to such effects Is necessary to (II) of section 4(a)(1)(B )(i) can b e level of testing
. develop such data, or (B)(i) a chemical substance at mixture is or interpreted as mutually exclusive
. Se e On the poli cy as a whole, CMA cumene decision
. 899 F .2d at 357 n . 19 . commented that EPA's proposed criteria will be produced in substantia l and (n it enters or may reasonably be Either finding is sufficient to requir e under TSCA section 4(a)(1 XB)(i) are anticipated to enter the environment In tes ti ng, so long as EPA finds that data reasonable as a basis for requiring substantial quantities or (11) there Is or may ' relevant to a determination of whether screening tests such as the Screening be ,igai6cant or substantial human sxposure a substance does or does not present an Informa ti on Data Set ( S ID S) utilized by to such substance or mixture, unreasonable ri sk of inju ry to health or the Organiza ti on for Economic ( ii) there are insufficient dais and the environment are insufficient and Cooperation and Development (OECD) experience upon which the effects of the that tes ting is necessary to develop such for high p roducti on volume ( HPV) manufac ture, distribution in oommeras, data . It is the interrela tionship of the chemicals . CMA stated, "EPA's processing . use . or disp osal of such substance exis ti ng data set and numerous othe r



### 'B' criteria would provide a or mixture or of any combination of rich proposed activities on health or the environment can substance-specific parameters, which suitable basis for selecting substances reasonably be determined or predicted . and are evaluated under subsections ( ii) an d for such screening tests" (Ref
. 1) . CMA (iii) testing of such subsfaaca or mixture ( iii) of section 4(a)(1)iB), that determine s proposed that, if screening studies with respect to such effects is necessa ry to the specific testing requirements, if any, reveal the poten ti al for adverse effects, develop such data ; and ••• . for a pa rticular substance . then EPA should add the chemical to a EP1, notes, however, that while it has the Administrator shall by rule require tha t subsequent p ro posed rule under the testing be conducted on such substance or th e authori ty to require tes ti ng for any authority of TSCA section 4(a)(1)(A), the mixture to develop data with respect to the health and envi ro nmental effects on ce it may present" finding . CMA proposed health and environmental effects for which has made a finding under either sectio n that, in the absence of toxicity concerns, there is an insufficiency of data and 4(a)(1)(A)(i) or (B)(i) of TSCA, the Act EPA should require additional testing expe ri ence and which are relevant to a does not compel EPA to require testing only if it concludes that exposure is determina ti on that the manufacture, of all health or environmental effects "unusually gr►

jat ." CMA argued that distribution in commerce, processing, use, or endpoints in all cases . Rather ; once EPA more ri go rous " B" c ri te ri a, which take disposal of such substance or mixture, or that has decided that it will require tes ti ng, into account all aspects of exposure, any combination of such activities, does or EPA must also determine what data ar e does not present an unreasonable risk o f must be developed by EPA to select inju ry to health or the environment
. sufficient and what testing is necessa ry such high exposure substances for in each pa rt icular case in promulgating additional testing . CMA stated that it 15 U .S .C 2 603(a) (emphasis added) . specific testing requirements . In would not oppose EPA's crite ri a if they The final paragraph of secti on 4(a) sets addition, once EPA has decided to were incorporated into the tiered out EPA's autho rity to require testing require tes ti ng, EPA also considers, approach described above . CMA would once the Agency has made the findings among other factors, "the rela tive costs oppose EPA's " B" criteria, if they are under section 4(a)(1)(A) or (B) . The of the various test p ro tocols •'• and the used for any other purpose . CMA directive of this final paragraph clearly reasonably foreseeable availabi li ty of the further asse rt ed that if a "B" finding is relates to the " data insufficiency" and facilities and personnel needed t o based "solely on the magnitude of "testing is necessary" findings of perform the testing required under the

### p . 5 Federal Reg id er I VOL 58 . - No . 9 2 ! Friday . May 14, 19g3 ! Notir,es
. 28M , rule," TSCA section 4(b)(1 j, 25 U .S .G that tbe extrtiag datr aad as P tfance d a no!

-- quantities equal to or greatet than 2603(b)(1). - suf fice as a bes i s 6ar k tareroaabix P nAk*- 220, 0 t7(1 $ peryean no Ne w Furthermore , if Cangress had that then will be aa beslwk or aavitonmeatai Chemical,

. prpgre m, as a matter of - intended that the testing required under injury from the manufac hld ag{os ~sowcsoli cy , may specify, h}ghat tared testin section 4(a}(1}(B) be related to whether etc .) of the rhemScal . than a~nnabva $ evidence and findings of risk of trucb injury e .g . . bioassay, ne~tantn x ddty ) under the findings are based oa information at hypothetical tux~tlr levels under section ' ~~ circumstances (Le, use in about human exposure or . 4(a)(1 ) (Bxtt are not necessary to provide it products) for those tdze~b environmental release . it is reasonable nexus between requiring sting under '• . anticipe,#s to be annually 

### produced ia to conclude that Congress would have section t(a)(i)( ) and congressional aonoem amounts . of 2-1 million pounds or used the word "or" instead of "and" for health and the en,riroument . graater ; however . the when directing the Adminiatrator to . - . substantial thrashold iar require testing to develop data with 899 F .2> ;} at 354 -3 55-(empbesfa . In consideung tastiag undersecfiaa respect to the health and environmental o ri ginal) . Given that TSCA section 5(e)(i)(A)(ii~ ia 22aA00 pounds OWL effects '••» in the final paragraph of - 4(a)(1)(B)(i) gives EPA authority to -' . 16) . .- - section 4(a) . However, the explicit require health and environmental effects EPA disagrees that the OECD HPV , choice of the word "and" in this final testing even in, the absence of threshold would be a more reasonable paragraph indicates that Congress • informa ti on that a substance is approach for the initial threshold uader authorized EPA to require health and hazardous . it is reasonable that the . . TSCA section 4 . The OECU 8PV environmental effects testing specific testing to be reguired relates to threshold was establisbed .uttd ar independent of the basis for an (A)(i) ar the data i nsufficiency and testing in different circumstaaces tban th e (B)(i) finding . Indeed, EPA has necessary findings uaderTSCA section proposed threshold for "substantial consistently interpreted the `testing is 4(a)(i ) (B ") and (iii) ratherthmt to the production
. ." Eighteea me-bet necessary " under TSCA sections • eavironme~at~ releesa or human ' countries (including all major 4(a)(1HAxiii) and (B)("iii) to mean that

- exposure finding made zmderl'St' .A
. countries) developed natioaal producing EPA may require any health or section 4(a)(2)(B) (i ) . . •• Inventories of HPV c hsmlc a Is environmental eftects testing .for which data manufactured or imported into their
. are Insufficient and which EPA bellev " are C . Substantial Production cou ntries_ These Inventories were "capable of developing the necessary EPA proposed a value of I million merged into a comprehensive inventt i y ie 1~98~Oj n ." See 45 FR 49510 .48530 () ; uly -pounds as a threshold level for findings maintained by the OECD . and is calle d of "substantial production ." 56 FR the OECD Representative List ( RaL 17) ; 322-96_ As an alte rn ati ve to, this
. which includes all chemicals (axciudrag EPA's broad mandate to require threshold

. EPA solicited comments on polymers and petroleum fractions ) testing is also reflected in the legislative the adop tion of the'FSC' .A section 5{e) reported in any member coua try ta history of TSCA
. See H . Rapt 1341 . 94th New Chemical Program's exposure-

. excess of 10 .000 tonnes (22 million Cong , 2d Seas . ( 19?6), at 3-8 . rep rinted based substantial production threshold po unds ) an d all chemicals reported In in Leg. . Hist, at 411-414 . The breadth of (i .e ., 220,000 pounds) or some higher two or more countries in excess of l,floo TSCA's authority to require testing is threshold ( 56 FR 32299) . tonnes (2 .2 million pounds) . Henco , the most apparent in TSCA section Both CMA and SPI commented that OE CD HPV production volume 4 ( a)(1)(B) which, according to the EPA's proposed production threshold is thres hold of Z .2 million pounds was Conference Report on TSCA, authorizes a reasonable interpreta tion of . . conceived merely to gw de the - 

### EPA to require testing "even though "substantial production" under TSCA genera ti on of national ' inventories which there is an absence of information section 4(a)(1)(B) ( Refs . I and 2) . when combined would yield an - - indicating that the substance or mixture However . according to 0 dA, •'(w)hile International list of high production - per se may be hazardous_" H . ConE . EPA's approach is a reasonable one . a volume ch emicals . It was assumed by Rept_ 1679, 94th Cong ., id Sess . ( 1976), production threshold of 2 .2mi ll ion . OECD that the roduction volume alone at 61, reprinted in Leg . f•iist . at 674 . See pounds would be pra€arabla to achieve would be a st~cient indicator o f also H . Rept . 1341, 94th Cong . . 2d Saas, consistency between EPA's activities potential exposu re suc h that the OECD`s (1976), at 18, reprinted in Leg . Hist, at underTSCA section 4 and the OECD
. p ro g ra m on existing chemicals has - 425 . HPV Existing Chemical Testing focused since 1988 on the chemical s Finaliy, in the cumene decisi®, , the Program" ( Ref. 2) . G4tA noted that for found on the OECD Re alive List
. Court supported EPA's interpreta ti on . • purposes of requiring certain extensive The TSCA section 41(a)(1)(13)(1) ffn&fig regarding the relationship between the types of studies, EPA also uses 2 .2 of substantial produc tion is not the sole findings under TSCA subsection million pounds as a production volume fi nding EPA must make to requir e 4(a)( L)(B)(i) and subsections . trigger in its new chemicals program testing . The threshold of I million' 4(a)(1)(B)(ii) and ( iii)c under TSCA section 5"- (Raf .1) . HSIA pounds set forth by EPA in its propose d~ .• A finding under section 4 (a)(1)(B)(i) does also suggested use of TSCA section 5 statement of po licy ( 56 FR 32294 ) is on e cot alone justify a testing order . It must also trigg er for substantial production ( ReL of several findings EPA must make be found under sec tion 4(a )(1 )(B)(ii) that 'there are insufficient data and experience 6) . Monsanto ( ReL 3), HSIA (RaL 6) . and before'a substance may be subject to u poo which the effects of th e menufactiae (or ETAD (RaE 4) also supp ort th e adop ti on testing . EPA must also fi nd that them is p,oceesing, etc-) ••• of such substance •-` of the OECD HPV threshold for the substan ti al release, or substan ti al o r on health or the environment can reasonably pu rpose of international harmonization
. signi fi cant human exposure unde r be •

- predicted .' S'unilarly . section E3'A disagrees with CMA and HSIA TSCA sec tions 4(a)(1)(B)(i)(I) and (II) . In 4(a)(x)(B ) (iii) imposes the furt her that 2 .2 million pounds produc ti on is addition, EPA must find that data are requirement that the testing be 'necessary to th e sole thresbold u ti lized in the TSCA Insufficient and testing to necessary develop such data' (emphasis added}- La. section 5 New Chemicals progrant . In under TSCA sections 4(a)(1)(B )( ii) and necessary to render the experience and dat a sufficient as it basis on which the health gBqersl, screening level toxicity studies ( iii) . EPA does not believe tha t and a environmental effects of'lha manufacturing for human health and/or environmental production volume
. threshold which is (or procesaing . etc.) can reasonably be effects may be required for chemical chosen to generate an inventory for an predicted '••, If the EPA properly concludes substances expected to be produced In ' inte m ati onal pro g ram on existing

### p . 6

28740' Federal Register / Vol . 58,
.No . 92 / Friday, May 14, 1993 / Notice s chemicals and which Is the only trigger particular production volume threshold to believe based on a lower thteshold for entry into that program should be
. would have any economic impact, alone that EPA would be overwhelmed . determinative of the threshold chosen EPA does, however, carefully • - - as Ca llery Chemical Company be lieves, for "substantial production" under consider the potential economic impacts by adoption of the TSCA section S• TSCA section 4(a)(1)(B)(i) . and the value of testing data for a ll threshold value for substantia l GAF, BASF, and ACC objected to the section 4 test rules . For each chemical production, Nevertheless, for the p ro posed threshold on two grounds . subject to testing, EPA conducts an reasons set forth above and in the - . : First, the p ro posed threshold value will analysis which estimates the costs of pro p osed poli cy, EPA will adopt the I involve subjecting 95 percent of U .S . testing . In addition, EPA considers any million pound threshold fo r 

### chemical p roduction ( on a total volume comments received on the economic ' "substantial production" under secti on basis--11 percent on number of effects of p roposed testing requiiensents 4(a)( 1 )(B)(i) of TSCA . chemicals basis) to potential testing . when developing final rules under D
. Substantial Release They .argue that because the threshold section 4, and may revise testing 11 th e criterion for "substantia t will encompass such a large p ercentage requirements when respo ndents of chemical production, the threshold demonstrate that the rule would impose p rod uction" is met, then at least one of reflects an incorrect interpretation of excessive economic burdens or 'would three additional findings under TSCA section 4(a)(1)(B) (Ref

. 7) . . stifle technological innovation' section 4(a)(1)(B)(i) must also be mad e As p re viously explained, EPA has' The consideration of economic before testing Is required,'TI ;e Ant of . broad discretion in defining Impacts is particularly important for these findings is that the substance

- -"substantial" and could choose a • chemical testing decisions because "enters or may reasonably be , quantitative threshold at any point' EPA's purpose in using section 4 Is to anticipated to enter the environment in" along a wide spectrum when construing obtain data for use in risk assessment substantial quanti ti es" under TSC A 

### the meaning of "substantial . . . . and, where necessa ry , risk management section 4(a)( 1 )(B)(i)(I) . EPA refers to 1 his production ." For instance, if one were activity . EPA recognizes that If the =' • finding as "substantial release'•_an d to create a cha rt ranking from lowest to testing it requires on a substance under proposed that a -value of 1 million'
. highest the aggregate producton for all' section 4 im p oses an unfair or excessive pounds per year release or release of i 0 substances on the TSCA Invento ry , EPA burden, the likely result of the section percent or more of total production could interpret the term "produced In 4 rule would be to drive the chemical volume, whichever is lower, be substantial quantities" nar rowly to from the market, rather than to produce established as the threshold value for apply only to substances produced in test data . To insure that test data are "substantial re lease ." As an alternative volumes at the extreme top and of the received, EPA must be concerned with to this threshold, EPA solicite d chart . EPA could also choose to adopt any significant adverse economic comments on the •adoption of a fixe d a broader interpretation, fi nding all impacts associated with section 4 test threshold, such as 100,000 pounds or 1 chemical producti on to be substantial rules . Economic considerati ons are m i llion pounds ( 56 FR P 2296) . therefore well inte ted into EPA's GMA, HSIA, and SPI disagree with unless it fell below a value at the gra F PA's interpretation that "enters the extreme low end of the chart . testing decisions
. In response to EPA's alterna ti ve environment in substantial quantities" EPA has proposed a°produetion figure ld r oonse osal for the substantial equates with "substantial" release . mil lio n in betwee n pound the tw o

threshold for extremes . The 1 p

ro duction pro threshol d production proposal ( 220 .000 pounds) ese commenters contend that EP A narrows the "universe" of chemicals used in the review of new chemical must consider not simply the tota l substances under section 5 of TSCA, poundage released but also other factors potentially subject to TSCA section 4 ~Ile ry Chemical Company stated, that address the potential for human testing under TSCA section 4(a)(i)(B) to (alt this threshold production level, the and/or environmental exposure such as 11 percent of the TSCA Inventory
. Since publication of production quantities will not th e chemical's persistence in the : that sma ll percentage of the Invento ry only reveal extremely sensitive confidential environment and its likely or estimated accounts for 95 percent of total chemical business information but will clearly concentrations in various environmental producti on, It is reasonable to use this overwhelm the Agency with work that It media (Refs . 1 . 2 and 6) . • information as a basis for making a cann6t'bandie ( R a t : 5) . EPA disagrees with the commenters' finding of "substan ti al produc ti on" for arguments regarding what informa ti on substances produced in excess of that EPA be li eves that adoptin g the • EPA must consider when making a threshold . threshold of substantial production used finding under TSCA sectio n GAF, BASF, and ACC also in the review of new chemical

- 4(a)(1)(B)(i)(n . In e ff ect ; CMA attempts commented that the I million pound substances under section 5(e) of TSCA to import the "exposure" corn nent of threshold "will impose an unfair is inapprop ri ate at this time, although clause (II) of secrtion 4(a)(1)(B) ro into ' economic burden on chemical for diffe re nt reasons . Callery Chemical clause (I) . However, as indicated by the manufacturers and processors that

- could Company's concern about pub li c word "or" between the two clauses, • sti fle technological innovation" (Ref . 7) . disclosure of sensi ti ve business clauses ( I) and (II) of section 4(a)(1)(B)(i) This co mment (which is unsupported information is addressed elsewhere in can be interp re ted as being mutua lly by any empi ri cal data) also appears to this notice ( Unit 17 Y . of this notice) . exclusive . While EPA may, 1f it chooses, reflect a misunderstanding of the scope EPA recognizes that the number of make a fi nding under both clause (1) and of this po licy statement . • chemicals which could be considered as clause ( II), a finding under either claus e Neither the "B" policy nor any potential testing candidates under alone, coupled with findings under particular numerical threshold set forth section 4 of TSCA would be greater If 4 (a)(1)(B)(ii) and (iii), is sufficient to herein constitutes an automatic trigger the lower threshold value of 220,000 su pp o rt a test rule . for testing . Furthermore, this policy pounds we re adopted . However, EPA believes that it is reasonable to statement does not address the amount substantial production is only one of the interp re t section 4(a)(1)(B)(i)(I) to mean of testing to be required for chemicals findings that EPA must make in order to that any re lease dussng the manufacture, meeting the " B" C~,tdings criteria, so it p ro pose chemical testing under section distribution in commerce, processing . is not possible to determine whether a 4 of TSCA
. Therefore, there is no reason use or disposal of a chemical . substance
.

### p . 7

Federal Register I -VoL . 58 : No. 92 1 Friday : Mey 14 . 1993 i Notices 2874 1 is, per se, "entry" of that substance into Inventory, theAgancyis limited to a account for 99 percent of the to W the environment . irrespective of the consideration of those e 5ects which reported release on the MU by volumesubstance's subsequent persistence or would occur "at coacr$tration levels Clearly, the sma ll percentage of TRI - concentration in the envtronmenL• . that are reasonably likely to 'exist .' chemicals that exceed the selsded

- ' :. TSCA .explicitly uses differezit terms, - beyond facility site boundaries as a poundage threshold accounts for thir "enters" in clause (I), and "exposure" in result of continuous, or frequently vast majority of total TRl releases : It is clause (II) . There is nothing in the
. . recurring releases ." This limitati on reasonable for EPA to use that .', statute or legislative histo ry that clearly app li es only in t his instance, and .doea information as a basis for fob, siag its . indicates that clause (1) necessarily not apply to or modify any other clause a tt ention on ch emicals released in

- . embraces or incorporates an "exposure" of EPCRA section 313 . Therefore . CMA's excess of that threshold . . . . ' component, or a durational or attempt to limit the scope of the term ' In addition, as stated in the . 

### p~ persistence requirement . Moreover, in "release" under EPCRA, and to relate . policy statement (56 FR 32296 r4he the cumene decision . the Court this ) imitation to releases considered p ercentage threshold has been proposed explicitly rejected C3v1A's argument that under TSCA, isbsse3ess because EPA is also concerned aliout EPA must incorporate a"petsistence•• - Moreover . naither'•release'•'nor chemical releases that are dsizable = cam on' in making a section - • enters, the environ .ment" ia defined in percentage of the production volume . at 4(a)(1)(B)(i)(I) finding
. See 899 F .2d at TSCA . As explained above, EPA • . that chemical EPA believes tbat whmn , 355-356, and n . 15-16 . For these ' believes that it is reasonable to interpret such a .sizable percentage of a reasons, E P A-believes that its ' clause ( I) of section 4(al(1KB)(i) of the . chemical's production volume is interp retation of the phrase "enters the Act to encompass any release of the . . . released, that release should be . envi ro nment" as encompassing any - substance ti) me enviranment . For, considered'•'subsiantial" for that ;'release" to the environment is a purposes of this policy and consistent chemical subssanca This lhreahold wi7 1 

### reasonable reading of section . with the definition of "environcnent" in allow EPA the flexibility to require . 4(a)(1)(B)(i}( 17 . • . TSCA . "enters the environment" under testing of cb amic aia with productio n C .ti1A also commented that section-4(a) ( 1)(B)(i) includes any - volumes equalt~ or greater than 1 . . EPA should'clarify that, as in section 3 1 3 releases to "water, air, and land" that million pounds per year .butwith . of EPCRA , the only releases on which a 

### ' .B', result from or may reasonably be . - releases of Is" 

### than 1-mil,lion pounds , fi nding will be based are releases to air" anticipated to result from the per year . water beyond site boundaries . Releases or manufacture, processing, dist ributi on in E. Substantial and S' c+ort! H~rmait transfe rs to treatment and waste disposal commerce, use or disposal of a ChemiCB l facilities 

### raise entirely different exposure Exposure considerations and should not be taken into substance or mixture, 

# regardles s of the account in making " W

" fi ndings ( Aet .1) . source or nature of the release
. . EPA proposed that "subsf8htial Furthermore, TSCA's scope is not exposure" means exposur e to large EPA disagrees with CMA's limited to considera tian of only releases numbers of people (56 FR 32297j, an d characterization of the scope of the term from a site or transfers to treatment and set out the following numerical . " waste disposal facilities
. Rather, TSCA thresholds for a fi nding of "substantia l release" in EPCRA, and as the Agency is intended to broad] address the exposure" : LOGO workers . 10,00 0 is using that tern in its interpretation of general uncertainty ~ ~ effects of consumers . and/or 100,000 parwns " in TSt :A section 4(a)(il(B)(i}(n . Contrary to the manufacture, processing . . the general population . E PA proposed C. .''rSA•s assar ti on, FPCRA does not limit distribu ti on in commeree , use or . that "significant exposure- refers to the the term "release" only to releases to disposal of a chemical substance or nature of the exposure . A tinding'of' '

- "air or water beyond site bounda ri es ." "si Ecani exposure" would g ° 

### Rather, "release-Js broadly 

### defined in mixture
. 

### 8m 1° ~ S P 42 U .S .C . • I commented that EPA's p roposed be made where the numerical thres$oL3 EPCRA secti on 329(8) .

, as 1 million pound release thxeshaid . and for numbers of persons ' exposed fo r 11049(B) s F illiag, looking, pumping . pouring, the proposed alternative 10 percent of "substan ti al exposure" is not iaet .but : emitting, emptytng, dis chargiQg, tnjectfng-, production volume threshold, were the nature of the exposure is sufficiently escaping, leaching, dutnpir ,& or disposing ar bi trary and that "EPA does not direct, large or prolonged . However : • : into the environment •'• provide any suppo rt for the selection of EPA may make a F :nfi~ng that thete he

r 10 percent of the p rodur3i~n volume may be both significant h u man ex---tae . Siiuilarly, EPCRA section . 329(2), 42 o th er than it wouid seem to be a sizable and substantial hus~aa exposure, If the U .S .C . 11049(2), defines the term number . Absent any frame of reference number of people qxpased exceeds the "envi ro nment" broadty to include such as exposure . or presence in the •- thresholds set forth W
. this policy and
. .- . water, air, and land and the envi .ronment, such a number is no loss the nature of the expos n is als o interrelationship which exists among and valid than 1 percent or 60 per ce nE" (Raf

. significant as set forth in this policy .-As between water, air, and land and all li ving 2) . an alternative to these thresholds .-EPA, -- things . EPA disagrees with SPrs cnmmenL In solicited comments on the adoption .of . choosing the 1 million pound threshold either theTS'CA section 5(e) New . An identical defini ti on of value to represent "substantial" release, Chemical Prog ram's exposu e- ba .sed "environment" appears in TSCA section EPA was guided by the same crite ria for "substantial" and • 3(51, S U .S .C . 2602(5 ) .The limiting considerations t h at were used to "signi ficant" human exposure or some phrase "beyond facility site boundaries" determine the threshold value for other criteria for which there is a strong appears only in EPCRA section "substantial" produc ti on . In choosing basis or supporting rationale (56 FR 313(d)(2)(A), 42 U .S .C . 11023(d)(2)(A) . the poundage threshold . EPA used the 3229 9 -32300) . Under this provision of EP( R A, when Toxics Release Inventory t•IRI) in OSHA and M OSH submitted considering the reasonably anticipated judging the " substan ti al" nature of that comments supportive of EPA's "signi fi cant adverse acutc human health amount of release . EPA has determined statement of policy for determining effects" of a chemical in the context of that 37 percent of the chemicals listed " substantial" and "signitirant" human an Agency decision to list or delist a on the TRI have releases of over i
. exposure . In fact . MOSH "urgea EPA to chemical on the Tnxica Release mil li on pounds and that these releases seriously consider its alt .emativs--r 

### p . 8 28742 Federal Register / Vol . 58, No . 92 / Friday, May 14, 1993 / Notice s p ro posal ••• that would result in testing determina tion of substan ti al human TSCA's statuto ry framework and compounds for which fewer than 1,000 exposure, they did not speci fi cally argue purposes . As explained above in Unit I ., workers are exposed" ( Ref. 9) . OSHA that these thresholds we re TSCA was enacted to ensure that, given agreed with EPA that ; for TSCA un re asonable, nor did they provide any the exposu re of humans and the purposes, the proposed definitions for speci fi c alterna ti ve crite ria or rati onale . environment to a large number of "substan ti al" human exposure and The diffe rent nume ri c thresholds for chemical substances and mixtures with "significant" human exposure set worker, consumer, and general potentially harmful effects, the re would reasonable criteria for determinin g if popula ti on exposure are EPA's attempt be effective regulation of commerce in testing is required when toxicity data to re flect the inherent diffe re nces in the such substances . TSCA section 2(a), 15 are absent or incomplete . Accordingly, p ro bable exposure scenarios for U .S .C . 2601(a) . Since the potential "OSHA be li eves that exposure of 1,000 pa rticular catego ri es of individuals . As effects of many chemical substances in workers to a chemical of unknown stated in the proposed policy statement, commerce are not known, the po licy toxi city repre sents adequate impetus to " workers generally are exposed on a provisions of TSCA reflect Congress ' require tes ti ng" (Ref. 8) . In addition, more ro utine or direct basis than intent that : ~ OSHA stated that the proposed consumers, and consumers are generally adequate data should be developed with distincti on between "substan ti al" exposed on a more direct basis than the respect to the effect of chemical substances human exposure and "signi fi cant" general pub lic" ( 56 FR 32297, July 15, and mixtures on health and the environment human exposure is app ro p ri ate ( Ref . 8) . 1991) . EPA has decided to apply a and that the devalopment of such data 1 . Substantial human exposure . CMA, diffe renti al equal to one order of should be the responsibili ty of those who SPI, Monsanto, ETAD, HSIA, GAF, magnitude between the worker, manufac ture and those who process such BASF, and ACC submitted comments consumer, and general po pulati on (substances)
. that ques ti oned the de fi niti ons and thresholds . EPA believes this ap p roach T SCA section 2(b)(1), 15 U .S .C . rati onale underlying the proposed is reasonable and sufficiently re flects 2601(b)(1) . Section 4 of TSCA provides criteri a . A common comment was that the inherent differences in the p robable EPA the authorit to uire suc h 

### EPA had not p rovided suf fi cient exposure scenarios for each of the y Peq testing .' rationale to jus tify the pro p osed catego ri es of individuals . Both OSHA , numeri cal thresholds for determining ( Ref. 8) and NIOSH (Ref. 9) suppo rte d 

### "substan ti al" human exposure . the basis for the dis ti nction between In effect, by urging EPA to make EPA disagrees with the commenters' substan ti al exposure to workers, " assum p ti ons about the exposure level s suggestion that EPA did not provide consumers, and the general popula tion . that would be of regulato ry conce rn if sufficient rati onale for the nume ri c EPA recognizes that this a p proach, testin g demonstrates adverse effects," thresholds chosen to guide which is consistent with the Fifth CMA argues that EPA must make an "substan tial" human exposure findings . Circuit's cumene decision, integrates to a ffirmative finding that a chemica l As ar ti culated in the proposed policy some extent the concepts of substance would pose an unreasonable statement ( 56 FR 32297), EPA chose "substan ti al" and "signific a nt" in ri sk of injury at some hypothe tical numeri c thresholds to characte rize determining what constitutes levels of toxicity and exposure in order "substaatial" human exposure because "substantial" human exposure . 899 F .2d to require tes ting under sectio n it is EPA's be li ef that TSCA section at 358, n . 17 (cumene decision) ; and 56 4(a)(1)(B) of TSCA . This contention was 4(a)(1)(B) was intended to address FR 32297-32298 (July 15 . 1991) . explicitly re j ected by the Court in the situa ti ons where large numbers of Although commenters generally cumene decision, 899 F .2d at 354-355 . people may be e xp osed to a chemical criticized EPA's ra ti onale for choosing Further, in contrast to the TSCA substance and little or no hazard data the nume ri c thresholds arti culated in section 4(a)(1)(A) risk-based criterion exists to indicate whether or not that the p ro posed policy statement, none of and the TSCA section 6 risk/benefit chemical substance may present an the comments offered any speci fi c analysis, a finding under TSCA section unreasonable ri sk . EPA has based its alte rna ti ve thresholds for making a 4(a)(1)(B) requires no risk analysis . See thresholds for workers on expe ri ence section 4(a)(1)(B)(i)(II) finding
. Many 899 F .2d at 354 ( cumene decision) ; and gained through case-by-case analysis of comments exp ressed the view that EPA 859 F .2d at 979, and 984-988 (ERA exis ting substances . Furthermore, must consider certain chemical speci fic decision) . Additionally, as both according to the National Occupa ti onal factors to make a "substanti al" human exposure and hazard are factors used to Exposure Survey (NOES) data (Ref . 18), exposure finding
. determine whether a chemical may pose an averag e of 650 workers are ~M~ A and other commenters objected a risk, without the necessa ry hazard potentially exposed to a chemical to EPA's threshold approach for informa ti on, making "prudent but substance produced in a quan tity of 1 determining "substan ti al" exposure realis ti c assumpti ons about the million po unds . In other words, for a because it is based solely on numbers of exposure levels that would be of chemical produced in a quanti ty of i people exposed and does not take into regulato ry concern if tes tin g million pounds, it is re lati vely account the p hysical and biological demonstrates adverse effects" would be uncommon that as many as 1,000 p ro perties of a chemical, the manner of a meaningless exercise . The utility of workers would be exposed . Given this its use and re lease, the level, f re quency, the frequency, dura tion, and levels of analysis and its experi ence of case-by- and dura ti on of exposure, nor any exposure is limited when EPA is acting case analysis of existing chemical available re levant exposure data . CMA in the absence of information about the exposure over the years, EPA believes argues that EPA should "make prudent hazard of the chemical substance in that it has reasonably interp re ted but realis tic assump ti ons about the . question . Given the statuto ry framework "substan tial human exposure" under exposure levels that would be of of TSCA, its legislati ve histo ry , and the TSCA section 4(a)(1)(B~(i)(II) by regulato ry concern if testing
. case law interp reting the section 4 u ti lizing a re la ti vely conserva ti ve demonstrates adverse effects" ( Ref . 1) . tes ting provisions, EPA does not believe threshold of exposure of 1,000 workers EPA believes that CMA's comments that it is required to unde rt ake the type to a chemical substance . Moreover, reflect an inaccurate understanding of of detailed exposure analysis urged although many respondents do not fa ror the ro le of chemical tes ti ng conducted upon it by CMA and other respondents EPA's rationale for making a under the autho rity of sec tion 4 within in making the TSCA section

### p . 9
--, Federal Register / Vol . 58, No . 92 / Friday, May 14, 1993 / Notices 28743

4(a)(1)(B)(i)(II) " substanti al" human Household Solvent Products : A National CMA at this time, the poten ti al sources exposure fi nding . Usage Survey, EPA/OTS 560/5-87 -0 05 ; of informati on identified by CMA Although EPA is not required to and the System for Tracking the present a number of problems for such consider the factors enumerated above Inventory of Chemicals ( STIC) Database, an analysis due to the li mited scope of in making a finding of "substan ti al" U .S . Consumer Product Safe ty their coverage . These li mita ti ons differ human exposure . EPA did, as a matter Commission (CPSC)1988 . CMA also from database to database, and include of policy, offer for considera ti on in the stated that about 400 substances have the number of chemicals covered , p ro posed policy statement an been screened under TSCA section 4 li mited overlap between the databases, alte rn ative set of human exposure and that EPA's RMt (Risk Management- the speci fi c data included in each criteri a, based on the TSCA section 5(e) 1) process has resulted in a systema tic database or information source , New Chemicals Program human review of available exposure imprecise data concerning current exposure guidelines, which informa ti on for a growing number of production of a given substance, gaps in incorporated some of these factors ( 56 existing chemicals (Ref. 1) . exposure, use and release informa ti on, FR 32299-32300, July 15, 1991) . As explained above, EPA disagrees and differences in the qua li ty of data However, despite an explicit invita ti on with commenters' fundamental premise and the basis for each estimate d for comments addressing the me ri t and that the Agency is required to undertake parameter . For example, the NOES feasibility of applying the" guidelines an analysis of typical exposures of all database developed by NIOSH contains in the context of section 4 test rules, chemical substanc es currently in information on more than 4,00 0 none of the comments addressed the commercial production in order to chemicals . This database contains specific nume ri cal values and other support Its interpretati on of the term useful information on the approximate factors outlined in .EPA's proposed "substan ti al" under section number of workers potentially exposed, alternative thresholds . Comments on the 4(a)(1)(B)(i)(II) of TSCA, or that such an the number of female worker s alternative thresholds expressed onl y approach was mandated by Congress . potenti ally exposed, the approximate the general view that the section 5(e) Neither the plain language of TSCA nor number of facilities in the indust ry crite ri a should not be applied to review the legisla ti ve histo ry require EPA to handlin g the chemical, and the industryof exis ti ng chemicals under section undertake the kind of exhaustive Standard Industrial Code ( SIC) where 4(a)(1)(B) . ( Refs . 1 and 2) . Fu rt hermore, analysis urged upon it by CMA and the chemical is found . However, by EPA so licited comments on adopting other respondents to sup po rt findings itself, the database is insufficient to "some other crite ri a than the criteria under TSCA section 4(a)(1)(B)( 1 ) . In fu lly characterize the potential worker proposed herein by EPA" and "the short, the cost of generating the exposures because the database does not supporti ng ra ti onale" for such criteri a, exposure information necessary for this contain informa ti on of the frequency . yet received no comments offering any type of analysis may well exceed the duration, or the levels of workers' alternative thresholds or other speci fi c cost of testing, and is not appropriate for exposures . Due to these limitations, EPA sugg estions or ra ti onales . a decision to require testing under does not believe that it is possible t o Despite EPA's attempt to elicit more section 4 of TSCA . develop an analysis of the vari ati ons in specific comments, most commenters EPA notes, however, that it does not human exposure potential for the entire addressed only the general concept of i gnore all of these factors in making universe of chemicals . However, in the the pro posed thresholds . For example, decisions to require testing under context of a substance-specifi c CMA argued that "Congress clearly section 4 of TSCA . For each substance- ~lemaking, EPA wi ll carefully consider expected EPA to demonstrate a pa tt ern speci fi c rulemaking under section 4, the human exposure scenario . Onc e of unusually large or widespread EPA must determine whether there is again, EPA invites interested parties to ex p osure wh ►ch differenti ates the test sufficient "data and experience" upon ~bmit for EPA's consideration all substance from typ ical chemicals in which to "reasonably determine o r commercial use" ( Ref. 1) . Based on this predict" the health and enviro nmental available and relevant information

during the notice and comment period argument, (MA suggested that EPA effects of a chemical substance, and for each substance-specific rulemaking develop an analysis of varia ti ons in whether testing of such substance i s 

### human exposure potential within the .necessary develop such data ." In under TSCA section 4 . y 2 . Significant human exposure . CMA, universe of commercially produced making these determinations, the suppo rted by SPI, agreed with EPA that chemicals . Such an analysis would Agency has always, and wi ll continue to *-exposure ~~,t ;onaidere d p ro vide a basis for "low", "medium", examine all available and relevant 'signi fi cant' where the po tential exposed and "high" exposure rbemicals .'For informa ti on concerning the substance in popula tion is not large but the , example, CMA stated that EPA had question, including the physical and conditions of exposure are unique and made no effo rt to determine whether biological prope rties of the substance, create unusually great concern about the there are many or few chemicals to the manner of its use and release, the substance's potential for advers e 

### which at least 1,000 workers are level, frequency, and dura ti on of effecta" (Refs .1 and 2) . OSHA also exposed . Without such an analysis, exposure, and any available relevant agre,ed and stated , CMA argued, one cannot conclude that exposure and toxicity data . It is the ( ilf a worker is expo s ed directly (i .e ., by exposure to 1,000 workers is large or responsibility of interested parties to inhalation) or on a routine or episodic basis, small for typical chemicals in provide any informa ti on they be li eve It is reasonable to determine that a significant commercial produc ti on . may be relevant to the Agency's human exposure exists, even if fewer tha n CMA suggested that data exist which determina ti on to require testing of a 100 0 workers are exposed (Ref. 8) . could be used to make order-of- par ticular chemical substance under magnitude distinctions regarding the TSCA section 4 . Consequently . EPA However, CMA, HSIA and others number of workers and consumers always welcomes the submission of commented that EPA's proposed po li cy exposed to different chemicals . Data such informa ti on during the no ti ce and does not "meaningfully iden ti fy where sources suggested by CMA Include the comment period provided p rior to the such 'significant' exposures might exist" NOES ; informa ti on collected under the promulga ti on of any final teat rule . (Ref. 1) . TSCA secti on 8(a) Preliminary Furthermore, even if EPA were to EPA does not believe that it has, at Assessment Information Rule (PAIR) ; condu a the analysis urged upon it by this ti me, sufficient expe ri ence to

### P . 10

2 11 744 Federal 'Reg ister / Vol : 58, No . 92 / Friday ; May 14, ~ 1993 .1' Notice s

~ generically define criteria .that it will' . , . exposure scenarios iuggested by C UA . , . F . Oteetlssaes: empioy in making a finding of ' would have miuudi utiL'ty : Howevar . EP A Ca tegories . EPA prop osed "tit "signi fi cant" human exposure under

- will examine, among otTler 6i*ctors, the would apply the generic namericcel, TSCA section ~t(a)(1)B)(i)(II) . Should-, criteria suggested by CMA and others in thresholds for most substauces ' - EPA make such a finding in a substance- the context of substance-specific considered for a ct ion-under TSCA specific rulemaking, it will fully explain rulemakings under TSCA section 4 . section 4(a)(1 )(B) . In 'some cum ; the bases for that findin at that time . including the manner of use, the however, whom the thresholds are not- QvIA also stated that V A has not chemical specific physical .pro p~~ met, EPA proposed that it may consi3ei : adequately defined or explained the and wheiher for the affected vopulation " additional factors" on a case-by

- cese . term "direct exposure" and how it the e xposure would involve al rge . I basis for making findings
. An example : relates to "significant" exposure (Ref. 1) . concentra ti ons or is frequent or , of such a cese mentioned by EPA In the A'•direct" exposure may be prolonged . Also, in response to an - 

### characterized as :havinB a clearl y p po proposed polic~ Mi'sa chemical _'• . . _ earlier suggesti on from commenters, : categories, - identifiable or likely source of the EPA did ropose , as an alternative to .(~A ~ chemical . an exp~ure pathway from the p , p ported by 5pf.believes~iitat the proposed sedion 4(a)(1)(B) Criteria categori es should be aartaiviv de fined . . source to the receptor that can be fo r "significant" exposure, 'adoptiag th e 

### expected, with reasonable certain ty , to qua litative and 'quantitative In © MA'a dgemen , the only a ~ result in the potential for exposure, and •substan ti al" and "aigCtificant" would ' be sui W for a'8' finding- vru~al ba an exposure route that wi ll or n - exposure guidelines used to Zsv(ew new one w" members members poissued similar reasonably be expected to resul tra in chemical substances under 'section 5(e) chemical s bUC2112 e 6aad ware than[wsltbty

at . intake/uptake by the receptor . For th .ese , of TSCA ( 56 FR 32299) : Then TSC .A to have closelyrslatad healt h reasons, it is reasonable to conclude that section 5(e) criteria do Include some environmental offe cts (XeEll . . ' in instances where exposure is "direct" co nsideration of frequenry, duration . . EPA may consider the exposure to be_ and magnitude of exposure for worl~ers ~A °ts° Comments that
. "significaat" under TSCA section and consideration of magnitude of ~ representatives 6 om.4 categary .oou l d be 4(a)(1)(B)(i)(ll) . • exposure for the general po pulation . selected fortestiug . obviating : the used GAF . BASF, and ACC stated that EPA The section 5(e) criteria for consumer to test each and eve ry member of the' has failed to establish a clear distinctio n between "substantial" and "signi fi cant" exposure are qualitative only .-These ~~ does not with the criteria were developed based o n exposure as p resented in Table 1 of the commenters that categories must . by proposed policy (Ref. 6) . experienc e . associated a with thousand s theousandas qf ~ new

m necesaity

, be limited to chemicals wit h As previously acknowledged, there ia chemicals with limited, but known, uses similar structures or toxicological . some overlap between the criteria used properties
. However . EPA does agree to construe "substan ti al" and and exposure settings . However . a s 

### explained above, none of the that ~emicals with afmilar s tuea or "significant" human exposure . e ~ - toxicological properties could
. In certain However, it is EPA's belief that such an commenters wer e in favor of EPA bystances, be grouped together an d overlap is not inconsistent with the adopting the TSCA section 5(e) human referred to collectively as a catego ry . statutory purpose and legislative histo ry exposure crite ri a . Additionally, after consideration of all of TSCA
. As stated in the cumene la summary, for the purpose of relevant chemical speci fic•paramelers . decision . 899 F .2d at 356, n . 17, . .t is determining whether there is or may be EPA may propose category ~~ on i not necessarily clear that "signi fi cant" "substantial" exposure under TSCA a case-by -case basis, and will solicit and "substanti al" as used in clause (II) section 4(a)(1)(B (i)(II), EPA will utilis e comments on this decision in the • 

### must be understood in a way that the nume ri cal thresholds of 1,000 specific proposed test rule . This is the prevents any

overlap ." workers, 10,000 consumers, and/or approach taken in the proposed test rul e CMA recommendped that "EPA should 100,000 persons in the general for1 cadols (56 FR 57144 , judge the "signi fi cance" of exposure by population . A finding of" significant" 11,1991) . . - -' . examining whether, for the affiected exposure will generally be made on a 2 . Additional or mitigating jadors . - populaiion, it involves large

- case-by-case basis . taking into (M A
. Monsanto and others stated that concentrations or is usually frequent or -- consideration
. among other factors, the EPA should . in implementing its policy prolonged" (Ref

. 1) . HSIA suggested that manner of use, substance specific ' under section 4(a)(1)(B) of TSCA , EPA consider "the mode of manufacture physical properties, concentration preserve the flexibility to conside r of the chemicals, the manner of use, and levels, and the duration and 6equency additional and mitigating factors on a physical properties which may make of the exposure to the subatance . [i la case-by -c ase basis
. Monsanto supports even quite direct exposure to the ~~ impo rt ant to note that TSCA section 4 the "substantial" and "significant" threshold levels of litt le or no concern is an information gathering tool only e xp osure criteria as benchmar ks but (Ref. 6) . To accomplish this evaluation, and that it places no limits on a believe that other factors, on a caw 04A recommended that " EPA should chemical substance's manufacture, ' speci fic basis, may need evaluation . For develop representative exposure processing, distri bution in commerce or example . CMA stated that where there scenarios for workers, consumers and use . Given the limited purpose of TSCA are no other indicators of substantial the general popula ti on . These scenarios section 4(a), to require testing, and ' exposure other than that a chemical should then be used to identify because the finding that there is or may a p pears in human adi p ea~e tissue, EPA workplace operations, consumer be "substantial" or "significant" human should consider that t?ie tisaue ma y be products or environmental releases with exposure is only one of several findings reflective of background levels in the uncommonly large exposure potential" EPA must make to req,uire testing, EPA environment, a metabo lic product of (Ref . 1) . believes that the cri teria set forth herein another compound, or release from nonBecause the determination of what is are a reasonable interpretation of the Lidustrial sources (W . 1) . In such a " significant" human exposure can be p hrase "significant or substantial situation, CMA suggests that testing very chemical and use specific, EPA human exposure" in TSCA section under section 4(a)(1)(B) of TSCA would does not believe that the representative' 4(a)(1)(B ) (i)(Q), - not be justified
.P . 11 ----~r Federal Register / Vol
. 58, No . 92 / Friday, May 14, 1993 / Notices 287 45

EPA agrees with the respondents that EPA would not be disclosing specific 2 . Polymer exclusion . Monsant o in implementing this po li cy, EPA information regarding any particular commented that polymer exemp ti ons should preserve the flexibility to manufacturer's production . Should such should be recognized by EPA under this consider ce rtain variables on a case-by- a statement affect a single manufacturer, po licy, because "(p)olymers represent a case basis . Furihermore, in as might be the case with specialty special class of chemic al substances that implemen ti ng section 4(a)(1)(B) of chemicals, EPA does not be li eve that a needs separate considera ti on under the TSCA . EPA intends to use the crite ri a statement that production volume is at p ro posed 'B' policy" ( Ref. 3) . Monsanto art iculated in this po licy statement as least I mil lion pounds would disclose noted that a number of polymer ' guidelines to retain the fle xibility to sufficient informa ti on to be considered substances are biologically benign and, consider all relevant variables in making a disclosure of informa tion which might therefore, do not represent substan ti al findings under sec ti on 4(a)(1)(B) of be en ti tled to confiden ti al treatment . health or environmental concern . In TSCA . As stated in the proposed Furthermore, TSCA section 14(a)(4) support of this posi tion, Monsanto statement of policy, EPA intends to autho ri zes the disclosure of informa tion noted that exemp ti on procedures are uti lize the generic thresholds for most which otherwise might be en ti tled to p ro vided for in the review of new chemical substances considered for con fi denti al treatment when relevant in chemical substanc e s under TSCA action under TSCA section 4(a)(1)(B) . In any proceeding under TSCA, including section 5 . Likewise, the OECD HPV some cases, however, where the rulemaking, provided that disclosure is program did not include polymers on thresholds are not met, EPA may made in such a manner as to preserve the Representa tive List. Monsanto consider "addi ti onal factors" on a case- confiden ti ality to the extent practicable believes a similar type of polymer by-case basis to make findings . without impai ri ng the proceeding
. See exemp ti on should be offered under th e EPA's authority to use this flexible 40 CFR 2 .306 ( 1991) . EPA believes that secti on 4(a)(1)(B) policy . approach was recognized by the Court by disclosing only that a substance is or Ag ain . Monsanto's concerns relate in its decision regarding the cumene test will be produced in volumes of 1 more to a discussion regarding TSCA rule . The Court stated that EPA's million pounds per year or greater, section 4(a)(1xB)(ii) and (iii) than TSCA definition need notbe precise - it need confiden tiali ty would be preserved to secti on 4 1 (a)(1)(E)(i) . EPA be li eves that in not "function like a mathema ti cal the extent prac ti cable while still making the absence of any submitted data, it is formula ." 899 F .2d at 359 . On the other findings under section 4(a)(1)(B) . difficult to address the manufac ft rers' hand, there may be some instances However, EPA will make this decision concern , Polymers do not have a wellwhen a chemical substance meets the on a case-by-case basis, in accordance defined composi ti on, and there may be criteria articulated under TSCA section with 40 CFR 2 .306, if such situations a need to test some lower molecular 4(a)(1)(B)(i), .but where testing under arise
. weight polymers or oligomers which TSCA section 4(a)(1)(B) will not be G
. Beyond Sco pe may have poten tial for health or required because EPA finds under environmental effects . Therefore, it subsection ( fi) or subsection (iii) of Respondents raised several issues would be premature for EPA to suggest section 4(a)(1)(B), respectively, that data which are beyond the scope of this that a blanket exemptian from testing are sufficient to reasonably determine or policy statement . The issues relate to for polymers may be appro p riate . To predict the effects of the manufacture, the use of structure activity date, EPA has not proposed or required process, distribu ti on, use, or disposal of relati onships ( SAR), exclusion of testing of a polyme ri c compound under the chemical or that testing is not polymers, tiered testing schemes, and TSCA . necessary . Monsanto, GAF, BASF, and tes ting prioriti es under TSCA section 3 . Tiered testing . Monsanto ACC strongly support the use of 4(a)(1)(B) . 

### commented that EPA should adopt a "mitigating factors" to justify not 1 . Structure activity relationships
. requiring testing for those chemicals Monsanto believes that "(tJhe'B' policy ti ered testing approach to evaluatin g that meet the section 4(a)(1)(B)(i) crite ria should recognize and authorize the use chemical substances • for which the available data are of structure activity relationships ( SAR) EPA believes that determina ti on of sufficient to reasonably determine or when evaluating the testing needs and whether ti ered testing is app rop riate predict the effects of the manufacture, priorities for substan tial production generally must be made on a case-byprocess, distribu ti on, use or disposal of chemicals" ( Ref. 3) . Monsanto case basis . EPA recognizes that the chemical and/or that testing is not commented that a large number of their incorpora ting a tiered tes ting scheme in high production volume chemicals are a test rule can generate pre liminary data n~fidential business information . p roduc e d as intermediates and then rela tively quickly with minor expense . Callery Chemical Company is concerned later conve rt ed to neutral salts to However, for a rela ti vely we ll that an EPA findin g under TSCA section faci li tate handling and shippin g, in characte ri zed chemical substance, it is 4(a)(1)(B)(i) that a chemical may be most of these cases, the salt and likel y that a ti ered testing approach p ro duced in substantial quantiti es may intermediate itself have essentially the would not be appropriate
. In other result in disclosure of confiden ti al same toxicological prio riti es . Therefore, instances, if the scientific literature business information (® I) and "could by testing and evalua ting one substance, contains informa tion which strongly provide valuable marketing informa tion the other chemical can be evaluated suggests that the chemical is used in a to competi tors and potential- using SAR . way that would result in widespread compe titors without jus ti fication" (Ref. Monsanto's comment is not relevant worker or consumer exposure ( e .g ., a 5), to a discussion of TSCA sectio n solvent use), then it is less likely that a EPA does not believe that disclosing 4(a)(1)(B)(i) . Rather, whether SAR will prelimina ry experiment would retur n to the public the fact that at least I be a factor in determining the "testing the kind of data to suppo rt the de fi nitive million pounds of a chemical substance needs and p ri o riti es for substantial answer needed for such widesprea d or mixture is produced per year would p ro duction chemicals," is a ma tter exposure . Thus, automati c be a disclosure of CBI . In making such relevant to TSCA section 4(a)(1)(B)(ii) incorpora ti on of a ti ered tes ti ng scheme a finding, EPA would be relying on the and ( iii) findings . Therefore, Monsanto's may result in the performance of aggregate production volume for all conce rns would be addressed in rela ti on screening studies which are unlikely tomanufacturers of the substance . Thus, to a chemical specifi : test rule . provide the needed informa tion .

### p . 12

28746 Federal Rij~A" 1 VoL 58, No . 92 J Friday, May • 14, 1993 / Notice s 4 . Testing priorities

: QtiiA commented under TSCA section 4, .yet accounts for policy (56 FR 32294) and in unit II .D . that ; In addition tq adopting the 2 2 95% of total chemical production by of this notice . EP A beli eves that this U-- million pound threshold for substantial volume . For the reasons ar ti culated in a reasonable interpretation' of the pl~ialma production
. EPA should adopt a tiered,
. the proposed statement of policy (58 FR "enters the environment in substanti sequential process for identifying data 32294) and Unit IM of this notice, EPA quan titi es", in TSCA sectio n needs on all high production volume believes a threshold value of i mi ll ion 4(a)( 1 )(B)(i)(I) . • (HPV) chemicals
. In CMA's opinion, ° • pounds is a reasonable interpretation of C . Substantial and Signi f1 cant .l :duman EPA should group HPV chemicals into the phrase "produced in substantial . . . categori es and establish priorities for the ' quantities" in TSCA section E~ pa s ' r e review of each chemical . '- - 4(a)(1)(B)(i) . ., EPA Is establishing the criteria in Once overall testing priori ties have been ' Table 1 of this Unit for "substantial" set, individual high volume chemicals B . Substantial Release and "significant" exposure : As • should be reviewed to determine w bether: EPA is establishing a threshold value a rt iculated in the proposed policy they warrant an initial set of screening tests - of 1 mill3on pounda of releaae to the • statement, EPA chose numeric : . - . comparable to those in the 08( :n Sraeeaiag eri vironment from all sources per yeer thresholds to characterize "substantlat" Information Data Set (SIDS) bactery or release equal to at greater than 10 human exposure because it is EPA's ' EPA clearly articulated in the percent of production volume per year . ' belief that TSCA section .4(a)(1)(B) Was :

Y whichever is lower, as the threshold for intended to address situations whom pro posed statement of po li cy . and in substantial release
. In choosing the 1 . .', large numbers of people mey be expo6sd Unit I . of this final notice that fames mil li on pound threshold value td to a chemical substance and little nr no' related to how EPA establish ea testing re present "substantial" release, EPA . haz ard data exists to indicate Whether or p ri o riti es and how EPA makes fi ndings

. u se d the TRI as a guide in judging the . . . not that chemical substance may present under subsections ( ii) and ( iii) of section ', substantial" nature of that amount of an unreasonable ris k
. EPA based Its= ;~ : . 4(a)(1)(B) of TSCA would not be .• re l ease . EPA has determined that * 37 thresholds for workers on experience = addressed in this statement of policy . If percent of the chemicals listed on the gained through c ase-by-case analysis of at s o me future point in time
. EPA TRI ha ve releases of 1 mil li on pounds existing chemicals . decides that adoption -of a testing or greater and that these releases The different numeric thresholds for program such as that proposed by CMA represent over 99 percent of the total worker . consumers, and genera2 - would be beneficial in the gathering of re ported release on the TRI by volume . population are EPA's attempt to'reflect data on existing chemical substanc m Clearly, the small percentage of TRI the inhe re nt differences in the probable EPA will clearly articulate that policy ch emicals that exceed the poundage exposure scenarios for p~ iaslar .- and the underlying ra ti onale in a notice . threshold accounts for the vast majority categories of individuals . EPA decided IlL Final Policy of total TRi releasas . to apply a differential equal to one order A . Substantial P

ro duction The percentage threshold reflects of magnitude between the worker . EPA's concern about chemical releases consumer, and general population' EPA is establishing a threshold value that are a sizable percentage of the thresholds . For the reasons articulated of I million pounds, aggregate production volume of that chemicaL in the proposed statement of policy (56 production volume of the substance per EPA believes that when such a sizable FR 32294) and Unit fLE . of this no tim year for all manufacturers, as the percentage of a chemical's production EPA believes that these criteria are a substantial produ ction threshold . This volume is released, that release should re asonable interpretation of the phrase threshold currently represents only 1196 be considered "substantial" for that "signi fi cant or substantial huma n 

### of the entire universe of chemical chemical substance . For the reasons exposure" in TSCA section substancas potentially subject to tes ti ng art iculated in the proposed statement of 4(a)(1)(B)(i)( II) .

TABLE 1 .-TSCA Section 4(a)(1)(B)(i) Human Exposu re Criteria Guidelines Category Subcteu ►tlal Significan t t',eneral poputetlon . . . 100, 000 peo- . <,100,000 peopie population exposed more direc ify or on a routine or episodic basis . p le 

### Consumers . . . . . . _ 

### . . . . . . . 10,000 peo- < 10,000 

### people exposed more directly or an a routine or episodic basis.



## t~ Workers
. . . . . . . . . . . . . . . . . . . . 1 .000 woAcare < 1,000 workers exposed more directly or on a routine or episoc9c basis . D . Additional Factors "additional factors" for making fi ndings of the chemical and/or that tes ti ng is not EPA will apply the generi c numeri cal for substances whi ch do not meet the necessa ry . - , thresholds for most substances numerical thresholds a rt iculated herein IV . Final Test Rule for Cumene considered for testing under TSCA for evaluating exis ti ng chemical s unde r section 4(a)(1)(B) . In some eases . TSCA section 4(a)(1)(B) . A . Response to Cumene Pane l however, where the thresholds are not Conversely, EPA may not re quire On July 27,1988 ( 53 FR 28195) EPA met, it may be more app ro priate to use testing under TSCA section 4(a)(1)(B) promulgated a final rule requirin g a case-by -c ase approach for making for a chemical that meets the section manufacturers and p rocessors of findings by applying other 4(a)(1)(B)(i) crite ri a if EPA finds . under cumene to perform health and considera ti ons . F c r the reasons sections 4(a)(1)(B)(ii) and (iii), that data environmental effects testing in erticuioted in the proposed statement of are sufficient to reasonably determine or response to the Interagency Tes ting policy ( 56 FR 32296) and Unit II .F .2 . of predict the effects of the manufacture, Committee's ( R'C) recommendation that this notice . ETA may consider process, distribution, use and disposal cumene be given pri ority testing

### p . 1 3 Federal >gegatSter . / Vol . 58, No . 92 / Friday, May 14 . 1993 / Notices 2874 7 consideration under TSCA section 4 . " disputed . For the reasons Aiscuesed 14 ongoing manufacturing and , Based on the available data, EPA found .' Unit II .G of this notice
. EPA believes activities would b e under TSCA section 4(a)(1)(B)(i) that ' that this level of production clearly distributed over a lalge portion of the cumene is "produced in substantial quali fi es as "substantial piodtuxion' ► - communities near manufacturing end quan ti ties and that it enters the under section 4(a)(i) (B)(i) of TSCA
. The processing facilities depending on the environment in substantial quantities, level of cumene p roduction reported in prevailing atmospheric conditions, with the poten ti al for resulting
. the final rule well exLeeda the . Thus, the Panel has not provided EPA substantial human exposure to cumene "substantial production" threshold with a convincing rationale to refute - from its manufacture, processing, use articulated in this notice
. EPA's finding that cumene "enters the and disposal ." EPA also made the C

. Substantial Release environment in substan ti al quantities" requisite findings under TSCA section

. or that there is not PAx stantial human 4(a)(1)(B)(ii) and (iii) ( 53 FR 282 00 , July. In suppo rt of the final test rule, EPA exposure ." Rather, the Panel has only 27, 1988) . EPA's fi

ndings were - found that cumene is released to the

- ,, demons trated that persistence, one of challenged by the Chemical

. environment in substantial quantities . many chemical-spetsfic parameters EPA Manufacturers Association in GMA v . based on an estimated 3 million pounds considers in evaluating a chemic al . may EPA, 899 F .2d 344 (5th Cir .1990) . The • per year of fugitive emissions of cumene be of limited importance whe n Court remanded the rule requiring EPA to the atmosphere from manufa cturing, considered with other factors, such as to : processing, and use activities . The Court the maaufactiuing and processing articulate the standards or criteria on the upheld the vali dity of EPA's es ti mate . s cenario . basis of which it found the quantities of - ; 899 F .2d at 352-353
. To a lesser extent, D. Substantial Human cumene entering the environment from the EPA also noted in the final rule that 

### Exposure facilities in question to be "substantial" and cu rnene was released in unspeci fi ed The Panel commented that . ovum if the human exposure potentially resulting to quanti ti es to the aquatic environment . th e release of cumene could be equated be "substantial ."

. Because EPA was unable to estimate to "substantial" environmental entry, - with reasonable ce rt

ain ty the magnitude EPA would-not be ;ustified in requiring 899 F .2d at 360 . The Court further ' of this release, EPA did not rely on this human health effects testing unless ft
. instructed EPA to : release in calculating human exposure ; were to make a$nding of "substan ti al articulate whether its"respective (TSCA nonetheless, EPA did believe that there human exposure, " section 4(a)(1)(B)(i)1 clause (1) and clause (11) was a poten ti al for human exposure as . Once again, the Panel is attempting to fi ndings fin the cumene rule) each constitute, a result of release of cumene to aquatic link the type of testing required to the alone, an independent and sufficient basis for bases for the TSCA section 4 its testing requirements, or whether, vn the environments . The Cumene Panel ~~ EPA does not believe this (be other hand, its testing requirements eeit only commented that EPA lacks an adequate g . on the clauses ( I) and (11) findings jotntly~•• . basis for fi nding that cumene "enters a valid interpretation of sec ti on 4(a) of The EPA shall further Indicate whether its the environment in substantial TSCA . Furthermore, EPA believe s, as - findings under either clause (I) or clause (11) quanti ti es ." Speci fi cally, the Panel stated in Unit ILB . of this notice, that are to any extent dependent on its flading, disagreed with EPA's equating clauses ( I) and (II) of1SC ' .A section which we have disappro ved . concerning •'substantial release" with "enters the 4 ( a)(1)(B)(i) can be interpreted a s 

### ent ry 

### into the aquatic environment ; and, if environment in substantial 

### quan ti 

### ties ." in 

### dependent . In particular, although so, shall reconsider its clause (I) and (II) EPA made for cumene under findings in the light of our referenced ruling . The has made no effo rt to analyze both clauses ( I ) and (II) . EPA believes a Id
. 

### at 360, n . 22 . Finally ; the 

### Court the 

### extensive evidence in the record finding under either clause alone . Y% regarding the persistence and dis tr ibution of constitutes an independent and directed EPA to consider new studies to cumene in the envi ronment or to relate sufficient basis for the testing required
. 

### be presented by CMA on remand
. cumene release levels 

### to human exposure 

### In suppo rt 

### of its final rule, EPA 

### "unless they would not be mate ri 

### al to patte rn

### s (Ref. 22 

### 1 . that there may be substantial huma n any of the EPA's cri te ria reli ed on for exposure to cumene based on the the testing ." Id . at 360-361 . On remand As discussed in Unit ILD . of this exposure potential to approximately the Cumene Panel of CMA,submitted notice, EPA rejects the premise that 13 .5 mil lion people living in th e both specific studies and general

. "enter the environment in substantial vicini ty of cumene manufacturing and comments on the cumene fi nal test rule . quantities," as used in sec ti on processing facilities : EPA believes thata The test rule remained in e ff ect, and test 4(a)(1)(B)(i)(I) of TSCA, be de fined to majori ty of the people would be - 

### data was submitted to EPA in response include a determination of "persistence exposed as a result of fugitive emissions to the rule . • in the environment of those substantial
. of cumene to the atmosphere . Th e EPA has addressed some of the quan ti ties ." The Court in the cumene majori ty of cumene manufacturing and Court 's instructions concerning EPA's case, 899 F .2d at 355-356, found that processing facilities are concentrated In statutory authority and the Cumene EPA is not obliged to follow CMA's a few large metropo li tan areag The' Panel's gene ri c comments regarding the construc tion of TSCA section 4 . Cou rt in the cumene case, 899 F .2d at "B" policy (Ref. 12) in Unit lI . of this . The Panel also raised this issue in 353, found that the rulemaking record notice . Specific comments on cumene their comments on the final rule for adequately suppo rt ed EPA's finding . and EPA's review of remand evidence cumene, asserting that
. considering the However, when CMA briefed its Case, it are addressed in this Unit IV . short half-life of cumene in the submitted a monitoring study, no t B . Substantial Production atmosphere, there is no reason to previously submitted as comments an believe that, except for populations ve ry the rule, that relates to the presence of In support of its final test rule, EPA close to the plant, there is any general many chemicals, including eumene, i n found that cumene is produced in popula ti on exposure to cumene . EPA the Houston Ship Channel area (Ref . substantial quantities, based on reported responded that the half-life of cumene 19) . U .S . cumena production of 3 .35 billi on in the atmosphere appears to be on the The Cumene Panel maintains that the pounds with an addi ti onal 339 mil li on order of 1 or 2 days
. At this rate of informa ti on contained in this study is pounds imported . This figure was not removaI, the curnene emissions from sufficient to show that E PA cannot make

### p .14

28748 Federal Register ./ Vol . 58, No . 92 / Friday, May 14,1993 / Notice s either the "enters the environment in Champlin modelled point source air review the studies . Each of the studiessubstantial quantities" or "substantial emissions from barges loading cumene . Is briefly discussed below
. ' human exposure" findings of section Annual emissions of cumene from these Modelling of cumene emissiona tram 4(a)(1)(B)(i) . ' . loading operations were estimated to be two Georgia Gulf Corporation facilities ; The remand evidence presented by the 23,000 pounds . However, there are one in Plaquemine, Louisiana, and the petitioners indicates that such exposure does shortcomings with the methodology other in Pasadena, Texas, wer e 

### not exist because cumene levels are not employed in the study . performed using -adjusted" EPCRA

-

- elevated even at short distances from the For modelling purposes, Champlin section 313 release data for reportin g cumene plants (Ref . 12) . divided the annual point source release year 1987 (Ref . 23) . The rationale to - estimate by the total number of minutes Justify the procedure used to adjust the As instructed by the Court on remand, in a year to derive the source term (mass EPCRA section 313 release dais and to . assumptions EPA has reviewed the study submitted release per minute) . Champlin should . -justify the meteorologica l by CMA . In general, EPA's review (Rsf have divided-the annual point source 'used for modeling air disperdoa wete 20) concluded that the study supports release estimate by the total number of not sufficiently detailed to enable ia '. the conclusions of Its authors . However, minutes per year in which barge loading adequate EPA review of the study
. the study cited by the Cumene Panel occurred to derive a friars realisti c The study describing the modelling of does not show, nor was it designed to source term for modelling potential air cm ene emissions from a Koch Refining show, the monitored environmental concentrations .•Based'on a 1990 joint Company facility (RaL 24) provided concentration from manufacturing and effort between EPA and the American sufficient details on methods and procesding facilities . The study's assumptions to allow for aa adequa~ introduction states : EP A Oi l EPA Company on the refining industry, EPA review . This modelling study ala o (tihe underlying goal of the monitoring estimates that the capacity of an purported using 1987 fiPCRA section" program is to provide member firms with hltercoastai barge or tanker ranges from 313 release data . However, the annual accurate ambient air quality measurements 2 .5 million to 70 million gallons . Based releases used in the study, 1,0 2 and technical data for better understanding on an-assumed I day fill rate and a 10 • ounds, show a l e un laine d 

### air quality concerns in the Houston Ship million gallon barge/tanker capacity . the discrepency with t~he 19,5~00 pounds of (lannel area (Ret :19) . entire capacity of production at th e Champlin facility could be loaded in 7 cumene emissions actually reported There are seven sites where days . If the cumene emissions were under EPCRA section 313 . released over a period of Modelling studies for the Shell Oil monitoring devices are maintained assumed to be ~a~ Company Deer Park . Texas, facility (RaL downwind from the Houston Ship 7 days rather than 365 deys, the source 25) and Texaco's El Dorado facility (Ref

. Channel . One site only monitors term (input) would be raised by a factor 26) were also submitted . However, " meteorology and any accidental of 50 . Additionally, Champlin used supporting data on the methods and releases . This site is the typical to better than average assumptions used in the studies was northeasternmost site and does not meteorological conditions of stability not sufficiently detailed to enable an monitor for any organic compound . The class C and a windspeed of 12 miles per adequate EPA review of the studies

. study states that the prevailing wind hour in the modelling exercise . A more The remand evidence wa s direction is from the southeast (Ref. 21) . conservative, yet still realistic, set of accompanied by an affidavit from Therefore, the monitoring sites are meteorologic conditions would be a Marvin B . Hertz, an industry consultant
. upwind from all but one of the cumene stability class of D and a windspeed of supporting the use of ambient air manufacturing and processing sites and 5 miles per hour . Therefore ; EPA monitoring data rather than the mass are gathering data on cumene emissions believes the resulting ambient emission data from the EPCRA section from refineries and other unknown concentrations of cumene from the 313 Toxic Release Inventory (TW) (ReL sources, Champlin modelling exercise 27)

. ' There is one manufacturing facility underestimate the ambient EPA recognizes that the use o f sited in the monitoring array . However, concentration of cumene resulting from ambient air monitoring data, whe n the facility appears to be at least 5 miles releases at the Champlin facility . performed correctly, plays a role In any from the closest downwind monitoring Furthermore . EPA's review of the exposure assessment, and thus, in risk site . Additionally, it is not clear fiom study indicates that the study does'not assessment . However, it is very difficult this study whether the detected shed any light on the number of people to perform any risk assessment wh® environmental concentrations were potentially exposed to cumene, iather it the hazards of the compoiund are either detected at the closest downwind is only concerned with determining a not known or not well characterized
. monitoring sites . The monitoring array level of cumene in the area of the For this reason, and the reason s is either upwind from all the other Houston Ship Channel . Therefore, the articulated in Unit II .E . of this notice, cumene manufacturing and processing study does not relate to whether EPA EPA does not depend on human sites or is over 30 miles away from these could make a substantial human exposure at a particular "level" in sites . At that distance, the facilities exposure finding . determining "exposure" underTSGA& would have to release extremely large Another section of the remand section 4(a)(1)(B)(i)
. amounts of cumene per minute to reach evidence submitted by CMA consisted Finally, the Cumene Panel stated that detectable levels in the monitoring of modeling studies of ambient air testing submitted pursuant to the final array . Therefore, it is unlikely that the concentrations of cumene that may test rule confirms that cumene does not data accurately assess the level of result from emissions from several present a risk . Moreover, the Panel cumene present in close proximity to cumene manufacturing sites . Although objected to EPA's reference to a TSCA the facility . all studies used the EPA Industrial - section B(e) submission, whic h The Curnene Panel submitted Source Complex Long Term (ISCLT) air Indicated cataract formation in rats additional information on modelling dispersion model, the level of detail exposed to cumene vapors, as an - performed at the Champlin Refining and concerning methods and assumptions example of the benefits of testing a Chemicals facility in Corpus Christi, used varied from study to study, thus chemical in the absence of hazard data
. Texas (Ref

. 22) . In this exercise . inhibiting EPA's ability to adequately Since that section 8(e) submission . thep .15

Federal Register / Vol . 58, No . 92 / Friday, May 14, 1993 / Notices 2874 9 Panel has undertaken a follow-up (4) Ecological and Toxicological letter from Charles L Elkins to Geraldine V

. subchronic study . Association of the Dyestuffs Manufacturing Cox (Chemical Manufacturers Association)

. On June 17, 1992, utilizing data Industry . Comments on EPA's section Office of Toxic Substances, USEP A submitted 4(a)(1)(B) Proposed Statement of Policy (September 22, 198 8

in response to the cumene submitted to the TSCA Public Docket Office, (17) Organization for Economi c test rule, EPA held an RM1 disposition USEPA (September 17, 1991) . Cooperation and Development . "OECD's for cumene to determine whether to take (5) Callery Chemical Company . Comments Work on Investigation of High Production risk management action on the chemical on EPA's section 4(a)(1)(B) Proposed Volume Chemicals ." Document 3, May 1991
. (Refs . 28 and 29) . EPA determined that Statement of Policy submitted to the TSCA (18) U .S . Department of Health and Human sufficient information for hazard Public Docket Office, USEPA (September 18, Services, National Institute for Occupational assessment is available and supports a 1991) . Safety and, Health . National Occupational low concern . When the hazard (6) Halogenated Solvents Industry Exposure tudy (NOES,1988)

. Alliance . Comments on EPA's sectio n information was considered in (19) Radian Corp . A Method for Assessing conjunction with available exposure 4(a)(1)(B) Proposed Statement of Policy Community Exposure to Selected Volatile submitted to the TSCA Public Docket Office, Indicator Co m information, EPA determined that USEPA (September 19, 1991) . Po~~ (July 20, 1988)
. (CMA cumene resents a relatively low risk to exhibits for remand evidence) .

presents (7) GAP Chemicals Corporation . BASF (20) USEPA . Review of Evidence human health, and has discontinued Corporation, and ARCO Chemical Company . Submitted by CMA on Remand of Cumene review of this chemical at this time . Comments on EPA's section 4(a)(1xB) Test Rule . Washington, DC : Office of Therefore, EPA does not believe any Proposed Statement of Policy submitted to Pollution Prevention Toxics, USEPA further testing of cumene is necessary at T SCA Public Information Office . USEPA (April . 1992)
. this time . (September 17,1991) . (21) Radian Corp . Volatile Indicato r (8) U .S . Department of Labor, Occupational Compound Measurement Results from the V . Public Record Safety and Health Administration . Comments Houston Reg Monitoring Network , A . Supporting Documentation Statement of Policy submitted to TSCA Phase IV (July 20, 1988) . (CMA exhibits for Public Docket Office, USEPA (October 7, remand evidence) . EPA has established a record for this 1991) . (22) Champlin Refining Company . Air policy under TSCA section 4, docket (9) U .S . Department of Health and Human Modelling of (limene Releases at Champlin number OPPTS-47002K . which is Services, National Institute for Occupational Refining Company (October 14, 1988) . (CMA available for inspection Monday Safety and Health . Comments on EPA's exhibits for remand evidencs)
. : through Friday, excluding legal section 4(a)(1)(B) Proposed Statement of (23) Georgia Gulf Corporation . LSC and holidays, in Rm . ET-4 ;102, •401 M St ., Policy submitted to TSCA Public Docket =T Air Modelling Results from Georgia SW ., Washington, DC ., 20460 from 8 Office, USEPA (September 17, 1991L Gulf Corporation Facilities (December 16, a .m . to 12 noon and from 1 p .m to 4 (10) CMA's Acetone and Ketones PaneL 1988) (CMA exhibits for remand evidence) . Comments on EPA's section 4(aXIXB) (?4) Koch Refining Company . Air p .m . This record includes basic Proposed Statement of Policy submitted to Modelling Results from Koch Refining information considered by EPA in TSCA Public Information Office, USEPA Company Facility (October 20 . 1988) (CMA developing this policy . This record (September 17, 1991) . exhibits for remand evidence)

. includes the following information : (li) CMA's Oxo Process Panel . Comments (25) Shell Oil Company . Air Modelling (1) Interagency memoranda, on EPA's section 4(a)(1)(B) Proposed . Results from Shell Deer Park Facility comments, and proposals . Statement of Policy submitted to TSCA (Undated) (CMA exhibits for reman d (2) Reports-published and Public Information Office, USEPA evidence) . unpublished data . (September 17, 1991) . (26) Star Research . Air Modelling Results (12) CMA's Cumene Panel . Comments on from Texaco's El Dorado Facility (September (3) Chemical Manufacturers EPA's section 4(a)(1)(B) Proposed Statement 30, 1988) (CMA exhibits for reman d Association v . EPA, 899 F .2d 344 (5th of Policy submitted to TSCA Public evidence) . Cir . 1990) . Information Office, USEPA (September 17, (27) Hertz, Marvin A . Affidavit on Use of 1991) . Monitoring Data versus Mass Emission Data B . References (13) CMA's Cyclobexane Panel . Comments (CMA exhibits for remand evidence)
. (1) The Chemical Manufacturers on EPA's section 4(a)(1)(B) Proposed (28) USEPA . Regulatory Management-1 Association . Comments on EPA's TSCA Statement of Policy submitted to TSCA (RMI) Summary for Cumene . Washington, section 4(a)(1)(B) Proposed Statement of Public Information Office, USEPA DC : Office of Pollution Prevention and Policy submitted to the TSCA Public Docket (September 17, 1991) . Toxia, USEPA Uanuary 10, 1991)

. Office, USEPA (September 17, 1991) . (14) CMA's Hexamethylene Diisocyanate (29) USEPA . Regulatory Management-I (2) Epoxy Resin Systems Task Group of Panel . Comments on EPA's section 4(a)(1)(B) CRMI) Summary for Cumene . Washington, The Society of the Plastics Industry . Inc . Proposed Statement of Policy submitted to DC . Office of Pollution Prevention and Comments on EPA's TSCA section 4(a)(1)(B) TSCA Public Information Office, USEPA Toxics, USEPA (June 17, 1992)
. Proposed Statement of Policy submitted to (September 12, 1991)

. the TSCA Public Docket Office . USEPA (15) Diethyl Ether Manufacturers Task Dated : May 5, 1993 . (September 17, 1991) . Group . Comments on EPA's section 4(a)(1)(B) Victor J . Kimm , (3) Monsanto Company . Comments on Proposed Statement of Policy submitted to ActingAssistant Administrator fo r EPA's TSCA section 4(a)(1XB) Proposed TSCA Public Information Office, USEPA Prevention . Pesticides and Toxic Substances

. Statement of Policy submitted to the TSCA (September 15, 1991)

. Public Docket Office, USEPA (September 12 . (16) USEPA . Implementation Proposal ; (I'R Doc . 93-11496 Filed 5-13-93 ; 8 :45 am] 1991) . "New Chemicals Exposure-Based Finding," ap-L" cooe eseo-e04