P.

Friday

May 14, 1993

~

Part III

!

F Environmental

Protection Agency

L TSCA Section 4(a)(1xB} Final Statement

a of Policy; Criteria for Evaluating

Substantial Production, Substantial

Release, and' Substantiai or Significant

Human Exposure; Notice

=

S
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28736 Federal Register / Vol. .58, No. 92 / Friday, May .14, 1993 / Notices

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 criteri 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 Prbduction, 1988). EPA has decided to-use this . 2601(b)(1). See Chemical Manufacturers

Substantial Release, and Substantial opportunity to articulate c riteria-for . Association v. EPA, 859 F.2d 977, 980

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

and mixtures (chemicals) considered for TSCA section 4 test EPA the 2603(a)(1j(Aj(ii}-(iii) an d

rule forcvmen

e 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 (CMA)• 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

Washington',

xics, rm E-543B. 401 M St, SW., 899 F.2d at 360. In this notice, EPA Is that the chemical may present an DC 20460, telephone: (202) articulating standards and criteria It will unreasonable risk, but that EPA could 554-1404, TDD (202) 554-0551. use in making findings under section establish existence and amount of SUPPLEMENTARY INFORitATM: 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 application ofsuch circumstances under which the

Federal Bulletin Board at 9 a .m. on the criteria to the cumene rule . chemical 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.2d 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
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Federal Reg ister / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices 28737

there are certain situations in which statute is silent or ambiguous on a developing adequate data with respect testing should be conducted even particular issue, deference is accorded to chemicals and making th though e

there is an absence of to any reasonable interpretation development ofthat data the information indicating that the consistent with the statutory purpose . responsibility of chemical substance or mixture per se may

hazardous be Chevron USA, Inc . v. EPA, 487 U.S. 837, manufacturers and processors, ." H. Conf. Rapt. 1679, 94th 842-844, (1984): NRDC v. EPA. 907 F.2d Cong ., 2d Sass. (1976), at 61, rep rinted 1146, 1153 (D.C . Cir. 1990). The Fifth II. R esponse to Public Comments in A Legislative Histo

Substances Control Act (Comm

ry of the Toxic Circuit Court of Appeals recognized this A . Summary . Print principle when reviewing the cumene

1976) ("Leg. Hist.") at 674 ; and H. Conf. test rule . According to the Court, where EPA received written comments on

kept. 1341, 94th Cong., 2d Sass. (1976), TSCA and its legislative history provide the proposed statement of policy from

at 18, reprinted in Leg. Hist., at 425. no definition of a term such as the Chemical Manufacturers Associa tion Thus, under section 4(a)(1)(B) of TSCA, "substantial," "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 Plastics information that the chemical may be power to define or inte rpret Industry, Inc. (SPD, the Monsanto

hazardous. Section 4(a)(1)(B)(i) requires 'substantial, "and we will sustain the Company, the Ecological and

the Administrator to find that "a Agency's interpretation as long as It Is Toxicological Associa tion of the

chemical substance or mixture is or will rational and consistent with the Dyestuffs Manufacturing Industry

be produced in substantial quantities, statutory scheme and legislative (ETAD), the Callery Chemical Company,' and (I) it enters or may reasonably be histo ry " 899 F.2d at 354. the Halogenated Solvents Industry

anticipated to enter the environment in (S)ubstantial Is an inherently Imprecise Alliance (HSIA), the GAF Chemicals substantial quanti ties, or (11) there is or word. ••• no definition or group of Corporation (GAF), the BASF

may be significant or substan tial human criteria can be established which will Corporation (BASF), the Arco Chemical

exp osure to such substance or mixture." function like a mathematical formula, so that Company (ACC), the U.S. Department of This policy statement sets out EPA's for every given set of facts a specific, Labor's Occupational Safety and Health

interpreta tion of section 4(a)(1)(B)(i) of predictable answer will always be Administration (DOIJOSHAL and the TSCA. This notice is not intended to forthcoming.

exerc

. Room must be leftfor the U.S. Department of Health and Human

address EPA's preliminary policy Id. at 359. Service's National Institute for decisions for selecting chemicals as Occupational 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 statutory language or legislative history CMA's Acetone and Ketones Panels, findings made under TSCA sections thatrestricts the Agency's allowed 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 Diethyl

by EPA. It is only intended to articulate particular quantities of or other Ether Manufacturers Task Group (Refs.

the standards and criteria EPA will use evidence relating to production, release, 10-15) also submitted comments which

in implementing its authority to make or exposure. In fact, Congress p rovided 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 published be considered by EPA in making TSCA are co llectively referred to as'•CMA "

in the Federal Register on July 15, 1991 section 4(a)(1)(B)(i) findings. H. Rept. hereafter in this notice. Comments (56 FR 32294), its proposed statement of 1341, 94th Cong., 2d Sess. (1978), at 18, submitted by them groups which are policy regarding section 4(a)(1)(B)(i) of rep rinted 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 specific chemical will be addressed, as construction of the phrases "produced ("Moreover, the quoted language in H. appropriate, in the final rule for tha t

in substantial quantities," "enters or Rept. 1341 '•• is permissive and specific chemical . Those rules will be may reasonably be anticipated to enter . expansive in respect to what the EPA published in the future . The comment the environment in substan tial may consider and when it may require periods were reopened for proposed test quantities," and "is or may be testing 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 articulating Cydohexane (52 FR 19096, May 20, 4(a)(1)(B)(i) of TSCA . quantitative 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 Section 4(a)(1)(B)(1

on, release, and methylpyrrolidone ( 55 FR 11398, March ) of TSCA requires human exposure . "Significant" human 28, 1990) ; See 56 FR 32292. (July 15, the Administrator to find that a exposure findings will be made on a 1991)

chemical substance or mixture is or will case-by-case basis . A summary of the comments . As explained In the received on the be produced in substan TSCA section 4(a)(1)(B) tial quantities, proposed policy statement (56 FR proposed statement of policy is

and "(I) it enters or may reasonably be 32294), it is EPA's belief that EPA may included in the fo

anti llowing Units II.B. cipated to enter the environment in make findings under section 4(a)(1)(B)(i)

substantial quan tities, or (II) there is or of -II.G., along with EPA's responses to TSCA based on quantita ti

may be signi ve comments. ficant or substan tial human thresholds. However, EPA does not

exposure to such substance or mixture," intend to limit itself to the use of these B. Scope of Testing

to impose testing requirements. criteria in making "B" findings and ( MA and other commenters have However, TSCA does not define the reserves the ability to consider other expressed the concern that, given the crite ria or standards to be used, or the factors on a case-by-case basis. Such an c riteria a rticulated in this notice, meanings of the words "significant" or interpretation is consistent with the "nearly 8,000 substances will require "substantial." Additionally, the legislative history of TSCA and [EPA] review under section 4(a)(1)(B)" legislative history of TSCA provides no effectuates the policy objectives (Refs. 1 and 5). These comments elucidation of these terms. Where a described in section 2 of TSCA of indicate that many commenters have
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28738 Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

misinterpreted the intended and actual environmental releases, the Agency sections 4(a )( 1XAgit) 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 has

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 risk, or under sets out EPA's interpretation of the findings made under TSCA sectfon TSCA section 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 substantial quantities and may either

will consider in evaluating section finding has been made, is misplaced, enter the environment in substan tial 4(a)(1)(Bxi)'s applicability in specific and indeed, based on a quantities or that there may be

cases. This policy statement is not misinterpreta tion of the scope of EPA's substantial or signifi cant human

intended to function as a tool for setting testing authority under section 4 of exposure to the substance, the

testing priorities. Testing priorities will 'l'S(',A. Administrator may require any type of

be set by EPA's ongoing efforts in . TSCA section 4(a) states: testing necessary to address unanswered

developing a Master Testing List. This ( a) TESTING REQUIR>E3MENTS.-If the questions about the effects of the

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 further information. chemical substance or mbcture, or that any findings. Many respondents. including CMA, combination 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

threshold criteria arti ted

cula in this environment.

(ii) there are Insufficient data and effectstesting even it it has only made

policy notice, so long as "B" findings experience upon which the offs rim of such a finding that there is or may be

are made only in support of rules manufechus, distribution in commerce. substantial entry into the environment requiring only tiered screening level or processing, use, or disposal of such substance of a substance, or require environmental

"baseline testing" of chemical or mixture or of any combination ofsuch 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 sipficent human

and indeed, use of EPA's section ( iii) testing ofsuch substance or mixture exposure to a substance. Clauses (I) and

4(a)(1)(B) testing authority for any other with respect to such effects Is necessary to (II) ofsection 4(a)(1)(B)(i) can be

level of testing.

develop such data, or

(B)(i) a chemical substance at mixture is or interpreted as mutually exclusive. Se e

On the policy as a whole, CMA cumenedecision. 899 F.2d at 357 n. 19.

commented that EPA's proposed criteria will be produced in substantia

(n it enters or may reasonably l and be Either finding is sufficient to require

under TSCA section 4(a)(1XB)(i) are anticipated to enter the environment In testing, 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 tion Data Set (SIDS) utilized by to such substance or mixture, unreasonable risk of injury to health or

the Organiza tion 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 testing is necessary to develop such

for high production volume (HPV) manufacture, distribution in oommeras, data. It is the interrela tionship of the

chemicals. CMA stated, "EPA's processing. use. ordisposal of such substance existing data set and numerous other

'B' criteria would provide a

or mixture or of any combination of ric

on health or the environment h proposed activities can substance-specific parameters, which

suitable basis for selecting substances reasonably be determined or predicted.

and are evaluated under subsections (ii) and

for such screening tests" (Ref. 1). CMA (iii) testing of such subsfaaca or mixture (iii) of section 4(a)(1)iB), that determines

proposed that, if screening studies with respect to such effects is necessa ry to the specific testing requirements, if any,

reveal the potential 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 proposed rule under the testing be conducted on such substance or the authority to require testing for any

authority of TSCA section 4(a)(1)(A), the mixture to develop data with respect to the health and environmental effects on ce it

may present" finding. CMA proposed health and environmental effects for which has made a finding under either section

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 experi ence and which are relevant to a does not compel EPA to require testing

only if it concludes that exposure is determina tion 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 rite ria, which take disposal of such substance or mixture, or that has decided that it will require tes ting,

into account all aspects of exposure, any combination of such activities, does or EPA must also determine what data are

must be developed by EPA does not present an unreasonable risk o f

to select injury to health or the environment.

sufficient and what testing is necessary

such high exposure substances for in each particular case in promulgating

additional testing . CMA stated that it 15U.S.C 2603(a) (emphasis added) . specific testing requirements. In

would not oppose EPA's criteri a if they The final paragraph of section 4(a) sets addition, once EPA has decided to

were incorporated into the tiered out EPA's authority to require testing require testing, EPA also considers,

approach described above . CMA would once the Agency has made the findings among other factors, "the relative costs

oppose EPA's " B" criteria, if they are under section 4(a)(1)(A) or (B). The of the various test protocols •'• and the

used for any other purpose. CMA directive of this final paragraph clearly reasonably foreseeable availabi lity 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
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Federal Regider I VOL 58.- No. 92 ! Friday. May 14, 19g3 ! Notir,es. 28M,

rule," TSCA section 4(b)(1 j, 25 U.S.G that tbe extrtiag datr aad asPtfance dano! -- quantities equal to or greatet than

2603(b)(1). - suffice as a besis 6ar k tareroaabix PnAk*- 220,0t7(1 $

peryean no New Furthermore, if Cangress had that then will be aa beslwk or aavitonmeatai Chemical,

. prpgrem, as a matter of -

intended that the testing required under injury from the manufac hldag{os ~sowcsolicy, 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~tantnxddty)under

the findings are based oa information at hypothetical tux~tlr levelsunder 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 354-355-(empbesfa. In consideung tastiag undersecfiaa

respect to the health and environmental o riginal). 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 • information that a substance is approach for the initial threshold uader

authorized EPA torequire health and hazardous. it is reasonable that the . . TSCA section 4.TheOECU 8PV

environmental effects testing specific testing to be reguired relates to threshold was establisbed.uttdar

independent of the basis for an (A)(i) ar the data insufficiency and testing in different circumstaaces tban the

(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

countries_ These Inventories were "capable of developing the necessary EPA proposed a value of I million merged into a comprehensive inventt iy

ie 1~98~Oj n

." See 45 FR 49510.48530 ();uly -pounds as a threshold level for findings maintained by the OECD. and is called

of "substantial production." 56 FR the OECD Representative List (RaL 17);

EPA's broad 322-96_ As an alternative to, this . which includes all chemicals (axciudrag mandate to require threshold. EPA solicited comments on polymers and petroleum fractions)

testing is also reflected in the legislative the adoption of the'FSC' history of TSCA .A section 5{e) reported in any member couatry ta

Cong

. See H. Rapt 1341. 94th New Chemical Program's exposure- . excess of 10.000 tonnes (22 million

, 2d Seas. (19?6), at 3-8 . reprinted based substantial production threshold pounds) and 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

most apparent

authority to require testing is threshold ( 56 FR 32299). tonnes(2.2 million pounds). Henco, the in TSCA section Both CMA and SPI commented that OECD HPV production volume 4 (a)(1)(B) which, according to the EPA's proposed production threshold is threshold of Z.2 million pounds was Conference Report on TSCA, authorizes a reasonable interpretation of .

. conceived merely to gwde the - EPA to require testing "even though "substantial production" under TSCA generation 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 0dA, •'(w)hile International list of high production - per se may be hazardous_" H . ConE. EPA's approach is a reasonable one. a volume chemicals.

It was assumed by Rept_ 1679, 94th Cong., id Sess. (1976), production threshold of 2.2million . 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 of

also H. Rept. 1341, 94th Cong. . 2d Saas, consistency between EPA's activities potential exposure suc h that the OECD`s (1976), at 18, reprinted in Leg . Hist, at underTSCA section 4 and the OECD . prog ram on existing chemicals has - 425. HPV ExistingChemical Testing focused since 1988 on the chemicals Finaliy, in the cumene decisi®,,

the Program" (Ref. 2). G4tA noted that for found on the OECDRe aliveList. Court supported EPA's interpreta tion .

• 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 production is not the sole findings under TSCA subsection million pounds as a production volume fi nding EPA must make to require

4(a)( L)(B)(i) and subsections . triggerin its new chemicals program testing. Thethreshold 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 proposed~ .• A finding under section 4(a)(1)(B)(i) does also suggested use of TSCA section 5 statement of policy ( 56 FR 32294 ) is one cot alone justify a testing order . It must also

be found under sec tion 4(a )(1 )(B)(ii) that

trigger for substantial production (ReL of several findings EPA must make

'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 support the adoption testing. EPA must also find thatthem is

p,oceesing, etc-) ••• of such substance •-` of the OECD HPV threshold for the substantial release, or substantial or

on health or the environment can reasonably pu rpose of international harmonization . signi fi cant human exposure under

be • - predicted.' S'unilarly. section E3'A disagrees with CMA and HSIA TSCA sections 4(a)(1)(B)(i)(I) and (II). In 4(a)(x)(B)(iii) imposes the further that 2 .2 million pounds produc tion is addition, EPA must find that data are requirement that the testing be 'necessary to the sole thresbold utilized in the TSCA Insufficient and testing to necessary develop such data' (emphasis added}- Lanecessary to render the experience and dat a

. section 5 New Chemicals progrant. In under TSCA sections 4(a)(1)(B )(ii) and

sufficient as it basis on which the health and gBqersl, screening level toxicity studies ( iii). EPA does not believe that 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 '••, Ifthe EPA properly concludes substances expected to be produced In ' inte mational program on existing
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28740' Federal Register / Vol. 58, .No. 92 / Friday, May 14, 1993 / Notices

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 Callery Chemical Company believes,

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 all threshold value for substantial

GAF, BASF, and ACC objected to the section 4 test rules. For each chemical production, Nevertheless, for the

proposed threshold on two grounds . subject to testing, EPA conducts an reasons set forth above and in the - . :

First, the proposed threshold value will analysis which estimates the costs of proposed policy, EPA will adopt the I

involve subjecting 95 percent of U .S. testing. In addition, EPA considers any million pound threshold for

chemical production ( on a total volume comments received on the economic ' "substantial production" under section

basis--11 percent on number of effects of proposed 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

will encompass such a large percentage requirements when respondents 11 th e criterion for "substantiat

of chemical production, the threshold demonstrate that the rule would impose p roduction" 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 made

As previously 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 quantities" under TSCA

the meaning of "substantial . .

.

.

and, where necessa ry, risk management section 4(a)( 1 )(B)(i)(I). EPA refers to1his

production." For instance, if one were activity. EPA recognizes that If the =' • finding as "substantial release'•_an d

to create a chart 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 poses an unfair or excessive pounds per year release or release of i0

substances on the TSCA Inventory, 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" narrowly 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 solicited

chart. EPA could also choose to adopt any significant adverse economic comments on the •adoption of a fixe

finding all impacts associated with section 4 test threshold, d a broader interpretation, such as 100,000 pounds or 1

chemical production to be substantial rules. Economic considerations are million 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. testingdecisions.

In response to EPA's alternative environment in substantial quantities" EPA has proposed a°produetion figure ld r

oonse osal for the substantial equates with "substantial" release.

millio

n in betwee

n poun

d the tw o

threshold fo

r extremes . The

roduction 1 p pr

o threshol

d production proposal ( 220.000 pounds) ese commenters contend that EPA

narrows the "universe" of chemicals used in the review of new chemical must consider not simply the total

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 the chemical's persistence in the :

that small 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

produc

information as a basis for making a cann6t'bandie

tion, It is reasonable to use this overwhelm the Agency with work

( R

thatIt media (Refs. 1 . 2 and 6). •

a t: 5). EPA disagrees with the commenters' finding of "substantial production" for arguments regarding what information substances produced in excess of that EPA be lieves 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 ffect; 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 inappropriate at this time, although clause (II) of secrtion 4(a)(1)(B)ro into '

economic burden on chemical for diffe rent reasons. Callery Chemical clause (I). However, as indicated by the manufacturers and processors that -could Company's concern about pub lic word "or" between the two clauses, •

stifle technological innovation" (Ref. 7). disclosure of sensi tive business clauses (I) and (II) of section 4(a)(1)(B)(i) This comment (which is unsupported information is addressed elsewhere in can be interp re ted as being mutua lly

by any empirical data) also appears to this notice (Unit 17Y. of this notice). exclusive. While EPA may, 1f it chooses, reflect a misunderstanding of the scope EPA recognizes that the number of make a finding under both clause (1) and of this po licy statement. • chemicals which could be considered as clause (II), a finding under either clause

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 support a test rule.

for testing. Furthermore, this policy pounds were adopted. However, EPA believes that it is reasonable to

statement does not address the amount substantial production is only one of the interpre 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 ropose 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 28741

is, per se, "entry" of that substance into Inventory, theAgancyis limited to a account for 99 percent of the toW

the environment. irrespective of the consideration of those e5ects which reported release on the MU by volumesubstance's subsequent persistence or would occur "at coacr$tration levels Clearly, the small 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 limitation reasonable for EPA to use that .',

statute or legislative history that clearly applies only in thisinstance, and.doea information as a basis for fob,siag its .

indicates that clause (1) necessarily not apply to or modify any other clause a ttention on chemicalsreleased 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 32296r4he

the cumene decision. the Court this) imitation to releases considered percentage 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 ofa

reasons, EPA-believes that its ' clause (I) of section 4(al(1KB)(i) of the . chemical's production volume is

interpretation of the phrase "enters the Act to encompass any release of the . .. released, that release should be .

environment" 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 cbamic aia with production

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 31 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 ,

finding will be based are releases to air" anticipated to result from the per year.

water beyond site boundaries. Releases or manufacture, processing, distribution in E. Substantial and S' c+ort! H~rmait transfe rs to treatment and waste disposal

commerce, use or disposal of a ChemiCBl

facilities raise entirely different exposure Exposure

considerations and should not be taken into substance or mixture, regardless of the

account in making "W" findings ( 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, and

characterization of the scope of the term from a site or transfers to treatment and set out the following numerical

facilities. Rather, TSCA thresholds for a . " waste disposal finding of "substantial

release" in EPCRA, and as the Agency is intended to broad] address the exposure": LOGO workers. 10,000

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 tion, FPCRA does not limit distribution 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 boundaries." "si Ecaniexposure" would g°

Rather, "release-Js broadly defined in mixture. 8m 1°~

SP

42 U.S.C. • I

commented that EPA's proposed be made where the numerical thres$oL3

EPCRA section 329(8).

, as 1

million pound release thxeshaid. and for numbers of persons' exposed for

11049(B)

s F illiag, looking, pumping . pouring, the proposed alternative 10 percent of "substan tial exposure" is not iaet.but:

emitting, emptytng, dischargiQg, tnjectfng-, production volume threshold, were the nature of the exposure is sufficiently

escaping, leaching, dutnpir ,& or disposing arbitrary and that "EPA does not direct, large or prolonged. However: •:

into the environment •'• provide any support for the selection of EPA may make a F:nfi~ng that thete her

10 percent of the produr3i~n volume may be both significant human ex---tae .

Siiuilarly, EPCRA section. 329(2), 42 other 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 ronment" 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 also

interrelationship which exists among and valid than 1 percent or 60 percenE" (Raf. significant as set forth in this policy.-As

between water, air, and land and all living 2). an alternative to these thresholds .-EPA, --

things. EPA disagrees withSPrs cnmmenL In solicited comments on the adoption .of .

choosing the 1 million pound threshold either theTS'CA section 5(e) New .

An identical defini tion 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 that were used to "significant" 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" production. 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 32299 -32300).

Under this provision of EP( RA, when Toxics Release Inventory t•IRI) in OSHA and MOSH submitted

considering the reasonably anticipated judging the " substantial" nature of that comments supportive of EPA's

"significant 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 million pounds and that these releases seriously consider its alt.emativs
--r

p. 8

28742 Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

p roposal ••• that would result in testing determination of substantial human TSCA's statutory framework and compounds for which fewer than 1,000 exposure, they did not specifi cally argue purposes. As explained above in Unit I workers are exposed" ., (Ref. 9). OSHA that these thresholds were TSCA was enacted to ensure that, given agreed with EPA that; for TSCA unreasonable, nor did they provide any the exposu re of humans and the purposes, the proposed definitions for specifi c alterna tive criteria or rationale. environment to a large number of "substantial" human exposure and The different 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 population exposure are EPA's attempt be effective regulation of commerce in testing is required when toxicity data to re flect the inherent differences in the such substances. TSCA section 2(a), 15 are absent or incomplete . Accordingly, probable exposure scenarios for U.S.C. 2601(a). Since the potential "OSHA be li eves that exposure of 1,000 particular categori 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 toxicity repre sents adequate impetus to "workers generally are exposed on a provisions of TSCA reflect Congress'

require tes

OSHA stated that the proposed consumers, and consumers are generally adequate data should be developed wit

ting" (Ref. 8). In addition, more routine or direct basis than intent that: ~

h

distinction between "substantial" exposed on a more direct basis than the respect to the effect of chemical substances

human exposure and "significant" general public" ( 56 FR 32297, July 15, and mixtures on health and the environment

human exposure is appropriate (Ref. 8). 1991). EPA has decided to apply a and that the devalopment of such data

1 . Substantial human exposure. CMA, diffe rential equal to one order of should be the responsibility of those who

SPI, Monsanto, ETAD, HSIA, GAF, magnitude between the worker, manufacture and those who process such

BASF, and ACC submitted comments consumer, and general population

(substances).

that questioned the de finitions and thresholds. EPA believes this approach T

rationale underlying the proposed is reasonable and SCA section 2(b)(1), 15 U.S.C.

sufficiently re criteria . A common comment was that the inherent diffe flects 2601(b)(1). Section 4 of TSCA provides rences in the probable

EPA had not provided sufficient exposure scenarios for each of the y EPA the authorit to uire suc Peq h

rationale to justify the proposed catego testing.' ri es of individuals. Both OSHA,

numerical thresholds for determining (Ref. 8) and NIOSH (Ref. 9) suppo rted

"substantial" human exposure. the basis for the distinction between In effect, by urging EPA to make

EPA disagrees with the commenters' substan tial exposure to workers, "assump tions about the exposure levels

suggestion that EPA did not provide consumers, and the general popula tion.

that would be of regulato ry conce rn if

sufficient rationale for the nume ric EPA recognizes that this a pproach, testing demonstrates adverse effects,"

thresholds chosen to guide which is consistent with the Fifth CMA argues that EPA must make an

"substantial" human exposure findings. Circuit's cumene decision, integrates to affirmative finding that a chemical

As ar ticulated in the proposed policy some extent the concepts of substance would pose an unreasonable

statement ( 56 FR 32297), EPA chose "substantial" and "signific ant" in risk of injury at some hypothetical

numeric 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 testing under section

it is EPA's belief 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 rej ected by the Court in the situations where large numbers of Although commenters generally cumene decision, 899 F .2d at 354-355 . people may be exposed to a chemical criticized EPA's ra tionale for choosing Further, in contrast to the TSCA

substance and little or no hazard data the numeric thresholds articulated in section 4(a)(1)(A) risk-based criterion

exists to indicate whether or not that the proposed policy statement, none of and the TSCA section 6 risk/benefit

chemical substance may present an the comments offered any specific analysis, a finding under TSCA section

unreasonable risk. EPA has based its alterna tive thresholds for making a 4(a)(1)(B) requires no risk analysis. See

thresholds for workers on expe rience 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 expressed the view that EPA 859 F.2d at 979, and 984-988 (ERA

existing substances. Furthermore, must consider certain chemical specific decision). Additionally, as both

according to the National Occupational factors to make a "substantial" human exposure and hazard are factors used to

Exposure Survey (NOES) data (Ref. 18), exposure finding. determine whether a chemical may pose

an average of 650 workers are ~M~ A and other commenters objected a risk, without the necessary hazard

potentially exposed to a chemical to EPA's threshold approach for informa tion, making "prudent but

substance produced in a quantity of 1 determining "substantial" exposure realistic assumptions about the

million pounds. In other words, for a because it is based solely on numbers of exposure levels that would be of

chemical produced in a quantity of i people exposed and does not take into regulatory concern if testing

million pounds, it is re latively account the physical and biological demonstrates adverse effects" would be

uncommon that as many as 1,000 properties 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, frequency, the frequency, dura tion, and levels of

analysis and its experience of case-by- and duration 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 reted but realistic assumptions about the . question. Given the statutory framework

"substantial human exposure" under exposure levels that would be of of TSCA, its legislative history, and the TSCA section 4(a)(1)(B~(i)(II) by regulatory concern if testing . case law interp reting the section 4

utilizing a re la tively conserva tive demonstrates adverse effects" (Ref. 1). testing provisions, EPA does not believe

threshold of exposure of 1,000 workers EPA believes that CMA's comments that it is required to unde rtake 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 role of chemical testing conducted upon it by CMA and other respondents

EPA's rationale for making a under the authority 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) "substantial" human Household Solvent Products: A National CMA at this time, the potential sources

exposure finding. Usage Survey, EPA/OTS 560/5-87-005; of information 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 limited scope of

in making a finding of "substan tial" U.S. Consumer Product Safety their coverage. These limitations differ

human exposure . EPA did, as a matter Commission (CPSC)1988 . CMA also from database to database, and include

of policy, offer for considera tion in the stated that about 400 substances have the number of chemicals covered,

proposed policy statement an been screened under TSCA section 4 limited overlap between the databases,

alte rnative set of human exposure and that EPA's RMt (Risk Management- the specifi c data included in each

criteria, 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 information 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 information,

FR 32299-32300, July 15, 1991). As explained above, EPA disagrees and differences in the quality of data

However, despite an explicit invitation with commenters' fundamental premise and the basis for each estimated

for comments addressing the merit 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 4,000

none of the comments addressed the commercial production in order to chemicals. This database contains

specific numerical values and other support Its interpretation of the term useful information on the approximate

factors outlined in .EPA's proposed "substantial" under section number ofworkers 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 only approach was mandated by Congress. potentially 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

criteria should not be applied to review the legisla tive history require EPA to handling the chemical, and the industryof existing chemicals under section undertake the kind of exhaustive Standard Industrial Code (SIC) where

4(a)(1)(B). (Refs. 1 and 2). Furthermore, analysis urged upon it by CMA and the chemical is found . However, by

EPA solicited comments on adopting other respondents to support findings itself, the database is insufficient to

"some other criteria than the criteria under TSCA section 4(a)(1)(B)(1). In fully characterize the potential worker

proposed herein by EPA" and "the short, the cost of generating the exposures because the database does not

supporting ra tionale" for such criteria, exposure information necessary for this contain informa tion 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 specifi c cost of testing, and is not appropriate for exposures. Due to these limitations, EPA

suggestions or rationales. 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 variations 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 proposed 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 pattern specifi c rulemaking under section 4, the human exposure scenario. Once

of unusually large or widespread EPA must determine whether there is again, EPA invites interested parties to

exposure wh ►ch differentiates the test sufficient "data and experience" upon ~bmit for EPA's consideration all

substance from typical 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 variations in whether testing of such substance is

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;onaidered

provide a basis for "low", "medium", examine all available and relevant 'signi fi cant' where the potential exposed

and "high" exposure rbemicals.'For information concerning the substance in population is not large but the,

example, CMA stated that EPA had question, including the physical and conditions of exposure are unique and

made no effort to determine whether biological properties 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 adverse

which at least 1,000 workers are level, frequency, and dura tion 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 exposed 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 tion they be lieve It is reasonable to determine that a significant

commercial production. may be relevant to the Agency's human exposure exists, even if fewer tha n

CMA suggested that data exist which determina tion to require testing of a 1000 workers are exposed (Ref. 8).

could be used to make order-of- particular 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 information during the notice and does not "meaningfully identify where

sources suggested by CMA Include the comment period provided prior to the such 'significant' exposures might exist"

NOES; information collected under the promulgation of any final teat rule. (Ref. 1).

TSCA section 8(a) Preliminary Furthermore, even if EPA were to EPA does not believe that it has, at

Assessment Information Rule (PAIR); condua the analysis urged upon it by this time, sufficient expe ri ence to
P. 10

211 744 Federal 'Register / Vol: 58, No. 92 / Friday; May 14, ~ 1993 .1' Notices

~ generically define criteria.that it will' . , . exposure scenarios iuggested by C UA. , . F. Oteetlssaes:

empioyin making a finding of ' would have miuudi utiL'ty: Howevar. EPA Categories. EPA proposed "tit

"signifi 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 CMAand others in thresholds for most substauces ' -

EPA make such a finding in a substance- the context of substance-specific considered for action-under TSCA specific rulemaking, it will fully explain rulemakings underTSCA 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, whomthe thresholds are not- QvIA also stated that VA has not chemical specific physical.prop~~ 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 exposure would involve al rge. I basis for making findings. An example :

relates to "significant" exposure (Ref. 1). concentra tions or is frequent or , of such a cese mentioned by EPA Inthe A'•direct" exposure may be prolonged. Also, in response to an -

characterized as:havinB a clearly

p po proposed polic~ Mi'sa chemical _'• . . _

earlier suggestion 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 , pported by 5pf.believes~iitat

the proposed sedion 4(a)(1)(B) Criteria categories should be aartaiviv defined..

source to the receptor that can be fo r "significant" exposure, 'adoptiag the

expected, with reasonable certain ty, to qualitative and'quantitative In ©MA'a dgemen ,

the only a ~

result in the potential for exposure, and •substan tial" and "aigCtificant" would 'be sui W fora'8' finding- vru~al ba an exposure route that will 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) chemicalsbUC2112e6aad ware than[wsltbty

intake/uptake by the receptor . For th.ese at.

, of TSCA (56 FR 32299):Then TSC.A to have closelyrslatad health

reasons, it is reasonable to conclude that section 5(e) criteria do Include some environmental offects (XeEll. . '

in instances where exposure is "direct" consideration of frequenry, duration . . EPA may consider the exposure to be_ and magnitude of exposure forworl~ers ~A °ts° Comments that.

"significaat" under TSCA section and consideration of magnitude of ~ representatives 6om.4 categary.oould be

4(a)(1)(B)(i)(ll). • exposure for the general population. selected fortestiug. obviating:the used

GAF. BASF, and ACC stated that EPA The section 5(e) criteria for consumer to test each and every member ofthe'

has failed to establish a clear distinction

between "substantial" and "signi ficant" exposure are qualitative only .-These ~~ does not with the criteria were developed based on

exposure as presented in Table 1 of the commentersthat categories must. by

proposed policy (Ref. 6).

experience

. associated a with thousands

th

eousandas qf ~ new

m

necesaity, be limited to chemicals with

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 "substantial" 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 were in favor of EPA bystances, be grouped together and

overlap is not inconsistent with the adopting the TSCA section 5(e) human referred to collectively as a category.

statutory purpose and legislative history exposure criteria

. Additionally, after consideration of all

of TSCA. As stated in the cumene la summary, for the purpose of relevant chemical specific•paramelers.

decision . 899 F.2d at 356, n. 17, ..t is i determining whether there is or maybe EPA may propose category~~on

not necessarily clear that "significant" "substantial" exposure under TSCA a case-by-case basis, and will solicit

and "substantial" 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 numerical thresholds of 1,000 specific proposed test rule . Thisis th

overlap." workers, 10,000consumers, and/or approach taken e prevents any in the proposed test rule

CMA recommendped that "EPA should 100,000 persons in the general for1 cadols(56 FR 57144,

judge the "signifi 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 mitigatingjadors. -

populaiion, it involves large - case-by-case basis. taking into (MA. 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 consider

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-case basis. Monsanto supports

even quite direct exposure to the ~~ impo rtant to note that TSCA section 4 the "substantial" and "significant"

threshold levels of little or no concern is an information gathering tool only exposure 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, ' specific basis, may need evaluation .For

develop representative exposure processing, distribution 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 population. 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 appears 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 metabolic product of

(Ref. 1). believes that the criteria 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 phrase "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 28745

EPA agrees with the respondents that EPA would not be disclosing specific 2 . Polymer exclusion. Monsanto

in implementing this policy, EPA information regarding any particular commented that polymer exemptions

should preserve the flexibility to manufacturer's production . Should such should be recognized by EPA under this

consider certain 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

implementing section 4(a)(1)(B) of chemicals, EPA does not be lieve that a needs separate consideration under the

TSCA. EPA intends to use the criteria statement that production volume is at proposed 'B' policy" (Ref. 3). Monsanto

articulated in this po licy statement as least I million pounds would disclose noted that a number of polymer '

guidelines to retain the flexibility to sufficient information 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 tial

findings under section 4(a)(1)(B) of be entitled to confidential treatment. health or environmental concern. In

TSCA. As stated in the proposed Furthermore, TSCA section 14(a)(4) support of this position, Monsanto

statement of policy, EPA intends to authorizes the disclosure of informa tion noted that exemption procedures are

utilize the generic thresholds for most which otherwise might be entitled to provided for in the review of new

chemical substances considered for confidential 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 "additional factors" on a case- confidentiality to the extent practicable believes a similar type of polymer

by-case basis to make findings. without impairing the proceeding. See exemption should be offered under th e

EPA's authority to use this flexible 40 CFR 2 .306 ( 1991). EPA believes that section 4(a)(1)(B) policy.

approach was recognized by the Court by disclosing only that a substance is or Again. 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 confidentiality would be preserved to section 4

1

(a)(1)(E)(i). EPA believes that in

not "function like a mathematical the extent practicable 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 manufacftrers'

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 tion, 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 Scope may have potential 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 appropriate. To

predict the effects of the manufacture, the use of structure activity date, EPA has not proposed or required

process, distribu tion, use, or disposal of relationships (SAR), exclusion of testing of a polymeric compound under

the chemical or that testing is not polymers, tiered testing schemes, and TSCA.

necessary. Monsanto, GAF, BASF, and testing priorities 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 tiered testing approach to evaluating

that meet the section 4(a)(1)(B)(i) criteria should recognize and authorize the use chemical substances•

for which the available data are of structure activity relationships (SAR) EPA believes that determina tion of

sufficient to reasonably determine or when evaluating the testing needs and whether tiered testing is appropriate

predict the effects of the manufacture, priorities for substantial production generally must be made on a case-byprocess, distribution, 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 testing scheme in

high production volume chemicals are a test rule can generate pre liminary data

n~fidential business information. produc ed as intermediates and then relatively quickly with minor expense .

Callery Chemical Company is concerned later converted to neutral salts to However, for a relatively well

that an EPA finding under TSCA section facilitate handling and shipping, in characterized chemical substance, it is

4(a)(1)(B)(i) that a chemical may be most of these cases, the salt and likely that a tiered testing approach

p roduced in substantial quantities may intermediate itself have essentially the would not be appropriate. In other

result in disclosure of confidential same toxicological priorities. Therefore, instances, if the scientific literature

business information (®I) and "could by testing and evaluating one substance, contains information which strongly

provide valuable marketing information the other chemical can be evaluated suggests that the chemical is used in a

to competitors and potential- using SAR. way that would result in widespread

compe titors without justification" (Ref. Monsanto's comment is not relevant worker or consumer exposure ( e.g., a

5), to a discussionof TSCA section 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 return

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 finitive

million pounds of a chemical substance needs and p ri o rities for substantial answer needed for such widesprea d

or mixture is produced per year would p roduction chemicals," is a matter exposure. Thus, automatic

be a disclosure of CBI. In making such relevant to TSCA section 4(a)(1)(B)(ii) incorpora tion of a tiered testing 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 concerns would be addressed in relation screening studies which are unlikely tomanufacturers of the substance . Thus, to a chemical specifi: test rule . provide the needed information .
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 inunitII.D.

that; In addition tq adopting the 22 95% of total chemical production by of this notice. EPA believes that this U--

million pound threshold for substantial volume . For the reasons articulated in a reasonable interpretation' ofthe 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 UnitIM of this notice, EPA quan tities", in TSCA section

needs on all high production volume believes a threshold value of i mi llion 4(a)(1 )(B)(i)(I). •

(HPV) chemicals. In CMA's opinion, ° • pounds is a reasonable interpretation of C. Substantial and Signif1 cant.l:duman EPA should group HPV chemicals into the phrase "produced in substantial . . .

categories and establish priorities for the 'quantities" in TSCA section E~

pa

s

'

re

review of each chemical. '- - 4(a)(1)(B)(i). ., EPAIs establishing the criteria in

Once overall testing priorities 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 wbether: EPA is establishing a threshold value articulated 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 erivironment 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

proposed statement of policy. and in substantial release. In choosing the 1 . .', large numbers of people mey be expo6sd

Unit I. of this final notice that fames million pound threshold value td to a chemical substance and little nrno'

related to how EPA establishea testing represent "substantial" release, EPA . hazard data exists to indicate Whether or

p rio rities and how EPA makes findings . used 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 risk. EPA based Its= ;~ : .

4(a)(1)(B) of TSCA would not be .• rel 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 case-by-case analysis of

at s ome future point in time. EPA TRI ha ve releases of 1 million 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 reported 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 rent differences in the probable

EPA will clearly articulate that policy chemicals that exceed the poundage exposure scenarios for p~iaslar .-

and the underlying rationale 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 Pro

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 notim

year for all manufacturers, as the percentage of a chemical's production EPA believes that these criteria are a

substantial production threshold. This volume is released, that release should reasonable interpretation of the phrase

threshold currently represents only 1196 be considered "substantial" for that "signi fi cant or substantial human

of the entire universe of chemical chemical substance. For the reasons exposure" in TSCA section

substancas potentially subject to testing articulated in the proposed statement of 4(a)(1)(B)(i)(II) .

TABLE 1 .-TSCA Section 4(a)(1)(B)(i) Human Exposure Criteria Guidelines

Category Subcteu►tlal Significant

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 findings of the chemical and/or that testing is not

EPA will apply the generic numerical for substances whi ch do not meet the necessary. - ,

thresholds for most substances numerical thresholds a rticulated herein IV. Final Test Rule for Cumene

considered for testing under TSCA for evaluating exis ting chemicals under

section 4(a)(1)(B). In some eases. TSCAsection 4(a)(1)(B). A. Response to Cumene Pane l

however, where the thresholds are not Conversely, EPA may not require On July 27,1988 (53 FR 28195) EPA

met, it may be more app ropriate to use testing under TSCA section 4(a)(1)(B) promulgated a final rule requiring

a case-by -case approach for making for a chemical that meets the section manufacturers and processors of

findings by applying other 4(a)(1)(B)(i) criteri a if EPA finds. under cumene to perform health and

considerations. Fc 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 priority testing
p. 1 3

Federal >gegatSter. / Vol. 58, No. 92 / Friday, May 14 . 1993 / Notices 28747

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 be

under TSCA section 4(a)(1)(B)(i) that 'that this level ofproduction clearly distributed over a lalge portion of the

cumene is "produced in substantial qualifi es as "substantial piodtuxion' ► - communities near manufacturing end

quantities 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 production reported in prevailing atmospheric conditions,

with the potential 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 substantial quantities"

requisite findings under TSCA section . or that there is not PAxstantial human 4(a)(1)(B)(ii) and (iii) ( 53 FR 282 00, July. In support of the final test rule, EPA exposure ." Rather, the Panel has only

27, 1988). EPA's findings were - found that cumene isreleased to the - ,, demonstrated 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 manufacturing, considered with other factors, such as

to: processing, anduse activities. The Court the maaufactiuing andprocessing articulate the standards or criteria on the upheld the validity ofEPA's estimate. scenario.

basis of which it found the quantities of - ; 899 F.2d at 352-353.To a lesser extent, cumene entering the environment from D. Substantial Human the EPA also noted in the final rule that Exposure

facilities in question to be "substantial" and curnene was released in unspecified The Panel commented that. ovum if the human exposure potentially resulting to quantities to the aquatic environment.

the release of cumene could be equated be "substantial." . Because EPA was unable to estimate to "substantial" environmental entry, -

with reasonable ce rtainty 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 "substantial 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 potential for human exposure as. Once again, the Panel is attempting to findings 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

its testing requirements, orwhether, vn thefor bases for the TSCA environments. The Cumene Panel ~~ section 4

other hand, its testing requirements eeit only commented that EPA EPA does not believe this (be lacks an adequate g

.

on the clauses (I) and (11) findings jotntly~••. basis for finding that cumene "enters a valid interpretation of section 4(a) of

The EPA shall further Indicate whether its the environment in substantial TSCA. Furthermore, EPA believes, as -

findings under either clause (I) or clause (11) quantities." Specifically, 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 disapproved. concerning •'substantial release" with "enters the 4(a)(1)(B)(i) can be interpreted a s

entry into the aquatic environment; and, if environment in substantial quantities." independent. In particular, although so, shall reconsider its clause (I) and (II) EPAmade for cumene under findings in the light of our referenced ruling.

The has made no effort 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 distribution of constitutes an independent and directed EPA to consider new studies to cumene in the environment orto 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 rial to patterns (Ref. 221. that there may be substantial human

any of the EPA's crite ria relied on for exposure to cumenebased 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 million people living in the

both specific studies and general . "enter the environment in substantial vicinity of cumene manufacturing and

comments on the cumene final test rule. quantities," as used in section processing facilities: EPA believesthata The test rule remained in effect, and test 4(a)(1)(B)(i)(I) ofTSCA, be defined to majority 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 . The

EPA has addressed some of the quantities." The Court in the cumene majority 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 metropolitan areag The' Panel's gene ric comments regarding the construction of TSCA section 4 . Court in the cumene case, 899 F.2d at "B" policy (Ref. 12) in Unit lI. ofthis . 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, not

B. Substantial Production atmosphere, there is no reason to previously submitted as comments an

believe that, except for populations very 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 tion 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 billion in the atmosphere appears to be on the The Cumene Panel maintains that the pounds with an additi onal 339 million order of 1 or 2 days. At this rate of information contained in this study is pounds imported. This figure was not removaI, the curnene emissions from sufficient to show that EPA cannot make
p.14

28748 Federal Register ./ Vol. 58, No. 92 / Friday, May 14,1993 / Notices

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, were

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 reporting -

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 .

EPA has reviewed the study submitted release per minute) assumptions . Champlin should . -justify the meteorological

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 cmene 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

l EPA Company on the refining industry, EPA review A Oi . 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 was

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, which

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 . the
p.15

Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices 28749

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 test rule, EPA held an RM1 disposition USEPA (September 17, 1991) c

. 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)

.

information was considered in (19) Radian Corp Alliance. Comments on EPA's section

. 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 information, EPA m 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 TSCA Public Information Office. USEPA (April. 1992).

this time . (September 17,1991)

(8) U.S . (21) Radian Corp. Volatile Indicator

. 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 for

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