# + 2

(,1 1/,1(

Citation: 58 Fed. Reg. 28736 1993

Content downloaded/printed from HeinOnline (http://heinonline.org) Thu May 5 13:17:21 2011

-- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from uncorrected OCR text.Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

ENVIRONMENTAL PROTECTION
AGENCY [OPPTS-47002K; FRL-4069--]

RIN 2070-AC31

TSCA Section 4(aX1XB) Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial

or SignificantHuman Exposure

AGENCY: Environmental Protection Agency (EPA). ACTION: Final Statement ofPolicy.

SUMMARY: EPA is articulating standards and criteria for making findings it will

use in implementing its authority under theToxic Substances ControlAct (TSCA) section 4(a)(1)(B)(i). Under this policy, EPA will use as guidance threshold amounts to make "substantial" production, release, and human exposure findings under TSCA section 4(a)(1)(B). However, EPA may also make such findings in situations where the quantitative numerical thresholds are notmet ifadditional factors exist. EPA will continue to develop and refine the criteria asits experience with chemical substances and mixtures (chemicals)considered for testing evolves, particularly with regard
to the findings of "significant" human
exposure, for which EPA is not establishing a minimum numerical threshold in this notice.This notice also addresses specific issues related to EPA's existing cumene testrule (July27, 1988, 53 FR 28195). FOR FURTHER INFORMATION CONTACT: Susan B.Hazen, Director, Environmental Assistance Division (TS799), Office ofPollution Prevention and Toxics,rm. E-543B, 401 M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENIARY INFORMATION: Electronic Availability: This document is available as an electronic file on The Federal BulletinBoardat 9 a.m. on the date of publication in the Federal Register. By modem dial (202) 512-1387

or call (202) 512-1530 for disks orpaper copies. This file is also available in Postscript. Wordperfect and ASCII.

EPA is articulating guidelines for finding that "a chemical substance or mixture is or willbe produced in substantial quantities, and (I)it enters or may reasonably be anticipated to enter the environment in substantial quantities, or(ii) there is or maybe significant orsubstantial human
exposure to such a substance or mixture," under TSCA section 4(a)(1)(B)(i). In ChemicalManufacturers Associationv. Environmental Protection Agency, 899F.2d 344 (5th Cir. 1990), the Fifth Circuit Court ofAppeals (the "Court") remanded to EPA the rule issued pursuant to 4(a)(1)(B) forcumene testing and required EPA to articulate criteria for the findings EPA made In the

cumene test rule (53 FR 28195, July 27, 1988). EPA has decided to use this opportunity to articulate criteria for making all findings under section 4(a)(1)(B)(i) ofTSCA.

This notice does not address how EPA will set priorities for testing or how EPA will determine the specific tests to be performed. Rather, this notice addresses

one element in EPA's process for selecting appropriate candidates for testing

- i.e, how EPA will determine whether the chemical is orwill be "produced in substantial quantities," whether it "enters ormay reasonably be anticipated to enter the environment in substantial quantities," and whether there is or may be "significant or substantial human exposure," as used in TSCA section 4(a)(1)(B)(i).

I. Introduction

A. Remand

On April 12, 1990, the Fifth Circuit Court ofAppeals remanded to EPA the TSCA section 4 test rule for cumene based on a challenge to the rule by the Chemical Manufacturers Association (CMA). CMA v.EPA, 899 F.2d 344 (5th Cir. 1990) (hereinafter "cumene decision"). The Court generally upheld EPA's factual findings in the rule as being supportedby substantial evidence but instructed the Agency to "articulate the standards orcriteria on the basis of which it found the quantities ofcumene entering the environment from the facilities in question to be 'substantial'," 899 F.2d at 360. In this notice. EPA is articulating standards and criteria It will

use in making findings under section 4(a)(1)(B)(i) ofTSCA. Additionally, EPA is responding to the instructions by the Court regarding the application of such criteria to the cumene rule.

B. Background

Congress enacted TSCA to give EPA the authority to assess and prevent unreasonable risks associated with the manufacture, processing, distribution in

commerce, use, or disposal ofchemicals through a variety ofregulatory moans. 15 U.E.C 2601, et seq. This authority includes, among other things, the authority to require chemical testing to develop data forrisk assessment, 15 U.S.C. 2603, and the authority toban chemicals if necessary to prevent unreasonable risks. 15 U.S.C. 2605. A principal tenet underlying TSCA is that "adequate data should be developed with respect to the effect ofchemical substances and mixtures on health and the environment and that the development of such data should be the responsibility ofthose who manufacture and those who process such chemical substances and mixtures." 15 U.S.C. 2601(b)(1). See ChemicalManufacturers Associationv.EPA, 859 F.2d 977, 980 (D.C. Cir. 1988) (hereinafter "EHA decision"). To accomplish this goal, EPA has established a program for the testing ofchemicals.

EPA must make findings under either section 4(a)(1)(A) ("A" finding) or 4(a)(1)(B) ("B" finding) ofTSCAbefore testingmay be required ofa manufacturer or processor. Both the "A" and "B" findings under TSCA section 4(a)(1) require the Administrator to find that "there are insufficient data and experience upon which the effects ofthe manufacture, distribution in commerce, processing, use, or disposal ofsuch substance or mixture or any combination ofsuch activities on health

or the environment can reasonably be determined or predicted," and that "testing of such substance ormixture with respect to such effects is necessary to develop such data." 15 U.S.C. 2603(a)(1)(A){ii)--iii) and 2603(a)(1)(B)(ii)--(ii).

To require testing under section 4(a)(1)(A) ofTSCA the Administrator
must find that "the manufacture, distribution in commerce, processing,
use, ordisposal ofa chemical substance

or mixture, orthat any combination of such activities, may present an unreasonable risk of injuryto health or the environment" (emphasis added). In the EHA decision, the Court found this provision to require EPA to establish a "more than theoretical basis" for finding that the chemical may present an unreasonable risk, but that EPA could establish existence and amoint of human exposure to the chemical on the basis ofinference drawn from circumstances under which the chemical is manufactured and processed. 859 F.2d at 991. This interpretation ofthe statute "prevents a testing rulebased on little more than scientific curiosity, yet allows the Agency to act when an existing possibility ofharm raises reasonable and legitimate cause forconcern." Ausimont U.S.A. v.EPA, 838 F.2d 93, 97 (3rd Cir. 1988).

In contrast to TSCA section 4(a)(1)(A), under TSCA section 4(a)(1)(B), there is

no risk-based criterion to satisfy. See 899 F.2d at 347, n.4 (cumene decision). According to the legislative history, the provisions of TSCA section 4(a)(1)(B)(i) reflect the "Conferees' recognition that 28736

HeinOnline -- 58 Fed. Reg. 28736 1993Federal Register / Vol. 58, No.. 92 / Friday, May 14, 1993 / Notices

there are certain situations in which testing should be conducted even though there is an absence of information Indicating that the substance ormixture per se may be hazardous." H. Conf.Rapt. 1679. 94th Cong., 2d Sess. (1976), at 61, reprinted in A Legislative History ofthe Toxic Substances Control Act (Comm. Print 1976) ("Leg.Hist.") at 674; and H. Conf. Rapt. 1341, 94th Cong., 2d Sess. (1976), at 18, reprinted in Leg.Hist., at 425. Thus, under section 4(a)(1)(B) ofTSCA, EPA can act even in the absence of information that thechemical may be hazardous. Section 4(a)(1)(B)(i) requires the Administrator to find that "a chemical substance or mixture is or will be produced in substantial quantities, and (I)it enters or may reasonably be anticipated to enter the environment in substantial quantities, or (II) there is or may be significant or substantial human exposure to such substance or mixture."

This policy statement sets outEPA's interpretation ofsection 4(a)(1)(B)(i) of TSCA. This notice is not intended to address EPA's preliminary policy decisions for selecting chemicals as potential candidates fortesting. Likewise, it is not intended to address findings made under TSCA.sections 4(a)(1)(B)(ii) or (iii), or the scope of testing that may eventually be imposed by EPA. It is only intended to articulate the standards and criteria EPA will use in implementing its authority to make findings under TSCA section 4(a)(1)(B)(i). To this end, EPA published in the Federal Register onJuly 15, 1991 (56 FR 32294), itsproposed statement of policy regarding section 4(a)(1)(B)(i) of TSCA. EPA requested comments on its construction of the phrases "produced in substantial quantities," "enters or may reasonably be anticipated to enter the environment in substantial quantities," and "is or may be significant orsubstantial human exposure" as used in section 4(a)(1)(B)(i) ofTSCA.

C. The "B" Policy

Section 4(a)(1)(B)(i) ofTSCA requires the Administrator to find that a chemical substance or mixture is orwill be produced in substantial quantities, and "(1) it enters or may reasonably be anticipated to enter the environment in substantial quantities, or (II) there is or may be significant or substantial human exposure to such substance or mixture," to impose testing requirements. However, TSCA does not define the criteria or standards tobe used, or the meanings ofthe words "significant" or "substantial." Additionally, the legislative history ofTSCA provides no elucidation of these terms. Where a statute is silent or ambiguous on a particular issue, deference is accorded to any reasonable interpretation consistent with the statutory purpose. ChevronUSA, Inc.v.EPA. 467 U.S. 837, 842-844, (1984); NRDCv.EPA, 907 

### F.2d 1146, 1153 (D.C. Cir. 1990). The Fifth Circuit Court ofAppeals recognized this principle when reviewing thecumene test rule. According to the Court, where TSCA and its legislative history provide

no definition ofa term such as "substantial," "Congress is deemed to have implicitly delegated to the EPA the power to define orinterpret 'substantial,' and we will sustain the Agency's interpretation as long as itis rational and consistent with the statutory scheme and legislative history." 899 F.2d at 354.

[S]ubstantial is an inherently imprecise word. * ' no definition or group of criteria can be established whichwill function like amathematical formula, sothat for everygiven set offacts aspecific, predictable answer will always be forthcoming. Room mustbe leftfor the exercise ofjudgment.

Id.at 359. Clearly, there is nothing in the statutory language or legislative history that restricts the Agency's allowed interpretation of "substantial" or "significant" to consideration of particular quantities ofor other evidence relating toprodctton, release,

or exposure. In.fact, Congress provided

a list offactors which may or may not be considered by EPA in making TSCA section 4(a)(1)(B)(i) findings. H. Rapt. 1341, 94th Cong., 2d Sess. (1976), at 18, reprinted In Leg.Hist., at 425. See also

cumene decision, 899 F.2d at 356, n.16 ("Moreover, the quoted language in H. Rapt. 1341 ***is permissive and expansive in respect to what the EPA may consider and when it may require testing under section 4(a)(1)(B) ***").

In this statement ofpolicy, EPA is exercising its discretion by articulating quantitative thresholds to serve as guidance in making findings of "substantial" production, release, and human exposure. "Significant" human
exposure findings will bemade on a case-by-case basis. As explained in the proposed policy statement (56 FR 32294), it isEPA's beliefthatEPA may make findings under section 4(a)(1)(B)(i) ofTSCA based on quantitative thresholds. However, EPA doesnot intend to limit itselfto the use ofthese criteria in making "B" findings and

reserves the ability to consider other factors on a case-by-case basis. Such an interpretation is consistent with the legislative history ofTSCA and effectuates the policy objectives described in section 2 ofTSCA of developing adequate data with respect to chemicals andmaking the development ofthat data the responsibility ofchemical manufacturers and processors.
I. Response toPublicComments

A. Summary

EPA received written comments on the proposed statement ofpolicy from the Chemical Manufacturers Association (CMA), the Epoxy Resin Systems Task Group ofThe Society ofthe Plastics Industry, Inc. (SPI), the Monsanto Company, the Ecological and Toxicological Association ofthe Dyestuffs Manufacturing Industry (ETAD), the Callery Chemical Company, the Halogenated Solvents ndustry Alliance (HSIA), the GAF Chemicals Corporation (GAF), the BASF Corporation (BASF), the Arco Chemical Company (ACC), the U.S. Department of Labor's Occupational Safety and Health Administration (DOL/OSHA), and the U.S. Department ofHealth and Human Service's National Institute for Occupational Safety and Health (HHS/ NIOSH) (Refs. 1-9).

CMA's Acetone and Ketones Panels, Oxo Process Panel, Cumene Panel, Cyclohexane Panel, and Hexamethylene Diiosocyanate Panel, and the Diethyl Ether Manufacturers Task Group (Refs. 10-15) also submitted comments which supported, in general, the comments" submitted by CMA. These commenters

are collectively referred to as "CMA" hereafter in thisnotice. Comments submitted by these groups which are specific to aproposed test rule fora specific chemical will be addressed, as appropriate, in the final rule forthat specific chemical. Those rules will be published in the future. The comment periodswere reopened.for proposed test rules for Office ofDrinkingWater Chemicals (55 FR 21393, May 24,1990), Cyclohexane (52 FR 19096, May 20, 1987), 1,6-Hexamethylene, Dilsocyanate (54FR 21240, May 17, 1989), andNmethylpyrrolidone (55 FR 11398, March 28, 1990); See 56 FR 32292 Uuly 15, 1991). A summary ofthe comments received on the TSCA section 4(a)(1)(B) proposed statement ofpolicy-is included in the following Units I.B. -II.G., along with EPA's responses to comments.

B. Scope ofTesting

CMA and other commenters have expressed the concern that, given the criteria articulated in this notice, "nearly 8,000 substances will require [EPA) review under section 4(a)(1)(B)" (Refs. I and 5). These comments indicatethat many commenters have 28737

HeinOnline -- 58 Fed. Reg. 28737 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

misinterpreted the intended and actual scope ofthispolicy. The "B" policy is not intended to be, nor willitbe used

as an automatic triggerto testing. Nothing in thispolicy will require EPA
to immediately review any ofthe chemical substances currently in

commerce. Rather, this policy statement sets out EPA's interpretation ofthe findings itmust make under section 4(a)(1)(B)(i) and the general factors EPA will consider in evaluating section 4(a)(1)(B)(i)'s applicability in specific

cases. This policy statement is not intended to function as a tool for setting testing priorities. Testing riorities will be set by EPA's ongoing efrts in developing aMaster Testing List.This listwas made available to the public in EPA's Chemicals-in-Progress Bulletin (June, 1990). See also 56 FR 42055 (Aug. 26. 1991) for further information.

Many respondents, including CMA, have indicated their tacit support forthe threshold criteria articulated inthis policy notice, so long as "B" findings

are made only in support of rules requiring only tiered, screening level or "baseline testing" ofchemical substances (Ref. 1). CMA opposes utilization of the "B" policy criteria, and indeed, use ofEPA's section 4(a)(1)(B) testing authority forany other level oftesting.

On the policy as a whole, CMA commented that EPA'sproposed criteria under TSCA section 4(a)(1XB)(i) are reasonable as abasis forrequiring screening tests such asthe Screening Information Data Set (SIDS) utilized by the Organization forEconomic Cooperation and Development (OECD) for high production volume (HPV) chemicals. CMA stated, "EPA's proposed 'B' criteria would provide a suitable basis for selecting substances for such screening tests" (Ref. 1). CMA proposed that, ifscreening studies reveal the potential for adverse effects. then EPA should add the chemical to a subsequent proposed rule underthe authority ofTSCA section 4(a)(1)(A), the "may present" finding. CMA proposed that, in the absence oftoxicity concerns, EPA should require additional testing only ifit concludes that exposure is "unusually great." CMA argued that

more rigorous "B"criteria, which take into account all aspects ofexposure, must be developed by EPA to select such high exposure substances for additional testing. CMA stated that it would not oppose EPA's criteria ifthey

were incorporated into the tiered approach described above. CMA would oppose EPA's "B" criteria, ifthey are used forany other purpose. CMA further asserted that ifa "B" finding is based "solely on the magnitude of environmental releases, the Agency should limit rules supported by such findings to chemical fate and environmental effects testing" (Ref. 1).

EPAbelieves that any linkage between the particular numerical threshold criteria articulated inthis policy statement, or theparticular findings made under TSCA section 4(a)(1)(B)(i), and the nature and scope of testing tobe required once such a finding has been made,is misplaced, and indeed, based on a misinterpretation ofthe scope ofEPA's testing authority under section 4 of TSCA.

TSCA section 4(a) states: (a)TESTINGREQUIREMENTS.--f the Administrator finds that-

(1)(A)(i)themanufacture, distribution in

commerce, processing, use,or disposal ofa chemical substance or mixture,or that any combination ofsuch activities,may present

anunreasonable riskofinjury tohealth or the environment, ii)there areinsufficient data and experience upon which theeffects ofsuch manufacture, distribution Incommerce, processing, use,or disposalofsuch substance

or mixture or ofanycombination 6fsuch activities onhealth ortheenvironment can reasonablybe determined or predicted, and

(iii) testing ofsuch substance or mixture with respectto such effects isnecessary to develop such data; or

(B)(i) achemical substance ormixture isor willbe producedin substantialquantities, and (I)itentersor mayreasonably be anticipated toenter theenvironment in substantial quantities or (I) there is ormay besignificant orsubstantial human exposure to such substance or mixture,

(ii)there are insufficient data and experience uponwhich theeffects ofthe manufacture, distribution Incommerce, processing,use,or disposal ofsuch substance

or mixture or ofanycombination ofsuch activities onhealth orthe environment can reasonably be determined orpredicted, and

(iii)testing ofsuch substance ormixture withrespect to such effects isnecessary to develop such data; and * * *

the Administrator shall byrulerequire that testingbe conducted on such substance or mixture to develop data withrespect tothe health andenvironmental effects for which there is an insufficiency of data and experience and which are relevant to a determination that themanufacture, distribution incommerce, processing, use,or disposal ofsuch substance or mixture,or that any combination ofsuch activities, does or does not present an unreasonable riskof injury tohealthor theenvironment.

15U.S.C. 2603(a) (emphasisadded).
The final paragraph ofsection 4(a) sets outEPA's authority to require testing

once the Agency has made the findings under section 4(a)(1)(A) or (B). The directive ofthisfinal paragraph clearly relates to the "data insufficiency" and "testing is necessary" findings of sections 4(a)(1)(A)(ii) and (iii)and (B)(ii) and (iii). it bearsno dependence on or other relationship to the findings under either subsection 4(a)(1)(A)(i) or(B)i).

Thus, once the Administrator has made a findingunder TSCA section 4(a)(1)(A)(i) that a substance may present an unreasonable risk, or under TSCA section 4(a)(1)(B)(i) that a substance is or will be produced in substantial quantities and may either
enter the environment in substantial quantities orthat there maybe substantial or significant human
exposure tothe substance, the Administrator may require any type of testing necessary to address unanswered questions about the effects ofthe substance. EPAneed notlimit the scope oftesting required to the factual bases for the section 4(a)(1)(A)(i) or (B)(i) findings.

Essentially, under TSCA section 4(a)(1)(B), EPA may require health effects testing even ifit has only made

a finding that there is or may be substantial entry into the environment ofa substance, orrequire environmental effects testing even ifit has only made

a finding that there is or may be substantial or significant human exposure to a substance. Clauses (I)and (II) ofsection 4(a)(1)(B)(i) can be interpreted as mutually exclusive. See

cumene decision, 899 F.2d at 357n. 19. Either finding is sufficient torequire testing, so long asEPA finds thatdata relevant to a determination ofwhether

a substance does or does not present an unreasonable riskofinjury to health or the environment are insufficient and that testing is necessary to develop such data. It is the interrelationship ofthe existing data set and numerous other substance-specific parameters, which

are evaluated under subsections (ii) and (iii) of section 4(a)(1)(B), that determines the specific testingrequirements, ifany, for a particular substance.

EPA notes, however, that while it has the authority to require testing forany health and environmental effects once it has made afinding under either section 4(a)(1)(A)(i) or (B)(i) of TSCA, the Act does notcompel EPA torequire testing ofall health orenvironmental effects endpoints in all cases. Rather, once EPA has decided that it willrequire testing, EPA must also determine what data are sufficient and what testing is necessary in each particular case in promulgating specific testing requirements. In addition, once EPA has decided to require testing,EPA alsoconsiders, among otherfactors, "the relative costs of the various test protocols * **and the reasonably foreseeable availability ofthe facilities and personnel needed to perform the testingrequired under the 28738

HeinOnline -- 58 Fed. Reg. 28738 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

rule." TSCA section 4(b)(1), 15 U.S.C. 2603(b)(1).

Furthermore, IfCongress had intended that the testing required under section 4(a)(1)(B) berelated to whether the findings are based on information about human exposure or environmental release, it is reasonable
to conclude that Congress would have used the word "or" instead of"and" when directing the Administrator to require testing "to develop data with respect to the health and environmental effects *'*" in the final paragraph of section 4(a). However, the explicit choice ofthe word "and" in this final paragraph indicates that Congress authorized EPA to require health and environmental effects testing independent ofthebasis for an (A)(i) or (B)(i) finding. Indeed, EPA has consistently interpreted the "testing is necessary" under TSCA sections 4(a)(I)(A)(iii) and (B)(iii) to mean that

EPA mayrequire any health or environmental effects testing for which data

are insufficient and which EPAbelieves are "capable ofdeveloping the necessary information." See 45 FR 48510,48530 (July 18.1980).

EPA's broad mandate to require testing is also reflected in the legislative history ofTSCA. See H. Rapt. 1341, 94th Cong., 2d Seass. (1976), at 3-6,reprinted in Leg. Hist. at 411-414. The breadth of TSCA's authority to require testing is
most apparent in TSCA section 4(a)(1)(B) which, according to the Conference Report on TSCA, authorizes EPA to require testing "even though there is an absence ofinformation indicating that the substance ormixture
per se may be hazardous." H. Conf. Rept. 1679,94th Cong., 2d Sass. (1976),

at 61, reprinted in Leg. Hist. at 674. See also H. Rapt. 1341, 94th Cong., 2d Seass. (1976), at 18, reprinted in Leg. Hist. at 425.

Finally, in the cumene decision, the Court supported EPA's interpretation regarding the relationship between the findings under TSCA subsection 4(a)(1)(B)(i) and subsections 4(a)(1)(B)(ii) and (iii):

Afinding under section 4(a)(1)(B)(i) does
not alonejustify a testing order. Itmust also be found under section 4(a)(1)(B)(ii) that 'there are insufficient data and experience upon which the effects ofthe manufacture for processing, etc.) *** ofsuch substance * *

on health orthe environment can reasonably be * predicted.' Similarly, section 4(a)(1)(B)(iii) imposes the further requirement that the testingbe 'necessary to develop such data' (emphasis added)-- i.e.,
necessary to renderthe experience and data sufficient asa basis on which the health and environmental effects ofthe manufacturing (orprocessing, etc.) can reasonably be predicted **

. Ifthe EPA properly concludes that the existing data and experience do not suffice as a basis for ittoreasonably predict that there will be nohealth or environmental injury fromthe manufacturing (orprocessing, etc.) ofthe chemical, then affirmative evidence and findings ofriskofsuch injury athypothetical toxicity levelsunder section 4(a)(1)(B)(i) are not necessary to provide a
nexus between requiring testing under section4(a)(1)(B) and congressional concern for health and the environment.

899 F.2d at 354-355 (emphasis in original). Given thatTSCA section 4(a)(1)(B)(i) gives EPA authority to require health and environmental effects testing even in the absence of information that a substance is hazardous, it is reasonable that the specific testing to be required relates to the data insufficiency and testing is
necessary findings under TSCA section 4(a)(1)(B)(ii) and (iii) rather than to the environmental release or human
exposure finding made under TSCA section 4(a)(1)(B)(i).

C. Substantial Production

EPA proposed a value of 1million pounds as a threshold level for findings of"substantial production." 56 FR 32296. As an alternative to this threshold, EPA solicited comments on the adoption ofthe TSCA section 5(e) New Chemical Program's exposurebased substantial production threshold (i.e., 220,000 pounds) or some higher threshold (56 FR 32299).

Both CMA and SPI commented that EPA's proposed production threshold is

a reasonable interpretation of "substantial production" underTSCA section 4(a)(1)(B) (Refs. 1and 2). However. according to CMA, "[wihile EPA's approach is a reasonable one, a production threshold of2.2 million pounds would be preferable to achieve consistency between EPA's activities under TSCA section 4 and the OECD HPV Existing Chemical Testing Program" (Ref. 1). CMA noted that for "purposes ofrequiring certain extensive types ofstudies, EPA also uses 2.2 million pounds as a production volume trigger in its new chemicals program under TSCA section 5" (Ref. 1). HSIA also suggested use ofTSCA section 5 trigger for substantial production (Ref. 6). Monsanto (Ref. 3), HSIA (Ref.6),and ETAD (Ref. 4) also support the adoption ofthe OECD HPV threshold for the

purpose ofinternational harmonization.

EPA disagrees with CMA and HSIA that 2.2 million pounds production is the sole threshold utilized in the TSCA section 5 New Chemicals Program. In general, screening level toxicity studies forhuman health and/or environmental effects may be required for chemical substances expected to be produced in quantities equal to or greaterthan 220,000 pounds per year. The New Chemicals Program, as a matter of poicy, may specify higher tiered testing e8g., bloassay, neurotoxicity) under certain circumstances (i.e.,use in

consumer products) for those chemicals anticipated tobe annually produced in
amounts of2.2 million pounds or greater, however, the exposure-based substantial production threshold for considering testing under section 5(e)(1)(A)(ii)(II) is220,000 pounds (Ref. 16).

-

EPA disagrees thatthe OECD HPV threshold would be a more reasonable approach forthe initial threshold under TSCA section 4. The OECD HPV threshold was established under different circumstances than the proposed threshold for "substantial production." Eighteen member countries (including all major producing countries) developed national inventories ofHPV chemicals manufactured or imported into their countries. These inventories were merged into a comprehensive inventory maintained by the OECD, and is called the OECDRepresentative List (Ref. 17), which includes allchemicals (excluding polymers andpetroleum fractions) reported in any member country in

excess of10,000 tonnes (22million pounds)and all chemicals reported in
two or more countries in excess of1,000
tonnes (2.2 million pounds). Hence, the OECDHPV production volume threshold of2.2 million pounds was conceived merely to guide the generation ofnational inventories which when combined would yield an international list ofhigh production volume chemicals. Itwas assumed by OECD that the production volume alone would be a sufficient indicator of potential exposure such thatthe OECD's program on existingchemicals has focused since 1988 on the chemicals found on the OECD Representative List.

The TSCA section 4(a)(1)(B)(i) finding ofsubstantial production isnot the sole finding EPA must make torequire testing. The threshold ofI million pounds set forth by EPA in itsproposed statement ofpolicy (56FR 32294) is one ofseveral findings EPA must make before a substance maybe subject to testing. EPA must also find that there is substantial release, or substantial or significant human exposure under TSCA sections 4(a)(1)(B)(i)(I) and (II). In addition, EPA must find that data are insufficient and testing is necessary under TSCA sections 4(a)(1)(B)(ii) and (iii). EPA does notbelieve that a production volume threshold which is chosen to generate an inventory for an international program on existing 28739

HeinOnline -- 58 Fed. Reg. 28739 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

chemicals and which is the only trigger for entry into that program should be determinative ofthe threshold chosen for "substantial production" under TSCA section 4(a)(1)(B)i).

GAF, BASF, and ACC objected to the proposed threshold on two grounds. First, the proposed threshold value will involve subjecting 95 percent ofU.S. chemical production (on a total volume basis--i1 percent on number of chemicals basis) to potential testing. They argue that because the threshold will encompass such a large percentage ofchemical production, the threshold reflects an incorrect interpretation of section 4(a)(1)(B) (Ref.7).

As previously explained, EPA has broad discretion in defining "substantial" and could choose a quantitative threshold atany point along a wde spectrum when construing the meaning of "substantial production." For instance, Ifone were to create a chart ranking from lowest to highest the aggregate production for all substances on the TSCA Inventory, EPA could interpret the term "produced in substantial quantities" narrowly to apply only to substances produced in volumes at the extreme top end ofthe chart. EPA could also choose to adopt

abroader interpretation, finding all chemical production tobe substantial unless itfell below a value at the
extreme low end ofthe chart.

EPA has proposed a production figure inbetween the twoextremes. The 1 million pound threshold for production

narrows the "universe" ofchemicals potentially subject to TSCA section 4 testing under TSCA section 4(a)(1)(B) to 11 percent ofthe TSCA Inventory. Since that small percentage ofthe Inventory
accounts for95 percent oftotal chemical production, it is reasonable to use this information as a basis formaking a finding of"substantial production" for substances produced in excess ofthat threshold.

GAF, BASF, andACC also commented that the I million pound threshold "will imposean unfair economic burden on chemical manufactUrers andprocessors that could stifle technological innovation" (Ref.7). This comment (whichis unsupported by any empirical data) also appears to reflect a misunderstanding ofthe scope ofthis policy statement.

Neither the "B" policy nor any particular numerical threshold set forth herein constitutes an automatic trigger for testing. Furthermore, this policy
statement does not address theamount oftesting tobe required for chemicals meeting the "B" fiadings criteria, so it is not possible to determine whether a particular production volume threshold would have any economic impact.

EPA does, however, carefully considerthe potential economic impacts and the value oftesting data forall section 4 testrules. For each chemical subject to testing, EPA conducts an analysis which estimates the costs of testing. In addition, EPAconsiders any comments received on the economic effects ofproposed testing requirements when developing final rules under section 4, and may revise testing requirements when respondents demonstrate that the rule would impose excessive economic burdens or would stifle technological innovation.

The consideration ofeconomic impacts is particularly important for chemical testing decisions because EPA's purpose in using section 4isto obtain data for use in risk assessment and, where necessary, risk management activity. EPA recognizes that ifthe testing it requires on a substance under section 4 imposes an unfair or excessive burden, the likely result ofthe section 4rule would be to drive the chemical from the market, rather than toproduce
test data.To insure that test data are received, EPA must be concerned with any significant adverse economic impacts associated with section 4test rules. Economic considerations are therefore well integrated into EPA's testing decisions.

Inresponse to EPA's alternative threshold proposal for the substantial production criterion (220,000 pounds) used in the review ofnew chemical substances under section 5ofTSCA, Callery Chemical Company stated,

Ia~t thisthreshold production level, the publication ofproduction quantities willnot only reveal extremely sensitive confidential business information but will clearly overwhelm the Agency withwork that it cannot handle (Ref. 5).

EPA believes that adopting the threshold ofsubstantial production used inthe review ofnew chemical substances under section 5(e) ofTSCA is inappropriate at thistime, although fordifferent reasons. Callery Chemical Company's concern about public disclosure ofsensitive business information is addressed elsewhere in this notice (UnitIl.F.ofthis notice). EPA recognizes that the number of chemicals which could be considered as potential testing candidates under section 4 ofTSCA would be greater if the lower threshold value of220,000 pounds were adopted. However, substantial production is only one ofthe findings that EPA must make in order to propose chemical testing under section 4 ofTSCA. Therefore, there is no reason tobelieve based on a lower threshold alone that EPA would be overwhelmed,

as Callery Chemical Company believes, by adoption ofthe TSCA section 5 threshold value for substantial production. Nevertheless, for the

reasons set forth above and in the proposed policy, EPA will adopt the 1 million poundthreshold for "substantial production" under section 4(a)(1)(B)(i) ofTSCA.

D. Substantial Release
Ifthe criterion for "substantial production" is met, then at leastone of three additional findings under TSCA section 4(a)(1)(B)(i) must also be made before testing isrequired. The first of these findings is that the substance "enters or may reasonably be anticipated to enter the environment in substantial quantities" under TSCA section 4(a)(1)(B)(i)(I). EPA refers to this finding as "substantial release" and proposed that a value ofI million pounds peryear release or release of10 percent ormore oftotal production volume, whichever is lower,be established as the threshold value for "substantial release." As an alternative
to this threshold, EPA solicited
comments on the adoption ofa fixed threshold, such as 100,000 pounds or 1 million pounds (56 FR 32296).

CMA, HSIA, and SPI disagree with EPA's interpretation that "enters the environment in substantial quantities"
euates with "substantial" release. These commenters contend thatEPA
must consider not simply the total poundage released but also other factors that address the potential for human and/or environmental exposure such as the chemical's persistence in the environment and its likely or estimated concentrations in various environmental media (Refs. 1,2 and 6).

EPA disagrees with the commenters' arguments regarding what information EPA must consider when making a findingunder TSCA section 4(a)(1)(B)(i)(I). In effect, CMA attempts to import the "exposure" component of clause (11) ofsection 4(a)(1)(B)(i) into clause (I). However, as indicated by the word "or" between the two clauses, clauses (I)and (I) of section 4(a)(1)(B)(i)

can be interpreted as being mutually exclusive. While EPA may, ifit chooses, make afinding under both clause (I) and clause (II), a finding under either clause alone, coupled with findings under 4(a)(1)(B)(ii) and (iii), is sufficient to support a test rule.

EPA believes that it is reasonable to interpret section 4(a)(1)(B)(i)(I) to mean that any release during the manufacture, distribution in commerce, processing,

use or disposal ofa chemical substance, 28740

HeinOnline -- 58 Fed. Reg. 28740 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

is, per se,"entry" ofthat substance into the environment, irrespective ofthe substance's subsequent persistence or concentration in the environment. TSCA explicitly uses different terms, "enters" in clause (I), and "exposure" in clause (II). There is nothing in the
statute or legislative history that clearly indicates that clause (I)necessarily embraces or incorporates an "exposure" component, ora durational or persistence requirement. Moreover, in the cumene decision, the Court explicitly rejected CMA's argument that EPA must incorporate a "persistence" component in making a section 4(a)(1)(B)(i)(l) finding. See 899 F.2d at 355-356, and n. 15-16. For these

reasons, EPA believes that its interpretation ofthe phrase "enters the environment" as encompassing any "release" to the environment is a reasonable reading ofsection 4(a)(1)(B1)(i)(1).

CMA also commented that EPA should clarify that, as in section 313 ofEPCRA, the only releases on which a "B" finding will be based are releases to airor water beyond site boundaries. Releases or transfers to treatment and waste disposal facilities raise entirely different exposure considerations and should not be taken into account in making "B" findings (Ref. 1).

EPA disagrees with CMA's characterization ofthe scope ofthe term "release" in EPCRA, and as the Agency is using that term in its interpretation of TSCA section 4(a)(1)(B)(i)(1). Contrary to CMA's assertion, EPCRA does not limit the term "release" only to releases to ."air or water beyond site boundaries." Rather, "release" isbroadly defined in EPCRA section 329(8), 42 U.S.C. 11049(8), as

spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing Into the environment *""

Similarly, EPCRA section 329(2), 42 U.S.C. 11049(2), defines the term "environment" broadly to include

water, air, and land and the interrelationship which exists among and between water, air, and land and all living things.

An identical definition of "environment" appears in TSCA section 3(5), 5 U.S.C. 2602(5). The limiting phrase "beyond facility site boundaries"
appearsonly in EPCRA section 313(d)(2)(A). 42 U.S.C. 11023(d)(2)(A). Under this provision ofEPCRA. when considering the reasonably anticipated "significant adverse acute human health effects" ofa chemical in the context of

an Agency decision to list or delist a chemical on the Toxics Release Inventory, the Agency is limited to a consideration ofthose effects which would occur "at concentration levels that arereasonably likely to exist beyond facility site boundaries asa result ofcontinuous, or frequently recurring releases." This limitation applies only inthis instance, and does
notapply to ormodify any other clause ofEPCRA section 313. Therefore, CMA's attemptto limitthe scope ofthe term "release" under EPCRA, and torelate thislimitation toreleases considered under TSCA, is baseless.

Moreover, neither "release" nor "enters the environment" is defined in TSCA. As explained above, EPA believes that it is reasonable to Interpret clause (I)ofsection 4(a)(1)(B)(i) ofthe Act to encompass any release ofthe substance to the environment. For purposes ofthis policy, and consistent with the definition of"environment" in TSCA, "enters the environment" under section 4(a)(1)(B)(i) includes any releases to "water, air, and land" that result from or may reasonably be anticipated to result fromthe manufacture, processing, distribution in
commerce, use or disposal ofa chemical substance or mixture, regardless ofthe

source or nature ofthe release.

Furthermore, TSCA's scope is not limited to consideration ofonly releases from a site ortransfers to treatment and waste disposal facilities. Rather,TSCA is intended to broadly address the general uncertainty about the effects of the manufacture, processing, distribution in commerce, use or disposal ofa chemical substance or mixture.

SPI commented that EPA's proposed 1million pound release threshold, and the proposed alternative 10percent of production volume threshold, were "arbitrary" and that "EPA does not provide any support forthe selection of 10percent ofthe production volume other than it would seem to be a sizable number. Absent any frame ofreference such as exposure, or presence in the environment, such a number is no less valid than Ipercent or 60 percent" (Ref. 2).EPA disagrees with SPI's comment. In choosing the 1million pound threshold value torepresent "substantial" release, EPA wasguided by the same considerations that were used to determine the threshold value for "substantial" production. In choosing the poundage threshold, EPA used the Toxics Release Inventory (TRI)in judging the "substantial" nature ofthat
amount ofrelease. EPA has determined that 37 percent of thechemicals listed

on theTRI have releases ofover 1 million pounds and that these releases account for99 percent ofthe total reported release on theTRI by volume. Clearly, the small percentage ofTRI chemicals that exceed the selected poundage threshold accounts for the
vast majority oftotal TRI releases. Itis reasonable for EPA to use that information asa basis forfocusing its attention on chemicals released in

excess ofthat threshold.

In addition, asstated in the proposed policy statement (56 FR32296). the percentage threshold has been proposed because EPA is also concerned about chemical releases that are a sizable percentage ofthe production volume of that chemical. EPAbelieves that when such a sizable percentage ofa chemical's production volume is released, that release should be considered "substantial" for that chemical substance. This threshold will allow EPA the flexibility torequire testing ofchemicals with production volumes equal to or greater than 1 million pounds per year,but with releases ofless than Imillion pounds
per year.
E.SubstantialandSignificantHuman Exposure

EPA proposed that "substantial exposure" means exposure to large numbers ofpeople (56 FR32297). and
set out the following numerical thresholds fora finding of"substantial exposure": 1,000workers, 10,000
consumers, and/or 100,000 persons in the general population. EPA proposed that "significant exposure" refers to the
nature ofthe exposure. A finding of "significant exposure" would generally be made where the numerical threshold for numbers ofpersons exposed for "substantial exposure" is not met.but the nature ofthe exposure Is sufficiently direct, large or prolonged. However, EPA may make a finding that there is or may be both significanthuman exposure and substantial human exposure, ifthe number ofpeople exposed exceeds the thresholds set forth in thispolicy and the nature ofthe exposure is also significant as set forth in this policy. As

an alternative to these thresholds, EPA solicited comments on the adoption of either the TSCA section 5(e) New Chemical Program's exposure-based criteria for "substantial" and "significant" human exposure or some other criteria forwhich there is a strong basis or supporting rationale (56 FR 32299-32300).

OSHA and NIOSH submitted
comments supportive ofEPA's statement ofpolicy for determining "substantial" and "significant" human
exposure. In fact, NIOSH "urges EPA to seriously considerits alternative 28741

HeinOnline -- 58 Fed. Reg. 28741 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

proposal*** that would result in testing compounds forwhich fewer than 1,000 workers are exposed" (Ref. 9). OSHA agreed with EPA that, for TSCA purposes, the proposed definitions for "substantial" human exposure and "significant" human exposure set reasonable criteria for determining if testing is required when toxicity data

are absent or incomplete. Accordingly, "OSHA believes that exposure of 1,000 workers to a chemical ofunknown toxicity represents adequate impetus to require testing" (Ref. 8). In addition, OSHA stated that the proposed distinctionbetween " Abstantial" human exposure and "significant" human exposure is appropriate (Ref. 8).

1. Substantial human exposure.CMA, SPI, Monsanto, ETAD, HSIA, GAF, BASF, and ACC submitted comments that questioned the definitions and rationale underlying the proposed criteria. A common comment was that EPA had notprovided sufficient rationale tojustify the proposed numerical thresholds fordetermining "substantial" human exposure.

EPA disagrees with the commenters' suggestion that EPA did not provide sufficient rationale forthe numeric thresholds chosen to guide "substantial" human exposure findings. As articulated in the proposed policy

statement (56 FR 32297), EPA chose numeric thresholds to characterize "substantial" human exposure because it is EPA's beliefthat TSCA section 4(a)(1)(B) was intended to address situations where large numbers of people may be exposed to a chemical substance and little orno hazard data exists to indicate whether or notthat chemical substance may present an unreasonable risk.EPA hasbased its thresholds forworkers on experience gained through case-by-case analysis of existing substances. Furthermore, according to the National Occupational Exposure Survey (NOES) data (Ref. 18),

an average of650 workers are potentially exposed to achemical substance produced In a quantity of 1 million pounds. In other words, fora chemical produced in a quantity of 1 million pounds, it isrelatively

uncommon that as many as 1,000 workers would be exposed. Given this analysis and its experience ofcase-bycase analysis ofexisting chemical exposure over theyears, EPA believes that ithas reasonably Interpreted "substantial human exposure" under TSCA section 4(a)(1)(B)(i)({I) by utilizing a relatively conservative threshold ofexposure of 1,000workers to achemical substance. Moreover. although manyrespondents do not favor EPA's rationale for making a determination ofsubstantial human
exposure, they did not specifically argue that these thresholds were unreasonable, nor didthey provide any specific alternative criteria orrationale.

The different numeric thresholds for worker, consumer, and general population exposure are EPA's attempt to reflect the inherent differences in the probable exposure scenarios for particular categories ofindividuals. As stated inthe proposed policy statement, "workers generly are exposed on a

more routine or directbasis than
consumers, and consumers are generally exposed on amore direct basis than the general public" (56 FR 32297, July 15, 1991). EPA has decided to apply a differential equal to one order of magnitude between the worker,
consumer, and general population thresholds. EPA believes this approach is reasonable and sufficiently reflects the inherent differences in the probable
exposure scenarios for each ofthe categories ofindividuals. Both OSHA (Ref. 8) and NIOSH (Ref. •9) supported the basis forthe distinction between substantial exposure to workers,
consumers, and the general population. EPA recognizes that this approach, which is consistent with the Fifth Circuit's cumene decision, integrates to

some extent the concepts of "substantial" and "significant" in determining what constitutes "substantial" human exposure. 899 F.2d
at 356, n. 17 (cumenedecision); and 56 FR 32297-32298 (July 15, 1991).

Although commenters generally criticized EPA's rationale for choosing the numeric thresholds articulated in the proposed policy statement, none of the comments offered any specific alternative thresholds formaking a section 4(a)(1)(B)(i)(H) finding. Many comments expressed the view that EPA
must consider certain chemical specific factors to make a "substantial" human
exposure finding.

CMA and other commenters objected
to EPA's threshold approach for determining "substantial" exposure because it is based solely on numbers of people exposed and does nottake into
account the physical andbiological properties orachemical, the manner of its use andrelease, the level, frequency, and duration ofexposure, nor any available relevant exposure data. CMA
argues that EPA should "make prudent butrealistic assumptions about the
exposure levels that would be of regulatory concern iftesting demonstrates adverse effects" (Ref. 1).

EPA believes thatCMA's comments reflect an inaccurate understanding of the role ofchemical testing conducted under the authority of section 4 within TSCA's statutory framework and
purposes. As explained above in Unit I., TSCA was enacted to ensure that, given the exposure ofhumans and the environment to a large number of chemical substances andmixtures with potentially harmful effects, there would effective regulation ofcommerce in such substances. TSCA section 2(a), 15 U.S.C. 2601(a). Since the potential effects ofmany chemical substances in

commerce are not known, the policy provisions ofTSCA reflect Congress' intent that:

adequate data should bedeveloped with respect tothe effectof chemical substances and mixtures on health andthe environment and that thedevelopment ofsuch data should bethe responsibility ofthose who manufacture and those who process such [substances).

TS6A section 2(b)(1), 15 U.S.C. 2601(b)(1). Section 4 ofTSCA provides EPA the authority torequire such testing.

In effect, by urging EPA to make "assumptions about the exposure levels that would be ofregulatory concern if testing demonstrates adverse effects," CMA argues that EPA must make an affirmative finding that a chemical substance would pose an unreasonable risk ofinjury at some hypothetical levels of toxicity and exposure in order
to require testing under section 4(a)(1)(B) ofTSCA. This contention was explicitly rejected by the Court in the

cumene decision, 899 F.2d at 354-355.

Further, in contrast to the TSCA section 4(a)(1)(A) risk-based criterion and the TSCA section 6 risk/benefit analysis, a finding under TSCA section 4(a)(1)(B) requires norisk analysis. See 899 F.2d at 354 (cumene decision); and 859 F.2d at 979, and 984-988 (EHA decision). Additionally, asboth
exposure and hazard are factors used to determine whether a chemical may pose
a risk, without the necessary hazard information, making "prudent but realistic assumptions about the exposure levels that would be of regulatory concern if testing demonstrates adverse effects" would be

a meaningless exercise. The utility of the frequency, duration, and levels of
exposure is limited when EPA is acting in the absence ofinformation about the hazard ofthe chemical substance in question. Given the statutory framework ofTSCA, its legislative history, and the

case law interpreting the section 4 testing provisions, EPA does notbelieve that it is required to undertake the type ofdetailed exposure analysis urged upon It by CMA and other respondents in making the TSCA section 28742

HeinOnline -- 58 Fed. Reg. 28742 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 

### / Notices

4(a)(1)(B)(i)(H) "substantial" human
exposure finding.

Although EPA is not required to consider the factors enumerated above in making a finding of "substantial" human exposure, EPA did, as a matter ofpolicy, offer for consideration inthe proposed policy statement an alternative set ofhuman exposure criteria, based on theTSCA section 5(e) New Chemicals Program human exposure guidelines, which incorporated some ofthese factors (56 FR 32299-32300, July 15, 1991). However, despite an explicit invitation forcomments addressing the merit and feasibility ofapplying these guidelines in the context ofsection 4 testrules,

none of the comments addressed the specific numerical values and other factors outlined in EPA's proposed altemaqve thresholds. Comments on the alternative thresholds expressed only the general viewthat the section 5(e) criteria should not be applied toreview ofexisting chemicals under section 4(a)(1)(B). (Refs. 1and 2). Furthermore, EPA,solicited comments on adopting "some other criteria than the criteria proposed herein by EPA" and "the supporting rationale" for such criteria, yet received no comments offering any alternative thresholds orother specific sugestions or rationales.

Despite EPA's attempt to elicit more specific comments, most commenters addressed only the general concept of the proposed thresholds. Forexample, CMA argued that "Congress clearly expected EPA to demonstrate a pattern ofunusually large or widespread exposure which differentiates the test substance from typical chemicals in commercial use" (Ref. 1). Based on this argument, CMA suggested that EPA develop an analysis ofvariations in human exposure potential within the universe of commercially produced chemicals. Such an analysis would provide a basis for "low", "medium", and "high" exposure chemicals. For example, CMA stated that EPA had made no effort to determine whether there are many orfew chemicals to which at least 1,000 workers are exposed. Without such an analysis, CMA argued, one cannot conclude that
exposure to 1,000 workers is large or small fortypical chemicals in commercial production.

CMA suggested that data exist which could be used to make order-ofmagnitude distinctions regarding the number ofworkers and consumers exposed to different chemicals. Data

sources suggested by CMA include the NOES; information collected under the TSCA section 8(a) Preliminary Assessment Information Rule (PAIR); Household Solvent Products: A National Usage Survey, EPA/OTS 560/5-87-005; and the System forTracking the Inventory ofChemicals (STIC)Database, U.S. Consumer Product Safety Commission (CPSC) 1988. CMA also stated that about 400 substances have been screened under TSCA section 4 and that EPA's RM1 (RiskManagement1)process hasresulted in a systematic review ofavailable exposure information for a growing number of existing chemicals (Ref. 1).

As explained above, EPA disagrees with commenters' fundamental premise that the Agency isrequired toundertake

an analysis oftypical exposures ofall chemical substances currently in commercial production in order to support its interpretation ofthe term "substantial" under section 4(a)(1)(B)(i)(II) ofTSCA, or that such an approach was mandated by Congress. Neitherthe plain language ofTSCA nor the legislative history require EPA to undertake the kind ofexhaustive analysis urged upon it by CMA and other respondents to support findings under TSCA section 4(a)(1)(B)(i). In short,the cost ofgenerating the
exposure information necessary for this type ofanalysis may well exceed the
cost oftesting, and is not appropriate for

a decision to require testing under section 4 of TSCA.

EPA notes, however, that it does not itmore allofthese factors in making decisions to require testing under section 4 ofTSCA. For each substancespecific rulemaking under section 4, EPA must determine whether there is sufficient "data and experience" upon which to "reasonably determine or predict" the health and environmental effects ofachemical substance, and whether testing ofsuch substance is "necessary to develop such data." In making these determinations, the Agency has always, and will continue to examine all available and relevant information concerning the substance in question, including the physical and biological properties of the substance, the manner ofits use and release, the level, frequency, and duration of exposure, and any available relevant
exposure and toxicity data.It is the responsibility ofinterested parties to provide any information theybelieve may be relevant to the Agency's determination to require testing ofa particular chemical substance under TSCA section 4. Consequently, EPA always welcomes the submission of such information during the notice and
comment period provided prior to the promulgation ofany final test rule.

Furthermore, even ifEPA were to conduct theanalysis urgedupon it by CMA at thistime, the potential sources ofinformation identified by CMA present a numberofproblems for such

an analysis due to the limited scope of their coverage. These limitationsdiffer from database to database, and include the numberofchemicals covered, limited overlap between the databases, the specific data included in each database orinformation source, imprecise data concerning current production ofa given substance, gaps in exposure, use and release information, and differences in the qualityof data and the basis foreach estimated parameter. For example, the NOES database developed byNIOSH contains information on morethan 4,000 chemicals. This database contains useful information on the approximate number ofworkerspotentially exposed, the number offemale workers potentially exposed, the approximate number offacilities inthe industry handling the chemical, andthe industry Standard Industrial Code (SIC) where the chemical is found. However, by itself,the database isinsufficient to fully characterize the potential worker
exposures because the database does not contain information ofthe frequency, duration, orthe levels ofworkers' exposures. Due to these limitations, EPA does notbelieve that it is possible to develop an analysis ofthe variations in human exposure potential for the entire universe ofchemicals. However, in the
context ofa substance-specific rulemaking, EPA willcarefully consider the human exposure scenario. Once again, EPA invites interested parties to submit for EPA's consideration all available andrelevant information during the notice and comment period for each substance-specific rulemaking underTSCA section 4.

2. Significanthuman exposure.CMA, supported by SPI, agreed with EPA that "exposure can be considered 'significant' where the potential exposed population isnot largebut the conditions ofexposure areunique and create unusually greatconcern about the substance's potential for adverse effects" (Refs. I and 2). OSHA also agreed and stated,

lilfaworkeris exposed directly (i.e., by inhalation) or on aroutine orepisodic basis, itIsreasonable to determine that asignificant human exposureexists, even iffewer than 1000workers are exposed (Ref. 8).

However, CMA, HSIA and others commented that EPA'sproposed policy does not "meaningfully identify where such 'significant' exposures might exist" (Ref. 1).

EPA does notbelieve that it has, at this time, sufficient experience to 28743

HeinOnline -- 58 Fed. Reg. 28743 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

generically define criteria that it will employ in making a finding of "significant" human exposure under TSCA section 4(a)(1)(B)(i)(il). Should EPA make such a finding in a substanceecific rulemaking, itwill fully explain the bases for that finding at that time.

CMA also stated that EPA has not adequately defined or explained the
term "direct exposure" and how it relates to "significant" exposure (Ref. 1).

A "direct" exposure may be characterized as having aclearly identifiable or likely source ofthe chemical, an exposure pathway from the

source to the receptor that can be expected, withreasonable certainty, to result in the potential forexposure, and

an exposure route that will or can reasonably be expected toresult in intake/uptake by the receptor. For these

reasons, it is reasonable to conclude that in instances where exposure is "direct", EPA may consider the exposure to be "significant" under TSCA section 4(a)(1)(B3)(i)(11)..

GAF, BASF, and ACC stated that EPA has failed to establish a clear distinction between "substantial" and "significant"
exposure aspresented in Table I ofthe proposed policy (Ref.6).

As previously acknowledged, there is

some overlap between the criteria used
to construe "substantial" and "significant" human exposure. However, itisEPA's belief thatsuch an overlap is notinconsistent with the statutory purpose and legislative history ofTSCA. As stated in the cumene decision, 899 F.2d at 356, n. 17, "it is
notnecessarily clear that "significant" and "substantial" as used in clause (II)
must be understood ina way that prevents any overlap."

CMA recommended that "EPA should judge the "significance" ofexposure by examining whether, forthe affected population, it involves large concentrations or is usually frequent or prolonged" (Ref. 1). HSIA suggested that EPA consider "the mode of manufacture ofthe chemicals, the manner ofuse, and physical properties which may make

even quite direct exposure to the threshold levels of little or noconcern" (Ref. 6). To accomplish this evaluation. CMA recommended that "EPA should develop representative exposure scenarios for workers, consumers and the general population. These scenarios should then be used to identify workplace operations, consumer products or environmental releases with uncommonly large exposure potential" (Ref. 1).

Because the determination ofwhat is "significant" human exposure can be very chemical and use specific, EPA does not believe that the representative exposure scenarios suggested by CMA would have much utility. However, EPA will examine, among other factors, the criteria suggested by CMA and others in the context ofsubstance-specific rulemakings under TSCA section 4, including the manner ofuse, the chemical specific physical properties, and whether forthe affected population the exposure would involve large concentrations oris frequent or prolonged. Also, inresponse to an earlier suggestion from commenters, EPA did propose, as an alternative to the proposed section 4(a)(1)(B) criteria for "significant" exposure, adopting the qualitative and quantitative "substantial" and "significant"
exposure guidelines used to review new chemical substances under section 5(e) ofTSCA (56 FR32299). These TSCA section 5(e) criteria doinclude some consideration offrequency, duration and magnitude ofexposure for workers, and consideration ofmagnitude of
exposure forthe general population. The section 5(e) criteria forconsumer exposure are qualitative only.These criteria were developed based on experience assessing the exposures associated with thousands ofnew chemicals with limited,but known, uses and exposure settings. However, as explained above, none ofthe
commenters were in favor ofEPA adopting the TSCA section 5(e) human
exposure criteria.

In summary, for the purpose of determining whether there is ormay be "substantial" exposure under TSCA section 4(a)(1)(B)(i)(U1), EPA will utilize the numerical thresholds of1,000 workers, 10,000 consumers, and/or 100,000 persons in the general population.A finding of"significant"
exposure will generally be made on a case-by-case basis, taking into consideration, among other factors, the

manner ofuse, substance specific Fhysical properties, concentration evels, and the duration and frequency oftheexposure to the substance. It is important to note that TSCA section 4 is an information gathering tool only and that itplaces no limits on a chemical substance's manufacture, processing, distribution in commerce or

use. Given the limited purpose ofTSCA section 4(a), to require testing, and because the finding that there is ormay be "substantial" or "significant" human
exposure is only one of several findings EPA must make torequire testing, EPA believes that the criteria set forth herein

are a reasonable interpretation ofthe phrase "significant or substantial human exposure" in TSCA section 4(al(1)(B)(i)(11). F.OtherIssues
1. Categories. EPA proposed that it would apply the generic numerical thresholds formost substances considered for action under TSCA section 4(a)(1)(B). In some cases. however, where the thresholds are not met, EPA proposed that it may consider "additional factors" on acase-by-case basis for making findings. An example of such a case mentioned by EPA in the proposed policy was chemical categories.

CMA, supported by SPI, believes that categories should be narrowly defined.

InCMA'sjudgement, theonly category that would besuitable for a 

### ' finding would be

one whose members possessed similar chemical structures andwere therefore likely tohave closely related health or environmental effects (Ref.1).

CMA also comments that representatives from a category could be selected for testing, obviating the need
to testeach and every member ofthe PA

,does not agree with the

commenters that categories must,by necessity, be limited to chemicals with similar structures ortoxicological properties. However, EPA does agree that chemicals with similar structures or toxicological properties could, in certain instances, be grouped together and referred to collectively as a category. Additionally, after consideration ofall relevant chemical specific parameters, EPA may propose category findings on

a case-by-case basis, and will solicit
comments on this decision in the specific proposed test rule. This is the approach taken in the proposed testrule for glycidols (56 FR 57144, November 11, 1991).

2. Additionalormitigating factors. CMA, Monsanto and others stated that EPA should, in implementing its policy under section 4(a)(1)(B) ofTSCA, preserve the flexibility to consider additional and mitigating factors on a case-by-case basis. Monsanto supports the "substantial" and "significant" exposure criteria as benchmarks but believe that other factors,on a casespecific basis, may need evaluation. For example, CMA stated that where there

are no otherindicators ofsubstantial
exposure otherthan that a chemical
appears in human adipose tissue, EPA should consider that the tissue may be reflective ofbackground levels in the environment, a metabolic product of another compound. orrelease from nonindustrial sources (Ref. 1). In such a situation, CMA suggests that testing under section 4(a)(1)(B) ofTSCA would
notbe Justified. 28744

HeinOnline -- 58 Fed. Reg. 28744 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

EPA agrees with the respondents that in implementing this policy, EPA should preserve the flexibility to consider certain variables on acase-bycase basis. Furthermore, in implementing section 4(a)(1)(B) of TSCA, EPA intends to use the criteria articulated in thispolicy statement as guidelines to retain the flexibility to consider all relevant variables in making findings under section 4(a)(1)(B) of TSCA. As stated in the proposed
statement ofpolicy, EPA intends to utilize the generic thresholds for most chemical substances considered for action under TSCA section 4(a)(1)(B). In

some cases, however, where the thresholds are not met, EPA may consider "additional factors" on a caseby-case basis to make findings.

EPA's authority to use this flexible approach was recognized by the Court in its decision regarding the cumene test rule. The Court stated that EPA's definition need not be precise

- itneed
not "function like amathematical formula." 899 F.2d at 359. On the other hand, there may be some instances when achemical substance meetsthe criteria articulated under TSCA section 4(a)(1)(B)(i), but where testing under TSCA section 4(a)(1)(B) will notbe required because EPA findsunder subsection (ii) or subsection (iii) of section 4(a)(1)(B), respectively, that data

are sufficient to reasonably determine or predict the effects ofthe manufacture, process, distribution, use, or disposal of the chemical or that testing is not necessary. Monsanto, GAF, BASF, and ACC strongly support the use of "mitigating factors" to justifynot requiring testing for those chemicals that meet the section 4(a)(1)(B)(i) criteria for which the available data are sufficient to reasonably determine or predict the effects ofthe manufacture, process, distribution, use or disposal of the chemical and/or that testing is not necessary.

3. Confidentialbusinessinformation. Callery Chemical Company is concerned that an EPA finding under TSCA section 4(a)(1)(B)(i) that a chemical may be produced in substantial quantities may result in disclosure ofconfidential business information (CBI) and "could provide valuable marketinginformation
to competitors and potential competitors withoutjustification" (Ref. 5).

EPA does notbelieve that disclosing
to the public the fact that at least 1 million pounds of achemical substance

or mixture Is produced peryear would be a disclosure ofCBI. In making such

a finding,EPA would be relying on the aggregate production volumefor all manufacturers ofthe substance. Thus, EPA would not be disclosing specific information regarding any particular manufacturer's production. Should such

a statement affect a single manufacturer,

as mightbe the case with specialty chemicals, EPA does notbelieve that a statement that production volume is at least 1million pounds would disclose sufficient information tobe considered

a disclosure ofinformation which might be entitled to confidential treatment. Furthermore, TSCA section 14(a)(4) authorizes the disclosure ofinformation which otherwise mightbeentitled to confidential treatment whenrelevant in
any proceeding under TSCA, including rulemaking, provided that disclosure is made in such amanner asto preserve confidentiality to the extent practicable without impairing the proceeding. See 40 CFR 2.306 (1991). EPAbelieves that by disclosing only that a substance is or will be produced in volumes of1 million pounds peryear orgreater, confidentiality wouldbe preserved to the extent practicable while still making findings under section 4(a)(1)(B). However, EPA will make this decision

on a case-by-case basis, in accordance with 40 CFR 2.306, ifsuch situations arise.

G. BeyondScope

Respondents raised several issues which arebeyond the scope ofthis policy statement. The issues relate to the use ofstructure activity relationships (SAR), exclusion of polymers, tiered testing schemes, and testing priorities under TSCA section 4(a)(1)(B).

1.Structureactivityrelationships. Monsanto believes that "[tihe 'B' policy should recognize and authorize the use ofstructure activity relationships (SAR) when evaluating the testingneeds and priorities for substantial production chemicals" (Ref.3). Monsanto commented that a large number oftheir high production volume chemicals are produced 'asintermediates and then
ater converted to neutral salts to facilitate handling and shipping; in
most ofthese cases, the salt and intermediate itselfhave essentially the

sametoxicological priorities. Therefore, by testing and evaluating one substance, the other chemical can be evaluated using SAR.

Monsanto's comment is notrelevant
to a discussion ofTSCA section 4(a)(1)(B)(i). Rather, whether SAR will be a factor in determining the "testing needs and priorities for substantial production chemicals," is amatter relevant to TSCA section 4(a)(1)(B)(ii) and (iii) findings. Therefore, Monsanto's

concerns would be addressed in relation
to achemical specific test rule. 2.Polymerexclusion.Monsanto commented thatpolymer exemptions should be recognized byEPA under this policy, because "[plolymers represent a special class ofchemical substances that needs separate consideration under the proposed 'B policy" (Ref.3). Monsanto noted that a number ofpolymersubstances arebiologically benign and, therefore, do notrepresent substantial health orenvironmental concern. In support ofthisposition, Monsanto noted that exemption procedures are provided for inthe review ofnew chemical substances under TSCA section 5. Likewise, the OECD HPV program did not include polymers on the Representative List. Monsanto believes a similartype ofpolymer exemption should be offered under the section 4(a)(1)(B) policy.

Again, Monsanto's concerns relate

more to a discussion regarding TSCA section 4(a)(1)(B)(ii) and (iii)than TSCA section 4(a)(1)(B)(i). EPA believes that in the absence ofany submitted data, it is difficult to address the manufacturers'

concern. Polymers do nothave a welldefined composition, and there may be

aneed to test some lower molecular weight polymers or oligomers which
may have potential for health or environmental effects. Therefore, it would be premature forEPA to suggest that ablanket exemption from testing forpolymers may be appropriate. To date, EPA hasnot proposed or required testing ofa polymeric compound under TSCA.

3. Tieredtesting.Monsanto commented that EPA should adopt a tiered testing approach to evaluating chemical substances.

EPA believes that determination of whether tiered testing is appropriate generally mustbe made on a case-bycase basis. EPA recognizes that incorporating atiered testing scheme in

atest rule can generate preliminary data relatively quickly with minor expense. However, fora relatively well characterized chemical substance, it is likely that a tiered testing approach would notbe appropriate. In other instances, ifthe scientific literature contains information which strongly suggests that the chemical isused in a waythat would result in widespread workeror consumer exposure (e.g., a solventuse), then it is lesslikely that a preliminary experiment would return the kind ofdata to support the definitive

answer needed for such widespread exposure. Thus, automatic incorporation ofa tiered testing scheme
may result in the performance of screening studies which are unlikely to provide the needed information. 

### 28745

HeinOnline -- 58 Fed. Reg. 28745 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

4. Testingpriorities. CMA commented that, in addition to adopting the 2.2 million pound threshold for substantial production, EPA should adopt atiered, sequential process for identifying data needs on all high production volume (HPV) chemicals. In CMA's opinion, EPA should group HPV chemicals into categories and establish priorities for the review of each chemical.

Once overall testing priorities have been set, individual high volume chemicals should be reviewed to determine whether they warrant an initial set ofscreening tests comparable to those in the OECD Screening Information Data Set (SIDS) battery (Ref.1).

EPA clearly articulated in the proposed statement ofpolicy and in Unit 1.ofthis final notice that issues related to how EPA establishes testing priorities and how EPA makes findings under subsections (ii) and (iii) ofsection 4(a){1)(B) ofTSCA would not be addressed in this statement ofpolicy. If
at some future point in time, EPA decides that adoption ofa testing
program such as that proposed by CMA would be beneficial in the gathering of data on existing chemical substances, EPA will clearly articulate that policy ,and the underlying rationale in a notice.

III. Final Policy

A. Substantial Production

EPA is establishing a threshold value ofI million pounds, aggregate production volume ofthe substance per year for all manufacturers, asthe substantial production threshold. This threshold currently represents only 11% ofthe entire universe ofchemical substances potentially subject to testing under TSCA section 4, yet accounts for 95% oftotal chemical production by volume. For the reasons articulated in the proposed statement ofpolicy (56 FR 32294) and Unit B.C. of this notice, EPA believes a threshold value ofI million pounds is a reasonable interpretation of the phrase "produced in substantial quantities" in TSCA section 4(a)(1)B)(i).

B. Substantial Release

EPA is establishing a threshold value ofI million pounds ofrelease to the environment from all sources per year;

orrelease equal to or greater than 10 percent of production volume per year, whichever is lower, as the threshold for substantial release. In choosing the 1 million pound threshold value to represent "substantial" release, EPA used the TRI as a guide in judging the "substantial" nature ofthat amount of release. EPA has determined that 37 percent ofthe chemicals listed on the TRI have releases ofI million pounds

orgreater and that these releases represent over 99 percent ofthe total reported release on the TRI by volume. Clearly, the small percentage ofTRI chemicals that exceed the poundage threshold accounts for the vast majority oftotal TRI releases.

The percentage threshold reflects EPA's concern about chemical releases that are a sizable percentage of the production volume ofthat chemical. EPA believes that when such a sizable percentage ofa chemical's production volume is released, that release should be considered "substantial" for that chemical substance. For the reasons articulated in the proposed statement of policy (56 FR 32294) and in Unit I.D. ofthisnotice, EPA believes that thisis

a reasonable interpretation ofthe phrase "enters the environment in substantial quantities" in TSCA section 4(a)(1)(B)(i)(l).

C. Substantial andSignificantHuman Exposure

EPA is establishingthe criteria in Table I ofthisUnit for "substantial" and "significant" exposure. As articulated in the proposed policy statement, EPA chose numeric thresholds to characterize "substantial" human exposure because it is EPA's beliefthat TSCA section 4(a)(1)(B) was intended to address situations where large numbers ofpeople may be exposed to a chemical substance and little orno hazard data exists to indicate whether or not that chemical substance may present

an unreasonable risk. EPA based its thresholds forworkers on experience gained through case-by-case analysis of existing chemicals.

The different numeric thresholds for worker, consumers, and general population areEPA's attempt toreflect the inherent differences in the probable
exposure scenarios for particular categories ofindividuals. EPA decided
to apply a differential equal to one order ofmagnitude between the worker,
consumer, and general population thresholds. For the reasons articulated in the proposed statement ofpolicy (56 FR 32294) and Unit II.E. ofthis notice, EPA believes that thesecriteria are a reasonable interpretation ofthe phrase "significant or substantial human exposure" inTSCA section 4{a){1){B){i)(II}.

TABLE 

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

Category Substantial Significant

General population

... 100,000 peo- < 100,000 people population exposed more directyoron a routine or episodic basis. pIG Consumers

............... 10,000peo- < 10,000 people exposed more directlyor on a routine or episodic basis. plo Workers

............ 1.000 workers <1,000 workers exposed more directly or on a routine or episodic 

### basis.

D.AdditionalFactors

EPA will apply the generic numerical thresholds formost substances considered for testing under TSCA section 4(a)(1)(B). In some cases, however, where the thresholds are not met, it may be more appropriate to use

a case-by-case approach formaking findings by applying other considerations. For the reasons articulated in the proposed statement of policy (56FR 32296) and Unit II.F.2. of this notice, EPA may consider "additional factors" for making findings for substances which do not meet the numerical thresholds articulated herein for evaluating existing chemicals under TSCA section 4(a)(1)(B).

ConverselyEPA may notrequire testing under TSCA section 4(a)(1)B) fora chemical that meets the section 4(a)(1)(B)(i) criteria ifEPA finds, under sections 4(a)(1)(B)(ii) and (iii), that data

are sufficient to reasonably determine or predict the effects ofthe manufacture, process, distribution, use and disposal ofthe chemical and/or that testing is not necessary.
IV. Final Test Rule for Cumene

A. Responseto CumenePanel

On July 27, 1988 (53 FR28195) EPA promulgated a final rule requiring manufacturers and processors of

cumene toperform health and environmental effects testing in response to the Interagency Testing Committee's (ITC) recommendation that

cumene be given priority testing 28746

HeinOnline -- 58 Fed. Reg. 28746 1993

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

### / Notices

consideration under TSCA section 4. Based on the available data, EPA found under TSCA section 4(aX1)(B)(i) that

cumene is "produced in substantial quantities and that it enters the environment in substantial quantities, with the potential forresulting substantial human exposure to cumene from its manufacture, processing, use and disposal." EPAalso madethe requisite findings under TSCA section 4(a(1L)(B)(ii) and (iii) (53 FR 28200,July 27, 1988). EPA's findings were challenged by the Chemical Manufacturers Association in CAlA v. EPA, 899 F.2d 344 (5thCir. 1990). The Court remanded the rule requiring EPA
to:

articulate the standards orcriteria onthe basis ofwhich itfound the quantities of

cumene entering the environment from the facilities in question tobe "substantial' and the human exposure potentially resulting to be "substantial."

899 F.2d at360. The Court'further instructed EPA to:

articulate whether its respective ITSCA section 4(a)(1)(B)(i)] clause (1) andclause (IM) findings (in the cumene rulel eachconstitute, alone, an independent and sufficient basis for its testing requirements, orwhether, onthe other hand, itstesting requirements restonly

onthe clauses (I) and (II) findingsjointly '. The EPA shall further indicate whetherits findings undereither clause () orclause (II)

are to anyextent dependenton its finding, which we have disapproved, concerning entry intothe aquatic environment; and, if
so, shall reconsider its clause (1) and (U] findings inthe light ofourreferenced ruling.

Id.at 360, n. 22. Finally, the Court directed EPAto consider new studies to be presented by CMA on remand "unless they would notbe material to any of the EPA's criteria relied on for the testing." Id. at 360-361. On remand the Cumene Panel ofCMA submitted both specific studies andgeneral
comments on the cumene finaltest rule. The test ruleremained in effect, and test data was submitted to EPA in response to the rule.

EPAhas addressed some ofthe Court's instructions concerning EPA's statutory authority and the Cumene Panel's generic commentsregarding.the "B" policy (Ref. 12) inUnit 11. ofthis notice. Specific comments on cumene and EPA'sreview ofremand evidence

are addressed in this Unit IV.

B. Substantial Production

In support ofIts finaltest rule, EPA found that cumene isproduced in substantial quantities, based onreported U.S. cumene production of3.35billion pounds with an additional 339 million pounds imported. Thisfigure was not disputed. For the reasons discussed in UnitII.C. ofthis notice, EPA believes that this levelofproduction clearly qualifies as "substantial production" under section 4(a)(1)(B)(i) ofTSCA. The level ofcumene production reported in the final rule well exceeds the "substantial production" threshold articulated in this notice.

C. Substantial Release

In support ofthe final test rule, EPA found that cumene is released to the environment in substantial quantities based on an estimated 3 million pounds
per year of fugitive emissions ofcumene to the atmosphere from manufacturing, processing, and use activities. The Court upheld the validity ofEPA's estimate. 899 F.2d at 352-353. To a lesser extent, EPA also noted in the final rule that

cumene was released in unspecified quantities to the aquatic environment. Because EPA was unable to estimate with reasonable certainty the magnitude ofthis release, EPA did not rely on this release in calculating human exposure; nonetheless, EPA did believe that there

was a potential forhuman exposure as

a result ofrelease of cumene to aquatic environments. The Cumene Panel commented that EPA lacks an adequate basis forfinding that cumene "enters the environment in substantial quantities." Specifically, the Panel disagreed with EPA'sequating "substantial release" with "enters the environment in substantial quantities." The Panel stated,

Itihe Agency has made no effort to analyze the extensive evidence in therecord regarding the persistence and distribution of

cumene in the environment orto relate

cumene release levels to human exposure patterns (Ref. 12).

As discussed in Unit ILD. ofthis notice, EPA rejects the premise that "enter the environment in substantial quantities," as used in section 4(a)(1)(B)(i)(I) ofTSCA, be defined to include a determination of"persistence in the environment ofthose substantial quantities." The Court in the cumene
case, 899F.2d at 355-356, found that EPA is not obliged to follow CMA's construction ofTSCA section 4.

The Panel also raisedthis issue in their comments on the final rule for

cumene, asserting that, considering the short half-life ofcumene in the atmosphere, there is no reason to believe that, except forpopulations very close to the plant, there is anygeneral population exposure to cumene. EPA responded thatthe half-life ofcumene in the atmosphere appears to be on the order of 1or 2 days. At this rate of removal, the cumene emissions from ongoing manufacturing andprocessing activities wouldbe expected tobe distributed over a large portion ofthe communities near manufacturing and processing facilities depending on the prevailing atmospheric conditions. Thus.the Panel hasnot provided EPA with a convincing rationale torefute EPA's finding that cumene "enters the environment in substantial quantities"

orthat there is not "substantial human exposure." Rather, the Panel has only demonstrated that persistence, oneof many chemical-specific parameters EPA considers inevaluating a chemical. may be oflimited importance when considered with otherfactors, such as the manufacturing and processing scenario.

D.Substantial HumanExposure
The Panel commented that.even if the release ofcumne could be equated
to "substantial" environmental entry. EPA would notbejustified in requiring human health effects testing unless It

were to make a finding of"substantial human exposure."

Once again, the Panel is attempting to link thetype oftesting required to the bases for theTSCA section 4(a)(1)(B)(i) finding. EPA doesnot believe this tobe

a validinterpretation ofsection 4(a) of TSCA. Furthermore, EPAbelieves, as stated inUnit I.B.ofthisnotice, that clauses (I)and (1) ofTSCA section 4(aX1)(B)(i) canbe interpreted as independent. In particular, although EPA made findings for cumene under both clauses (I)and (1), EPAbelieves a finding under either clause alone constitutes an ndependent and sufficient basisfor the testing required.

In support ofits final rule, EPA found that there may be substantial human exposureto cumene based on the
exposure potentialtoapproximately 13.5 million people living in the vicinity ofcumene manufacturing and processing facilities. EPA believes that a majority ofthe people would be exposed as aresult- of fugitiveemissions ofcumene to the atmosphere. The majority ofcumene manufacturing and processing facilities are concentrated in

a few largemetropolitan areas. The Courtinthe cumene case, 899 F.2d at 353, found that the rulemaking-record adequately supported EPA's finding. However, when CMA briefed its case, it submitted amonitoring study, not previously submitted as comments on the rule,thatrelates to the presence of
many chemicals, including cumene, in the Houston Ship Channel area (Ref. 19).

.The Cumene Panel maintains that the information contained inthis study is sufficient to show that EPA cannot make 28747

HeinOnline -- 58 Fed. Reg. 28747 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

either the "enters the environment in substantial quantities" or "substantial human exposure" findings of section 4(a)(1)(B})(i}.

Theremand evidence presented by the petitioners indicates that such exposure does not exist because cumene levels are not elevated even at short distances from the

cumene plants (Ref.12).

As instructed by the Court on remand, EPA has reviewed the study submitted by CMA. In general, EPA's review (Ref. 20) concluded that the study supports theconclusions ofits authors. However, the study cited by the Cumene Panel does not show, nor was it designed to show, the monitored environmental concentration from manufacturing and processing facilities. The study's Introduction states:

Itlhe underlyinggoal ofthemonitoring program is toprovide member firms with
accurate ambient airquality measurements andtechnical data forbetterunderstanding airquality concerns in theHouston Ship Channel area (Ref. 19).

There are seven sites where monitoring devices are maintained downwind from the Houston Ship Channel. One site only monitors meteorology and any accidental releases. This siteis the northeasternmost site and does not monitor forany organic compound. The study statesthat the prevailing wind direction is from the southeast (Ref.21). Therefore, the monitoring sites are upwind from all but one ofthe cumene manufacturing and processing sites and

are gathering data on cumene emissions from refineries and other unknown

sources.

There Is one manufacturing facility sited In the monitoring array. However, the facility appears to be at least 5 miles from the closest downwind monitoring site. Additionally, it is not clear from this studywhether the detected environmental concentrations were detected atthe closest downwind moIiitoring sites.The monitoring array is either upwind from all the other

cumene manufacturing and processing sites oris over 30 miles away from these sites. At that distance, the facilities would have torelease extremely large
amounts ofcumene perminute toreach detectable levels inthe monitoring
array. Therefore, it is unlikely that the data accurately assess the level of

cumene present in close proximity to the facility.

The Cumene Panel submitted additional information on modelling performed atthe Champlin Refining and Chemicals facility inCorpus Christi, Texas (Ref. 22). In thisexercise, Champlin modelled point source air emissions from barges loading cumene. Annual emissions ofcumene from these loading operations wereestimated tobe 23,000 pounds. However, there are shortcomings with the methodology employed in the study.

For modelling purposes, Champlin divided the annual point source release estimateby the totalnumber ofminutes in a year to derive the source term (mass release perminute). Champlin should have divided the annual point source release estimate by the total number of minutes peryear in which barge loading occurred to derive amore realistic

source term for modelling potential air concentrations. Based on a 1990 joint effort between EPAand the American Oil Company on the refining industry, EPA estimates that the capacity ofan intercoastal barge or tankerranges from 2.5 million to 70 million gallons. Based

on an assumed I day fill rate and a 10 million gallon barge/tanker capacity, the entire capacity ofproduction at the Champlin facility could be loaded in 7 days. Ifthe cumene emissions were assumed to bereleased over a period of 7days rather than 365 days, the source term (input)would be raised by a factor of50. Additionally, Champlin used typical tobetter than average meteorological conditions of stability class C and a windspeed of 12 miles per hour in the modelling exercise. A more conservative, yet still realistic, set of meteorologic conditions would be a stability class ofD and awindspeed of 5miles perhour. Therefore, EPA believes the resulting ambient concentrations ofcumene from the Champlin modelling exercise underestimate the ambient concentration ofcumene resulting from releases atthe Champlin facility.

Furthermore, EPA's review ofthe studyindicates that the study does not shed any light on the number ofpeople potentially exposed to cumene, rather it is only concerned with determining a level ofcumene in the area ofthe -Houston Ship Channel. Therefore, the studydoes not relate to whether EPA could make a substantial human
exposure finding.

Another section ofthe remand evidence submitted by CMA consisted ofmodeling studies ofambient air concentrations ofcumene that may result from adiissions from several

cumene manufacturing sites. Although all studies used the EPA Industrial Source Complex Long Term (ISCLT) air dispersion model, the level ofdetail concerning methods and assumptions used varied from study to study, thus inhibiting EPA's ability to adequately review the studies. Each ofthe studies Isbriefly discussed below.

Modelling ofcumene emissions from
two Georgia GulfCorporation facilities,

one in Plaquemine, Louisiana, and the other inPasadena, Texas, were performed using "adjusted" EPCRA section 313 release data forreporting
year 1987 (Ref.23). The rationale to justify the procedure used to adjustthe EPCRA section 313 release data and to justify the meteorological assumptions used formodeling air dispersion were not sufficiently detailed to enable an adequate EPA review ofthe study.

The study describing the modelling of

cumene emissions from a Koch Refining Company facility (Ref.24) provided sufficient details on methods and assumptions to allow foran adequate EPA review. This modelling study also purported using 1987 EPCRA section 313 release data. However, the annual releases used in the study, 1,971 pounds, show a large unexplained discrepancy with the 19,500 pounds of

cumene emissions actually reported under EPCRA section 313.

Modelling studies for the Shell Oil Company Deer Park, Texas, facility (Ref. 25) and Texaco's El Dorado facility (Ref. 26) were also submitted. However, supporting data on the methods and assumptions used in the studies were not sufficiently detailed to enable an adequate EPA review ofthe studies.

The remand evidence was accompanied by an affidavit from Marvin B. Hertz, an industry consultant, supporting the use ofambient air monitoring data rather than the mass emission data from the EPCRA section 313 Toxic Release Inventory (TRI) (Ref. 27).

EPA recognizes that the use of ambient air monitoring data, when performed correctly, plays arole in any exposure assessment, and thus, inrisk
assessment. However, it is very difficult
toperform any risk assessment when the hazards ofthe compound are either
not known or not well characterized. For this reason, and the reasons articulated in Unit II.E. ofthisnotice, EPA does not depend on human
exposure at aparticular "level" in determining "exposure" under TSCA section 4(a)(1)(B)(i).

Finally, the Cumene Panel stated that testing submitted pursuant to the final
test rule confirms that cumene doesnot present a risk. Moreover, the Panel objected to EPA's reference to aTSCA section 8(e) submission, which indicated cataract formation inrats exposed to cumene vapors, as an example ofthe benefits oftesting a chemical in the absence of hazard data. Since that section 8(e) submission, the 28748

HeinOnline -- 58 Fed. Reg. 28748 1993Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices

Panel has undertaken a follow-up subchronic study.

On June 17, 1992, utilizing data submitted in response to the cumene test rule, EPA held an RM1 disposition for cumene to determine whether to take risk management action on the chemical (Refs.28 and 29). EPA determined that sufficient information forhazard
assessment is available and supports a low concern. When the hazard information was considered in conjunction with available exposure information, EPA determined that

cumene presents a relatively low risk to human health, and has discontinued review ofthis chemical at this time. Therefore, EPA does not believe any further testing ofcumene is necessary at this time.

V. Public Record

A. SupportingDocumentation

EPA has established a record for this policy under TSCA section 4, docket number OPPTS-47002K, which is available for inspection Monday through Friday, excluding legal holidays, in Rm. ET-G102, 401 M St., SW., Washington, DC., 20460 from 8

a.m. to 12 noon and from 1 p.m. to 4
p.m. This record includes basic information considered by EPA in developing this policy. This record includes the following information:

(1) Interagency memoranda, comments, and proposals.

(2) Reports-published and unpublished data.

(3) Chemical Manufacturers Association v. EPA, 899 F.2d 344 (5th Cir. 1990).

B.References

(1)The Chemical Manufacturers Association. Comments on EPA's TSCA section 4(a)(l)(B) Proposed Statement of Policy submitted to the TSCA Public Docket Office, USEPA (September 17, 1991).

(2)Epoxy Resin Systems Task Group of The Society ofthe Plastics Industry, Inc. Comments on EPA'sTSCA section 4(a)(1)(B) Proposed Statement of Policy submitted to the TSCA Public Docket Office, USEPA (September 17, 1991).

(3)Monsanto Company. Comments on EPA's TSCA section4(a)(1)(B) Proposed Statement ofPolicy submitted to the TSCA Public Docket Office, USEPA (September 12, 1991). (4) Ecological and Toxicological Association ofthe Dyestuffs Manufacturing Industry. Comments on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to the TSCA Public Docket Office, USEPA (September 17, 1991).

(5) Gallery Chemical Company. Comments

on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to the TSCA Public Docket Office, USEPA (September 18, 1991).

(6)Halogenated Solvents Industry Alliance. Comments on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to the TSCA Public Docket Office, USEPA (September 19, 1991).

(7)GAF Chemicals Corporation, BASF Corporation, and ARCO Chemical Company. Comments on EPA's section 4 (a)(1)(B) Proposed Statement of Policy submitted to TSCA Public Information Office, USEPA (September 17, 1991).

(8) U.S. Department ofLabor, Occupational Safety and Health Administration. Comments

on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to TSCA Public Docket Office, USEPA (October 7, 1991).

(9) U.S. Department ofHealth and Human Services, National Institute for Occupational Safety and Health. Comments on EPA's section 4(a)(1)(B) Proposed Statement of Policy submitted toTSCA Public Docket Office, USEPA (September 17, 1991).

(10) CMA's Acetone and Ketones Panel. Comments on EPA's section 4(a)(1)(B) Proposed Statement of Policy submitted to TSCA Public Information Office, USEPA (September 17, 1991).

(11) CMA's Oxo Process Panel. Comments

on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to TSCA Public Information Office, USEPA (September 17, 1991).

(12) CMA's Cumene Panel. Comments on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted toTSCA Public Information Office, USEPA (September 17, 1991).

(13) CMA's Cyclohexane Panel. Comments

on EPA ssection 4(a)(1)(B) Proposed Statement of Policy submitted to TSCA Public Information Office, USEPA (September 17. 1991).

(14) CMA's Hexamethylene Diisocyanate Panel. Comments on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to TSCA Public Information Office, USEPA (September 12, 1991).

(15) Diethyl Ether Manufacturers Task Group. Comments on EPA's section 4(a)(1)(B) Proposed Statement ofPolicy submitted to TSCA Public Information Office, USEPA (September 15, 1991).

(16) USEPA. Implementation Proposal; "New Chemicals Exposure-Based Finding," letterfrom Charles L. Elkins to Geraldine V. Cox (Chemical Manufacturers Association). Office ofToxic Substances, USEPA (September 22. 1988).

(17) Organization for Economic Cooperation and Development. "OECD's Work on Investigation ofHigh Production Volume Chemicals." Document 3, May 1991.

(18) U.S. Department ofHealth and Human Services, National Institute for Occupational Safety and Health. National Occupational Exposure Study (NOES,1988).

(19) Radian Corp. A Method for Assessing Community Exposure to Selected Volatile Indicator Compounds (July20. 1988). (CMA exhibits for remand evidence).

(20) USEPA. Review ofEvidence Submitted by CMA on Remand ofCumene Test Rule. Washington, DC: Office of Pollution Prevention and Toxics, USEPA (April, 1992).

(21) Radian Corp. Volatile Indicator Compound Measurement Results from the Houston Regional Monitoring Network, Phase IV (July 20,1988). (CMA exhibits for remand evidence).

(22) Champlin Refining Company. Air Modelling ofCumene Releases at Champlin Refining Company (October 14,1988). (CMA exhibits for remand evidenCe).

(23) Georgia GulfCorporation. ISC and ISCLT Air Modelling Results from Georgia GulfCorporation Facilities (December 16, 1988) (CMA exhibits for remand evidence).

(24) Koch Refining Company. Air Modelling Results from Koch Refining Company Facility (October 20, 1988) (CMA exhibits for remand evidence).

(25) Shell Oil Company. Air Modelling Results from Shell Deer Park Facility (Undated) (CMA exhibits for remand evidence).

(26) StarResearch. Air Modelling Results from Texaco's El Dorado Facility (September 30,1988) (CMA exhibits for remand evidence).

(27) Hertz, Marvin A. Affidavit on Use of Monitoring Data versus Mass Emission Data (CMA exhibits for remand evidence).

(28) USEPA. Regulatory Management-i (RM1) Summary forCumene. Washington, DC: Office ofPollution Prevention and Toxics. USEPA (January 10, 1991).

(29) USEPA. Regulatory Management-I (RM1) Summary forCumene. Washington, DC: Office ofPollution Prevention and Toxics, USEPA (June 17, 1992).

Dated: May 5, 1993.

VictorJ. Kinmm, ActingAssistant Administrator for Prevention, PesticidesandToxic Substances.

[FR Doc. 93-11496 Filed 5-13-93; 8:45 am]

MLUN OOOE CO-- 28749

HeinOnline -- 58 Fed. Reg. 28749 1993