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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 Significant Human Exposure

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Statement of Policy.

SUMMARY: EPA is articulating standards

and criteria for making findings it will

use in implementing its authority under

the Toxic Substances Control Act

(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 not met if additional

factors exist. EPA will continue to

develop and refine the criteria as its

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 test rule (July 27,

1988, 53 FR 28195).

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division (TS799), Office of Pollution 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 Bulletin Board at 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 or paper

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 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 a substance or

mixture," under TSCA section

4(a)(1)(B)(i). In Chemical Manufacturers

Association v. Environmental Protection

Agency, 899 F.2d 344 (5th Cir. 1990),

the Fifth Circuit Court of Appeals (the

"Court") remanded to EPA the rule

issued pursuant to 4(a)(1)(B) for cumene

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) of TSCA.

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 or will be

"produced in substantial quantities,"

whether it "enters or may 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 of Appeals 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 supported by substantial evidence

but instructed the Agency to "articulate

the standards or criteria on the basis of

which it found the quantities of cumene

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) of TSCA. 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 of chemicals

through a variety of regulatory moans.

15 U.E.C 2601, et seq. This authority

includes, among other things, the

authority to require chemical testing to

develop data for risk assessment, 15

U.S.C. 2603, and the authority to ban

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 of chemical

substances and mixtures on health and

the environment and that the

development of such data should be the

responsibility of those who manufacture

and those who process such chemical

substances and mixtures." 15 U.S.C.

2601 (b)(1). See Chemical Manufacturers

Association v. 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 of chemicals.

EPA must make findings under either

section 4(a)(1)(A) ("A" finding) or

4(a)(1)(B) ("B" finding) of TSCA before

testing may be required of a

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 of the

manufacture, distribution in commerce,

processing, use, or disposal of such

substance or mixture or any

combination of such activities on health

or the environment can reasonably be

determined or predicted," and that

"testing of such substance or mixture

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) of TSCA the Administrator

must find that "the manufacture,

distribution in commerce, processing,

use, or disposal of a chemical substance

or mixture, or that any combination of

such activities, may present an

unreasonable risk of injury to 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 of inference drawn from

circumstances under which the

chemical is manufactured and

processed. 859 F.2d at 991. This

interpretation of the statute "prevents a

testing rule based on little more than

scientific curiosity, yet allows the

Agency to act when an existing

possibility of harm raises reasonable

and legitimate cause for concern."

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

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there are certain situations in which

testing should be conducted even

though there is an absence of

information Indicating that the

substance or mixture per se may be

hazardous." H. Conf. Rapt. 1679. 94th

Cong., 2d Sess. (1976), at 61, reprinted

in A Legislative History of the 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) of TSCA,

EPA can act even in the absence of

information that the chemical 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 out EPA's

interpretation of section 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 for testing.

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 on July 15, 1991

(56 FR 32294), its proposed 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 or substantial human

exposure" as used in section

4(a)(1)(B)(i) of TSCA.

C. The "B" Policy

Section 4(a)(1)(B)(i) of TSCA requires the Administrator to find that a

chemical substance or mixture is or will

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 to be used, or the

meanings of the words "significant" or "substantial." Additionally, the

legislative history of TSCA 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.

Chevron USA, Inc. v. EPA. 467 U.S. 837,

842-844, (1984); NRDC v. EPA, 907 F.2d

1146, 1153 (D.C. Cir. 1990). The Fifth

Circuit Court of Appeals recognized this

principle when reviewing the cumene

test rule. According to the Court, where

TSCA and its legislative history provide

no definition of a term such as "substantial," "Congress is deemed to

have implicitly delegated to the EPA the

power to define or interpret 'substantial,' and we will sustain the

Agency's interpretation as long as it is

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 which will

function like a mathematical formula, so that

for every given set of facts a specific, predictable answer will always be

forthcoming. Room must be left for the

exercise of judgment. 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 of or other

evidence relating to prodctton, release,

or exposure. In.fact, Congress provided

a list of factors 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 of policy, 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 be made on a

case-by-case basis. As explained in the

proposed policy statement (56 FR

32294), it is EPA's belief that EPA may make findings under section 4(a)(1)(B)(i)

of TSCA based on quantitative

thresholds. However, EPA does not

intend to limit itself to the use of these

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 of TSCA and

effectuates the policy objectives

described in section 2 of TSCA of

developing adequate data with respect

to chemicals and making the

development of that data the

responsibility of chemical

manufacturers and processors.

I. Response to Public Comments

A. Summary

EPA received written comments on

the proposed statement of policy from

the Chemical Manufacturers Association

(CMA), the Epoxy Resin Systems Task

Group of The Society of the Plastics

Industry, Inc. (SPI), the Monsanto

Company, the Ecological and

Toxicological Association of the

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 of Health 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 this notice. Comments

submitted by these groups which are

specific to a proposed test rule for a

specific chemical will be addressed, as

appropriate, in the final rule for that

specific chemical. Those rules will be

published in the future. The comment

periods were reopened. for proposed test

rules for Office of Drinking Water

Chemicals (55 FR 21393, May 24, 1990),

Cyclohexane (52 FR 19096, May 20,

1987), 1,6-Hexamethylene, Dilsocyanate

(54 FR 21240, May 17, 1989), and Nmethylpyrrolidone (55 FR 11398, March

28, 1990); See 56 FR 32292 Uuly 15,

1991). A summary of the comments

received on the TSCA section 4(a)(1)(B)

proposed statement of policy-is

included in the following Units I.B.

-II.G., along with EPA's responses to

comments.

B. Scope of Testing

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

indicate that many commenters have

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misinterpreted the intended and actual

scope of this policy. The "B" policy is

not intended to be, nor will itbe used

as an automatic trigger to testing.

Nothing in this policy will require EPA

to immediately review any of the

chemical substances currently in

commerce. Rather, this policy statement

sets out EPA's interpretation of the

findings it must 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 a Master Testing List. This

list was 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 for the

threshold criteria articulated in this

policy notice, so long as "B" findings

are made only in support of rules

requiring only tiered, screening level or

"baseline testing" of chemical

substances (Ref. 1). CMA opposes

utilization of the "B" policy criteria,

and indeed, use of EPA's section

4(a)(1)(B) testing authority for any other

level of testing.

On the policy as a whole, CMA

commented that EPA's proposed criteria

under TSCA section 4(a)(1XB)(i) are

reasonable as a basis for requiring

screening tests such as the Screening

Information Data Set (SIDS) utilized by

the Organization for Economic

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, if screening studies

reveal the potential for adverse effects.

then EPA should add the chemical to a

subsequent proposed rule under the

authority of TSCA section 4(a)(1)(A), the "may present" finding. CMA proposed

that, in the absence of toxicity concerns,

EPA should require additional testing

only if it concludes that exposure is "unusually great." CMA argued that

more rigorous "B" criteria, which take

into account all aspects of exposure,

must be developed by EPA to select

such high exposure substances for

additional testing. CMA stated that it

would not oppose EPA's criteria if they

were incorporated into the tiered

approach described above. CMA would

oppose EPA's "B" criteria, if they are

used for any other purpose. CMA

further asserted that if a "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).

EPA believes that any linkage

between the particular numerical

threshold criteria articulated in this

policy statement, or the particular

findings made under TSCA section

4(a)(1)(B)(i), and the nature and scope of

testing to be required once such a

finding has been made, is misplaced,

and indeed, based on a

misinterpretation of the scope of EPA's

testing authority under section 4 of

TSCA.

TSCA section 4(a) states:

(a) TESTING REQUIREMENTS.--f the

Administrator finds that-

(1)(A)(i) the manufacture, distribution in

commerce, processing, use, or disposal of a

chemical substance or mixture, or that any combination of such activities, may present

an unreasonable risk of injury to health or the

environment,

ii) there are insufficient data and

experience upon which the effects of such

manufacture, distribution In commerce,

processing, use, or disposal of such substance

or mixture or of any combination 6f such

activities on health or the environment can

reasonably be determined or predicted, and

(iii) testing of such substance or mixture

with respect to such effects is necessary to

develop such data; or

(B)(i) a chemical substance or mixture is or

will be producedin substantial quantities, and (I) it enters or may reasonably be

anticipated to enter the environment in

substantial quantities or (I) there is or may be significant or substantial human exposure

to such substance or mixture,

(ii) there are insufficient data and

experience upon which the effects of the

manufacture, distribution In commerce,

processing, use, or disposal of such substance

or mixture or of any combination of such

activities on health or the environment can

reasonably be determined or predicted, and

(iii) testing of such substance or mixture

with respect to such effects is necessary to

develop such data; and * * *

the Administrator shall by rule require that

testing be conducted on such substance or

mixture to develop data with respect to the

health and environmental effects for which

there is an insufficiency of data and

experience and which are relevant to a

determination that the manufacture,

distribution in commerce, processing, use, or

disposal of such substance or mixture, or that

any combination of such activities, does or

does not present an unreasonable risk of

injury to health or the environment.

15 U.S.C. 2603(a) (emphasis added).

The final paragraph of section 4(a) sets

out EPA's authority to require testing

once the Agency has made the findings

under section 4(a)(1)(A) or (B). The

directive of this final 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 bears no 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 finding under 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 or that there may be

substantial or significant human

exposure to the substance, the

Administrator may require any type of

testing necessary to address unanswered

questions about the effects of the

substance. EPA need not limit the scope

of testing 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 if it has only made

a finding that there is or may be

substantial entry into the environment

of a substance, or require environmental

effects testing even if it has only made

a finding that there is or may be

substantial or significant human

exposure to a substance. Clauses (I) and

(II) of section 4(a)(1)(B)(i) can be

interpreted as mutually exclusive. See

cumene decision, 899 F.2d at 357 n. 19.

Either finding is sufficient to require

testing, so long as EPA finds that data

relevant to a determination of whether

a substance does or does not present an

unreasonable risk of injury to health or

the environment are insufficient and

that testing is necessary to develop such

data. It is the interrelationship of the

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 testing requirements, if any,

for a particular substance.

EPA notes, however, that while it has

the authority to require testing for any

health and environmental effects once it

has made a finding under either section

4(a)(1)(A)(i) or (B)(i) of TSCA, the Act

does not compel EPA to require testing

of all health or environmental effects

endpoints in all cases. Rather, once EPA

has decided that it will require 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 also considers,

among other factors, "the relative costs

of the various test protocols * * * and the

reasonably foreseeable availability of the

facilities and personnel needed to

perform the testing required under the

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

2603(b)(1).

Furthermore, If Congress had

intended that the testing required under

section 4(a)(1)(B) be related 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 of the word "and" in this final

paragraph indicates that Congress

authorized EPA to require health and

environmental effects testing

independent of the basis 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 may require any health or environmental effects testing for which data are insufficient and which EPA believes are "capable of developing 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 of TSCA. 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 of information

indicating that the substance or mixture

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):

A finding under section 4(a)(1)(B)(i) does

not alone justify a testing order. It must also

be found under section 4(a)(1)(B)(ii) that

'there are insufficient data and experience

upon which the effects of the manufacture for

processing, etc.) *** of such substance * * on health or the environment can reasonably

be * predicted.' Similarly, section

4(a)(1)(B)(iii) imposes the further

requirement that the testing be 'necessary to

develop such data' (emphasis added)-- i.e.,

necessary to render the experience and data

sufficient as a basis on which the health and

environmental effects of the manufacturing

(or processing, etc.) can reasonably be

predicted ** . If the EPA properly concludes

that the existing data and experience do not

suffice as a basis for it to reasonably predict

that there will be no health or environmental

injury from the manufacturing (or processing,

etc.) of the chemical, then affirmative

evidence and findings of risk of such injury

at hypothetical toxicity levels under section

4(a)(1)(B)(i) are not necessary to provide a nexus between requiring testing under

section 4(a)(1)(B) and congressional concern for health and the environment.

899 F.2d at 354-355 (emphasis in

original). Given that TSCA 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 1 million

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 of the 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" under TSCA

section 4(a)(1)(B) (Refs. 1 and 2).

However. according to CMA, "[wihile

EPA's approach is a reasonable one, a

production threshold of 2.2 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 of requiring certain extensive

types of studies, 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 of TSCA section 5

trigger for substantial production (Ref.

6). Monsanto (Ref. 3), HSIA (Ref. 6), and

ETAD (Ref. 4) also support the adoption

of the OECD HPV threshold for the

purpose of international 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

for human health and/or environmental

effects may be required for chemical

substances expected to be produced in

quantities equal to or greater than

220,000 pounds per year. The New

Chemicals Program, as a matter of

poi cy, may specify higher tiered testing

e8g., bloassay, neurotoxicity) under

certain circumstances (i.e., use in

consumer products) for those chemicals

anticipated to be annually produced in

amounts of 2.2 million pounds or

greater, however, the exposure-based

substantial production threshold for

considering testing under section

5(e)(1)(A)(ii)(II) is 220,000 pounds (Ref.

16). - EPA disagrees that the OECD HPV

threshold would be a more reasonable

approach for the 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 of HPV chemicals

manufactured or imported into their

countries. These inventories were

merged into a comprehensive inventory

maintained by the OECD, and is called

the OECD Representative List (Ref. 17),

which includes all chemicals (excluding

polymers and petroleum fractions)

reported in any member country in

excess of 10,000 tonnes (22 million

pounds) and all chemicals reported in

two or more countries in excess of 1,000

tonnes (2.2 million pounds). Hence, the

OECD HPV production volume

threshold of 2.2 million pounds was

conceived merely to guide the

generation of national inventories which

when combined would yield an

international list of high production

volume chemicals. It was assumed by

OECD that the production volume alone

would be a sufficient indicator of

potential exposure such that the OECD's

program on existing chemicals has

focused since 1988 on the chemicals

found on the OECD Representative List.

The TSCA section 4(a)(1)(B)(i) finding

of substantial production is not the sole

finding EPA must make to require

testing. The threshold of I million

pounds set forth by EPA in its proposed

statement of policy (56 FR 32294) is one

of several findings EPA must make

before a substance may be 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 not believe that a

production volume threshold which is

chosen to generate an inventory for an

international program on existing

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chemicals and which is the only trigger

for entry into that program should be

determinative of the 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 of U.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

of chemical 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 at any point

along a wde spectrum when construing

the meaning of "substantial

production." For instance, If one 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 of the

chart. EPA could also choose to adopt

a broader interpretation, finding all

chemical production to be substantial

unless it fell below a value at the

extreme low end of the chart.

EPA has proposed a production figure

in between the two extremes. The 1

million pound threshold for production

narrows the "universe" of chemicals

potentially subject to TSCA section 4

testing under TSCA section 4(a)(1)(B) to

11 percent of the TSCA Inventory. Since

that small percentage of the Inventory

accounts for 95 percent of total chemical

production, it is reasonable to use this

information as a basis for making a

finding of "substantial production" for

substances produced in excess of that

threshold.

GAF, BASF, and ACC also

commented that the I million pound

threshold "will impose an unfair

economic burden on chemical

manufactUrers and processors that could

stifle technological innovation" (Ref. 7).

This comment (which is unsupported

by any empirical data) also appears to

reflect a misunderstanding of the scope

of this 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 the amount

of testing to be 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

consider the potential economic impacts

and the value of testing data for all

section 4 test rules. For each chemical

subject to testing, EPA conducts an

analysis which estimates the costs of

testing. In addition, EPA considers any

comments received on the economic

effects of proposed 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 of economic

impacts is particularly important for

chemical testing decisions because

EPA's purpose in using section 4 is to

obtain data for use in risk assessment

and, where necessary, risk management

activity. EPA recognizes that if the

testing it requires on a substance under

section 4 imposes an unfair or excessive

burden, the likely result of the section

4 rule would be to drive the chemical

from the market, rather than to produce

test data. To insure that test data are

received, EPA must be concerned with

any significant adverse economic

impacts associated with section 4 test

rules. Economic considerations are

therefore well integrated into EPA's

testing decisions.

In response to EPA's alternative

threshold proposal for the substantial

production criterion (220,000 pounds)

used in the review of new chemical

substances under section 5 of TSCA,

Callery Chemical Company stated,

Ia~t this threshold production level, the

publication of production quantities will not

only reveal extremely sensitive confidential

business information but will clearly overwhelm the Agency with work that it

cannot handle (Ref. 5).

EPA believes that adopting the

threshold of substantial production used

in the review of new chemical

substances under section 5(e) of TSCA

is inappropriate at this time, although

for different reasons. Callery Chemical

Company's concern about public

disclosure of sensitive business

information is addressed elsewhere in

this notice (Unit Il.F. of this notice).

EPA recognizes that the number of

chemicals which could be considered as

potential testing candidates under

section 4 of TSCA would be greater if

the lower threshold value of 220,000

pounds were adopted. However,

substantial production is only one of the

findings that EPA must make in order to

propose chemical testing under section

4 of TSCA. Therefore, there is no reason

to believe based on a lower threshold

alone that EPA would be overwhelmed,

as Callery Chemical Company believes,

by adoption of the 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 pound threshold for "substantial production" under section

4(a)(1)(B)(i) of TSCA.

D. Substantial Release

If the criterion for "substantial

production" is met, then at least one of

three additional findings under TSCA

section 4(a)(1)(B)(i) must also be made

before testing is required. 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 of I million

pounds per year release or release of 10

percent or more of total 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 of a 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 that EPA

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

finding under TSCA section

4(a)(1)(B)(i)(I). In effect, CMA attempts

to import the "exposure" component of

clause (11) of section 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, if it chooses,

make a finding 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 of a chemical substance,

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is, per se, "entry" of that substance into

the environment, irrespective of the

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, or a 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 of the phrase "enters the

environment" as encompassing any "release" to the environment is a

reasonable reading of section

4(a)(1)(B1)(i)(1).

CMA also commented that

EPA should clarify that, as in section 313

of EPCRA, the only releases on which a "B"

finding will be based are releases to air or 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 of the scope of the 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" is broadly 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"

appears only in EPCRA section

313(d)(2)(A). 42 U.S.C. 11023(d)(2)(A).

Under this provision of EPCRA. when

considering the reasonably anticipated "significant adverse acute human health

effects" of a 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 of those effects which

would occur "at concentration levels

that are reasonably likely to exist

beyond facility site boundaries as a

result of continuous, or frequently

recurring releases." This limitation

applies only in this instance, and does

not apply to or modify any other clause

of EPCRA section 313. Therefore, CMA's

attempt to limit the scope of the term "release" under EPCRA, and to relate

this limitation to releases 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) of section 4(a)(1)(B)(i) of the

Act to encompass any release of the

substance to the environment. For

purposes of this 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 from the

manufacture, processing, distribution in

commerce, use or disposal of a chemical

substance or mixture, regardless of the

source or nature of the release.

Furthermore, TSCA's scope is not

limited to consideration of only releases

from a site or transfers 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 of a chemical substance or

mixture.

SPI commented that EPA's proposed

1 million pound release threshold, and

the proposed alternative 10 percent of

production volume threshold, were "arbitrary" and that "EPA does not

provide any support for the selection of

10 percent of the production volume

other than it would seem to be a sizable

number. Absent any frame of reference

such as exposure, or presence in the

environment, such a number is no less

valid than I percent or 60 percent" (Ref.

2).

EPA disagrees with SPI's comment. In

choosing the 1 million pound threshold

value to represent "substantial" release,

EPA was guided 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 of that

amount of release. EPA has determined

that 37 percent of the chemicals listed

on the TRI have releases of over 1

million pounds and that these releases

account for 99 percent of the total

reported release on the TRI by volume.

Clearly, the small percentage of TRI

chemicals that exceed the selected

poundage threshold accounts for the

vast majority of total TRI releases. It is

reasonable for EPA to use that

information as a basis for focusing its

attention on chemicals released in

excess of that threshold.

In addition, as stated in the proposed

policy statement (56 FR 32296). the

percentage threshold has been proposed

because EPA is also concerned about

chemical releases that are a sizable

percentage of the production volume of

that chemical. EPA believes that when

such a sizable percentage of a

chemical's production volume is

released, that release should be

considered "substantial" for that

chemical substance. This threshold will

allow EPA the flexibility to require

testing of chemicals with production

volumes equal to or greater than 1

million pounds per year, but with

releases of less than I million pounds

per year.

E. Substantial and Significant Human

Exposure

EPA proposed that "substantial

exposure" means exposure to large

numbers of people (56 FR 32297). and

set out the following numerical

thresholds for a finding of "substantial

exposure": 1,000 workers, 10,000

consumers, and/or 100,000 persons in

the general population. EPA proposed

that "significant exposure" refers to the

nature of the exposure. A finding of "significant exposure" would generally

be made where the numerical threshold

for numbers of persons exposed for "substantial exposure" is not met. but

the nature of the 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, if the

number of people exposed exceeds the

thresholds set forth in this policy and

the nature of the 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 for which there is a strong

basis or supporting rationale (56 FR

32299-32300).

OSHA and NIOSH submitted

comments supportive of EPA's

statement of policy for determining "substantial" and "significant" human

exposure. In fact, NIOSH "urges EPA to

seriously consider its alternative

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proposal* * * that would result in testing

compounds for which 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 of unknown

toxicity represents adequate impetus to

require testing" (Ref. 8). In addition,

OSHA stated that the proposed

distinction between " 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 not provided sufficient

rationale to justify the proposed

numerical thresholds for determining "substantial" human exposure.

EPA disagrees with the commenters'

suggestion that EPA did not provide

sufficient rationale for the 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 belief that 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 or no hazard data

exists to indicate whether or not that

chemical substance may present an

unreasonable risk. EPA has based its

thresholds for workers 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 of 650 workers are

potentially exposed to a chemical

substance produced In a quantity of 1

million pounds. In other words, for a

chemical produced in a quantity of 1

million pounds, it is relatively

uncommon that as many as 1,000

workers would be exposed. Given this

analysis and its experience of case-bycase analysis of existing chemical

exposure over the years, EPA believes

that it has reasonably Interpreted

"substantial human exposure" under

TSCA section 4(a)(1)(B)(i)({I) by

utilizing a relatively conservative

threshold of exposure of 1,000 workers

to a chemical substance. Moreover.

although many respondents do not favor

EPA's rationale for making a

determination of substantial human

exposure, they did not specifically argue

that these thresholds were

unreasonable, nor did they provide any

specific alternative criteria or rationale.

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 of individuals. As

stated in the proposed policy statement, "workers generly are exposed on a

more routine or direct basis than

consumers, and consumers are generally

exposed on a more 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 of the

categories of individuals. Both OSHA

(Ref. 8) and NIOSH (Ref. •9) supported

the basis for the 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 (cumene decision); 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 for making 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 not take into

account the physical and biological

properties ora chemical, the manner of

its use andrelease, the level, frequency,

and duration of exposure, nor any

available relevant exposure data. CMA

argues that EPA should "make prudent

but realistic assumptions about the

exposure levels that would be of

regulatory concern if testing

demonstrates adverse effects" (Ref. 1).

EPA believes that CMA's comments

reflect an inaccurate understanding of

the role of chemical 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 of humans and the

environment to a large number of

chemical substances and mixtures with

potentially harmful effects, there would

effective regulation of commerce in

such substances. TSCA section 2(a), 15

U.S.C. 2601(a). Since the potential

effects of many chemical substances in

commerce are not known, the policy

provisions of TSCA reflect Congress'

intent that:

adequate data should be developed with

respect to the effect of chemical substances

and mixtures on health and the environment

and that the development of such data

should be the responsibility of those who

manufacture and those who process such

[substances).

TS6A section 2(b)(1), 15 U.S.C.

2601(b)(1). Section 4 of TSCA provides

EPA the authority to require such

testing.

In effect, by urging EPA to make "assumptions about the exposure levels

that would be of regulatory concern if

testing demonstrates adverse effects,"

CMA argues that EPA must make an

affirmative finding that a chemical

substance would pose an unreasonable

risk of injury at some hypothetical

levels of toxicity and exposure in order

to require testing under section

4(a)(1)(B) of TSCA. 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 no risk analysis. See

899 F.2d at 354 (cumene decision); and

859 F.2d at 979, and 984-988 (EHA

decision). Additionally, as both

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 of information about the

hazard of the chemical substance in

question. Given the statutory framework

of TSCA, its legislative history, and the

case law interpreting the section 4

testing provisions, EPA does not believe

that it is required to undertake the type

of detailed exposure analysis urged

upon It by CMA and other respondents

in making the TSCA section

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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

of policy, offer for consideration in the

proposed policy statement an

alternative set of human exposure

criteria, based on the TSCA section 5(e)

New Chemicals Program human

exposure guidelines, which

incorporated some of these factors (56

FR 32299-32300, July 15, 1991).

However, despite an explicit invitation

for comments addressing the merit and

feasibility of applying these guidelines

in the context of section 4 test rules,

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 view that the section 5(e)

criteria should not be applied to review

of existing chemicals under section

4(a)(1)(B). (Refs. 1 and 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 or other specific

sugestions or rationales.

Despite EPA's attempt to elicit more

specific comments, most commenters

addressed only the general concept of

the proposed thresholds. For example,

CMA argued that "Congress clearly

expected EPA to demonstrate a pattern

of unusually 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 of variations 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 or few 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 for typical chemicals in

commercial production.

CMA suggested that data exist which

could be used to make order-ofmagnitude distinctions regarding the

number of workers 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 for Tracking the

Inventory of Chemicals (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 (Risk Management1) process has resulted in a systematic

review of available exposure

information for a growing number of

existing chemicals (Ref. 1).

As explained above, EPA disagrees

with commenters' fundamental premise

that the Agency is required to undertake

an analysis of typical exposures of all

chemical substances currently in

commercial production in order to

support its interpretation of the term "substantial" under section

4(a)(1)(B)(i)(II) of TSCA, or that such an

approach was mandated by Congress.

Neither the plain language of TSCA nor

the legislative history require EPA to

undertake the kind of exhaustive

analysis urged upon it by CMA and

other respondents to support findings

under TSCA section 4(a)(1)(B)(i). In

short, the cost of generating the

exposure information necessary for this

type of analysis may well exceed the

cost of testing, and is not appropriate for

a decision to require testing under

section 4 of TSCA.

EPA notes, however, that it does not

itmore all of these factors in making

decisions to require testing under

section 4 of TSCA. 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 of a chemical substance, and

whether testing of such 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 of its use and release, the

level, frequency, and duration of

exposure, and any available relevant

exposure and toxicity data. It is the

responsibility of interested parties to

provide any information they believe

may be relevant to the Agency's

determination to require testing of a

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 of any final test rule.

Furthermore, even if EPA were to

conduct the analysis urged upon it by

CMA at this time, the potential sources

of information identified by CMA

present a number of problems for such

an analysis due to the limited scope of

their coverage. These limitations differ

from database to database, and include

the number of chemicals covered,

limited overlap between the databases,

the specific data included in each

database or information source,

imprecise data concerning current

production of a given substance, gaps in

exposure, use and release information,

and differences in the quality of data

and the basis for each estimated

parameter. For example, the NOES

database developed by NIOSH contains

information on more than 4,000

chemicals. This database contains

useful information on the approximate

number of workers potentially exposed,

the number of female workers

potentially exposed, the approximate

number of facilities in the industry

handling the chemical, and the industry

Standard Industrial Code (SIC) where

the chemical is found. However, by

itself, the database is insufficient to

fully characterize the potential worker

exposures because the database does not

contain information of the frequency,

duration, or the levels of workers'

exposures. Due to these limitations, EPA

does not believe that it is possible to

develop an analysis of the variations in

human exposure potential for the entire

universe of chemicals. However, in the

context of a substance-specific

rulemaking, EPA will carefully consider

the human exposure scenario. Once

again, EPA invites interested parties to

submit for EPA's consideration all

available and relevant information

during the notice and comment period

for each substance-specific rulemaking

under TSCA section 4.

2. Significant human exposure. CMA,

supported by SPI, agreed with EPA that "exposure can be considered

'significant' where the potential exposed

population is not large but the

conditions of exposure are unique and

create unusually great concern about the

substance's potential for adverse

effects" (Refs. I and 2). OSHA also

agreed and stated,

lilf a worker is exposed directly (i.e., by inhalation) or on a routine or episodic basis,

it Is reasonable to determine that a significant human exposure exists, even if fewer than

1000 workers are exposed (Ref. 8).

However, CMA, HSIA and others

commented that EPA's proposed policy

does not "meaningfully identify where

such 'significant' exposures might exist"

(Ref. 1).

EPA does not believe that it has, at

this time, sufficient experience to

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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, it will 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 a clearly

identifiable or likely source of the

chemical, an exposure pathway from the

source to the receptor that can be

expected, with reasonable certainty, to

result in the potential for exposure, and

an exposure route that will or can

reasonably be expected to result 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 as presented in Table I of the

proposed policy (Ref. 6).

As previously acknowledged, there is

some overlap between the criteria used

to construe "substantial" and "significant" human exposure.

However, it is EPA's belief that such an

overlap is not inconsistent with the

statutory purpose and legislative history

of TSCA. As stated in the cumene

decision, 899 F.2d at 356, n. 17, "it is

not necessarily clear that "significant"

and "substantial" as used in clause (II)

must be understood in a way that

prevents any overlap."

CMA recommended that "EPA should

judge the "significance" of exposure by

examining whether, for the affected

population, it involves large

concentrations or is usually frequent or

prolonged" (Ref. 1). HSIA suggested that

EPA consider "the mode of manufacture

of the chemicals, the manner of use, and

physical properties which may make

even quite direct exposure to the

threshold levels of little or no concern"

(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 of what 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 of substance-specific

rulemakings under TSCA section 4,

including the manner of use, the

chemical specific physical properties,

and whether for the affected population

the exposure would involve large

concentrations or is frequent or

prolonged. Also, in response 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)

of TSCA (56 FR 32299). These TSCA

section 5(e) criteria do include some

consideration of frequency, duration

and magnitude of exposure for workers,

and consideration of magnitude of

exposure for the general population.

The section 5(e) criteria for consumer

exposure are qualitative only. These

criteria were developed based on

experience assessing the exposures

associated with thousands of new

chemicals with limited, but known, uses

and exposure settings. However, as

explained above, none of the

commenters were in favor of EPA

adopting the TSCA section 5(e) human

exposure criteria.

In summary, for the purpose of

determining whether there is or may be "substantial" exposure under TSCA

section 4(a)(1)(B)(i)(U1), EPA will utilize

the numerical thresholds of 1,000

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 of use, substance specific

F hysical properties, concentration

evels, and the duration and frequency

of the exposure to the substance. It is

important to note that TSCA section 4

is an information gathering tool only

and that it places no limits on a

chemical substance's manufacture,

processing, distribution in commerce or

use. Given the limited purpose of TSCA

section 4(a), to require testing, and

because the finding that there is or may

be "substantial" or "significant" human

exposure is only one of several findings

EPA must make to require testing, EPA

believes that the criteria set forth herein

are a reasonable interpretation of the

phrase "significant or substantial

human exposure" in TSCA section

4(al(1)(B)(i)(11).

F. Other Issues

1. Categories. EPA proposed that it

would apply the generic numerical

thresholds for most 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 a case-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.

In CMA's judgement, the only category that

would be suitable for a ' finding would be

one whose members possessed similar

chemical structures and were therefore likely

to have 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 test each and every member of the

PA ,does not agree with the

commenters that categories must, by

necessity, be limited to chemicals with

similar structures or toxicological

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 of all

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 test rule

for glycidols (56 FR 57144, November

11, 1991).

2. Additional or mitigating factors.

CMA, Monsanto and others stated that

EPA should, in implementing its policy

under section 4(a)(1)(B) of TSCA,

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 other indicators of substantial

exposure other than that a chemical

appears in human adipose tissue, EPA

should consider that the tissue may be

reflective of background levels in the

environment, a metabolic product of

another compound. or release from nonindustrial sources (Ref. 1). In such a

situation, CMA suggests that testing

under section 4(a)(1)(B) of TSCA would

not be Justified.

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EPA agrees with the respondents that

in implementing this policy, EPA

should preserve the flexibility to

consider certain variables on a case-bycase basis. Furthermore, in

implementing section 4(a)(1)(B) of

TSCA, EPA intends to use the criteria

articulated in this policy 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 of policy, 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 - it need

not "function like a mathematical

formula." 899 F.2d at 359. On the other

hand, there may be some instances

when a chemical substance meets the

criteria articulated under TSCA section

4(a)(1)(B)(i), but where testing under

TSCA section 4(a)(1)(B) will not be

required because EPA finds under

subsection (ii) or subsection (iii) of

section 4(a)(1)(B), respectively, that data

are sufficient to reasonably determine or

predict the effects of the 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 justify not

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 of the manufacture,

process, distribution, use or disposal of

the chemical and/or that testing is not

necessary. 3. Confidential business information.

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 of confidential

business information (CBI) and "could

provide valuable marketing information

to competitors and potential

competitors without justification" (Ref.

5).

EPA does not believe that disclosing

to the public the fact that at least 1

million pounds of a chemical substance

or mixture Is produced per year would

be a disclosure of CBI. In making such

a finding, EPA would be relying on the

aggregate production volume for all

manufacturers of the substance. Thus,

EPA would not be disclosing specific

information regarding any particular

manufacturer's production. Should such

a statement affect a single manufacturer,

as might be the case with specialty

chemicals, EPA does not believe that a

statement that production volume is at

least 1 million pounds would disclose

sufficient information to be considered

a disclosure of information which might

be entitled to confidential treatment.

Furthermore, TSCA section 14(a)(4)

authorizes the disclosure of information

which otherwise might be entitled to

confidential treatment when relevant in

any proceeding under TSCA, including

rulemaking, provided that disclosure is

made in such a manner as to preserve

confidentiality to the extent practicable

without impairing the proceeding. See

40 CFR 2.306 (1991). EPA believes that

by disclosing only that a substance is or

will be produced in volumes of 1

million pounds per year or greater,

confidentiality would be 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, if such situations

arise.

G. Beyond Scope

Respondents raised several issues

which are beyond the scope of this

policy statement. The issues relate to

the use of structure activity

relationships (SAR), exclusion of

polymers, tiered testing schemes, and

testing priorities under TSCA section

4(a)(1)(B).

1. Structure activity relationships.

Monsanto believes that "[tihe 'B' policy

should recognize and authorize the use

of structure activity relationships (SAR)

when evaluating the testing needs and

priorities for substantial production

chemicals" (Ref. 3). Monsanto

commented that a large number of their

high production volume chemicals are

produced 'as intermediates and then

ater converted to neutral salts to

facilitate handling and shipping; in

most of these cases, the salt and

intermediate itself have essentially the

same toxicological priorities. Therefore,

by testing and evaluating one substance,

the other chemical can be evaluated

using SAR.

Monsanto's comment is not relevant

to a discussion of TSCA 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 a matter

relevant to TSCA section 4(a)(1)(B)(ii)

and (iii) findings. Therefore, Monsanto's

concerns would be addressed in relation

to a chemical specific test rule.

2. Polymer exclusion. Monsanto

commented that polymer exemptions

should be recognized by EPA under this

policy, because "[plolymers represent a

special class of chemical substances that

needs separate consideration under the

proposed 'B policy" (Ref. 3). Monsanto

noted that a number of polymersubstances are biologically benign and,

therefore, do not represent substantial

health or environmental concern. In

support of this position, Monsanto

noted that exemption procedures are

provided for in the review of new

chemical substances under TSCA

section 5. Likewise, the OECD HPV

program did not include polymers on

the Representative List. Monsanto

believes a similar type of polymer

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 of any submitted data, it is

difficult to address the manufacturers'

concern. Polymers do not have a welldefined composition, and there may be

a need to test some lower molecular

weight polymers or oligomers which

may have potential for health or

environmental effects. Therefore, it

would be premature for EPA to suggest

that a blanket exemption from testing

for polymers may be appropriate. To

date, EPA has not proposed or required

testing of a polymeric compound under

TSCA.

3. Tiered testing. 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 must be made on a case-bycase basis. EPA recognizes that

incorporating a tiered testing scheme in

a test rule can generate preliminary data

relatively quickly with minor expense.

However, for a relatively well

characterized chemical substance, it is

likely that a tiered testing approach

would not be appropriate. In other

instances, if the scientific literature

contains information which strongly

suggests that the chemical is used in a

way that would result in widespread

worker or consumer exposure (e.g., a

solvent use), then it is less likely that a

preliminary experiment would return

the kind of data to support the definitive

answer needed for such widespread

exposure. Thus, automatic

incorporation of a tiered testing scheme

may result in the performance of

screening studies which are unlikely to

provide the needed information.

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4. Testing priorities. CMA commented

that, in addition to adopting the 2.2

million pound threshold for substantial

production, EPA should adopt a tiered,

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 of screening tests

comparable to those in the OECD Screening

Information Data Set (SIDS) battery (Ref. 1).

EPA clearly articulated in the

proposed statement of policy and in

Unit 1. of this final notice that issues

related to how EPA establishes testing

priorities and how EPA makes findings

under subsections (ii) and (iii) of section

4(a){1)(B) of TSCA would not be

addressed in this statement of policy. If

at some future point in time, EPA

decides that adoption of a 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

of I million pounds, aggregate

production volume of the substance per

year for all manufacturers, as the

substantial production threshold. This

threshold currently represents only 11%

of the entire universe of chemical

substances potentially subject to testing

under TSCA section 4, yet accounts for

95% of total chemical production by

volume. For the reasons articulated in

the proposed statement of policy (56 FR

32294) and Unit B.C. of this notice, EPA

believes a threshold value of I 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

of I million pounds of release to the

environment from all sources per year;

or release 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 of that amount of

release. EPA has determined that 37

percent of the chemicals listed on the

TRI have releases of I million pounds

or greater and that these releases

represent over 99 percent of the total

reported release on the TRI by volume.

Clearly, the small percentage of TRI

chemicals that exceed the poundage

threshold accounts for the vast majority

of total TRI releases.

The percentage threshold reflects

EPA's concern about chemical releases

that are a sizable percentage of the

production volume of that chemical.

EPA believes that when such a sizable

percentage of a 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.

of this notice, EPA believes that this is

a reasonable interpretation of the phrase "enters the environment in substantial

quantities" in TSCA section

4(a)(1)(B)(i)(l).

C. Substantial and Significant Human

Exposure

EPA is establishing the criteria in

Table I of this Unit 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

belief that 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 or no

hazard data exists to indicate whether or

not that chemical substance may present

an unreasonable risk. EPA based its

thresholds for workers on experience

gained through case-by-case analysis of

existing chemicals.

The different numeric thresholds for

worker, consumers, and general

population are EPA's attempt to reflect

the inherent differences in the probable

exposure scenarios for particular

categories of individuals. EPA decided

to apply a differential equal to one order

of magnitude between the worker,

consumer, and general population

thresholds. For the reasons articulated

in the proposed statement of policy (56

FR 32294) and Unit II.E. of this notice,

EPA believes that these criteria are a

reasonable interpretation of the phrase "significant or substantial human

exposure" in TSCA 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 directy or on a routine or episodic basis.

pIG Consumers ............... 10,000 peo- < 10,000 people exposed more directly or 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. Additional Factors

EPA will apply the generic numerical

thresholds for most 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 for making

findings by applying other

considerations. For the reasons

articulated in the proposed statement of

policy (56 FR 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 not require

testing under TSCA section 4(a)(1)B)

for a chemical that meets the section

4(a)(1)(B)(i) criteria if EPA finds, under

sections 4(a)(1)(B)(ii) and (iii), that data

are sufficient to reasonably determine or

predict the effects of the manufacture,

process, distribution, use and disposal

of the chemical and/or that testing is not

necessary.

IV. Final Test Rule for Cumene

A. Response to Cumene Panel

On July 27, 1988 (53 FR 28195) EPA

promulgated a final rule requiring

manufacturers and processors of

cumene to perform health and

environmental effects testing in

response to the Interagency Testing

Committee's (ITC) recommendation that

cumene be given priority testing

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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 for resulting

substantial human exposure to cumene

from its manufacture, processing, use

and disposal." EPA also made the

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 (5th Cir. 1990). The

Court remanded the rule requiring EPA

to:

articulate the standards or criteria on the

basis of which it found the quantities of

cumene entering the environment from the

facilities in question to be "substantial' and

the human exposure potentially resulting to

be "substantial."

899 F.2d at 360. The Court'further

instructed EPA to:

articulate whether its respective ITSCA

section 4(a)(1)(B)(i)] clause (1) and clause (IM)

findings (in the cumene rulel each constitute,

alone, an independent and sufficient basis for

its testing requirements, or whether, on the

other hand, its testing requirements rest only

on the clauses (I) and (II) findings jointly '.

The EPA shall further indicate whether its

findings under either clause () or clause (II)

are to any extent dependent on its finding,

which we have disapproved, concerning

entry into the aquatic environment; and, if

so, shall reconsider its clause (1) and (U]

findings in the light of our referenced ruling.

Id. at 360, n. 22. Finally, the Court

directed EPA to consider new studies to

be presented by CMA on remand "unless they would not be material to

any of the EPA's criteria relied on for

the testing." Id. at 360-361. On remand

the Cumene Panel of CMA submitted

both specific studies and general

comments on the cumene final test rule.

The test rule remained in effect, and test

data was submitted to EPA in response

to the rule.

EPA has addressed some of the

Court's instructions concerning EPA's

statutory authority and the Cumene

Panel's generic comments regarding. the

"B" policy (Ref. 12) in Unit 11. of this

notice. Specific comments on cumene

and EPA's review of remand evidence

are addressed in this Unit IV.

B. Substantial Production

In support of Its final test rule, EPA

found that cumene is produced in

substantial quantities, based on reported

U.S. cumene production of 3.35 billion

pounds with an additional 339 million

pounds imported. This figure was not

disputed. For the reasons discussed in

Unit II.C. of this notice, EPA believes

that this level of production clearly

qualifies as "substantial production"

under section 4(a)(1)(B)(i) of TSCA. The

level of cumene production reported in

the final rule well exceeds the "substantial production" threshold

articulated in this notice.

C. Substantial Release

In support of the 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 of cumene

to the atmosphere from manufacturing,

processing, and use activities. The Court

upheld the validity of EPA'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

of this release, EPA did not rely on this

release in calculating human exposure;

nonetheless, EPA did believe that there

was a potential for human exposure as

a result of release of cumene to aquatic

environments. The Cumene Panel

commented that EPA lacks an adequate

basis for finding that cumene "enters

the environment in substantial

quantities." Specifically, the Panel

disagreed with EPA's equating "substantial release" with "enters the

environment in substantial quantities."

The Panel stated,

Itihe Agency has made no effort to analyze

the extensive evidence in the record

regarding the persistence and distribution of

cumene in the environment or to relate cumene release levels to human exposure

patterns (Ref. 12).

As discussed in Unit ILD. of this

notice, EPA rejects the premise that

"enter the environment in substantial

quantities," as used in section

4(a)(1)(B)(i)(I) of TSCA, be defined to

include a determination of "persistence

in the environment of those substantial

quantities." The Court in the cumene

case, 899 F.2d at 355-356, found that

EPA is not obliged to follow CMA's

construction of TSCA section 4.

The Panel also raised this issue in

their comments on the final rule for

cumene, asserting that, considering the

short half-life of cumene in the

atmosphere, there is no reason to

believe that, except for populations very

close to the plant, there is any general

population exposure to cumene. EPA

responded that the half-life of cumene

in the atmosphere appears to be on the

order of 1 or 2 days. At this rate of

removal, the cumene emissions from

ongoing manufacturing and processing

activities would be expected to be

distributed over a large portion of the

communities near manufacturing and

processing facilities depending on the

prevailing atmospheric conditions.

Thus. the Panel has not provided EPA

with a convincing rationale to refute

EPA's finding that cumene "enters the

environment in substantial quantities"

or that there is not "substantial human

exposure." Rather, the Panel has only

demonstrated that persistence, one of

many chemical-specific parameters EPA

considers in evaluating a chemical. may

be of limited importance when

considered with other factors, such as

the manufacturing and processing

scenario.

D. Substantial Human Exposure

The Panel commented that. even if

the release of cumne could be equated

to "substantial" environmental entry.

EPA would notbe justified 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 the type oftesting required to the

bases for the TSCA section 4(a)(1)(B)(i)

finding. EPA does not believe this to be

a validinterpretation of section 4(a) of

TSCA. Furthermore, EPA believes, as

stated in Unit I.B. of this notice, that

clauses (I) and (1) of TSCA section

4(aX1)(B)(i) can be interpreted as

independent. In particular, although

EPA made findings for cumene under

both clauses (I) and (1), EPA believes a

finding under either clause alone

constitutes an ndependent and

sufficient basis for the testing required.

In support of its final rule, EPA found

that there may be substantial human

exposure to cumene based on the

exposure potential to approximately

13.5 million people living in the

vicinity of cumene manufacturing and

processing facilities. EPA believes that a

majority of the people would be

exposed as a result- of fugitive emissions

of cumene to the atmosphere. The

majority of cumene manufacturing and

processing facilities are concentrated in

a few large metropolitan areas. The

Court in the 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 a monitoring study, not

previously submitted as comments on

the rule, that relates to the presence of

many chemicals, including cumene, in

the Houston Ship Channel area (Ref.

19). .The Cumene Panel maintains that the

information contained in this study is

sufficient to show that EPA cannot make

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either the "enters the environment in

substantial quantities" or "substantial

human exposure" findings of section 4(a)(1)(B})(i}.

The remand 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

the conclusions of its 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 underlying goal of the monitoring

program is to provide member firms with

accurate ambient air quality measurements

and technical data for better understanding

air quality concerns in the Houston 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 site is the

northeasternmost site and does not

monitor for any organic compound. The

study states that the prevailing wind

direction is from the southeast (Ref. 21).

Therefore, the monitoring sites are

upwind from all but one of the 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 study whether the detected

environmental concentrations were

detected at the closest downwind

moIiitoring sites. The monitoring array

is either upwind from all the other

cumene manufacturing and processing

sites or is over 30 miles away from these

sites. At that distance, the facilities

would have to release extremely large

amounts of cumene per minute to reach

detectable levels in the 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 at the Champlin Refining and

Chemicals facility in Corpus Christi,

Texas (Ref. 22). In this exercise,

Champlin modelled point source air

emissions from barges loading cumene.

Annual emissions of cumene from these

loading operations were estimated to be

23,000 pounds. However, there are

shortcomings with the methodology

employed in the study.

For modelling purposes, Champlin

divided the annual point source release

estimate by the total number of minutes

in a year to derive the source term (mass

release per minute). Champlin should

have divided the annual point source

release estimate by the total number of

minutes per year in which barge loading

occurred to derive a more realistic

source term for modelling potential air

concentrations. Based on a 1990 joint

effort between EPA and the American

Oil Company on the refining industry,

EPA estimates that the capacity of an

intercoastal barge or tanker ranges 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 of production at the

Champlin facility could be loaded in 7

days. If the cumene emissions were

assumed to be released over a period of

7 days rather than 365 days, the source

term (input) would be raised by a factor

of 50. Additionally, Champlin used

typical to better 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 of D and a windspeed of

5 miles per hour. Therefore, EPA

believes the resulting ambient

concentrations of cumene from the

Champlin modelling exercise

underestimate the ambient

concentration of cumene resulting from

releases at the Champlin facility.

Furthermore, EPA's review of the

study indicates that the study does not

shed any light on the number of people

potentially exposed to cumene, rather it

is only concerned with determining a

level of cumene in the area of the

-Houston Ship Channel. Therefore, the

study does not relate to whether EPA

could make a substantial human

exposure finding.

Another section of the remand

evidence submitted by CMA consisted

of modeling studies of ambient air

concentrations of cumene 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 of detail

concerning methods and assumptions

used varied from study to study, thus

inhibiting EPA's ability to adequately

review the studies. Each of the studies

Is briefly discussed below.

Modelling of cumene emissions from

two Georgia Gulf Corporation facilities,

one in Plaquemine, Louisiana, and the

other in Pasadena, Texas, were

performed using "adjusted" EPCRA

section 313 release data for reporting

year 1987 (Ref. 23). The rationale to

justify the procedure used to adjust the

EPCRA section 313 release data and to

justify the meteorological assumptions

used for modeling air dispersion were

not sufficiently detailed to enable an

adequate EPA review of the 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 for an 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 of the studies.

The remand evidence was

accompanied by an affidavit from

Marvin B. Hertz, an industry consultant,

supporting the use of ambient 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 a role in any

exposure assessment, and thus, in risk

assessment. However, it is very difficult

to perform any risk assessment when

the hazards of the compound are either

not known or not well characterized.

For this reason, and the reasons

articulated in Unit II.E. of this notice,

EPA does not depend on human

exposure at a particular "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 does not

present a risk. Moreover, the Panel

objected to EPA's reference to a TSCA

section 8(e) submission, which

indicated cataract formation in rats

exposed to cumene vapors, as an

example of the benefits of testing a

chemical in the absence of hazard data.

Since that section 8(e) submission, the

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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 for hazard

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 of this chemical at this time.

Therefore, EPA does not believe any

further testing of cumene is necessary at

this time.

V. Public Record

A. Supporting Documentation

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 of the Plastics Industry, Inc.

Comments on EPA's TSCA 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 section 4(a)(1)(B) Proposed

Statement of Policy submitted to the TSCA

Public Docket Office, USEPA (September 12,

1991).

(4) Ecological and Toxicological

Association of the Dyestuffs Manufacturing

Industry. Comments on EPA's section

4(a)(1)(B) Proposed Statement of Policy

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 of Policy 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 of Policy

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 of Labor, Occupational

Safety and Health Administration. Comments on EPA's section 4(a)(1)(B) Proposed

Statement of Policy submitted to TSCA

Public Docket Office, USEPA (October 7,

1991).

(9) U.S. Department of Health and Human

Services, National Institute for Occupational

Safety and Health. Comments on EPA's

section 4(a)(1)(B) Proposed Statement of

Policy submitted to TSCA 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 of Policy 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

of Policy submitted to TSCA Public

Information Office, USEPA (September 17,

1991).

(13) CMA's Cyclohexane Panel. Comments

on EPA s section 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 of Policy 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 of Policy submitted to

TSCA Public Information Office, USEPA

(September 15, 1991).

(16) USEPA. Implementation Proposal;

"New Chemicals Exposure-Based Finding,"

letter from Charles L. Elkins to Geraldine V.

Cox (Chemical Manufacturers Association).

Office of Toxic Substances, USEPA

(September 22. 1988).

(17) Organization for Economic

Cooperation and Development. "OECD's

Work on Investigation of High Production

Volume Chemicals." Document 3, May 1991.

(18) U.S. Department of Health 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 (July 20. 1988). (CMA

exhibits for remand evidence).

(20) USEPA. Review of Evidence

Submitted by CMA on Remand of Cumene

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 of Cumene Releases at Champlin

Refining Company (October 14, 1988). (CMA

exhibits for remand evidenCe).

(23) Georgia Gulf Corporation. ISC and

ISCLT Air Modelling Results from Georgia

Gulf Corporation 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) Star Research. 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 for Cumene. Washington,

DC: Office of Pollution Prevention and

Toxics. USEPA (January 10, 1991).

(29) USEPA. Regulatory Management-I

(RM1) Summary for Cumene. Washington,

DC: Office of Pollution Prevention and

Toxics, USEPA (June 17, 1992).

Dated: May 5, 1993.

Victor J. Kinmm,

Acting Assistant Administrator for

Prevention, Pesticides and Toxic Substances.

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

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