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32294 Federal Register / Vol. 56. No. 135 / Monday, July 15, 1991 / Notice s

ENVIRONMENTAL PROTECTION TSCA section 4(a)[1)(B) policy substantial human exposure to such

3ENCY definitions should be submitted to: substance or mixture,

TSCA Public Docket Office (TS-793), (2) There are insufficient data and

~TS-47002J; FRL 3847-21 Office Toxic Substances, Environmental experience upon which the effects of the

rtiN 2070-AC31 Protection Agency. Rm. NE-G004, 401 M manufacture, distribution in commerce ,

St., SW.. Washington, DC 20460. A processing, use, or disposal of such

TSCA Section 4(a)(1)(B) Proposed public version of the administrative substance or mixture or any

Statement of Policy record supporting this action is combination of such activities on health

available for inspection at the above or the environment can reasonably be

AGENCY : Environmental Protection address from 8 a .m. to 12 noon . and 1 determined or predicted, and

Agency (EPA). p.m. to 4 p.m., Monday through Friday, (3) Testing of such substance or ACTION : Proposed Statement of Policy. except legal holidays. mixture with respect to such effects is

Information submitted in an : EPA is proposing standards y SUMMARY comment on this notice may be claimed necessary to develop such data

.

and criteria it intends to use in These are known as "release or

interpreting its legal authority to make as "Confidential Business Information ." exposure-based" findings as opposed to

findings under the Toxic Substances Information so marked will not be the "risk-based" findings of TSCA

Control Act (TSCA) section 4(a)(i)(B)(i) disclosed except in accordance with section 4(a)(1)(A).

for determining substantial production, procedures set forth in 40 CFR part 2 . A

copy of the comment that does not On April 12,1990, the Court remanded

release to the environment in to EPA the TSCA section 4 test rule for

substantial quantities, and substantial contain CBI must be submitted for cumene in response to a challenge to the

or significant human exposure. This inclusion in the public record.

rule by the Chemical Manufacturers is not intended to address how Information not marked confidential wil l

policy be disclosed publicly by EPA by placing Association (CMA). The Court generally

EPA establishes priorities for testing or upheld EPA's factual findings in the rule

whether any individual chemical should it in the public record without prior as being supported by substantia l

be tested. Further, EPA does not intend notice to the submitter.

evidence but instructed EPA to ""'

to require testing of every chemical that FOR FURTHER INFORMATION CONTACT: articulate the standards or criteria on

meets the criteria under TSCA section David Kling, Acting Director. the basis of which it found the quantities

4(a)(1)(B)(i) as articulated in this notice Environmental Assistance Division (TS- of cumene entering the environment

because EPA must also find under 799). Office of Toxic Substances, rm. E- from the facilities in question to be

TSCA section 4(a)(1)(B)(ii) and (iii) that 543B, 401 M St., SW., Washington, DC 'substantial' and potentially resulting

data are inadequate to determine or 20460, (202) 554-1404. TDD (202) 554- human exposure to be 'substantial' ."

predict the effects of the chemical and 0551. EPA decided to use the opportunity to

'hat testing of such chemical is SUPPLEMENTARY INFORMATION : EPA is explain its criteria for making all legal

-essary. This notice is not intended to proposing to establish quantitative findings under section 4(a)(1)(B)(i) of

Aress the policy issues related to how criteria (numerical thresholds) and other TSCA. This notice is not intended to A identifies candidates for testing. factors for evaluating "substantial address EPA's policy decisions for

or the reasons articulated in this production," "substantial" and selecting chemicals as potential

notice. EPA is proposing that in cases "significant" exposure, and candidates for testing . Afte r

where the actual numbers for "substantial" release findings as set consideration of public comments . EPA

production, re)ease, or exposure are forth in test rules developed under will publish a final notice on this policy .

above certain quantitative numerical TSCA section 4(a)(1)(B). In Chemical

thresholds, these numbers are per se Manufacturers Association et al., V

. TSCA provides EPA with little

substantial. Furthermore, EPA guidance on what criteria and standards proposes Environmental Protection Agency, 899 should be used in making section

that such findings are also appropriate F .2d. 344, (5th Cir.1990), the Fifth Circuit 4(a)(1)(B) findings. The statute does not in situations where the quantitative Court of Appeals (the "Court" )

numerical thresholds are not met, if define the terms "significant" or remanded to EPA the rule requiring "substantial." It is usefu), however, to "additional factors" exist. EPA will cumene testing and required EPA to understand EPA's legal authority in

continue to develop and refine the articulate criteria for the findings EP

A criteria as its experience with chemicals TSCA section 4 in the context of th e

made in the cumene test rule (53 FR entire statute. The general of considered for testing evolves, 28195) with red to the findings are set forth in TSCA section 2(b) . EPA has decided to use this purposes :

particularly gar opportunity to propose criteria fo

r of significant human exposure, for which 'making all findings under section (b) Policy .-It is the policy of the Unite d

EPA is not proposing a minimum cut-off 4(a)(1)(B)(i) of TSCA. States thatin this notice . If EPA needs to provide (1) adequate data should be developed

further rationale for its findings beyond I. Introduction with respect to the effect of chemica l

the explanation resented in this substances and mixtures on health and the

P Under section 4(a)(1)(B) of TSCA, EPA environment and that the development of proposal. EPA will articulate the criteria must require testing of a chemical such data should be the responsibility of

used in making such findings in the substance or mixture (chemical) to those who manufacture and those who

proposal for that individual test rule . develop health effects, environmental process such chemical substances and

This notice also addresses the effects, or chemical fate data, or other mixtures ;

application of the proposed criteria to data relevant to determining risk, if it (2) adequate authority should exist to

EPA's existing cumene test rule (July 27, finds that: regulate chemical substances and mixtures

1988, 53 FR 28195). (1) The chemical substance or mixture which present an unreasonable risk of injury

DATES: Submit written comments on or is or will be produced in substantial to health or the environment . an.i to take

`?efore September 13. 1991 . action with respect to chemical substance s

quantities, and (a) it enters or may and mixtures which are imminent hazards:

)DRESSES : Written comments, in reasonably be anticipated to enter the an d

1plicate, identified by the docket environment in substantial quantities, or (3) authority over chemical substances e• d

imber (OPTS-47002J) for the proposed (b) there is or may be significant or mixtures should be exercised in such a

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

manner as not to impede unduly or create number of people exposed, or the extent of knowledge on the vast majo rity, it is

unnecessary economic barriers to of environmental exposure are among reasonable to interpret TSCA section

technological innovation while fulfilling the the considerations which may be 4(a)(1)(B) as authorizing EPA to require

prima ry purpose of this Act to assure that relevant in particular circumstances.- testing for eve ry chemical that presents

such innovation and commerce in such (Legislative History at 425). a scenario of environmental or human

chemical substances and mixtures do no t

present an unreasonable risk of injury to For example, the benefits of testing a exposure which may need to be

health or the environment chemical in the absence of hazard data addressed on the basis of test data .

( 1 5 U.S.C.2em(b)li)). is demonstrated by testing conducted EPA is proposing quantitative criteria

As explained in section 2 of TSC under the cumene rule . The sponsors of

A, ( numerical thresholds) and other factors

the cumene testing conducted under the

testing is only a first step. Once test that will generally be used to make rule found effects of cumene that were

data are obtained, EPA can then those determinations while reserving the

consider whether any regulatory important enough to submit to EPA ability to consider other factors on a

restrictions on the manufacturing.

under TSCA section 8(e), Notice to case-by-case basis. As a matter of

p rocessing, distribution in commerce, Administrator of Substantial Risks, prior course, EPA has reviewed past test rules

use, and disposal of the chemical are to the time they were required to report mul ated under section 4(a)(1)(B) of

necessary . If EPA decides that the the data under the test rule . Also, test ~ A, ghreshoids embraced in both EP t A

chemical presents an unreasonable risk sponsors indicated to EPA that they and non-EPA regulatory ams, and

of injury, EPA may

then initiate intended to notify workers and apro~

rulemaking under section 6 of TSCA .

consumers about these results, reduce economic indices in developing these

Since testing is only a first step in worker exposure to cumene, provide crite ria. EPA believes that these

protecting the public from unreasonable employee training. and revise their proposed criteria and factors are both

risk of injury to health and the material safety data sheets for cumene appropriate and reasonable for

environment, Congress gave EPA broad (Ref. 1). implementing the congressional

authority to require testing of chemicals EPA recogr.izes that it should not mandate of requiring testing o f

not only when there is some preliminary interpret the words "significant" and chemicals under TSCA sec tion

conce rn about the chemical (TSCA "substantial" in ways that would require 4(a)(1)(B) .

section 4(a)(1)(A)), but also in the case it to make findings for eve ry chemical in EPA has implemented a po li cy

of chemicals wi th large production (

and commerce, or the statute would have designed to routinely seek data on new

release or exposure), even in the simply required testing for all chemicals. chemical substances which may present

absence of any information that the Nevertheless, TSCA section 4(a)(1)(B) is widespread human or environmenta l

designed to support risk management

chemical may be hazardous to

health or the environment. This human activities under the other provisions of for the e

dthat provides

of a policy f~or~tn a evelopment

t

sense because in the case of "large" TSCA, including sec tion 6. TSCA is existing chemicals. Section 5(e) of TSCA

production volume chemicals, it is most different from most other environmenta l statutes in that it is intended to be provides EPA with the authority to

likely that these chemicals may have preventative. To all ow the continued regulate new substances pending

either the release or human exposure widespread exposure to chemicals with development of health and scenarios that EPA may wish to restrict unknown hazards would be contra ry

to environmental effects data based on

based on the results of testing .

the preventative goal of TSCA. which either the potential risk presented by the

The legislative history of TSCA

provides some guidance on criteria to be was expressed in the legislative history substance (section 5(e)(1)(A)(ii)(11) orthe potential for substantial production

used in making section 4(a)(1)(B) as follows:

findings: "The conditions specifi ed in This vast volume of chemicals have, for the volume and substantial or

significant

(TSCA) section 4(aKi)(B) reflect the most part. been released into the human exposure or substantial

Committee's recognition that the re are environment with little or no knowledge of environmental release (sec tion

certain situations in which testing is their long-term health or environmental 5(e)(1)(A)(ii)(II))_

desirable even though there is an effects

. As a result, chemicals currently in In initiating the section 5(e) policy,

commercial and household use are now being EPA developed crite ria (guidelines) to

absence of information indicating that found to cause or contribute to health or ,

the substance or mixture may be environmental hazards unknown at the time define the terms , 'substantial' and

harmful" (H. Conf. Rept. 2341 . 94th commercial use of the chemical begaa "significant" in the section

Cong., 2d sess. (1976), at 18 reprinted in, • • • • • 5(e)(1)(A)(ii)(I) and 5(e)(1)(A)(ii)(II)

A Legisla tive History of the Toxic [I)t is often many years after exposure to a findings. These guidelines are illustrated

Substances Control Act (Comm.Print harmful chemical before the effects of its in Unit 1V. A. of this no tice. Because the

1976) ("Legislative History") at 425) and harm become visible. By that time it ma y be production volumes of new substances

"•' * the re are certain situations in too late to reverse those effects. are typically small er until they have

which testing should be conducted even ' ' ' • • been in produc tion for sometime and

though there is an absence of Because of the lack of ►eatiag by because of the greater uncertainty in

manufacturers and processors of chemicals to

information indicating that the , determine their health and environmental accurately predicting the exposures

substance or mixture per se may be effects, the general popula tion and the which may result to humans and the

hazardous" (H. Conf. Rept.1679, 94th environment now se rve as the laboratory for environment from the manufactnring .

Cong., 2d sess. ( 1976), at 61 reprinted in, discovering adverse health and processing, distribu tion in commerce,

Legislative Histo ry at 674). The environmental effects. Aside from inequities use, and/or disposal of these new

legislative history also indicates that in relying on human experience to indicate substances, EPA has adopted threshold

"" • the Administrator is not limited to when a chemicalis harmful, such a method is values for new substances which are

consideration of sheer volume of also a grossly inefficient way to identi

fy lower than those which are being

production or exposu re at a specific problems.

point in time. The duration of the (Legislative History at 411-413). proposed in this notice for the testing of

existing chenucab under TSCA section

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

.

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

~
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32296 Federal Register / Vol . 56, No. 135 / Monday, July 15, 1991 j Notice s

II. Proposed Approach production volume is at least 1 million by volume released . However. the TRI is

iubstantial Production pounds, would not disclose sufficient comprised only of the releases of a

information to be considered a select group of chemicals. and therefore

ae first finding under TSCA section disclosure of information which might may not be representative of the

ata)(1)(B) is whether the chemical "is or be entitled to confidential treatment . In releases of all chemicals in commerce.

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

quantities," referred to as "substantial authorizes the disclosure of information only 11 percent of all chemicals are

production." EPA is proposing that a which otherwise might be entitled to produced in quantities that exceed I

threshold value of I million pounds confidential treatment when relevant in million pounds, the percentage of those

(lbs.), 454,000 kilograms (kgs .), be any proceeding, including rulemaking, chemicals that are released in this

established as the substantial provided that disclosure is made in such quantity will be much smaller. Although

production threshold. EPA believes it is manner as to preserve confidentiality to EPA believes TSCA allows it the

reasonable to interpret production in the extent practicable without impairing discretion to interpret substantial

substantial quantities to mean large the proceeding. By disclosing only that a release at amounts lower than 1 million

production, and that 1 million pounds is chemical is or will be produced in pounds per year, EPA believes it is

a large amount of production . The TSCA volumes of 1 million pounds per year or reasonable to interpret the term

section 8(b) inventory of the chemical greater, EPA would preserve "substantial release" to include this

substances in commerce shows that confidentiality to the extent practicable limited group of chemicals (i .e. . less than

only about 11 percent of the listed while still making findings under section 11 percent) .

substances have production volumes 4(a)(1)(B) . The alternative of at least 10 percent over I million pounds, together

B. Substantial Release of production volume threshold is

accounting for over 95 percent of the incorporated into this criterion to allow total production volume of all If tfie criterion for substantial EPA some flexibility to require testing of substances produced in the United production under section 4(a)(1)(B)(i)(I) chemicals that are produced i

n

States (Ref. 2). EPA believes that'TSCA is met, then at least one of the following quantities equal to or greater than I

section 4(a)(1)(B) gives EPA sufficient three separate findings under section million pounds per year, but that are

discretion to set the level of substantial 4(a)(1)(B)(i)(II) would also have to be released in amounts less than I million production lower than I million pounds met to legally require testing: (1) There pounds per year. Although few

per year, however, it is well within is or may be substantial release, (2) chemicals with production volumes

reason to find that this small number of there is or may be substantial human between 1 and 10 million pounds will chemicals (i.e ., the top il percent exposure, or (3) there is or may be have releases of greater than 10 percent

according to production volume), which significant human exposure. Substantial of production volume, EPA believes it is account for the vast majority of all release is discussed in this Unit II .B, reasonable to require testing of suc h

~duction, clearly are chemicals with while both human exposure components chemicals because a release of 10

stantial production as that term is are discussed together in Unit II.C. of percent of production means that a -i in TSCA section 4(a)(1)(B). this notice

.owever. some may feel that a EPA believes that the intent of produced is escaping into th . sizable amount of what is being

e

substantial production threshold value Congress was that the phrase "enter the environment . Given the results of the of 1 million pounds per year is too low a environment in substantial quantities" testing, EPA may want to act to limit

value; others may feel it is too high. (referred to as "substantial release")

Therefore, EPA is soliciting comments captures chemicals for which there is or such releases. Again, by setting the level

on adoption of a different threshold may be extensive release to the at 10 percent of production, EPA

value and the supporting rationale for environment which, in itself, would be, believes that this is a reasonabl e

such choice . sufficient to require testing even in the interpretation of EPA's authority under

Some manufacturers of chemicals for absence of any information that the TSCA section 4(a)(1)(B) .

which TSCA section 4(a)(1)(B) findings chemical may be hazardous to human However, some may feel that the 1

would be made may claim that their health or the environment because such million pounds of release or 10 percent

individual production volumes of a releases might be amenable to risk of production volume threshold may

particular chemical are confidential management. In other words, as with lead to inconsistent results. For

business information. EPA recognizes substantial production, release of instance, under these criteria a chemical

that whenever it makes a finding under substantial quantities means large with 1 million pounds of production and

TSCA section 4(a)(1)(B) based on the release . EPA is proposing that, a value 100,000 pounds of release would met the

numerical threshold for substantial of I million pounds per year release or criteria for substantial release, while a

production (i.e ., l million pounds per release of at least 10 percent of total chemical with 2 million pounds o f

year), it would be publicly production volume, whichever is lower, production and 100,000 pounds of

acknowledging that the chemical is or be established as the threshold . EPA release would not met the criteria for

will be produced in the aggregate in believes that 1 million pounds of release substantial release. Therefore, EPA

quantities exceeding I million pounds to the environment each year is a solicits comments on the adoption of a

per year. EPA does not believe that sufficiently large amount of release fixed threshold, such as 100.000 pounds

disclosing to the public the fact that a where testing could be required even in or i million pounds.

chemical is produced in at least 1 the absence of any hazard information . C. Substantial and Significant Human million pounds per year would be a The Toxics Release Inventory (TRI) F-xposure

disclosure of CBI. In making such a (Ref. 3) established under section 313 of

finding, EPA would be relying on the the Emergency Planning and Community The TSCA section 4(a)(1)(B) findings

aggregate production volume of the Right-to-Know Act. 42 U.S.C.11023, for human exposure have two bases:

'npmical for all manufacturers. Thus, shows that 37 percent of the listed substantial or significant. Because a

~ would not be disclosing specific chemicals have releases over 1 million basic principle of statutory construction

.,rmation regarding any particular pounds, accounting for over 99 percent is that when Congress used tw o

duct. Moreover, a statement that a of the total reported releases on the TRI different words, it intended them to
p. 4

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

have two different meanings, EPA these terms within the bounds threshold set forth in the policy and the

believes that interpreting the two words established in TSCA and in its nature of the exposure is also significant

to have different meanings is a legislative history. Note that EPA can as set forth in this policy . The following

reasonable interpretation of the statute. make a finding that there is or may be Table I

compares the proposed criteria

United States v. Johnson, 462 F.2d 463 both significant human exposure and for "substantial" and "significant "

(3rd Cir. 1972). cert. denied, 410 U-

. EPA has attempted S (1093) to define937 nmsbert exposure

:

of people exposed exceeds th e

TABLE 1 .-PROPOSED TSCA SECTION 4(A)(1)(B) HUMAN EXPOSURE CRITERIA

Category

Substantial Significant

General popula tion 100,000people < 100 .000 people exposed more directly or on a rou tine or episodic bas is

Consumers 10,000 people < 10,000 people exposed more directl y or on a routine or episodic basis

Workers 1,000 workers < 1 .000 workers exposed more directl y or on a routine or episodic basis.

While there was little guidance data on that chemical. EPA believes that requiring testing . Further, EPA rejects

provided by the statute itself or the the different numerical thresholds for this approach because TSCA section 4

legislative history, under TSCA EPA has workers, consumers, and the general requires only that EPA find that there

traditionally interpreted the word population are necessary to re flect the "is or may be significant or substantial

"substantial" as a quantitative measure, inherent differences in each probable human exposure" ( emphasis added) to a

referring in this case to widespread exposure scenario ( e .g ., workers chemical, not that EPA definitively

exposure-large numbers of people . EPA generally are exposed on a more routine prove exposure at a particular level.

believes that it is reasonable to interpret or direct basis than consumers, and A finding of significant exposure

the term "substantial human exposure" consumers are generally exposed on a would generally be made where the

to mean widespread human exposure, or more direct basis than the general numerical threshold for numbers of

in other words, exposure to large public). persons exposed for substantial

numbers of people. This is reasonable As a general matter, EPA has found exposure is not met, but the nature of

because where large numbers of people that workers tend to be subject to the exposure is more direct than that

are exposed to a chemical, EPA and routine or episodic exposure over a long which usually characteri zes general

others should have data indicating pe riod of time. Thus, exposure, to be population exposure, consumer

whether the chemical presents an considered substantial, does not have to exposure, or worker exposure . For

unreasonable risk, to decide whether be as widespread for workers as for example, if there is general population

actions are necessary to protect the consumers or the general population. exposure to fewer than 100.000 people,

public against such unreasonable risk. Similarly, TSCA and its legislative but the nature of the exposure is quite

EPA does not rely on levels of exposure history provide little guidance about direct, e .g., via drinking water, EPA may

in determining substantial exposure, what constitutes significant human find that there is significant exposure for

because the risk presented by a level of exposure . Under TSCA. EPA has purposes of requiring testing under

exposure cannot be determined unless generally interpreted the term TSCA section 4 . An example o f

the toxicity of the chemical is known . "significant" as relating to the nature or significant consumer exposure might be

Further, EPA can also require testing importance of exposure. EPA therefore where fewer than 10,000 consumers are

under TSCA section 4(a)(1)(B) to is proposing to interpret "significant" as exposed, but the consumers use the

determine the level of exposure to a referring to the nature of the exposure . product near their food, or are likely to

particular chemical. EPA believes that if the nature of some inhale it or dermally contact the

EPA believes this is a reasonable exposure is sufficiently direct, large or substance .

interpretation of the word "substantial" prolonged, even if the number of people EPA recognizes that the approach

because Congress made it clear that exposed is not "substantial", there is a explained in this proposal integrates to

EPA should require testing under TSCA need to develop data on the chemical some extent the concepts of

section 4(a)(1)(B) even in the absence of because, on the basis. of the data, EPA "substantial" and "significant" in

information that the chemical may be may take some risk management action defining what constitutes "substantial

hazardous, if the other findings could be to control the exposure. human exposure" by distinguishing

made . In risk assessment, it is necessary By its interpretation of "significant between the nature of the exposure to

to take into account both the toxicity human exposure," EPA does not adopt workers, consumers, and the general

and the exposure to determine the risk. the approach suggested by CMA in the population. The Court in CMA

Under TSCA section 4(a)(1)(B), where cumene litigation to require testing only recognized that there could be some

there is or may be a substantial number if EPA demonstrates that people are overlap between substantial an d

of people exposed and toxicity is not exposed to levels that would be significant human exposure : " it is

characte rized, EPA believes it is considered toxic if the chemical were not necessa rily clear that 'significant'

appropriate to obtain data on those found to be hazardous. EPA rejects this and 'substantial' as used in clause (II)

chemicals for which EPA might consider approach because it cannot know what must be understood in a way that

further assessment. EPA believes that level of exposure is hazardous until the prevents any overlap in their respective

when there may be tens of thousands of chemical's toxici ty has been fully tested. meanings or requires that any factor

people exposed to a chemical, Currently, EPA and the scientific relevant to one be necessa rily irrelevant

thousands of consumers exposed to a community do not have sufficient data to the other ." CMA at 356, note 17.

chemical, or 1,000 workers exposed to a about the universe of chemicals to set Finally, EPA believes its approach is a

chemical, it is reasonable to require test such an absolute cutoff level for reasonable interpretation of its lega l

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322,qg Federal Register / Vol. 56. No. 135 / Monday . July 15, 1991 / Notice s

~-uthority because there must be pound or 10 percent threshold for therefore, cumene is produced in

tistantial production before EPA even substantial release is not met. substantial quantities.

siders whether there is or may be Further, existence of a chemical in Based on release estimates, EPA

_astantial release or significant or human adipose tissue may indicate found that cumene is released to the

substantial human exposure. Thus the widespread human exposu re to the environment in substantial quantities.

criteria listed above for release and chemical, if the tissue survey represents EPA has found, and the Court in CMA

exposure will not result in testing any a large population. Therefore, for upheld EPA's finding that the fugitive

chemicals other than those in the - example, exposure as demonstrated by emissions of cumene to the atmosphere

highest 11 percent of all chemicals existence of a chemical in the Na tional from manufacturing, processing . and use

produced . Human Adipose Tissue Survey may be activities are estimated to be 3 million

D. Additional Factors the basis for making a finding of pounds per year . For the reasons

substantial human exposure to the discussed elsewhere in this notice, I

EPA would apply the generic chemical. million pounds of release to the

numerical thresholds for most chemicals Finally, in some cases, EPA may environment is substantial release, and

considered for action under TSCA consider a category of chemicals for therefore cumene may be released into

section 4(a)(1)(B). In some cases, testing where it does not have the environment in substantial

however, where the thresholds are not information for each chemical within the quantities .

met, it may be more appropriate to use a category that shows that each chemical EPA also found that there may be

case-by-case approach for making meets the thresholds established in this substantial human exposure to cumene .

findings by applying other policy. In these cases, EPA believes it is The indust rial re leases of cumene are

considerations. That is to say, EPA may reasonable to use the thresholds concentrated in a few large metropolitan

consider "additional factors" for making articulated in this no tice for making areas where the majority of cumene

findings for chemicals which do not findings on the entire catego ry, rather manufacturing and processing facilities

meet the numerical thresholds proposed than requiring EPA to show that each are located. The Court in CMA found

herein for evaluating existing chemicals individual within the catego ry meets the that the record adequately supported

under TSCA section 4(a)(1)(B). EPA's criteria set forth in this notice . EPA's finding that approximately'13.5

authority to use this flexible approach On the other hand, there may be some million people living in - the vicinity of

was recognized by the Court in its instances when a chemical meets the cumene manufacturing and processing

decision regarding the cimiene test rule . criteria proposed in this notice under facilities may be exposed to this

The Court stated that EPA's definition TSCA section 4(a)(i)(B)(i), but EPA chemical.

need not be precise -

it need not decides not to propose testing under When CMA briefed its case, it

"function like a mathematical formula."

TSCA section 4(a)(1)(B) because EPA submi tt ed a monitoring study not

Further, the Court stated EPA need not

finds that data are sufficienYto submitted as comments on the rule that

en adopt a definition applicable to all

ses, but may proceed on a case-by- reasonably determine or predict the relates to the presence of many

e interpretation, if it ra tionally effects of the manufacture, process, chemicals in the Houston Ship Channel

,,.plains its exercise of discretion. (CMA distribution, use and disposal of the area; including cumene . CMA submitted

at 359.) chemical and/or thattesting is not the study in support of its argument that

An example of an "additional factor" necessary. there was not substantial exposure to

is bioaccumulation. Bioaccumulation cumene. The Court in CMA said. "The

M. Application of Proposed Criteria to extent to which this information may be

refers to the tendency of ce rtain the Final Test Rule for Cumene material may significantly depend on

chemicals to concentrate in animal

tissue in increasing levels as it EPA issued a fina test rule under the c l rite ria a rticulated or developed by

progresses up the food chain. The term TSCA section 4(a)(1)(B), requiring EPA on remand. We direct that EPA on

refers to both uptake from water manufacturers and processors of remand afford CMA an opportunity to

(bioconcentration) and uptake from cumene to, perform health effects testing . present such studies ( and any others

ingested food and sediment residues Based on the available data an c unene that EPA deems appropriate) unless

(Ref. 4). Chemicals that bioaccumulate dis

cussed in Unit II. ofthe preamble to they would not be material to any of

have been found in shellfish. birds, the final rule (July

27 .19M13 FR 28295) EPA's criteria relied on -for the testing"

mammals, and human adipose tissue. As (Ref.5).and Unit II. of the preamble to (CMA at 360-361).

a general matter. EPA believes that- the the proposed rule (November 6, 198 5, 50 EPA's preliminary review of the study

release to the environment of a chemical FR 46UH). EPAfound that cumene .is indicates that the study presents the

that bioaccumulates is of greater produced in substantial quantities, that level of cumene found at certain times in

concern than the release of a substance the re is or may be substantial human the Houston Ship Channel a rea, rather

that does not bioaccumulate . EPA exposure from its man.ufacture, than the number of people exposed .

believes that the persistence of a procesaing, use, and disposaL and that it Because the crite ria for finding that

chemical in the environment, the is released in substantial quantities to there is or may be substan tial human

subsequent storage of a chemical in the environment based on estimates of exposure is based on the number of

animal tissue, and the likelihood for release. peoplewhich are or may be exposed,

concentration of a chemical in the food EPA found that cumene is produced in rather than the levels of exposure , the

chain are factors that could indicate that substantial quantifies. EPA has found, study does not relate to whether EP A

a chemical should be tested to and the Court in CMA upheld EPA's could make a substantial human

determine if risk management measu res finding that U.S.-production of cumene exposure finding. However, because the

are necessary even at release levels in 1.984 was reported to-be 3.35 billion finding that there is substantia l

below those specified in the general pounds, and an additional 339 million production and that there is or may be

teria. Thus, release to the pounds was imported. For the reasons substantial release to the environment

vironment of a chemical that discussed elsewhere in this notice. EPA are legally sufficient to suppo rt the test

)accumulates may be considered to be finds- that 1 .million;pounds of production rule and the testing of cumene has been

,stantial release even,if the S .million per year is substantialproduction-and completed It is not,necessary for4?FA'to
p. 6

Federal Register / Vol. 56, No. 135 / Monday, July 15, 1991 / Notices 32299

give further consideration to the is unreasonable and inappropriate for established in interpreting each of the

question of whether there is or may be determining release into the same statutory terms for the review of

substantial human exposure to cumene environment of "substantial quantities" new substances pursuant to EPA' s

at this time. of chemicals. A fixed threshold of 1 TSCA section 5(e) authority. In general .

Therefore, for the reasons set forth million pounds would, in essence, the guidelines used for evaluating new

elsewhere in this notice proposing the exclude almost all chemicals with substances under section 5(e) have

minimum criteria for testing under production volumes of between I and 10 lower threshold values than those

TSCA section 4(a)(1)(B), and because million pounds from testing under TSCA proposed herein for section 4(a)(1)(B) .

cumene exceeded these thresholds. EPA section 4(a)(1)(B), based on release Therefore, EPA encourages publi c

finds that there is substantial production volume ; rendering the 1 million pound comment of the adoption of the section

of cumene and there is or may be "substantial production" threshold 5(e) guidelines for evaluating chemicals

substantial release of cumene based on meaningless. This is because few under section 4(a)(1)(B) . If comments

its manufacture, processing, use, and chemicals with production volumes indicate to EPA that there is a

disposal. betweenI and 10 million pounds have sufficiently strong basis for adopting releases which exceed I million pounds.

IV. Alternatives to Proposed Criteria Finally, EPA rejected the section 5(e) guidelines, or some other

y' percentage criteria, than the criteria propose d

4. Substantial Production only approach because in the absence of herein by EPA, EPA will conside

r

EPA considered other options for data similar to TRI for all chemicals, it adopting those criteria. The section 5(e)

interpreting "substantial production" : may be difficult for EPA to determine •~substantial" and "significant" human

First, the 220,000 pound (100,000 kg .) precisely what percentage of a exposure guidelines for all substances

substantial production threshold (Ref

. 6) chemical's production volume i

s released to the environment having annual production volumes of a t

used by EPA under its TSCA section . least 220,000 pounds are as follows:

5(e) authority ; and second, a production Furthermore, even when releases ar e

volume threshold based on the less than 10 percent of production

uppermost quartile of chemicals volume, they may be large in quantity TABLE 2.-TSCA SECTION 5(e) HUMAN

for extremely high production volume EXPOSURE GUIDELINES

produced. These two options would substance

s

capture essentially the same chemicals. and therefore they merit

testing. For these reasons, EPA believes Substantial ~lor

That is to say, chemicals with that these options are less appropriate s'9"~'~'t~Expoaure Description of Criteria

production volumes in or near the than the proposed criteria . EPA als o

220,000 pound range and above. EPA solicits comment on whether a higher Worker: .... . . .. . .... .... . . . . . ... . .... .

thinks that 220,000 pounds, while threshold should be used and th e

appropriate for new substances which high number of ~ 1,000 workers

inherently have smaller production supporting rationale for using such a workers exposed . exposed (substantial)

higher threshold.

volumes early in their commercial life, acute worker exposure . . r~_ 100 workers exposed

may be an unreasonably low production C. Substantial And Significant Human by inhalation to 2 10

threshold for an existing chemical . For Exposure '"g/dsy(subst`'"t'al

and ~nificant)

these reasons, EPA thinks that these EPA considered other options for chronic worker

options are less appropriate than the interpreting "substantial" and exposure:

proposed criterion . EPA also solicits "significant" human exposure : First, inhalation ... . . .. . . .... . ... . .. . = 100 workers exposed

comment on whether a higher threshold define the terms "substantial" and to 1-10 mg/day for ~

100 days/year

should be used and the supporting "significant" solely on the basis of (substantial and

rationale for using such a higher numbers of people exposed without sigrificanU

threshold . regard to whether the persons are ~rrrW Z 250 workers exposed

B. Substantial Release workers, consumers, or members of the to by routine dermal

general population, and base contact for a 100

EPA considered other options for "significant" human exposure on the daya/yea. (substantiai

interpreting "substantial release" : First, nature of exposure; or second, adopt the and significant)

the 22,000 pound (10,000 kg.) substantial "substantial" and "significant" human Consumer:

release (all environmental media) exposure thresholds used by EPA unde r

threshold used by EPA under its TSCA its TSCA section 5(e) authority (see consumer exposure . . ..., . Presence of the

section 5(e) authority; second, a set Table 2.). EPA believes that the first substance in any product where (1) the

threshold of I million pounds of release ; option may not adequately address the physical state of the

and third, release greater than 10 inherent differences in magnitude and substance in the

percent of a chemical's production duration of exposures to workers, product and (2) the

volume. consumers, and the general """"°` of use would

population. make exposures likely

EPA believes that 22,000 pounds of Option 2 was rejected because new (Significant)

release, while appropriate for new chemicals are more likely to have lower General Population:

substances which inherently have levels of exposure or less widesprea d

smaller production and release volumes exposure than existing chemicals and ambient surface water j.* 70 mg/year of

early in their commercial life, could therefore the levels and numbers of exposure . exposure via surface

include the release volumes of most persons exposed used by EPA in water (significant)

existing commercial chemicals, and is implementing TSCA section 5(e) may be ambient a ir exposure . . .,. j-. 70 mg/year of

therefore not indicative of the term more appropriate for new chemicals . For exposure via air

"substantial release" as it relates to these reasons, EPA thinks these options (significant )

TSCA section 4(a)(1)(13). are less appropriate than the proposed

Also, EPA believes that assigning a approach . ambient yroundwater. .... ~ 70 mg/year of

release threshold based solely on a As discussed above, quantitative and e7PO""e via

fixed release volume of 1 million pounds qualitative guidelines have been (significant)
p. 7

32300 Federal Register / Vol . 56, No. 135 / Monday, July 15, 1991 / Notices

TABLE 2 .-TSCA SECTION 5(e) HUMAN policy under TSCA section 4 . docket (2) USEPA. Chemicals in Commerce

:XPOSURE GUlDELtNEs-Continued number OPTS-47002J, which is available Info rmation Systems Search (CICIS ). Office

for inspection Monday through Friday, of Toxic Substances . USEPA (1977).

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

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

. Office of Toxic Substances. USEPA (1988).

Crnena (4) Casarett, I., and )- 7ou11. Toxicology :

20460 from 8 a .m. to 12 noon and from I The Basic Science of Po ; tons. Macmillian

p .m. to 4 p.m. This record includes basic Publishing Company . ttie v York. (1986).

aggregate ambient 22.000 tbs.tyear information considered by EPA in (5) USEPA . Cumene; Fi-A Test Rul e

exposure through release to all developing this policy. This record (OPTS-4207A; FRL 342t11-7 . Office of Toxic

surface water• or. enwonarensat media includes the following information: Substances. USEPA ()idy z. .198c).

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

(where +Be~

~

from landfill is comments, and proposals. Chemicals Exposure-Based Fi :iding," letter

expected). from Charles L. Elkins to Geraidine V. Cox

(2) Reports - published an d

' unpublished data

. (Chemical Manufacturers Ass, iation).

uOffice of Toxic Substances, t1'-x'DA

EPA also solicits cnmment on whether (3) Chemical Manufacturers (September 22 .19 88).

a higher threshold should be used and Association v . EPA. 899 F.2d R44

the supporting rationale for using such a (5th Cir. 1990). Ps op ri• 111 1 V5, 1001 .

higher threshold .

B. References

Victor ) . Kimm,

V. Record Acting Assistant Administrator !or PNStrcides

(1) USEPA. Section 8(e) Notice. Public and Toxic Substances.

A. Supporting Documentation Docket Control No. W-900000018 . 8EHQ0190-0646 FLWP, Office of Toxic Substances. (FR Doc. 91-16747 Filed 7-12-91-.8.45 amj

EPA has established a record for this USEPA (January 2a. 1990). OILUNG CODE 61560404

l l