P. 1

Friday

~ May 17, 1985

ss -

_, ..._

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01=1

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~~----$ Part II

- -- Environmental

~

Protection Agency

-

40 CFR Part 790

Toxic Substances Test Rule Development

and Exemption Procedures; Final Rule

= 40 CFR Part 79

~

9

• Identification of Specific Chemical

~

Substance ahd Mixture Testing

Requirements; Final Rule

40 CFR Parts 798 and 799

2-Ethyihexanoic Acid; Proposed Test Rule

40 CFR Part 79 9

Bisphenol A; Proposed Test Rule

M

LO

.~W _

Le
p. 2

20652 Federal Register J Vol, 50, No. 96 / Friday, May 17, 1985 / Rules and Regulation s

ENVIRONMENTAL PROTECTION chemicals may present to health or the fate and ecological effects were

AGENCY environment. published in the Federal Register of

Section 4(b) of TSCA requires that November 21,1980 (45 FR 77332) . Th e

40 CFR Part 790 each section 4(a) test rule identify the Agency planned to adopt such "test

chemical substance or mixture for which standards" or "generic methodology

(OPTS-42052A; TSFi-FRL 2009-7] testing is being required, provide requirements" for all of the major types

standards for the development of test of tests which might be required under Toxic Substances; Test Rule data, and specify deadlines for the section 4 test rules . The Agency planned Development and Exemption submission of test data. The standards to incorporate by reference whichever of

Procedures are to prescribe: (1) The health and these test methodologies was

AOENCY: Environmental Protection environmental effects, and information appropriate for use in each chemicalAgency (EPA).

relating to toxicity, persistence, and specific test rule.

ACTION: Interim final rule .

other characteristics which affect health In response to comments that the

and the environment for which test data codified testing standards approach

SUMlNARY: EPA is amending the are to be developed, and (2) to the would provide insufficient flexibility in

procedural rule, published in the Federal extent necessary to assure development teat design, EPA proposed in the Federal

Register of October 10, 1984 (49 FR of adequate and reliable data, the Register of March 26, 1982 (47 FR 13022)

39774), describing a two-phase manner in which the data are to be a different approach for providing

rulemaking process it would use to' developed, the test protocol or testing standards . In that notice, the

develop certain test rules under section methodology to be employed, and such Agency proposed to abandon the idea of

4(a) of the Toxic Substances Control Act other requirements as are necessary to codifying its approved generic test

(TSCA) and to grant exemptions from provide such assurance (TSCA section methodologies and to publish them as

those test rules under section 4(c) of 3(~he$res responsibility required testing test rule development a two-phase

describing an alternative single-phase is borne jointly by all manufacturers process . In the first phase, EPA would

rulemaking process it will use in most (including importers) and/or processors establish by rule the effects and

cases to develop test rules under section of the subject chemical, depending on characteristics for which a given

4(a) of TSCA and to grant exemptions which activities give rise to the testing chemical must be tested and refer

from those test rules. This rule describes requirement (TSCA section 4(b)(3)(B)) . subject manufacturers and/o r

the procedures which persons subject to Manufacturers or processors required by processors to suitable guidelines for

those test rules must follow. rule to sponsor testing may do so either how the testing should be performed.

DATES: Effective on June 17, 1985. individually or jointly through formation The subject firms would be required by

Submit written comments on or before of a testing consortium (TSCA section a specified date to submit study plans

July Is. 1985.

4(b)(3)(A)). The test sponsors must detailing the methodologies an d

conduct the testing according to the protocols they intended to use to

ADDRESS: Submit written comments standards provided in the test rule . perform the required tests and including

identified by the document control Alternatively, manufacturers and/or proposed schedules for initiation and

number (OPTS-42052A) in triplicate to : processors required by rule to test may completion of the-testing and

TSCA Public Information Office (TS- choose to apply for a testing exemption submission of test data . In the second 793), Office of Pesticides and Toxic under TSCA section 4(c) based on the .phase, after consideration of public Substances, Environmental Protection . belief that the required testing will be comment on the proposed study plans,

Agency, Rm . E--108,401 M St., SW., performed by another person subject to the Agency would promulgate another

Washington, D.C. 20460. the rule, To approve an exemption rule adopting the study plans (reflecting

FOR FURTHER INFORMATION CONTACT: application, EPA must find that : (1) The any modifications deemed necessary by Edward A. Klein, Director, TSCA substance or mixture which the EPA to assure the development of

Assistance Office (TS-799), Office of applicant manufacturers or processes is reliable and adequate data) as test

Toxic Substances, Environmental equivalent to the substance or mixture standards for the development of test

Protection Agency, Rm. E-543, 401 M St. for which test data have been submitted data and deadlines for the submission of

SW., Washington, D.C. 20480; Toll Free : or are being developed, and (2) data test data .

(800424-9085), In Washington, D .C.: submitted by the applicant under a In the Federal Register of October 10,

(554-1404), Outside the United States: section 4 test rule would be duplicative 1984 (49 FR 39774), EPA issued a (Operator-202-554-1404). of data already submitted or being procedural rule adopting this two-phase

SUPPLEMENTARY INFORMATION: This rule developed pursuant to the rule (TSCA process for the development of certain

amends a procedural rule, published in section 4(c)(2)) . test rules.

the Federal Register of October 10, 1984 H. Testing Standards and Test Rule B. Change in Process forAdopting Test (49 FR 39774), by prescribing an Development

Standards

alternaive process EPA will use to

develop test rules under section 4 of In December 1983, the Natura A. Prior Proposals and Rules

l

TSCA and to grant exemptions from Under EPA's original approach to Resources Defense Council (NRDC) and

those test rules. providing testing guidance, the Agency the Industrial Union Department of the

1 . Statutory Background proposed to publish and codify in the American Federation of Labor-Congress

Code of Federal Regulations (CFR), a of industrial Organizations (AFL-CIO)

Section 4(a) of TSCA (Pub. L. 94-469, number of model test methodologies, A filed an action under TSCA section 20

90 Stat. 2003 et seq.; 15 U.S.C 26Yi et number of proposed "test standards" for which challenged, among other things,

seq.) authorizes EPA to promulgate rules health effects were published in the the use of the two-phase process . NRDC

requiring testing of chemical substances Federal Register of May 9, 1979 (44 FR and AFIrC1O v. EPA, 595 F. Supp. 1255

and mixtures to develop data relevant to 27334) and on July 26, 1979 (44 FR 44054); (S.D .N.Y. 1984). In an August 23, IM

determining the risks that those similar proposed standards for chemical Opinion and Order, the Court found that
p. 3

Federal Register / Vol. 50, No. 98 / Friday, May 17, 1985 / Rules and Regulations 20653

utilization of the two-phase rulemaking submission deadlines. All such substances being tested were

p rocess was permissible. However, the submissions, including alternative test equivalent . Therefore, if an exemption Court also held that the Agency was methodologies, will be placed in the applicant establishes that its chemical is subject to a standard of promulgating rulemaking record and will be available equivalent to a substance which is to be test rules within a reasonable time for review by the public. The final rule tested according to the standards

frame.NRDC and AFL-CIO v . EPA, 595 will promiilgate as the test standard described in the test rule, the Agency F. Supp. 1255 (S.D.N.Y.1984). eitherthe OTS test guideline or other will accept the contention that testing of Subsequent to the issuance of that suitable guidelines, a modified version that applicant's chemical would yield Opinion, the Agency submitted papers ofthese guidelines, the alternative duplicative data .

to the Court which indicated that in methodology submitted by commenters, Where possible, EPA plans to select a order to expedite the test rule or a modifi ed version of the alternative single representative

development p test substance and ro cess, EPA would utilize methodology . The proposed test to consider all forms of the chemical a single-phase rulemaking process for standards and data submission, °equivalent" to each o

most test rules ther for . The Agency also deadlines will be open for discussion at

indicated that EPA would exemption publicly any public meeting held pursuant to purposes. The selection is to

announce this policy in the first test rule TSCA section 4(b)(5). involve, among other factors,

proposal to be published in the spring of The single-phase approach offers a consideration of the nature of the test

. [Declaration of Don R. Clay, at 12 number of advantages over the two- , 1985 the various grades of the chemical on

(September 24,1984)). In accordance with phase approach. First, the Agency the market, the toxicity of the various

that commitment, the Agency is setting believes that the single-phase app roach components found in those different

forth in this rule guidelines and will shorten the rulemaking period and grades of the chemical, and the effects

procedures for utilization of single- expedite initiation of th e required that various additives and impurities

phase rulemaking in th e test rules testing. Secondly, because the OTS test might have on the outcome of the

program. The Agency is issuing th ese guidelines or other appropriate testing. However, if it is necessary to

procedures as an interim final rule . The methodologies will be proposed as the require testing of two or more test

Agency will apply these procedures in • test standards, the one-phase process substances, the Agency will require that

the development of individual test rules , eliminates the requirement under the each exemption applicant provide data

The Agency believes it is unnecessary to two-phase approach for industry to to establish which test substance its

issue these specific procedures as a submit test protocols for approval. Yet., chemical is to be considered equivalent

proposal because the Agency- has by allowing commenters to submit to. EPA will provide guidance in each

received comment on the issues relating test methodologies during test rule concerning what data must be

to these test ~

rule the comment period, it preserves the submitted to substantiate equivalence .

procedures in response to previous at a reduced administrative cost development flexibility ofthe two-phase process, but For a more in-depth discussion of the

proposals (see Unit ILA above).

. Agency's interpretation of TSCA section

Because of these advantages, the 4(c) c, selection of test substance, an , d

an

Nevertheless,

opportunity

fth

eor publi

c Agency is providing

comment on Agency intends e y to utilize single-phase equivalency. the reader is directed to

this interim final rule in the event rulemaking for most rules promulgated the Federal Register of October 10, 1984

persons wish to provide comments on under TSCA section 4(a). However, EPA (49 FR 39774).

these specific procedures. If these will continue to utilize the two-phase Under the procedures issued October

comments result in a need for changes pro cess for rulemakings where the two- 10, 1984, if EPA found the applicant's

to the rule, EPA will modify the rule ae guivalent to bne for phase process may be a more chemical to be e

appropriate. expeditious route to a final test rule, e.g., which study plans had been submitted

Section 4(b)(1) of TSCA specifies that in cases where no well-accepted test and app roved, the Agency would grant a

test rules shall include standards for the methodology is available for inclusion in conditional exemption. Exemption a proposed test rule. development of test data ("test applicants would be notified in a Phase

standards") and deadlines for M. Exemptions II test rule or by certified mail that they

submission of test data. Under the two- EPA issued a procedural rule, have received conditional exemptions.

phase process, both test standards and published in the Federal Register of All exemptions granted prior to

data submission deadlines are October 10,19$4 (49 FR 39774), completion of testing would be

established during the second phase of describing the process it would use to conditional upon the sponsor's proper

rulemaking . However, in the single- grant exemptions from test rules under completion of the required tests.

phase appro ach, EPA will propose the section 4(c) of TSCA. EPA has not Because study plans are not required

pertinent OTS test guidelines(s) or other changed its approach to granting to be submitted for approval under

suitable test guideline(s) as the required exemptions . According to the October single-phase rulemaking, EPA ha s

test standard in the initial noti ce of 10, 1984 rule, each exemption applicant incorporated the following procedure to

proposed rulemaking, and EPA will also must submit an application establishing' accommodate the single-phase process.

p ropose time frames for the submission that the chemical for which the EPA will grant conditional exemptions

of the teat data. Industry and other exemption is being sought is equivalent under single-phase rulemaking following

commenters may suggest an alternative to the one being tested and that EPA's receipt of a letter of intent to

methodology or modification to th e OTS duplicative data would result from its conduct the required test rather than

test guideline, i.e., the proposed teat testing. The Agency stated its belief that after receipt and approval of a study

standard, during the public comment one properly designed and executed plan. Exemption applicants will be

period, and such comment should state study will normally provide a sufficient notified in a Federal Register notice or

why the alternative methodology or basis for making a regulatory decision by certified mail that they have received

modification is more suitable for the on a given characteristic or effect of a conditional exemption . No changes have chemical substance in question than the chemical and decided to consider all been made to the procedures for

F.PA-proposed test standard . Comment tests meeting its standards to be granting exemptions under two-phase

will also be sought on the proposed data duplicative of each other as long as the rulemaking .
p. 4

20654 Federal Register / Vol. 50, No. 96 / Friday, May 17, 1985 / Rules and Regulations

Unless otherwise indicated in the the development of test data, deadlines submit exemption applications . EPA will

single-phase test rule, only for the submission of data, the persons automatically grant such processors

manufacturers (including importers) will responsible for testing, the required test exemptions without requiring th e

be expected to submit exemption substance(s), and instructions for submission of exemption applications .

applications or letters of intent to showing equivalence. The final rule will It is expected that, in most cases,

conduct testing. Normally, processors promulgate as the test standard either testing will be performed by the

will share the testing costs with the the OTS test guideline or other suitable manufacturers and that part of the cost

manufacturer through the pricing guidelines, a modified version of these of testing will be passed on to

mechanism. However, if the exposure or guidelines the alternative methodology processors through the pricin g

risk upon which the test rule is based is submitted by commenters, or a modified mechanism, thereby enabling them to

associated with processing as well as version of the alternative methodology, share in the costs of testing . However,

manufacturing.or with other down- 2 . Persons subject to single-phase test processors will be called upon to

stream activities (distribution in rule. Each test rule will specify whether sponsor tests if manufacturers fail to do

commerce, use, and disposal), and if manufacturers, processors, or both are so, or may be required to provide

manufacturers fail to submit letters of found under TSCA section 4(b)(3)(H) to reimbursement directly to those

intent to conduct testing, the Agency be responsible for testing and submitting sponsoring this testing (See Data

will publish a notice in the Federal data on the subject chemical substance Reimbursement rule, 40 CFR 791 .45).

Register and call upon processors to or mixture . Once the test rule is in effect, 44 days

submit letters of intent to conduct a. Manufacturers only. If testing is after publication in the Federal Register,

testing or exemption applications, being required solely to allow each current manufacturer will have 30

IV. Discussion of Final Rule Amendment evaluation of risks associated with days to submit, for each required test ,

manufacturing, only manufacturers of either a letter of intent to perform the

A. SinglePhase Test Rule Development the chemical substance or mixture will test or an application for exemption.

1. Promulgation of a single-phase test be subject to the rule. Once the test rule Each manufacturer who submits a letter

rule. Under single-phase rulemaking, the is in effect, 44 days after publication in of intent to perform a specific test will

proposed test rule will discuss who the Federal Register, each current be obligated to perform that testing .

should conduct testing (manufacturers manufacturer will have 30 days to If no manufacturer submits a letter of

or processors or both), the health and submit, for each required test, either a intent to perform a particular test within

environmental effects or other letter of intent to conduct testing or an the 30-day period, EPA will publish a

characteristics for which testing will be application for exemption. Each notice in the Federal Register to notify

required, appropriate Good Laboratory manufacturer who submits a letter of all processors of the subject chemical .

Practice requirements, OTS test intent to conduct a specific test will be The notice will state that EPA has not

guidelines or other test guidelines as obligated to conduct testing and submit received letters of intent to perform

proposed test standards, schedules for data. certain tests and that current processors

submission of test data, and the b. Processors only. If the test rule's will have 30 days to submit, for each

representative substance or substances findings are based solely on exposure test remaining, either a letter of intent to

to be tested. If more than one substance associated with processing, only perform the test or an exemptio n

is to be tested, the proposed test rule processors will be subject to the rule. application for that test. Each processor

will also give proposed instructions for Each processor of the chemical who submits a letter of intent to perform

showing equivalence. substance or mixture will be required a specific test will be obligated t o

The Agency will accept comment oa within 30 days of the effective date of perform the testing .

its proposal for 60 days. An opportunity the test rule to submit a letter of intent if no manufacturer or processor

will also be provided for oral comment to conduct testing or an exemption submits a letter of intent to perform a

at a public meeting with EPA, if application. Each processor who submit particular test, EPA will notify all

requested. Comments will be solicited a letter of intent to conduct testing will manufacturers and processors, either by

on EPA's findings under section 4(a) of be obligated to conduct testing and letter or by notice in the Federal

TSCA, on the particular health or submit data. ' Register, that all exemption applications

environmental effects or other c . Both manufacturers and processors. concerning that test will be denied and

characteristics for which testing is If testing is being required to allow that beginning 30 days later all

proposed, on the test substance or evaluation of risks associated with manufacturers and processors will be in

substances proposed to be tested, on the manufacturing and processing, or with violation of the rule unless a

proposed standards for the development distribution in commerce, use, or manufacturer or processor submits a

of test data, and on the schedules for the disposal of the chemical, both letter of intent within that period to

submission of test data . Commenters manufacturers and processors will be perform the tests.

may suggest alternative test subject to the rule. Although both ~ d. New manufacturers and processors.

methodologies or modifications to the manufacturers and processors are Any person not manufacturing or

OTS test guidelines, i .e ., the proposed legally subject to the test rule in these processing the chemical at the time the

test standards. Such comments should circumstances, EPA expects that only rule goes into effect, or within the first

state why the alternative methodology manufacturers ordinarily will be 30 days after the rule goes into effect,

or modification is more suitable for the required to submit letters of intent to who later begins manufacturing or

specific chemical substance than the conduct testing or exemption processing before the end of th e

EPA proposed test standards . applications and to conduct testing and reimbursement period and who is

After considering public comments, submit data . If manufacturers submit subject to the rule, will be required to

including any oral comments, EPA will letters of intent to conduct,testing and submit a letter of intent to conduct

publish a final rule specifying the health perform all the required tests, testing or an exemption application for

and environmental effects and other processors will not be requited to each required test by the day the person

characteristics for which data are submit letters of intent to conduct begins manufacture or processing . If

required to be developed, standards for testing, to perform the testing, or to both manufacturers and processors are
_ . ._ , . . .

.} .. .. _ °" : ~_

p. 5

Federal Register / Vol. 50, No. 96.1 Friday, May 17, 1985 / Rules and Regulations 20685

subject to a rule, processors are not concerning confidentiality aspects of its considered equivalent to it, and the

required to submit letters of intent or test rule and exemption process, the Agency will contact the applicant only if

exemption applications unless EPA has reader is directed to the Federal Register information is missing or unclear . published a notice in the Federal of October 10, 1984 (49 FR 39774). Register telling processors to submit 4 . Submission of stud lans.

nder If two or more chemical substances

YP are to be tested, equivalency claims will letters of intent or exemption single-phase rulemaking, EPA is be assessed according to the criteria in applications for certain tests, in which requiring the submission of study plans the test rule. If the Agency finds an

case any person not processing the no later than 30 days before the equivalency claim to be in error, or if

chemical at the time the rule goes into initiation of testing for each required information needed to make

effect or within 30 days after .an the test. EPA will not be approving study equivalency determination is missing, publication of the notice, who later plans under single-phase rulemaking . the applicant wil be notified . If the begins processing before the end of the The submission of study plan equivalency claim is being questioned

reimbursement period, will be required information is being required, however, because supporting data are inadequate,

to submit a letter of intent to test or an to facilitate lab inspections and data the applicant will be given 15 days to

exemption application for each test audits to assure th specified in the Federal Register notice which is being undertaken is e Agency that testing provide explanatory information . If EPA reliable by the day the person begins processing finds the applicant's chemical

. and adequate 3 . equivalent to a different test substance . Submission of letter of intent to Study plans must contain:

conduct testing or exemption (

than was claimed in its application, EPA a) The identity of the test rule application.

. will notify the applicant in writing and Those subject to a single- (b) The specific test requirements explain why

phase test rule must ei . ther submit a covered by the study plan.

letter of intent to perform testing, or (c) The names and addresses of the 3 . Approvalof exemption f PnOn

request an exemption based on the test sponsors, testing facilities, applications. Provided that the first

belief that the test will be performed by responsible administrative officials, condition for granting exemptions

another, for each of the tests required by project managers, and appropriate ( equivalence to the test substance) has

the test rule . Persons subject to a test individual to contact for been satisfied, the second condition, i .e.,

rule who do not submit a letter of intpnt communications with EPA. duplicativeness of data, will be

to conduct testing or an exemption ( d) Brief summaries of the training and considered to have been met and

application will be in violation of the experience of each testing facility conditional exemptions will be granted

rule. professional involved in the study. following EPA's receipt of a letter o f

Letters of intent to conduct testing (a) Data on the chemical substance intent to conduct that test. Exemption

must specify which study or studies the being tested . applicants will be notified by certified

respondent will sponsor and, if more (f) Study protocol . mail in a Federal Register notice that

than one representative form of the (g) Schedule for initiation and they have received conditional

chemical is to be tested, which test completion of each test and for exemptions. The exemptions will be

substance will be used in each of those submission of interim progress and final conditional because they will be given

studies. For applicants participating in a reports to EPA . based onthe assumption that the test

the

testtm a

consorti

t include~the nam

letter

es

of intent to B. Exemption Process for Single-Phase testing according to the specifications

signatures of all consortium members Test Rules and schedules in the test rule . TSCA

and the identity of the primary 1. Submission of exemption section 4(c)(4)(B) provides that if an

spokesperson for the consortium. EPA application. Any person subject to a exemption is granted prospectively, i.e.,

will consider such notices as single-phase test rule may request an on the basis that one or more persons

commitments to perform testing unless exemption from conducting any of the are developing test data, rather than on

EPA agrees to the substitution of an tests required under the test rule based the basis of prior test data submissions,

exemption application in instances on the belief that the test will be the Agency must terminate the

where more than one company indicates performed by another. Exemption exemption, after an opportuni ty for

an intent to sponsor equivalent tests , applications must list the test hearing, if the test sponsor has not

Exemption applications must list the requirements for which an exemption Is complied wi th th e test rule .

test requirements for which an being sought and discuss the applicant's 4 . Appeal of exemption denials.

exemption is being sought and discuss basis for believing that the tests will b,e Persons whose exemption applications

the applicant's basis for believing that performed by another party. If more are denied will be notified by certified

the tests will be performed by ano ther than one representative substance is to mail or by Federal Register notice and

party. If more than one representative be tested, the applicant must also state may appeal that denial . Appeals must

substance is to be tested, the applicant which test substance it believes its be filed with EPA within 30 days of the

must also state which test substance it chemical to be equivalent to and support receipt of the letter or publication of the

believes its chemical to be equivalent to this assertion with the types of data Federal Register notice denying th e

and support this asse rtion with the types called for in the test rule. exemption. Appeals should include a of data called for in the test rule . 2. Evaluation of exemption detailed explanation of why the

Under section 14(c) of TSCA, any applications. EPA will examine applicant disagrees with EPA's decision. person submitting data under the Act exemption applications after their The applicant may request a hearing. may assert a claim of confidentiali ty receipt to determine whether properly EPA will notify applicants of its decision

with regard to information afforded such completed exemption applications have within 60 days after EPA receives the

protection under section 14(a) of TSCA . been received from all those not appeal or 60 days after the hearing if the

Section 14(b) severely limits pponsoring testing or participating in a request for a hearing is granted .

confidentiality claims for health and consortium sponsoring testing, and to S. Termination of conditional

safety data on chemicals subject to evaluate equivalency claims . When s exemptions. Exemptions granted section 4 test rules. For a discussion of single representative substance is to be prospectively are conditional . The

the Agency's policy and procedures tested, all forms of the chemical will be Agency will terminate the exemption if
p. 6

20656 Federal Register / Vol. 50, Na. 98 / Friday, May 1 7, 1985 / Rules and Regulations

the test sponsor does not comply with (c) Proposed rule related notice than those referred to in the two-phase

the test rule. If EPA determines that one describing changes in EPA's test teat rule development process described

or more of the test requirements standards policy and test rule in the Federal Register of October 10,

contained in a test rule has not been development process. 1984 (49 FR 39774). Because EPA will

fully complied with because (a) data ( 2) Federal Register notices related to propose pertinent OTS test guidelines or

required by the rule were not submitted this rule consisting of. other guidelines as test standard

by the date specified in the rule, or (b) (a) Proposed health effects testing requirements, indust ry will not have to

data were not generated according to standards. develop proposed study plans for

the test standards or in accordance with (b) Proposed chemical fate and submission and approval. This will

EPA's Good Laboratory Practice ecological effects testing standards. reduce the burden an industry.

requirements, EPA will notify holders of ( c) Final rule concerning EPA's good In addition, by facilitating an

exemptions based on that testing by laboratory practice standards. exemption process in which a single

certified letter or Federal Register notice (d) Final rule concerning data manufacture r or processor can sponsor as to its basis for believing that the reimbursement

tests on behalf of all those subject to a testing supporting the exemptions has (3) Comments pertaining to this rule . TSCA section 4 tiest rule, this rule

not satisfied the test rule's requirements Thisrecord, which includes basic reduces the administrative and financial

and of its intent to terminate those information considered by the Agency in burden which those testing rides might condi ti onal exemptions. developing this rule and appropriate otherwise impose on regulated

Such exemption holders may file Federal Register notices, is available for industries.

written comments concerning EPA's inspection in the OPTS Reading Room,

intent to terminate such exemptions and Rm. E-107, 401 M St., SW., Washington, C. Paperwork Reduction Act

may request an opportunity for a D.C., from S a.m. to 4 p.m., Monday The information collection

hearing to re fute EPA's tentative through Friday, except legal holidays. requirements contained in this rule have

decision or may submit a letter of in tent VI

. Other Regulatory. Requirements been approved by the Office o f

to conduct the required t.est. .Comments. Management and Budget (OMB) under

hearing requests and letters of intent to A. Executive Order 12291 the provisions of the Paperwork

test must be in writing and must be Under Executive Order 12291, EPA Reduction Act of 1980, 44 U.S.C. 3501 et

received by EPA within 30 days of must judge whether a regulation is seq., and have been assigned OMB

receipt of the letter or publication of the I'Major" and, therefore, subject to the control number 2070-OOS3 .

Federal Register notice announcing the requirement of a Regulatory Impact,

Agency's intent to terminate the Analysis List of Subjects in 40 CFR Part 790 . This rule on test rule

exemptions. The comments and hearing development and exemption application Testing, Exemptions, Environmental

requests should include a brief procedures to not major because it does protection, Hazardous materials,

statement of the basis for the exemption not meet any of the criteria set forth in Chemicals . holder's belief that the conditional section 1(b) of the Order. The regulation Dated : May 7.1985.

exemption should not be terminated

an exemption holder requests a hearing,

. If is a procedural rule and willhave ~A.

~

m

virtually no effect on the economy. The i

a single hearing will be held by EPA to rule describes the process EPA will use AssistontAdministr~ator forPesticideaand

address the concerns of all conditional to develop test rules under section 4(a) TbxlcSubstancea.

exemption holders objecting to the of TSCA,and to grant exemptions from Therefare, 40 CFR Part 790 is

termination unless confidentiality those test rules under section 4(c) of amended asfollows:

claims preclude a joint hearing. TSCA. It will not cause price or cost 1. The authority citation for Part 790 is

Exemption holders will receive written increases to the regulated community. revised to read as follows:

notification of EPA's final decision The regulation will not significantly Authodty:15 U.S .C 2e0&

whether the exemption will be affect competition, employment.

terminated. investment, productivity, innovation, or 2. In Subpart A, by revising # 790.5. to

If theAgency finds it necessary to the ability of U.S: based enterprises to read as follows:

terminate conditional exemptions, it will compete wi th fo reign-based enterprises J 780,5 Submisolm of notify the exemption holders to that in domestic or export markets i~~8tim

.

effect, will explain the reason for the This rule was submitted to the Office ( a) All submissions to EPA under this

Agency's decision and will give ofManagement and Budget (OMB) for part must bear the Code of Federal

instructions as to what actions the review as required by Executive Order Regulations (CFR) section number of the

former exemption holders must take to 12291. Any comments from OMB to EPA, subject chemical test rule, e.g.,

avoid being found in viola tion of the test and any EPA response to those 1 799.4400 1,~1-~lrichloroethane.

rule• comments, will be included in the (b) Submissions containing

V. Rulemaking Record rulemaking re cord. confidential business information must

be

EPA has established a public reL•ord B. RegulatoryFlexibilityAct

addressed to. Document Control

Office (TS-793), Office of Pesticides and

for this rulemaking, docket number Under the Regulatory Flexibility Act Toxic Substances, Environmental

[OPTS-42052A], which contains the (15 U.S.C. e01 et seq., Pub. L. 96•,954, Protection Agency, 401 M St., SW..

following information: Sept. 19,1980), .EPA is certifying that this Washington, D .C . 20460.

(1) Federal Register notices pertaining rule will not have a significant impact (c) Submissions not containing

directly to this rule consisting of. on a substantial number of small confidential business information must

( a) Rule concerning two-phase test entities. be addressed to: TSCA Public

rule development and exemption The alterna tive procedures for the information Office (TS-793). Office of

procedures. development of test standards described Pesticides and Toxic Substances.

(b) No tice of proposed rule pertaining in this rule are expected to present an Environmental Protection Agency. 401 M

to exemptions. even smaller burden to the test sponsor St., SW, Washington, D.C. 20480.
p. 7

Federal Register J Vol. 50., No. 96 / Friday, May 17, 1985 / Rules 'and,Regulations 2tr)57

Wo

(d) In addition, a copy of the cover (iii) Which test substance(s) must be EPA an application for an exemptio n

memo for all submissions must be . tested. from testing requirements for the test.

addressed to : Director, Office of (iv) A reference to appropriate (b) EPA will consider letters of intent

Compliance Monitoring (EN-342), Office guidelines for the development of test to test as commitments to sponsor the

of Pesticides and Toxic Substances, data. tests for which they are submitted

Environmental Protection Agency, 401 M (v) The EPA Good Laboratory Practice unless EPA agrees to the substitution of St., SW., Washington, D.C. 20480. requirements for the required testing. an exemption application in instance s

3. By revising Subpart B to read as (vi) Who must submit either letters of where more than one person Indicates follows: intent to conduct testing and study an intent to sponsor equivalent tests.

Subpart B-Test Rule Development plans, or exemption applications. (c) Each letter of intent to conduct

Sec. (vii) What types of data EPA will testing must include:

790.20 Promulgation of test rules, examine in determining equivalence if (1) Identification of test rule.

790.22 Persons subject to a test rule. more than one test substance is to be (2) Name . address, and telephone

790.25 Submission of letter of intent to tested . number of the firm(s) which will be

conduct testing or exemption application. (3) Under two-phase test rule sponsoring the tests.

790.28 Procedure if no one submits a letter development, test standards and (3) Name, address, and telephon e

of intent to conduct testing. schedules will be developed in a second number of the appropriate individual to 790.30 Submission of study plans.

790.32 Phase II test rule. phase of rulemaking as described in contact for further information .

.

790.35 Modification of test standards or § § 790.30 and 790.32. (4) For sponsors participating in a

schedules during conduct of test. testing consortium-a list of all

790.39 Failure to comply with a test rule . § 790.22 Persons subject to a test rute. members of the consortium, the

(a) Each test rule described in § 790.20 signature of an authorized

Subpart B--Test Rule Development will specify whether manufacturers, representative of each member, and a

¢ 790.x0 Promulgation of tsst rules. processors, or both are subject to the designation of who is to serve as

requirement for testing of the subject principal sponsor.

(a) If EPA determines that it is chemical under section 4(b)(3)(B) of the (5) A list of the testing requirements

necessary to test a chemical substance Act and will indicate who will be for which the sponsor(s) intends t o

or mixture under section 4 of the Act, It required to submit letters of intent to conduct tests .

will promulgate a test rule in Part 799 of conduct testing. (6) If EPA is requiring chapter . quiring testing of more

(b) EPA will promulgate specific test (1) If testing is being required to allow than one representative substance-

(b) in Part 799 of this chapter either by evaluation of risks: which test substance the sponsor(s)

a single-phase rulemaking procedure or (I) Primarily associated with intends to use in each of the tests .

by a two-phase rulemaking procedure . manufacture of the chemical, or (d)(i) Any person not manufacturing

(1) Under single-phase test rule in Part (ii) Associated with both or processing the subject chemical as of

799 of this chapter through a notice and manufacturer and processing of the the effective date of the,test rule

comment rulemaking which specifies the chemical, or describing in § 790 .20 or by 30 days after

following: (iii) Associated with distribution in the effective date of the rule who, before

(i) Identii`ication of the chemical for commerce, use, and/or disposal the end of the reimbursement period,

which testing Is required under the rule . activities concerning the chemical, each manufacturers or processes the test

(ii) The health or environmental effect manufacturer of the chemical will be chemical and who is subject to and

or effects or other characteristics for subject and must comply with the required to comply with th e

which testing is being required requirements of the teat rule. requirements of the test rule must

(iii) Which test substance(s) must be (2) While legally subject to the test submit the letter of intent to test or an

tested. rule in circumstances described in exemption application required b y

(iv) Standards for the development of paragraph (a)(1) (ii) and (iii) of this paragraph (a) of this section by the data

test data . section, processors of the chemical must manufacture or processing begins, or

(v) The EPA Good Laboratory Practice comply with the requirements of the test (2) When both manufacturers an d

requirements for the required testing . rule only if processors are directed to do processors are subject to the rule, any

(vi) Schedule for submission of interim so in a subsequent notice as set forth in person not processing the subject

reports and/or final reports to EPA. $ 790.28(b). chemical as of the effective date of the

(vii) Who must submit either letters of (3) If testing is being required to allow test rule described in 1790.20 or by 30

intent to conduct testing or exemption evaluation of risks associated solely days after publication of the Federal

applications. with processing of the chemical, Register notice described in

(viii) What types of data EPA will processors will be subject and must $ 790 .28(b)(2) who, before the end of the

examine in determining equivalence if comply with the requirements of the test reimbursement period, processes the

more than one test substance is to be rule . test chemical and who is required to

tested. (b) [Reserved] comply with the requirements of the rule

(2) Under two-phase test rule must submit the letter of intent to test or

development, EPA will promulgate a $ 790.25 Submission of letter of intent to an exemption application required by

Phase I test rule in Part 799 of this conduct testing or exemption apptlcatiott. $ 790 .28(b)(3) of the date processing

chapter through a notice and comment (a) No later than 30 days after the begins.

rulemaking which specifies the effective date of a test rule described in (e) Manufacturers subject to a test

following: § 790.20, each person subject to that rule rule described in g 790 .20 who do not

(I) Identification of the chemical for and required to comply with the submit to EPA either a letter of their

which testing is required under the rule . requirements of that rule as provided in intent to conduct tests or a request for

(ii) The health or environmental effect ; 790.22(a) must, for each test required, an exemption from testing for each test

or effects or other characteristics for either notify EPA by letter of his or her for which testing is required in the test

which testing is being required. Intent to conduct testing or submit to rule will be considered in violation of
p. 8

20658 Federal Register I Vol. 50, No. 96 / Friday, May 17, 1985 / Rules and Regulations

that rule beginning on the 31st day after (2) If no manufacturer subject to the submitted and give the processors an the effective date of the test rule rule has notified EPA of its intent to opportunity to take corrective action . described in § 790.20 or on the date conduct testing for one or more of the ( 3) If no processor submits a letter of manufacture begins as described in required testifwithin 30 days after the intent to conduct one or more of the paragraph (d) of this section. effective date of the test rule described required tests within 30 days afte r

(f) Processors subject to a test rule in § 790.20, EPA will publish a notice in receipt of the certified letter or described in § 790.20 and required to the Federal Register of this fact publication of the Federal Register comply with the requirements of test specifying the tests for which no letter of notice described in paragraph ( c)(2) of rule pursuant to § 790.22(a)(2) or a intent has been submitted . this section, all processors subject to the Federal Register notice as described in (3) No later than 30 days after the date rule will be in violation of the test rule

§ 790.28(b)(2) who do not submit to EPA of publication of the Federal Register from the 31st day after receipt of the either a letter of their intent to conduct notice described in paragraph (b)(2) of certified letter or publication of the

tests or a request for an exemption for this section, each person processing the Federal Register notice described in this

each test for which testing is required in subject chemical as of the effective date paragraph ,

the test rule will be considered in of the test rule described in § 790 .20 or

violation of that rule beginning on the by 30 days after the date of publication § 790 .30 Submission of study plans.

31st day after the effective date of the of the Federal Register notice described (a) Who must submit study plans. (1) test rule described in § 790.20 or 31 days in paragraph (b)(2) of this section must, Persons who notify.EPA of their intent

after publication of the Federal Register for each test specified in the Federal to conduct tests in compliance with the

notice described in § 790 .28(b)(2) or on Register notice, either notify EPA by requirements of a single-phase rule as

the date processing begins as described letter of his or her intent to conduct described in I 790.20(b)(1) must submit in paragraph (d) of this section, as testing or submit to EPA an application study plans for those tests no later than

appropriate . for an exemption from the testing 30 days before the initiation of each of

§ 790~8 Procedure it no one submits a requirements for the test. those tests.

letter of Intent to conducttesting.

( 4) if no manufacturer or processor of (2) Persons who notify EPA of their

the test chemical has submitted a letter intent to conduct tests in compliance (a) If only manufacturers are subject of intent to conduct one or more of the with the requirements of a Phase I test

to.the rule. (1) This paragraph applies if required tests within 30 days after the rule as described in § 790 .20(b)(2) must testing is being required solely to allow date of publication of the Federal submit proposed study plans for those

evaluation of risks associated with Register notice described in paragraph tests on or before 90 days after the manufacturing and the test rule (b)(2) of this section, EPA will notify all effective date of the Phase I rule; or, for described in 1790 .20 states that manufacturers and processors by processors complying with the notice

manufacturers only are responsible for certified letter or publish a Federal described in § 790 .28(b)(2), 90 days after testing. Register notice of this fact specifying th e the publication date of that notice; or 60

(2) If no manufacturer subject to the tests for which no letter of intent has days after the date manufacture or

test rule has notified EPA of its intent to been submitted . This letter or Federal processing begins as described in

conduct one or more of the required Register notice will give the §790.25(d), as appropriate .

tests within 30 days after the effective manufacturers and processors an (3) Study plans must be prepared

date of the test rule described in oppo rtunity to take corrective action . according to the requirements of this

§ 790 .20, EPA will notify all the (5) If no manufacturer or processor Subpart B and Part 792 of this chapter. manufacturers by certified mail or submits a letter of intent to conduct one Only one set of study plans should be

publish a notice in the Federal Register or more of the required tests within 30 prepared and submitted by persons who of th is fact specifying the tests for which days after receipt of the certified letter are jointly sponsoring testing .

no letter of intent has been submitted or publication of the Federal Register (4) Any person subject to a test rule and will give the manufacturers an notice described in paragraph (b)(4) of may submit a study plan for any test opportunity to take corrective action. this section, all manufacturers and required by the rule at any time ,

(3) If no manufacturer submits a letter processors subject to the rule will be in regardless of whether the perso n

of intent to conduct one or more of the violation of the test rule from th e 31st previously submitted an application for required tests wi thin 30 days after day after receipt of the certified letter or exemption from testing for that test.

receipt of the certified letter or publication of the Federal Register (5) Unless EPA has granted an publication of the Federal Register notice described in paragraph (b)(4) of extension of time for submission of notice described in paragraph (a)(2) of this section . proposed study plans, manufacturers this section, all manufacturers subject to (c) Onlyprocessors are subject to the who notify EPA that they intend to

the rule will be in violation of the test ru1e. ( 1) This paragraph applies if testing conduct testing in compliance with the

rule from the 31st day after receipt of the is being required solely to allow requirements of a Phase I test rule as

certified letter or publication of the evaluation of risks associated with described in § 790 .20(b)(2) and who do

Federal Register notice described in this processing and the test rule described in not submit proposed study plans for

paragraph. § 790.20 states that only processors are those tests on or before 90 days after th e

(b) If manufacturers and processars responsible for testing . effective date of the Phase I test rule or are subject to the rule. (1) This (2) If no processor subject to the rule 60 days after the date manufacture

paragraph applies if testing is being has notified EPA of its intent to conduct begins as described in § 790 .25(d) will

required to allow evaluation of risks one or more of the required tests within be considered in violation of the test

associated with manufacturing and 30 days after the effective date of the rule as if no letter of intent to test had

processing or with distribution in test rule described in 1 790 .20, EPA will been submitted .

commerce, use, or disposal of the notify all the processors by certified (6) Unless EPA has granted an chemical and the test rule described in mail or publish a notice in the Federal extension of time for submission of

§ 790 .20 states that manufacturers and Register of this fact, specifying the tests proposed study plans, processors who

processors are re sponsible for testing. for which no letter of intent has been notify EPA that they intend to conduct
p. 9

Federal Register / Vol. 50, No. 96 / Friday, May 17, 1985 / Rules and Regulations 206 5 9

testing in compliance with the the testing facilities' administrative § 790.32 Phase ti test rule.

requirements of a Phase I test rule as officials and project manager(s) (a) If EPA determines that the

described in Q 790 .20(b)(2) and who do responsible for the testing . proposed study plan described in

not submit proposed study plans for (2) Brief summaries of the training and § 790.30(a)(2) complies with I 790.30(c),

those tests on or before 90 days after the experience of each professional EPA will publish a proposed Phase II

effective date of the Phase I test rule or involved in the study, including study test rule in the federal Register

90 days after the publication date of the director, veterinarian(a), toxicologist(s), requesting comments on the ability of

notice described in ji 790.28(b)(2), or 60 pathologist(s), chemist(a), the proposed study plan to ensure that

days after the date processing begins as microbiologist(s), and laboratory data from the test will be reliable and described in § 790.25(d), as appropriate, assistants. adequate.

will be considered in violation of the (iv) Identity and data on the chemical (b) EPA will provide a 45-da y

test rule as if no letter of intent to test substance(s) being tested, including comment period and will provide an had been submitted.

(b) Extensions of time for submission physical constants, spectral data, opportunity for an oral presentation

of study plans.

(1) The Agency may chemical analysis, and stability under upon the request of any person . EPA

grant requests for additional time fo.r the test and storage conditiens, as may extend the comment period if it

development of study plans on a case- appropriate. appears from the nature of the issues

by-case basis. Requests for additional (v) Study protocol, including rationale raised by EPA's review or from public

time for study plan development must for species/strain selection ; dose comments that further comment is

be made in writing to EPA. Each selection (and supporting data) ; route(s) warranted.

extension request must demonstrate or method(s) of exposure ; description of (c) After receiving and considering

why that extension should be granted. diet to be used and its source, including public comment, EPA will adopt the

(2) Under two-phase rulemaking, nutrients and contaminants and their study plan, including the time deadlines

extension requests must be submitted to concentrations; forin vitro test systems, and reporting schedules, as proposed or

EPA within 60 days after the effective a description of culture medium and its as modified in response to EPA review

date of the Phase I test rule as described source ; and a summary of expected and public comments, in a final Phase II

in $ 790.20(b)(2); or for processors spontaneous chronic diseases (including test rule as test standards and schedules

complying with the notice described in tumors), genealogy, and life span . for the required testing.

§ 790.28(b){2), 60 days after the (vi) Schedule for initiation and §790.35 Modification of test standards or publication date of that notice ; or 30 completion of each short-term test and schedules during conduct of test.

days after the date manufacture or of each major phase of long-term tests;

processing begins as described in schedule for submission of interim (a) Application. Any test sponsor who

$ 790.25(d), as appropriate . wishes to modify the test standards or

(3) EPA will notify the submitter by ' progress and final reports to EPA . schedules for any test required under a

certified mail of EPA's decision to grant (2) Information required in paragraph test rule must submit an application in

or deny an extension request. (c)(1)(iii)(D) of this section is not accordance with this paragraph.

(4) Persons who have been granted an required in proposed study plans Application for modification must be

extension of time for submission of submitted in compliance with the made in writing to the Director, Office of

study plans as described in paragraph requirements of a Phase I test rule if the Compliance Monitoring (EN-342), Office

(b)(1) of this section and who do not information is not available at the time of Pesticides and Toxic Substances,

submit proposed study plans in of study plan submission; however, the EPA, 401 M St., SW., Washington, D.C.

compliance with the requirements of a information must be submitted before 20460, or by phone, with writte n

Phase I test rule in accordance with the the initiation of testing. confirmation to follow within 10

new deadline granted by EPA will be (d) Incomplete studyplans. (1) Upon working days. Applications must include

considered in violation of the test rule receipt of a study plan, EPA will review appropriate explanation of why th e

as if no letter of intent to test had been the study plan to determine whether it modification is necessary . %

submitted as- described in § 790.25(e) complies with paragraph (c) of this (b) Adoption. (1) To the extent

and (f)• section. If EPA determines that the feasible, EPA will seek public comment

(c) Content of studyplans. (1) All study plan does not comply with on all substantive changes in test

study plans are required to contain the paragraph (c) of this section, EPA will standards and schedules. EPA will Issue

following information: notify the submitter that the submission a notice in the Federal Registe r

(i) Identity of the test rule . is incomplete and will identify the requesting comments on requeste d

(ii) The specific teat requirements of deficiencies and the steps necessary to modifications. However, EPA will act on

that rule to be covered by the study complete the submission. the requested modification without

plan.

(iii)(A) The names and addresses of (2) The submitter will have 15 days seeking public comment if either :

the test sponsors. after the day it receives this notice to (i) EPA believes that an immediate

(B) The names, addresses, and submit appropriate information to make modification to a test standard is

telephone numbers of the responsible the study plan complete . necessary to preserve the accuracy or

administrative officials and project (3) If the submitter fails to provide validity of an ongoing study, or

manager(s) in the principal sponsor's appropriate information to complete a (ii) EPA determines that a

organization. proposed study plan submitted in modification clearly does not pose an y

(C) The name, address, and telephone compliance with the requirements of a substantive issues.

number of the appropriate individual to Phase I test rule on or before 15 days (2) EPA will notify the sponsor of

contact for oral and written after receipt of the notice, the submitter EPA's approval or disapproval . When

communications with EPA. will be considered in violation of the 'EPA approves a modification, it will

(D) (1) The names and addresses of test rule as if no letter of intent to publish a notice in the Federal Register

the testing facilities and the names, conduct the test bad been submitted as indicating that the test standard or

addresses, and telephone numbers of described in $ 790.25(e) and (f). schedule has been modified.
P. 10

20660 Federal Register / Vol. 50, No. 96 / Friday, May 17, 1985 / Rules and Regulation s

~ 790.39 Failure to comply with a test rule. processing begins by any person not chemical, each exemption applicant

(a) Persona who notified EPA of their manufacturing or processing the subject must submit the following data :

intent to conduct a test required in a test chemical as of the effective date of the (a) The chemical identity of each

rule in Part 799 of this chapter and who test rule described in J 790.20 or by 30 technical-grade chemical substance or

fail to conduct the test in accordance days after the effective date of the test mixture manufactured and/or processed

with the test standards and schedules rule described in 1 790.20, who, before by the applicant for which th e

adopted in the test rule, cr as modified the end of the reimbursement period, exemption is sought. The exact type of

in accordance with $ 790.35, will be in manufactures or processes the test identifying data required will be

violation of the rule, substance and who is subject to the specified in the test rule, but ma y

(b) Any person who fails or refuses to requirement to submit either a letter of include all characteristics and

comply with any aspect of this Part or a intent to test or an exemption properties of the applicant's substance

test rule under Part 799 of this chapter is application . or mixture, such as boiling point, melting

in violation of section 15 of the Act. EPA (3) When both manufacturers and point, chemical analysis (including

will treat violations of the Good processors are subject to the rule, identification and amount of impurities),

Laboratory Practice standards as exemption applications must be filed by additives, spectral data, and other

indicated in § 792 .17 of this chapter. the date processing begins by any physical or chemical information tha t

4. By revising Subpart E. to read as person not processing as of the effective may be relevant in determining wheth6r

follows: date of the test rule described in § 790.20 the applicant's substance or mixture is

Subpart E-Exemptions or by 30 days after publication of the equivalent to the specific test substance .

Federal Register notice described in (b) The basis for the applicant's belief Sec. § 790.28(b)(2) who, before the end of the that the substance or mixture is

790.80 Submission of exemption reimbursement period, processes the equivalent to the teat substance or

applications, test substance and who is subject to the mixture . 790.82 Content of exemption application . requirement to submit either a letter o f

790.85 Submission of equivalence data. (c) Any other data which exemption

790.87 Approval of exemption applications. Intent to test or an exemption applicants are directed to submit in the

790.88 Denial of exemption application. application. test rule which may bear on a

790.90 Appeal of denial of exemption (c) Scope of application. A person determination of equivalence. This may application . may apply for an exemption from all, or include a description of the process by

790.93 Termination of conditional one or more, specific testing which-each technical-grade chemica l

exemption. requirements in atest rule in Part 799 of substance or mixture for which an 790.97 Hearing procedures . this chapter. exemption is sought is ]nanufactured or 790.99 Statement of financial responsibility . (Approved by the Office of processed prior to use or distribution in

Subpart E-Exemptions Management and Budget under control commerce by the applicant .

§ 790.80 Submission of exemption number

2070-0033).

$ 790 .87 Approval of exemption

applications. § 790.82 Content of exemption apptications.

(a) Who should file applicatians. (1) application. ' (a) EPA will conditionally approve

Any manufacturer or processor subject The exemption application must exemption applications if :

to a test rule in Part 799 of this chapter contain : (1)(i) For single-phase test rules, EPA

may submit an application to EPA for an (a) The identity of the test rule . has received a letter of intent to conduct

exemption from performing any or all of (b) The specific testing requirement(s) the testing from which exemption i s

the tests required under the test rule. from which an exemption is sought and sought;

(2) Processors will not be required to the basis for the exemption request . (ii) For two-phase test rules, EPA has

apply for an exemption or conduct • (c) Name, address, and telephone received a complete proposed study

testing unless EPA so specifies in a test number of applicant. plan for the testing from which

rule or in a special Federal Register (d) Name, address, and telephone exemption is sought and has adopted

notice as described'in J 790.28(b)(2) number of appropriate individual to the study plan, as proposed or modified,

under the following circumstances: contact for further information. as test standards and schedules in a

(i) If testing is being required to allow (e)(1) If required in the test rule to final Phase II test rule ; an d

evaluation of risks associated with establish equivalence : (2) The chemical substance or mixture

manufacturing and processing or with (i) The chemical identity of the test with respect to which the application

distributionin commerce, use, or substance on which the application is was submitted is equivalent to a test

disposal of the chemical and based. substance or mixture for which the

manufacturers do not submit notice(s) of [ii} Equivalence data specified In required data have been or are being

intent to conduct the required testing; or 1790.85 . submitted in accordance with a test rule ;

(ii) If testing is being required solely to (2) If a test rule requires testing of a an d

allow evaluation of risks associated single representative substance, EPA (3) Submission of the required test

with processing of the chemical . will consider all forms of the chemical data concerning that chemical substance

(b) When applications must be 7/led. subject to that rule to be equivalent and or mixture would be duplicative of dat a

(1) Exemption applications must be filed will not require the submission of which have been or are being submitted

within 30 days after the effective date of equivalence data as described in to EPA in accordance with a test rule .

the test rule described in § 790.20 or, if 790.85 . (b)(1) If a single representative

being submitted in compliance with the substance is to be tested under a test

Federal Register notice described in § 790.85 Submission of equivalence data. rule, EPA will consider all forms of the

$ 790.28(b)(2), within 30 days after the If EPA requires in a test rule chemical subject to that rule to be

publication of that notice . promulgated under section 4 of the Act equivalent and will contact th e

(2) Exemption applications must be the testing of two or more test exemption applicant only if information

filed by the date manufacture or substances which are forms of the same is missing or unclear .
P. 11

Federal Register / Vol. 50, No. 98 / Friday, May 17, 1985 / Rules and Regulations 20661

(2) If two or more representative notifi cation that EPA has denied an letter of notifi cation or publication of a

substances are to be tested under a test application for exemption, the applicant notice in the Federal Register that EPA

rule, EPA will evaluate equivalence may file an appeal with EPA . intends to terminate a conditional

claims made in each exemption (b) The appeal shall indicate the basis exemption, the exemption holder may

application according to the criteria for the applicant's.request for submit information to rebut EPA's

discussed in the test rule . reconsideration. preliminary decision or notify EPA by

(i) If EPA finds an equivalence claim (c)(1) The applicant may also include letter of its intent to conduct the

to be in error or inadequately supported, a request for a hearing . Hearings will be required test pursuant to the test

the applicant Will be notified by held according to the procedures standard established in the final test

'certified mail. The applicant will be described in § 790 .97. rule . Such a letter of intent shall contain

given 15 days to provide clarifying (2) Hearing requests must be in all of the information required by

information. writing and must be received by EPA ~ 790 25(c)

(ii) Exemption applicants will be within 30 days of receipt of the letter or (d)(1) The exemption holder may also

no tified that equivalence has been publication of the Federal Register Include a request for a hearing. Hearings accepted or rejected . notice described in ¢ 790.88(b). Hearing

(c) The final Phase Il test rule which requests must provide reasons why a will be held in accordance with the

adopts the study plans in two-phase hea rt'ng is necessary. procedures set forth in $ 790.97.

rulemaking, a separate Federal Register (d) If EPA determines that there are (2) Hearing requests must be in

notice in single-phase rulemaking, or a• material issues of fact, then the request writing and must be received by EPA

letter by certified mail will give for a hearing will be granted. If EPA within 30 days after receipt of the letter

exemption applicants final notice that denies a hearing request, EPA will base or publication in the Federal Register

they have received a conditional its decision on the written submission . notice described in paragraph (b) of this

exemption. All conditional exemptions (e) EPA will notify the applicant of its section.

thus granted are contingent upon the decision within 60 days after EPA (e) EPA will notify the exemption

test sponsors' successful completion of receives the appeal described in holder by certified letter or by Federal

testing according to the specifications in paragraph (a) of this section or within 80 Register notice of EPA's final decision

the test rule . days after completion of a hearing concerning termination of conditiona l

described in paragraph (c) of this exemptions and will give instructions as g 790.88 Denial of exemption application . section. to whatactions the former exemption (a) EPA may deny any exemption (f) The filing of an appeal from the holder must take to avoid being found i n

application if: denial of an exemption shall not act to violation of the test rule

.

(i) EPA determines that the applicant stay the applicant's legal obligation s

has failed to demonstrate that the under a test rule promulgated under 1 790,97 Hearing procedu res.

applicant's chemical is equivalent to the section 4 of the Ac t

test substance ; or (a) Hearing requests must be in

(2) The exemption applicant fails to # 790.93 Termination of conditional writing to EPA and must include the

submit any of the information specified exemption . applicant'sbasis for appealing EPA's

in 1 790.82; or (a) EPA shall terminate a conditional decision.

(3) The exemption-applicant fails to exemption if it determines that:

(b) If more than one applicant has

submit any of the information specified (1) The test which provided the basis requested a hearing on similar grounds,

in (j 790.85 if required in the test rule; or for approval of the exemption all of those appeals will be considered

(4)(i) For single-phase test rules, EPA applicationhas not been started by the at the same hearing unless

has not received a letter of intent to deadlines for initiation of testing con fidentiality claims preclude a joint

conduct the test for which exemption is adopted in the test rule or modified in hearing.

sought; or accordance with Q 790.35; o

r (ii) For two-phase test rules, EPA has (2) Data required by the test rule have ( c) EPA will notify each applicant of

not received an adequate study plan for not been generated in accordance with EPA's decision within 60 days after the

the test for which exemption is sought; the test standards or submitted in hearing.

or accordance with the deadlines for

submission of test data that were § 7~•" statement of financial

(5) The study sponsor(s) fails to the test rule or modified in responsibility .

Initiate the required testing by the adopted in

deadlines adopted in the test rule; or accordance with f 790.35 ; or Each applicant for an exemption shall

(8) The study sponsor(s) fails to (3) The testing has not been conducted submit the following sworn statement

submit data as required in the test or the data have not been generated in with his or her application :

standard and deadlines for submission accordance with the Good Laboratory I understand that if this application is

of test data as adopted in the test rule or Practice requirements in Part 792 of this granted before the reimbursement period

as modified in accordance with 1 790.35. chapter. described in cection 4(c)(3)(e) of TSCA

(b) EPA will notify the exemption (b) If EPA determines that one or more expires, I must pay fair and equitable

applicant by certified mail or Federal of the criteria listed in paragraph ( a) of reimbursement to the person or persons who

Register notice of EPA's determination this section has been met, EPA will incurred or shared in the costs of complying

that the exemption application is notify each holder of an affected with the requirement to submit data and upon

denied. conditional exemption by certified mail whose data the granting of my applicatio n

or Federal Register notice of EPA's was based.

1790.90 Appeal of denial of exemption intent to terminate that conditional ~ Doc. 85-115e7 Filed 5-16-85 : 8:45 am]

(a) Within 30 days after receipt of (c) Within 30 days after receipt of a

exemption. ( 1

BILLING CODE 6590-5"-y