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Protection Agency

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40 CFR Part 79 0 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 Rul e

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 _

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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 2 0 09-7] testing is being required, provide requirements" for all of the major type s 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 wa s 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$re s 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 an d 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 an d 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 Standard s alternaive process EPA will use to A . Prior Proposals and Rule s develop test rules under section 4 of In December 1983, the Natura 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-Congres s 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 thatp . 3

Federal Register / Vol . 50, No . 98 / Friday, May 17, 1985 / Rules and Regulations 20 653 utilization of the two-phase rulemaking submission deadlines . All such substances being tested wer e p ro cess 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 p romulgating 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 th e standard s 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) . either the OTS test guideline or o th er will accept the contention that testing of Subsequent to the issuance of that suitable guidelines, a modi fied version that applicant's chemical would yield Opinion, the Agency submitted papers of these guidelines, the alte rnative duplicative data . to the Court which indicated that in methodology submitted by commenters, Where possible, EPA plans to select a order to expedite th e test rule or a modi fi ed version of the alternative single representative test substance and development p ro cess, EPA would utilize methodology . The pro posed test to consider all forms of the chemica l a single-phase rulemaking process for standards and data submission, °equivalent" to each o th er for most test rules . The Agency also deadlines will be open for discussion at exemption indicated that EPA would 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 th e spring of The single

- phase approach offers a consideration of the nature of the test , 1985 . [Declaration of Don R
. Clay, at 12 number of advantages over the two- the various grades of the chemical o n (September 24,1984)) . In accordance with phase approach . First, th e Agency the market, the toxici ty of the various that commitment, the Agency is setting believes that the single-phase app ro ach 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 mi ght have on th e outcome of the program . The Agency is issuing th ese gui delines 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, th e one-phase process substances, the Agency wi ll 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 p ro tocols 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 .

development flexibility ofthe two-phase process, but For a more in-depth discussion of th e procedures in response to previous at a reduced administrative cost . Agency's interpretation of TSCA section proposals ( see Unit ILA above)
. Because of these advantages, the 4(c) , c, selection of test substance, and 

### a n Nevertheless , opportunity ftheor public Agency is providin g

comment on Agenc y

e y intends to utilize single-phase equivalency
. the reader is directed to this interim final rule in the event rulemaking for most rules p romulgated the Federal Register of October 10, 1984 persons wish to p ro vide 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 p ro cess for rulemakings where the two- 10, 1984, if EPA found the applicant' s to the rule, EPA will modify phase process may be a more chemical to be e the rule ae guivalent to bne for appropriate . expeditious route to a final test rule, e .g ., which study plans had been submitted Section 4(b)(1) of TSCA specifies th at 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 exemp tion . Exempti on 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, bo th test standards and published in th e Federal Register of All exemptions granted prior t o data submission deadlines are October 10,19$4 (49 FR 39774), completion of testing would be established during the second phase of describing the pro cess 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 app ro 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 no ti ce of 10, 1984 rule, each exemption applicant incorporated the following p ro cedure to proposed rulemaking, and EPA wi ll 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 exemp tion 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 pro posed 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 p ro vide 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 Regulation s 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 th e 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 thos e 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 . Single Phase 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 Federa l 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 o r 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 2 0 685 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 tel ling 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 th e criteria in applications for certain tests, in which requiring th e submission of study plans th e 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 .an effect or within 30 days after th e 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 e Agency that testing provide explanatory information . If EPA specified in th e Federal Register notice which is being undertaken is reliable finds the applicant's chemica l by the day the person begins processing . and adequate . equivalent to a different test substance 3. Submission of letter of intent to Study plans must contain : th an was claimed in its application, EPA conduct testing or exemption ( a) The identity of the test rule . will notify the applicant in writing and application
. 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 . 3

. App ro val of exemption letter of intent to perform testing, or (c) The names and addresses of the f PnO n 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 anoth er, for each of the tests required by project managers, and appropriate ( equivalence to th e 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 b e 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 th e experience of each testi ng 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 conditiona l 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 on the assumption that the tes t

the test tm a consorti t include~the na m

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 . S ubmission 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 th e substitution of an tests required under the test rule based th e basis of prior test data submissions, exemption application in instances on the belief th at th e test will be the Agency must terminate th e where more than one company indicates p erformed 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 th e 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 . exemp ti on is being sought and discuss basis for believing that th e tests will b,e Persons whose exemption applications the applicant's basis for believing that performed by ano ther 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 thi s assertion with the types of data Federal Register notice denying th e and support this asse rt ion 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 th e Under section 14(c) of TSCA, any applications . EPA w ill examine applicant disagrees with EPA's decision . person submitting data under the Act exemption applications after th eir 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 th ose 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 conditiona l 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 p ro cedures tested, all forms of the chemical will be Agency will terminate the exemption ifp . 6

20 656 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 noti ce 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 re quired by the rule were not submitted this rule consisting of
. other guidelines as test standar d 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 fo r 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 . exemp tion 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 reimbursemen t tests on behalf of all those subject to a testing supporting the exemptions has (3) Comments p ertaining to this rule . TSCA section 4 tiest rule, this rul e not satisfied the test rule's re quirements This re cord, which includes basic reduces the administra tive 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 regulate d Such exemp tion holders may file Federal Register no ti ces, is available for industries
. written comments concerning EPA's inspecti on in the OPTS Reading Room , intent to terminate such exemp tions 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 collectio n 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 re quired t .est. .Comments
. Management and Budget ( OMB) under hearing re quests and letters of intent to A . Executive Order 12291 the provisions of the Paperwor k 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 re gulation is seq ., and have been assigned OMB receipt of the letter or publication of the I'Major" and, therefo re , subject to the cont rol number 2070-OOS3 . Federal Register notice announcing the requirement of a Regulatory Impact, List of Subjects in 40 CFR Part 790 Agency's intent to terminate the Analysis . This rule on test rul e exemp tions . The comments and hearing development and exemp tion application Testing, Exemptions, Environmental requests should include a brief procedures to not major because it does protec tion, Hazardous materials, statement of the basis for the exemption not meet any of the criteria set forth in Chemicals . holder's belief that the condi ti onal section 1(b) of the Order . The regulation Dated : May 7 .1985 . exemption should not be terminated . If is a procedural rule and wi ll have ~ A
. ~ m an exemption holder requests a hearing, 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 f orPesticidea and 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 exemp tions from Therefare, 40 CFR Part 790 is termination unless confidentiality those test rules under sec tion 4(c) of amended as follows : claims preclude a joint hearing . TSCA . It wi ll not cause price or cost 1 . The authority cita ti on for Part 790 is Exemption holders wi ll receive written increases to the regulated community . revised to re ad as follows : notifi cation of EPA's final decision The re gulation will not significantly Authodty :15 U .S .C 2e0 & whether the exempti on will be affect competition, employment . terminated . investment, productivity, innovati on, or 2
. In Subpart A, by revising # 790 .5 . to If the Agency finds it necessary to the ability of U .S : based enterprises to read as follows : terminate conditional exemp tions, it will compete wi th fo reign-based enterprises J 780,5 Submisolm of i~~ 8tim notify the exemption holders to that in domestic or export markets
. effect, will explain the re ason for the This rule was submitted to the Office ( a) All submissions to EPA under this Agency's decision and will gi ve of Management and Budget ( OMB) for part must bear the Code of Federal instructions as to what actions the review as re quired 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 containin g V . Rulemaking Record rulemaking re cord . confidential business information must be EPA has established a public reL•ord B
. Regulatory Flexibility Act addressed to

. Document Contro l 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, Protec tion 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 Publi c 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)5 7 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 b e 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 P ersons subject to a test rute . members of the consortium, th e (a) Each test rule described in § 790 .20 signature of an authorize d 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, befor e (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 mus t (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 th e (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 i n (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 rul e (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 thei r 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 Regulation s 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 test if within 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 th an 30 days after the date rule will be in violation of the test rul e § 790 .28(b)(2) who do not submit to EPA of publication of th e 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 o r violation of that rule beginning on th e by 30 days after the date of publication § 790 .30 Submission of study plans
. 31st day after the effective date of th e 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 re quirements 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 conduct testing . ( 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 th e with the requirements of a Phase I tes t 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 th e 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 th e §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 rtuni ty to take corrective action . according to the requirements of thi s § 790 .20, EPA will notify a ll 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 wi thin 30 prepared and submitted by persons who of th is fact specifying th e 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 th in 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) Only processors are subject to the who notify EPA that they intend t o 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 o f § 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 20 6 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 i n 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 Registe r 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 i s 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 th e (2) Under two-phase rulemaking, nutrients and contaminants and their study plan, including the time deadlines extension requests must be submitted to concentrations ; for in 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 1 0 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 exten t 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 tes t 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 . 9 6 / 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 an d 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 (includin g 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 i s 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 a ll , or include a description of the process by 79 0 .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 whic h 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 representativ e 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 2066 1 (2) If two or more representative noti fi cation that EPA has denied an letter of noti fi 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 ma y 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 b y (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 tes t the applicant Will be notified by held according to the procedures standard established in the fi nal 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) . Hearin g (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 certi fi ed mail will give for a hearing will be granted . If EPA within 30 days after receipt of the letter exemption applicants fi nal 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 wi thin 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 what actions the former exemption (a) EPA may deny any exemption (f) The filing of an appeal fr om 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 re s . 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's basis 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 specifi ed (1) The test which provided the basis requested a hearing on similar grounds, in (j 790 .85 if required in the test rule ; or fo r approval of the exemption all of those appeals will be considere d (4)(i) For single-phase test rules, EPA application has not been started by the at the same hearing unles s 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 th e test rule or modified in hearing
. sought ; or accordance with Q 790 .35 ; or (ii) For two-phase test rules, EPA has (2) Data required by the test rule have ( c) EPA will notify each applicant o f 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 fo r 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 i n 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 Pr actice 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 TSC A (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] exemption . ( 1 (a) Within 30 days after receipt of (c) Within 30 days after receipt of a BILLING CODE 6590 -5"-y