Document rpGaGR3QgeajzdpYJNLRKXEL0

54160 ` Federal Register ./ Vdl'|7.' Wo. Cl /^Monjay. -November 16. .1992 f. Notice*' DEPARTMENT Of HEALTH AND FOURNtTHOl mFOfliMTlON COKTACT: manufacturers and processors of the HUMAN SERVICES _____ , ... . . * . " ?v .. . Dr. WiUianl Cibulas. Division at .U Toxicology, Research Implementation hazardous substances under the Toxic' 'Substance* Control Act (TSCA) and Agency for Toxic Substances and Branch: Agency for Toxic Substances .. registrants under the Federal `; Disease Registry ;; *v *; ^ 'andDisease'RegUtiy.MaIlstopE-29, ' Insecticide. Fungicide. and Rodentidde :* [ATSOR-SU ---1600 Clifton Road NR, Atlanta,Georgia Act (FIFRA), or by cost recovery from ; ; 1-30333, telephone 40*^639-8306. responsible parties under CERCLA.: . J~ ` 'v, f 1 V11*!-''.''-f:* js, v- Furthermore, section 10*(i)(5)(C) states Revised Procedures For Conducting .SUPPLEMENTARYINFORMATION:.s-. ithat in developing and implementing the' Voluntary Research ; ~ Background, * researchprogram, the Administrator of -f - fi.! i;-.- ATSDR and the Administrator of EPA AOENCYr'Agency for Toxic Substances ^ '-'the Comprehensive Environmental . -shall coordinate such program with the - and Disease Registry (ATSDR), Public . Response. Compensation, and Liability . National Toxicology Program (NTP) and. Health Service (PHS], Department nf ; Act of 1980 (CHICLA). bs amended by .with programs of toxicological testing ^ Health and Human Services (HHS).'; the Superfund Amendments And established under TSCA and FIFRA. To - _a_cti_o_n_:N_otice. * : ' -*,* Reautborization Act of 1986 (SARA) (42 U&C. 9604(1]), requires that ATSDR: (1) " \ achieve this coordination. ATSDR- - established the Triagency Superfund * Develop jointly with the Environmental.- .-Applied Research Committee (TASARC) Summary: This'notice announces the - Protection Agency (EPA) a list of . * [ - as a forum for ATSDR. EPA, and NTP to revised procedures for volunteering to *r * 'hazardous substances found at National' discuss and coordinate use of potential conduct research as part of the ATSDR .Priorities List (NPL) sites fin order of j.\ ' mechanisms for developing and ... _ Substance-Specific Applied Research priority), (2) prepare toxicological ' - implementing this CERCLA Substance^" Program authorized by the jv.- . profiles of these substances, and (S)-'-"* ' Specific Applied Research Program. Comprehensive Environmental assure the initiation of a research ,_ Meetings of the TASARC are not open Response. Compensation, and Liability program to fill Identified data needs Act (CERCLA or Superfund), as associated with the substances. - to the public. The first meeting of TASARC was held on April 20,1992. to amended. The procedures for conducting voluntary research were initially announced in the Federal Register on' February 7,1992 (57 FR 4758). The public was invited to comment on the . v~ procedures and the attendant Memorandum of Understanding (MOU), The voluntary research will be conducted by the private sector to fill priority data needs for hazardous substances that are the subjects of the ATSDR toxicological profiles. This notice describes the revised procedures. The identification of the priority data inform the Committee on the Agency's needs for 38 priority hazardous v. ' ' progress in implementing the Substance- substances was described in the Federal Specific Applied Research Program, and Register (56 FR 52178. October 17.1991). to seek the Committee'* input in - public comments were invited, and . planning for the Agency'* public meeting companies were requested to volunteer . on voluntary research held on April 29, to conduct research to fill specific 1992.'. - : -... priority data needs during the public" - The ATSDR encourages private sector comment period for that notice. The - organizations to conduct voluntary Federal Register notice. "Announcement, research to fill specific priority data - of Final Priority Data Needs for 38 needs identified in the Agency's Priority Hazardous Substances", .which Substance-Specific Applied Research . includes a second call for private* sector Program. Toward that end, the DATES: The ATSDR considers this " voluntarism, is being published in this procedures for conducting voluntary voluntary research effort to be of ' 'issue of the Federal Register. Future research, and the attendant significant importance to the continuing - Federal Register notices will announce Memorandum of Understanding, were development of the Substance-Specific the names of companies that have developed by ATSDR and announced in Applied Research Program. Therefore, volunteered to fill specific priority data the Federal Register on February 7.1962 public comments concerning this - needs.' (57 FR 4758). The Agency is aware of Federal Register notice will be accepted throughout the Agency's involvement with voluntary research. , . . * The major purpose of this ATSDR ' Substance-Specific Applied Research Program is to supplement the substance- addresses: Comments on this notice.. specific information needs of the public should bear the docket control number and scientific community, and to supply ATSDR-61 and should be submitted to necessary information for conducting the Division of Toxicology, Research comprehensive public health concerns within some segments of the public regarding voluntary research conducted by oompanies with vested ... interests in the research. Therefore, the Agency encouraged the public to comment on ATSDR's procedure for conducting voluntary research. Additionally, for each research project Implementation Branch, Agency for . Toxic Substances and Disease Registry,. Mailstop E-29,1600 Clifton Road NE, ~ Atlanta. Georgia 30333. Requests for a copy of the model Memorandum of Understanding should be addressed - similarly. , Comments on this notice will be j assessments for populations living in the vicinity of hazardous waste sites. This ' Erogram will also provide datnhat can e generalized to other substances or -ureas of science, including risk - -' assessments of chemicals, thus creating a sdentific base for filling a broader range of data needs.,. , conducted voluntarily, the MOU (signed by ATSDR and the interested company), the ATSDR approved study plan, peer reviewer's comments, and the final - research report and supporting data will be available for public inspection at the location and times indicated in the addresses section of this notice. available for public inspection at the Agency for Toxic Substances and Disease Registry, Building 4, Suite 2400, Procedure for Conducting Voluntary : Research _ ; ATSDR intends to enter into voluntary research projects in ways that lead only to high quality scientific work. This Executive Park Drive, Atlanta. Georgia CERCLA. as amended in section' 5 necessitates peer review of study .(not a mailing address), from 6 a.m. until l04(i)(5)(D), states that it is the sense f protocols and results consistent with 430 p.mH Monday through Friday. - , Congress that the costB for conducting CERCLA section 104(0(13). CERCLA except for legal holidays. this research program be borne by the requires the peer review panel to consist R&S14712o Federal Register / Vol. 57.1;Jo.'i21 / Monday, November 16. 1992 f Notice* . , 5^,161, '^ * * \-* of three to seven peer reviewers who (a)1 ' . The Agency is cognizant'trf the private Private sector rganlzationi (companies) are selected by the Administrator of sector's concern that EPA may require -- Interested in volunteering to conduct" " ATSDR, (b) are disinterested identified industry tasting during or following a ' research on priority data needs are . ' experts, (c) have a reputation-for - w--4"" voluntary research effort with ATSDR '. asked to submit to ATSDR. in writing, a scientific objectivity, and (d) lade; **1 ' which may be regarded as duplicative of brief statement that addresses the institutional ties with any person - - that effortThere are several safeguards ' priority data need(s) to be filled and die . involved in the conduct of the study or to prevent this from happening. First methods to be need. It should be noted research under review. - ' i ATSDR, EPA, and NTP are coordinating that ATSDR encourages innovative The ATSDR held a public meeting on to conserve the testing resources of both protocols.'where appropriate. Therefore, April 29,1992, to discuss the proposed the government end the private sector (he Interested company sh old Indicate procedures for voluntary research. -`l----1 - and avoid unnecessary or duplicative ^ wheninnovative protocols are being Comments were received from industry- testing. This coordination occurs at ` " proposed-Interested companies mty `' groups, environmental groups and *V many points: the review of ATSDR'a - - . address substance-specific data heeds Federal agencies. As a result of ' **'' J'-~ ' toxicological profiles, review of ATSDR" or. where appropriate, propose to discussions at these two meetings and ' data needs documents, meetings of conduct research that will provide * ' other public comments received by the TASAKC and the Interagency Testing' ' information relevant to classes of Agency, ATSDR has revised the *" - ' Committee, and review of research chemical substances or which may be voluntary research procedures.The ' proposals developed tinder ATSDR'a ` " generalized to ether areas of science. It major revisions and clarification of the' voluntary research program. EPA, .should be noted (hat all voluntary - . .. procedures are described below. intends to review research proposals research conducted to fill ATSDR's ATSDR now believes that prior to developed under this program for priority data needs should comply with . negotiation of the study plan, it would conformity with basic testing concepts the Department of Health and Human be more appropriate to have a Letter of under TSCA. FIFRA. and the OECD, Services' Laboratory Animal Welfare Intent submitted by the interested ' Second, the Toxic Substances Control Act of 1966 (Pub. L. 89-544. as amended. company, rather than to have the MOU - Act expressly requires EPA to find that 7 U.S.C. 2131 et seq.) or Protection of signed by the interested company and data are inadequate to reasonably r r',. Human Subjects (45 CFR part 46). the Agency as originally indicated. In determine or predict the effects of a .... The interested company's statement the revised procedures, the interested ` chemical substance. EPA has already will be reviewed by TASARC. Based on Company and ATSDR will enter into an . interpreted this to mean that it cannot TASARCs recommendations, ATSDR MOU after the study plan has been require duplicative testing. As a matter ' will determine which, and how. specific approved by the Agency. Furthermore, of policy EPA will not require testing in ,, voluntary research projects wQl be . the procedures will now indicate that a rule which duplicates ongoing testing pursued with volunteering companies. In ATSDR encourages innovative by government or the private sector instances where volunteered research protocols, where appropriate. With ' pursuant to an MOU until the test data * initiatives are considered by TASARC . respect to the role of peer review, - , *' are submitted, reviewed and determined to be more appropriate for EPA . - . ATSDR will continue to pursue its ' \ to be inadequate. There may be response. EPA may negotiate directly policy of peer review of both study - - instances where research conducted , wilh the interested company. - protocols and results as mandated under under an'lndustiy/ATSDR MOU will If ATSDR decides to pursue a specific CERCLA. However, to the extentlhat yield results which indicate additional . voluntary research project submitted by research protocols entail accepted test testing is necessary or where the testing . a company, the Agency will request the guidelines developed under TSCA. - under the MOU is not intended to. -v * company to forward a Letter of Intent FIFRA or by organizations such as the' address the endpoint ofconcern to EPA. within four weeks of the approval of the Organization for Economic Cooperation In these cases. EPA may exercise its company's statement The Letterof - and Development (OECD), less rigorous authority to require testing under TSCA Intent should Indicate that the company peer review of the study protocol may or FIFRA. - is prepared to enter into discussion with be required. Furthermore, the peer It is generally the policy of ATSDR to ATSDR regarding the research plan to review process will not supersede the rely on data and studies which are . . . fill a specific data need identified by the function of Institutional Review Board-- publidy available, with the exception of . ATSDR Substance-Specific Applied * ' activities related to protection of human personally identifiable Information on Research Program. Furthermore, the-. subjects or animals. ' study projects. Therefore, research -. Letter of Intent will state that if the.- With respect to potential termination conducted under this program should be . research plan Is approved by ATSDR, of the MOU at the convenience of either designed so as not to disclose Trade * - the company will negotiate an MOU party. ATSDR intends that this action Secrets or other.Confidential Business - with ATSDR prior to initiation of the will be taken as a last resort, and (bat Information. If the company finds that research.; - k * ' - - " prior to such an action, all possible - \ such research is impossible to conduct. * The Agency recognizes that two or avenues of dialogue with the private " ' under this restriction. ATSDR will enter - more companies or a consortium of * sector organization would be pursued,.'7 into discussions of alternative solutions, interested firms may elect to enter into within reasonable limits. However, - - or may choose to terminate negotiations.' collaborative efforts in pursuing one or decisions as to what constitutes a Finally, in reference to research costs, more research projects, therefore, where breach of the MOU will be at the ' < . the direct and indirect hosts associated \ appropriate, a single MOU will be discretion of ATSDR. Moreover. ATSDR with the research program are those signed between ATSDR and multiple recognizes that in the course of ' incurred by the research sponsor and companies. Following the submission of conducting research, unexpected and --. not by ATSDR. The Agency will assume the Latter of Intent and prior to the " unanticipated delays may occur and' - responsibility for administrative costs . initiation of the research, the interested wherever possible this will be including the cost of peer review as part -company will negotiate with ATSDR to negotiated with the private sector :ic> ofits overall program.-'*..- - v-vr'-',-` agree upon an approved study plan , organization in the spirit of mutual '^'-i -The procedures for conducting . including testing protocols and time ** cooperation. -- voluntary research are described below. schedules.-.- ' R&S147121 '54162 Federal Register / Veil 7, No. 2a 7 Monday.-November 16,1992 j Notion Tbs company shell submit to ATSDR- The testing schedule and completion -the MOU. and(li) inspect (and in the : s study plan for etch test six weeks - date of tea study will be established case of records, copy) any records and after submitting the Letter ofInteaL.The from the .approved study plan Interim.?.? ' specimens required to be maintained to study plan shall include test protocols, 4' progress reports shall be submitted to... ' connection,with research performed . and a schedule with reasonable ATSDR within six months after tee .r-*- pursuant to the MOIL - ... . j,.- rJ . timetable and deadlines for initiation Initiation of testing'end thereafter within . (8) Submission and publication of - _ and completion of each test and - six months after submission of each data--All data and reports submitted to submission or interim and final reports.. previous interim report. The final report ATSDR pursuant to the MOU shall be . ,7he test protocols will be reviewed by on tee results of testing shall be .* sent toATSDR. in duplicate, at the - an ATSDR-appointed peer review paneL submitted to ATSDR no more than 20 V address indicated In the ADonesscs If ATSDR disapproves the study plan, it ` weeks following the end of the study.- section. Final reports will not be - will inform the company of the Final reports will not be accepted if tee.' accepted if tee date is designated ___ deficiencies of the plan. The company* ; date are designated Confidential . Confidential Business Information (CBI) may request reconsideration of the - Business Information (CEQ or otherwise or otherwise restricted from public study plan, resubmit a modified study ... - -restricted from public disclosure, with. - disclosure. Furthermore, acceptance of plan, or elect to terminate further discussion on the proposed research with no obligation of either party. In the event that the company resubmits ' tee exception of personally Identifiable information on study subjects.,- . . Moreover. ATSDR'* acceptance of the final report wfll be contingent upon tee final report is contingent upon approval by ATSDR following the peer reviewers* recommendations, consistent with CERCLA peer review requirements. modified study plan and ATSDR . approval by ATSDR following tea pea ' The company maintains all rights to ' disapproves it, the Agency may elect to reviewers' recommendations, consistent publication of data and results, however terminate further discussion. -- . with CERCLA section 104{i}[13] peer all results of research conducted . . .. ff the study plan Is approved by review requirements. All results of 'J pursuant to the MOU and all supporting ATSDR upon tire recommendations of research conducted pursuant to tee . . data associated with the final research ,, the peerreviewers, the company will MOU end all supporting data assodated report will be provided to ATSDR and enter into an MOU with the Agency. The with tee research report will be - -made available by the Agency to the content of the MOU is described below; provided to ATSDR and made available public as part of its implementation of (1) identification of the party or \ parties comprising the company which enters into the MOU--This section . by the Agency to tee public as part of its . section 104(i)(5) of CERCLA. . Implementation of sections 104(0(3) and (9) Payments of costs and expenses-- (S) of CERCLA. , ", Each company shall agree to pay all consists of the name and address of ' each party responsible for the conduct' of the research. (2) Identification of the snbstancefs) subject to research requirements under the MOU--This section consists of the name and Chemical Abstract Service ' (CAS) Number of the chemical ubstance(s) that is the subject of the MOU. The chemical substance(s) to be tested shall be as pure as reasonably can be attained. However, under certain circumstances, ATSDR recognizes teat it may be more desirable to test mixtures or technical grade products. Furthermore, alternate language will be substituted when the subject of the research is a human population. ss in epidemiologic studies. - (3) Identification of tee effects or characteristics for which research is to be conducted--In thu section, the health effects, environmental fate or other (5) Modifications of study plans, costs, direct and indirect, associated ; guidelines, and schedules--If a company with the research programs. The Agency intends to modify a study plan, protocol, or schedule that was approved by will assume responsibility for administrative costs including the cost ATSDR, it must notify ATSDR in writing of tee proposed modifications and of peer review as part ofits overall program. reasons therefor. If ATSDR approves of the modifications, the time schedule . established for completion of tee teste shall be re-negotiated and appended to the existing MOU. If ATSDR - disapproves tee company's request and the company does not accept ATSDR's " decision to disapprove the modified study plan, the company may terminate the MOU. (6) Observance of Good Laboratory - Practices--All research agreed to In the MOU shall be conducted in accordance with the Good laboratory Practice - (CLP) standards codified in 40 CFR part 782, to the extent that such GLP Standards apply. Should Good - ' (10) Events constituting a breach of .the MOU--Failure by the company to: (a) Initiate any test agreed to in the MOU by the date established pursuant to the MOU; (b) Adhere to CLP standards, established test procedures or accepted practices ofgood science to the extent teat these standards and practices ppfy;-. /- (c) Submit any interim report required under the MOU by the date established pursuant to the MOU; or . (d) Submit any final report that receives ATSDR's approval following peer review conducted by the Agency, characteristics for which research is to Epidemiology Practices ("Guidelines for shall constitute a breach of the MOU, In be conducted under the MOU sbaQ be Good Epidemiology Practices for the event of a breach. ATSDR will not listed. Occupational and Environmental Impose any claim to damages, but at the (4) Initiation of Research and Epidemiologic Research'*--The ' Agency's discretion may terminate the Submission of Interim and Final ' '' Qiemical Manufacturer Association's MOU., -- Reports--The starting date of the' Epidemiology Task Group, Journal of v - For research completed subsequent to research project may be negotiated \ Occupational Medicine, Volume 33.' termination of an MOU. or termination depending on the type of research being 1221-1229,1991) be relevant to a - of negotiations in anticipation of an conducted. However, as a general research project, those Practices should MOU, companies may not represent guideline, the research effort shall be ' be affixed to the study protocol - endorsement of such research by initiated within eight weeks of tee , (7) Inspections--The company shall ATSDR based on ATSDR's approval of approval of the study plan and ~ ensure that authorized employee* of a study protocol, plan or other aspect of * - attendant test protocols, end the signing . ATSDR are permitted, at reasonable - the research. v of the MOU. Written notification of the times and In a reasonable manner, to (1) (11) Termination--Since the MOU is starting date of the test will be - - inspect any research or testing facilities entered into voluntarily by ATSDR and' submitted to ATSDR by the company. that is conducting research pursuant to the company, termination by ATSDR is it R&S147122 Federal Register f V l 87, No. 221 / Monday. November 16. 1992 / Notices - 541&V not considered review.bleegency : '' .' thebaiitWtilrmderany other Rearch Program will be used for - ^ '' action pursuant to the Administrative provisioa of lawi or the response and; public health assessment purpose* and Procedure* Act or any other applicable - abatement authorities JCER{XA.:-"*: to reassess ATSDR's substance-specific Federal law, and there will be no appeal - As previously stated. EPA is not priority data needs. It is the intention of process beyond that set out in the MOU. currently planning to participate as a; the Agency, at this time, to reevaluate The company may elect to terminate the potential signatory in MOU negotiations _ the priority data needs for the listed MOU at any time. ... arising from this Notice. However, if hazardous substances every three !yyeears. . (12) Statutory compliance--Consistent EPA were to participate, the contents __< with section 104(i)(12) of CERCLA. as described above wouldneed to be i amended (42 U.S.C. 9804(i)(l2)). nothing appropriately revised to reflect t ` / * - WDEamURopw..i_ .1-- xtmt --ii i--------- ----- 1 *- j*'-- ' -ommitaii--* rthermat ______ .______________ , bepartie-- . ... Administrator of ATSDR or the : - The resulU or the research viathis Administrator of EPA to exercise any of .ATSDRSubstance-Specific Applied ^ .. ,vr V`V. . -/ .. VV C V'. - -.' *--- - : vr ^ ' ** . -`--v ... t ' fc . _* 2 `^Vv-.vV*. ~vy..y-vyyy . v >-*T. * . - * -- -> ... `.-r- --'' V .I.-Vrjr., : T ' -./ ".J ,. -- * * . '- . - . r* ~ - ^ . . .- -__ 'i.y"v: * . ,1 *-** J i*. ' ' ;*' Vv.' . * ^ **-';r ' r . .f. ^ . - - " * " -;-?T .---v . <^1 v'.v.^.yr '> - :-.r-. *.' " v:*1 *Jr:** ^` ' - V r-j{ *r-;' 'r * . .-1-..,. . r- -- ' .' .. . . . . .i - -r: ? : ->v v-v.;v. ^ i.-. ftr\ r --:V^ - v-- r 7T~~. *-*v'l" ^* Z.' - j . ' * V. . * ^ *. '* : -Tv. .. * r? -i- ' : J '*' - . '. ; ;Vi : v j. I J V --j'T J -** V--V`v,VV -'T .TJ- ., . . - ..yV * : " :s.'.. _ .... - V: '*' *' : :'' "\ my;--V-v. v : ^ ,v ' l--' ^' ' *V ; ' " *' . . " - - -j,.- r-- -. * ; * ' ',' '. * "V... * >" *; ''-L : l',` - - *- ' it ' * - - "* ' -; ,, r ' ` 1, - - - '-:y.`7 *--- !*..,: 7> t: . v ` . s.^V.v * .? > -- Wv; v- **'**..**' . . . * . *, 7 . . vf" :7 -v. ` y1* v * ' .. ; * L- . *> N .*' *. * '`..J* ` R j -v'"'-1 . '- .?1 ' * . * .a' '*! . T/;r.'. t.,ez* *' * -- *- 't *.V `V. `f-e, > `*"l ,v. . r;- ? *--- f i-; *;; ***ij'> *' :v.` ..... - 4" J, V ^ ; * .V-V,*-uV.. ' *-7` '*' *Sr** - ; ' i.-.t ' V ' ' \ ' - - " R&S147123