Document 3Jy5ngYp6E8qMn8dNbz9n4yZO

54160 Federal Register ./ Veil 17.' No- X2X / Monday, -November 16, .1992 f. Notices DEPARTMENT OF HEALTH AND toftFURTHER INFORMATION CONTACt^-l manufacturer* and processors of the HUMAN SERVICES L.* :- ^ ^``-v C- Dr* Wimantabulas.Diviman a!i:->r.* hazardous substances under the Toxic . , i, * ; a- Toxicology.ResearchImplementation;; Subslances Control Act (TSCA) and - *-- Agency for Toxic Substances and - - Agency for Toxic Substances 'registrants under the Federal Disease Registry ; ^ndDiseaseTtegistry.MailstopE-29. 4 : Insecticide. Fungicide, and Rodentidde * --^4-4--1600Clifton Road NR, Atianta,Georgia V Act (FEFRA), or by cost recovery from _? lATSDR-StJ , * telephone404z639-6308. responsible parties under CERCLA.; . ' i-**- ~ Revtsed Procedures For Conducting }" , * ' .z> '"'Sre?>' v- Furthermore, section lM(i)(5)(C) states - supplementary information: ^,4 *.- that in developing and implementing the' Voluntary ; Research Vj- --w = V v. :V>V'"pi.* -ii'.' ; research.program, the Administrator of ATSDR and the Administrator of B'A j. agency:"Agency for Toxic Subtle* - ^The aOTprehen.iveEnyirtmmentrf_^. ^hall coordinate such program with the ~ and Disease Registry (ATSDR). Public . Response. Compensation. and UabUJhr . National Toxicology Program (NTP) and. Health Service (PHS). Department nf. '*' Act of 1BSO (CERCLAbes amended by .with programs of toxicological testing ^ Health and Human Services (HHSJ. V Superfund Amendmentj andi .rf; . established under TSCA and FIFRA. To . .. ., ACTION: Notice. Reauthorization Act of 1986 (SARA) (42 achieve this coordination. ATSDR - - -1. JJS.C. P604(iJ). requires that ATSDR: {1) ` established the Triagency Superfund -> ' Develop jointly with the Environmental . Applied Research Committee (TASARC) Summary: This*notice announces the - Protection Agency (BPA) a list of . as a forum for ATSDR. EPA. and NTP to. revised procedures for volunteering to' * hazardous' substances found at National* "discuss and coordinate use of potential conduct research bs part of the ATSDR Priorities List (NPL) sites fin order of -..V^ mechanisms for developing and . Substance-Specific Applied Research priority), (2) prepare toxicological *; '* - implementing this CERCLA Substance^ Program authorized by the - . ;v-:- - profiles of these substances, and (3) ' Specific Applied Research Program. Comprehensive Environmental assure die initiation of a research . ... Meetings of the TASARC are not open - Response; Compensation, and Liability " program to 11 identified data needs ." )o the public. The first meeting of Act (CERCLA or Superfund), as associated with the substances. . - TASARC was held on April Zti, 1992. tn 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 die -* 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 profile*. This notice describes the revised procedures. The identification of the priority data needs for 38 priority hazardous :.* ~ * substances was described in the Federal Register (56 FR 52178. October 17.1991), public comments were invited, and companies were requested to volunteer . to conduct research to fill specific \ priority date needs during the public ' comment period for that notice. The Federal Register notice, "Announcement. of Final Priority Data Needs for 38 Priority Hazardous Substances", which ; includes a second call for private' sector inform the Committee on the Agency's progress in implementing the Substance- Specific Applied Research Program, and to seek the Committee's input in - - planning for the Agency's public meeting on voluntary research held on April 28, 1982.*. - . - ' The ATSDR encourages private sector organizations to conduct voluntary research to fill specific priority data . needs identified in the Agency's Substance-Specific Applied Research . Program. Toward that end, the OATES: The ATSDR considers this * voluntarism, is being published in thla 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 7,1982 public comments concerning this - needs.' (57 FR 4758). The Agency is aware of Federal Register notice will be accepted throughout the Agency's involvement The major purpose of this ATSDR ~ ! with voluntary research. . . Subttance-Spedfic Applied Research ' Program is to supplement the substance^ addresses: Comments on this notice.. specific information needs of the public concerns within some segments of the public regarding voluntary research conducted by companies with vested ... interests in the research. Therefore, the Agency encouraged the public to should bear the docket control number and scientific community, and to supply comment on ATSDR'e procedure for . ATSDR-61 and should be submitted to . necessary information for conducting conducting voluntary research. the Division of Toxicology, Research Implementation Branch, Agency for . . Toxic Substances and Disease Registry, comprehensive public health - . Additionally, for each research project assessments for populations living in the conducted voluntarily, the MOU (signed vicinity of hazardous waste sites. This ' by ATSDR and the interested company), Mailstop E-29.1600 Clifton Rodd NE. - program will also provide datrthat can Atlanta, Georgia 30333. Requests for a be generalized to other substance* or copy of the model Memorandum of -areas of science, including risk - Understanding should be addressed : assessments of chemicals, thus creating similarly. , ... . a scientific base for filling a broader ; 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 Comments on this notice will be _ range of data needs. ;.^.r addresses section of this notice. available for public inspection at the \ ATSDR intends to enter into voluntary Agency for Toxic Substances and Procedure for Conducting Voluntary Disease Registry, Building 4, Suite 2400, Research ,, ; research projects in ways that lead only to high quality scientific work. This Executive Park Drive. Atlanta, Georgia CERCLA. as amended in section' necessitates peer review of study .(not a mailing address), from 8 a.m. until 104(!)(5)(D), states that it is the sense of protocols and results consistent with 4-30 p.nL, Monday through Friday.* , Congress that the costs for conducting CERCLA section 104(i)(13). CERCLA - except for legal holidays. -- this research program be borne by the requires the peer review panel to consist R&S151816 Federal Register / Vo1.57.~Nq.221 / Monday, November 16. 1992 f Notices SM61 of three to seven peer reviewer* who (a)' V The Agency is cognizant-of the private Private sector organizations (companies) areseiected by the Administrator of -7" sector's concern that EPA may require -V interested in volunteering to conduct - -- ATSDR (b) are disinterested scientific '* industry testing during or following a' ' research on priority data needs are experts, (c) have a reputation-for voluntary research effort with ATSDR'- asked to submit to ATSDR In writing, a scientific objectivity, and (d)Iadc --;; which may be regarded as duplicative of brief statement that addresses the institutional ties with any person r ` that effort There are several safeguards priority data needfs) to be filled and the . involved in the conduct of the study or to prevent this from happening. First * " methods to be used. It should be noted research under review. ' ' ' ^ ATSDR, EPA. and NIP era coordinating that ATSDR encourages innovative The ATSDR held a public meeting on to conserve the testing resources of both .protocols.'where appropriate. Therefore. April 29,199Z, to discuss the proposed the government and the private sector the interested company should indicate procedures for voluntary research. "` - and avoid unnecessary or duplicative ^ whan innovative protocola are being Comments were received from industry "] testing. This coordination occurs at'" . proposed.Interested companies may ` ~- groups, environmental groups and' many points: the review of ATSDR'# * ' address substance-specific data needs Federal agencies. As a result of 'ly\ 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 TASARC 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 under ATSDR's " generalized to other areas of science. It major revisions and clarification of the *" voluntary research program. EPA^ >/'" .should be noted that all voluntary / .___ procedures are described below. intends to review research proposals' research conducted to fill AJSDR'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 Latter of under TSCA. F1FRA. and the OECD. Services' Laboratory Animal Welfare Intent submitted by the interested : J_ ' Second, the Toxic Substances Control Act of 1966 (Pub. L. 89-544. as amended. company, rather than to have the MOU; signed by the interested company and.' Act expressly requires EPA to find that 7 U.S.C. 2131 et seq.) or Protection of data are inadequate to reasonably . ,; Human Subjects (45 CFR part 44)... 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 will 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 dsta - initiatives are considered by TASARC . respect to the role of peer review." ere 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 with the interested company. protocols and results as mandated under under an'indusby/ATSDR MOU wifi If ATSDR decides to pursue a specific .CERCLA. However, to the extentlhat yield reaults 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. ' company to forward a Letter of Intent F1FRA or by organizations such as the* address the endpoint of concern to EPA. within four weeks of the approval of the Organizetion-for Economic Cooperation' In these cases. EPA may exercise its company'sstatemenLTheLetterof - and Development (OECD), less rigorous authority to require testing under TSCA Intent should Indicate that the company peer review of the study protocol may orFIFRA. - 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"- publicly available, with the exception of . ATSDR Substance-Spedfic Applied . - - activities related to protection of human personally identifiable information on -ResearchProgram.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 - 7 with ATSDR prior to initiation of the will be taken as a last resort, and (bat Information. If the company finds that research.; - - ' ' - prior to such an action, all possible- v. such research is impossible to conduct- - The Agency recognizes that two or avenues of dialogue with the private ' - under tbit restriction. ATSDR will enter - more companies or a consortium of - sector organization would be pursued '' 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 , : Finally, in reference to research costs, more research projects, therefore, where breech of the MOU will be at the < * . the direct and indirect tost* associated 7 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 Letter 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 -v-1-- including the cost of peer review as part company will negotiate with ATSDR to negotiated with the private sector - of its overall program. *-" -. - v- ~- ' agree upon an approved study plan organization in the spirit of mutual - - The procedures for conducting .:r ">**' including testing protocols and time " cooperation. * - ' 'wl. voluntary research are described below. schedules.v --- - --"- R&S151817 W162 Federal Register / VoLS7.No. 221 / Monday.-Novtanber-1ft, 1992 / Notices The company shell submit to ATSDR -- The testing schedule and completion -!v Ibe MOU. and (ii) Inspect (and fat the. s study plan for each test six weeks :- date of the study will be established case ofrecords, copy) any records and after submitting the Letter ofIntent The -from the approved study plan. Interim,?.; ' specimens required to be maintamed fas study plan shall include test protocols. progress reports shell be submitted to---. ' connection with research performed . l and a schedule with reasonspie ATSDR within six months after the .re -pursuant to the MOU. - timetable and deadlines far initiation ^ initiation of testing and thereafterwithin _ (8) Submission and publication of - - and completion of each test and /' six months after submission of eadi - data--All data and reports submitted to submission ofinterim and final reports. previous interim report. The final report ATSDR pursuant to the MOU shall be . ,The test protocols will be reviewed by on the results of testing shall be sent farATSDR. to duplicate, at the ; an ATSDR-appolntcd peer review panel, submitted to ATSDR no more than 2D V -address indicated In the adoes*is 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 Pinal reports will not be accepted If the.' accepted if the data is designated deficiencies of the plan. The company-. - data are designated Confidential -v.. Confidential Business Information (CBI) may request reconsideration of the . Business Information (CBQ 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 the exception of personally Identifiable the final report is contingent upon . discussion on the proposed research ' information on study subjects.,. . . approval by ATSDR following the peer with no obligation of either party. In the Moreover. ATSDR'* acceptance of the . reviewere* IXMmmwiiliHniu, eanhtalult event that the company resubmite a* ' final report will be contingent upon with CERCXA peer review requirements. modified study plan and ATSDR approval by ATSDR following the peer ., '.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 If the study plan is approved by . review requirements. All results ff 'J - pursuant to the MOU and all supporting ATSDR upon die recommendations of research conducted pursuant to the date associated with the final research _ the peerreviewers, the company wiQ MOU and all supporting data associated report will be provided to ATSDR end enter into an MOU with the Agency. The with the research report will be - made available by file Agency to the . content of the MOU is described below: . provided to ATSDR and made available public as pert of its implementation of - (1) Identification of the party or by the Agency to the public as part of its ..section 104(f)(5)ofCTECLA . ' parties comprising the company which Implementation of sections 104(i)(3) and (9) Payments of costs end expenses-- enters into the MOU--This section . (S) of CERCLA. ' -t . -V Each company ehellegree to pey ell consists of the name and address of - -" (5) Modifications of stndy plans, coats, direct and indirect, associated 1 each party responsible for the conduct' guidelines, and schedules--If a company with the research programs. The Agency of the research. intends to modify a study plan, protocol, will assume responsibility for (Z) Identification of the rubstancefs) or schedule that was approved by administrative costs including the cost subject to research requirements under the MOU--This section consists of the name and Chemical Abstract Service (CAS) Number of the chemical substance(s) that is the subject of the ATSDR. it most notify ATSDR in writing of the proposed modifications and reasons therefor. If ATSDR approves of the modifications, the time schedule . established for completion of the teste Of peer review as part of its overall program. - (10) Events constituting s breach of .the MOU--Failure by the company to: (a) Initiate any test agreed to in the MOU. The chemical substance(s) to be tested shall be as pure as reasonably can be attained. However, under certain circumstances. ATSDR recognizes that ft 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, as in epidemiologic studies. - (3) Identification of the effects or characteristics for which research is to be conducted--In this section, the health effects, environmental fate or other shall be re-negotiated and appended to MOU by the date established pursuant the existing MOU. If ATSDR > -totbeMOU: . disapproves tiae company's request and (b) Adhere to GLP standards, the company does not accept ATSDR's " established test procedures or accepted decision to disapprove the modified study plan, tike company may terminate theMOU. (0) Observance of Cood Laboratory - Practices--AH research agreed to In the MOU shall be conducted in accordance with the Cood Laboratory Practice -. ' (CLP) standards codified in 40 CFR part782, to the extent that such GLP standards apply. Should Good - ` practices ofgood science to the extent - that these standards end practices apply;.. . - (e) 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 e breach of the MOU. In be conducted under the MOU shall be Good Epidemiology Practices for , the event of a breech, ATSDR will not listed. Occupational end 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 . .. Chemical Manufacturer Association's . MOU. . -- Reports--The starting date of the' .. . Epidemiology Task Group, journal of research project may be negotiated Occupational Medicine, Volume 33L ~ . depending on the type of research being 1221-1229,1991) be relevant to a - For research completed subsequent to termination of an MOU, or termination 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 the . (7) Inspections--The company shall ATSDR based on ATSDR's approval of approval of the study plan and ensure that authorized employees of ` a study protocol, plan or other aspect of -attendant test protocols, and the signing . ATSDR are permitted, at reasonable the research. of the MOU. Written notification of the times and in a reasonable manner, to (i) (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 U conducting research pursuant to the company, termination by ATSDR is R&S151818 Federal Register / VoL 57. No. 221 / Monday. November 16. 1992 / Notices S4ltiS not considered revieweble agency.."''i: _ - their authority under any other V? - Research Progrant will be used fr -^ action pursuant to the Administrative .provision of law; or the response and r - public health assessment purposes and Procedures Act or any other applicable - abatement authorities of tiKQA.; - ? - -to reassess ATSDR's substance-specific Federal law, end there will be no appeal - As previously stated. EPA is not -'KC - 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 re-evaluate The company may elect to terminate toe potential signatory in MOU negotiations _ (ha priority data needs for the fisted MOU at any time. - arising from this Notice. However, if hazardous substances every three years. , (12) Statutory compliance--Consistent EPA were to pwfidpate, the contents ` * . .. with section 104(i)(i2) of CEROA. as described above would need to be p- - . .. Date* November* im -.-t-:; . - amended (42 U.S.C. 9604(i)(12)), nothing appropriately revised to reflect * * \^ wiffism LRoper. ,u-:. in toe MOU shall be construed to delay commitments made by or to B*A. and' ; Administrator. Agencyfor ToxicSubttonce* ' *7 - . \v- 7 -r-.-. . -**-;: - ^7- - - '-r - -V ~7. . * ` ` ;v -- - *- - =. .. - '' ... .' ' : ' v.? . v? j . r'-' \ - 'v -- 't`? 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