Document 06Y2w9E8R9Nk14DNnZwQVrDbx

54160 ` Federal Register / VoL 17,' No. tZl/ Monday, Novembe 16, .1992 / Notices - r DEPARTMENT OF HEALTH AND r' Foa rjuthea information contact:Jr': manufacturers and processors of die j HUMAN SERVICES : . ,; 'iT Dr. Wiliiam Cibola*. Division of ; : >.. hazardous substances under the Toxic ,1 J * F ,,V;,, Toxicology. Research Implementation, Substances Control Act (TSCA) and ":<* Agency for Toxic Substances and BrandL Agency for Toxic Sub*tancee ' registrants under the Federal - Disease Registry ;*ndD!ea*e'Registry,Maflst0pE-28, K 1 Insecticide. Fungicide, and Rodentidde ` [ATSDA-4U , r: ,7*9. J. -1800 Clifton Road NR. Atlanta, Georgia Act (FIFRA), or by cost recovery from _J* *, v- ; 30333, telephone 404-639-6306. r responsible parties under CERCLA. . . Furthermore, section 104(i)(5)(C) states - Reviaed Procedures For Conducting SUPPLEMENTARY MPORMA7MMC. that in developing and implementing the Voluntary Research ; Background,: ' research program, the Administrator of ATSDR and the Administrator of EPA ; aocncy: Agency for Toxic Substances ~ _The Comprehensive Environmental; and Disease Registry (ATSDR). Public . Response, Compensation, and Liability Health Service (PHS), Department of . ' Act of 1980 (CBtCLA). as amended by - Health and Human Services (HHSJ. V the Superfund Amendments and Reauthorization Act of 1988 (SARA) (42 acnore Notice. U.S.C. #004(1]), requires that ATSDR: (1) shall coordinate such program with the. ~ National Toxicology Program (NTP) and. .with programs of toxicological testing ^ established under TSCA and FIFRA, T achieve this coordination, ATSDR - - -L established the TTiagency Superfund > summary: This* notice announce* the revised procedures for volunteering to * conduct research as part of the ATSDR Substance-Specific Applied Research Program authorized by the- . Comprehensive Environmental Response. Compensation, and Liability Act (CERCLA or Superfund), as . 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 ,- > 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. Thie notice describes the revised procedures. Develop jointly with the Environmental. Protection Agency (ERA) e list of - ' hazardous substances found at National' Priorities List (NPL) sites fin order of . priority), (2) prepare toxicological profile* of these substances, and (3) assure the initiation of e research , , program to fill identified data needs associated with the substances.. The identification of the priority data needs for 38 priority hazardous substance* was described in the Federal Register (58 FR 52178. October 17,1991), public comments were invited, and companies were requested to volunteer to conduct research to fill specific , priority data needs during the public ' ' comment period for that notice. The Federal Register notice, "Announcement of Final Priority Date Needs for 38 Priority Hazardous Substances", which includes a second call for private sector .Applied Research Committee (TASARC) a# a forum for ATSDR. EPA and NTP to discuss and coordinate use of potential mechanisms for developing end implementing this CERCLA SubstanceSpecific Applied Research Program. Meetings of the TASARC ere not open to the public. The first meeting of TASARC was held on April 20,1992. to inform the Committee on the Agency's progress in implementing the SubstanceSpecific Applied Research Program, and to seek the Committee's input in planning for the Agency's public meeting on voluntary research held on April 29, 1992. 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 DATES: The ATSDR considers this voluntary research effort to be of ' voluntarism, is being published in this issue of the Federal Register. Future procedures for conducting voluntary 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 end announced in Applied Research Program. Therefore, volunteered to fill specific priority date the Federal Register on February 7.1992 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 concerns within some segments of the public regarding voluntary research conducted by companies with vested ... Program is to supplement the substance- interests in tire research. Therefore, the addresses: Comments on this notice . should bear the docket control number ATSDR-61 and should be submitted to the Division of Toxicology, Research specific information needs of the public and scientific community, and to eupply . necessary information for conducting comprehensive public health Agency encouraged the public to , comment on ATSDR'* procedure for conducting voluntary research. Additionally, for each research project Implementation Branch, Agency for . assessments for populations living in the Toxic Substances and Disease Registry,. vicinity of hazardous waste sites. This ' Mailstop E-29,1600 Clifton Road NR, - program will also provide dafTthat can Atlanta. Georgia 30333. Requests for e be generalized to other substances or copy of the model Memorandum of -areas of science, including risk conducted voluntarily, the MOU (signed by ATSDR end the interested company), the ATSDR approved study plan, peer reviewer's comments, and the final research report and supporting data will Understanding should be addressed - similarly. , assessments of chemicals, thus creating be available for public Inspection at the a scientific base for filling a broader ,- location and times indicated in the Comments on this notice will be available for public inspection at the - range of data needs. ^ , *- .. . ADDRESSES section of this notice. 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 (not a mailing address), from 8 a.m. until CERCLA, as amended in section l04(i)(5)(D), states that it is the sense of necessitates peer review of study ' protocols and results consistent with 4:30 pm., Monday through Friday,- , Congress that the costs 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 * CMA 113701 Federal Register f Vol. S7,'Na22l / Monday, NovemWr 16. 1992 f Notices 54161 s.-. . , \- of three to seven peer reviewers who (*) ' The Agency it cognizant of the private frivate sector organizations (companies! ere selected by the Administrator of -sector's concern that EPA may require -' interested in volunteering to conduct - ATSDR, (b) are disinterested scientific Industry testing during or following a" ~r ' 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) lade which may be regarded as duplicative of brief statement that addresses the institutional ties with any person that effort There are several safeguards priority date need(s) 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 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 and the private sector the interested company should indicate procedures for voluntary research. *-- ; and avoid unnecessary or duplicative ^ when innovative protocols are being Comments were received from industry testing. This coordination occurs at proposed.Interested companies may '' groups, environmental groups and 'V many points; the review of ATSDR'e address substance-specific data needa Federal agencies. As a result of 'l'*''. 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 under ATSDR's " lenerallzed to other areas of science. It major revisions and clarification of the f voluntary research program. EP^ .should be noted that all voluntary.. .. procedure* 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. 69-544. 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 ._ Human Subjects (45 CFR part 46).. the Agency as originally indicated, in determine or predict the effects of a V . 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 TASARC'S recommendations. ATSDR MOU after the study plan has been require duplicative testing. As a matter will determine white, 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 tide 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 with the interested company. protocols and results as mandated under under an industry/ATSDR MOU will If ATSDR decides to pursue a specific CERCLA However, to the extent that yield results which indicate additional voluntary research project submitted by research protocols entail accepted teat 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 FIFRA or by organizations such as the* address the endpoint of concern 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 1 with ATSDR prior to initiation of the will be taken as a last resort, and that Information. If the company finds that research. *- - prior to such an action, all possible - * . such research is impossible to conduct 1 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, ~ into discussions of alternative solution!, 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 tests 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 wilt Bssume 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 wrill be - / ^ ; including the cost of peer review ae part company will negotiate with ATSDR to negotiated with the private sector *:> of its overall program. -*' *. t *-> v r*- agree upon an approved study plan organization in the spirit of mutual * ^ - The procedures for conducting including testing protocols and time " cooperation. - `e-; > - voluntary research are described below. schedules.-.- - ** - ...... * CMA113702 S41B2 Federal Raster / Vet S7. ffo. 221 / Monday. -November 16.1882 / Noboaa Tbs company shall submit to ATSDR - The testing schedule and completion v-y the MOU. and (ii) inspect (and in the s study plan lor each test six Meeks date of the study wifi be established case of records, copy) any records and slier submitting the Letter of Intent. The -from the approved study plan. Interim^,j ' spedman* required to be ssamtatead to study {dsn shall Include test protocols progress reports shall be submitted to connection with research performed . l and a schedule with reasonable ATSDR within six months after the pursuant to the MOU. - \ r-. timetable and deadlines for initiation Initiation of testing and 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 of interim and final reports. previous interim report The final report ATSDR pursuant to the MOU shall be ,Tbe test protocols will be reviewed by on the results of testing shall be sent to ATSDR. to duplicate, at the - an ATSDR-appointed peer review penal. submitted to ATSDR no more than 20 address indicated in the Aoosusa 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 (be Final reports wul not be accepted lithe accepted if the date is designated deficiencies of the plan. The company data are designated Confidential Confidential Business Information (CBQ may request reconsideration of the Business Information [CBQQ 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, to the Moreover, ATSDR't acceptance of the reviewers* recommendations, consistent event that the company resubmits a ' *= final report will be contingent upon with CERCTA peer review requirements. modified study plan and ATSDR . approval by ATSDR following the peer '.The company maintsins ell rights to disapproves it, the Agency may elect to reviewers* recommendations, consistent publication of data and results, however teiminete further discussion. : with CERCLA section 104(0(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 the recommendations of research conducted pursuant to the . date associated with the final research . the peerreviewers, the company will MOU and all supporting data assodated report will be provided to ATSDR end enter into an MOU with the Agency. The with the research report will be - -made available by the Agency to the Scontent of the MOU is described below: (1) Identification of the parly or rovided to ATSDR and made available public as part of its implementation of y the Agency to the public as part of its section 104(f)(5) of CERCLA. . parties comprising the company which enters into the MOU--This section consists of the name and address of implementation of sections 104(0(3} and (9) Payments of cost* and expense* - (S) of CERCLA. Each company shall agree to pay all costs, direct and indirect, associated each party responsible for the conduct of the research. (2) Identification of the subetancefs) 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 ia the subject of the MOU. The chemical substance(s) to be tested shall be as pure as reasonably can be attained. However, under certain drcumstances. ATSDR recognize* that It may be more desirable to test mixtures or technical grade product!. Furthermore, alternate language will be guidelines, and schedules--If a company intends to modify e study plan, protocol, or schedule that was approved by ATSDR, it must notify ATSDR in writing of the proposed modifications and reasons therefor. If ATSDR approves of die modifications, the time schedule established for completion of the tests shall be renegotiated end appended to the existing MOU. tf ATSDR disapproves die company's request and the company doe* not accept ATSDR's decision to disapprove die modified study plan, the company may terminate the MOU. - with the research programs. The Agency wifi assume responsibility for administrative costs including the coat of peer review ae part of its overall program. - (10) Events constituting a breach of the MOU--Failure by the company to: (a) Initiate any test agreed to to the MOU by the date established pursuant to the MOU; . . (bj Adhere to GLP standards, established test procedures or accepted practice* ofgood science to the extent that these standards and practices substituted when the subject of the research ia s human population, es to epidemiologic studies. (3) Identification of the effecta or characteristics for which research ia to be conducted--to this section, the health effects, environmental fate or other (6) Observance of Good Laboratory Practical All research agreed to to tbe MOU shall be conducted in eocordanoe with the Good Laboratory Practice (GLP) standard* codified in 40 CFR part 792, to tbe extent that such GLP standards apply. Should Good - " ` 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 1 peer review conducted by the Agency, characteristics for which research is to Epidemiology Practices ("Guidelines for shall constitute a breach of the MOU. to be conducted under the MOU shall be Good Epidemiology Practices for the event of breach. ATSDR will not listed Occupational and Environmental impose any claim to damage*, but at tbe (4) Initiation of Research end Epidemiologic Research"--The ' Agency's discretion may terminate the Submission of Interim and Final Chemical Manufacturer Association'* MOU. , Reporta--The starting date of tbe' - Epidemiology Task Group, Journal of For research completed subsequent to research project may be negotiated . Occupational Medicine. Volume 3& '. 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 s 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 ofthe times and in a reasonable manner, to (i) (11) Termination--Since the MOU ie 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 ia conducting research pursuant to tbe company, termination by ATSDR ia CMA113703 Federal Register /VI. 57, No. 221 / Monday, November 16. 1992 / Notices 54163 not considered reviewable agency/' . . their authority under any other c^ Research Program will be used for - action pursuant to the Administrative provision of law; or the response and public health assessment purposes end Procedures Act or any other applicable - abatement authorities of CERCLA.: - "'2 to reassess ATSDR's substance-specific Federal law, and there will be no appeal - As previously stated, EPA is not - priority data need*. 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 the potential signatory tn MOU negotiations the priority data needa for the listed MOU at any time. . (lz) Statutory compliance--Consistent with section 104(i)(12) of CERCLA. as amended (42 U.S.C. 9004(i)(12)), nothing arising from this Notice. However, if EPA were to participate, the contents described above would need to be v appropriately revised to reflect * " / \ hazardous substances every three years. Dated: Novembers, Mt William L Ropar*. - in the MOU shall be construed to delay commitments made by or to EPA, and Adminietralor, Agencyfor Toxic Subttancet or otherwise affect or impair die 5a' - "*- other matters deemed appropriate by - ' one Dinar*Regietry. authority of the President,ihe theparties/1" '>*. . r- . "V (FR Doc. 92-27034 Hied 11-13-02 8:45 am) Administrator of ATSDR or the The results of the'research viathis ; Administrator of EPA to exercise any of .ATSDR Substance-Specific Applied ~i ^v.;V ~ . .- ^ >x` >. .*. ** * p . * t. t, '* . Virf * . .- ,, -a *- . w <-r' . v-.V- -;?' CMa 113704