Document x5MRgqBe1JJ6kx9wyzxoQ1oxQ

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry Atlanta GA 30333 li'M 2 3 [925 Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel Chemical Manufacturers Association 2501 M Street, N.W. Washington, DC 20037 rre~crreciv.'efrd\ Dear Dr. Shah: This is in response to your November 28 letter regarding the intent of the Chemical Manufacturers Association (CMA) Vinyl Chloride Panel to address vinyl chloride data needs identified by the Agency for Toxic Substances and Disease Registry (ATSDR). We have discussed your letter with Dr. Auer and his staff at the Environmental Protection Agency (EPA) . ATSDR and EPA will continue to coordinate all voluntary research interests concerning chemicals identified in the September 30 notice (59 FR 49934) . We are pleased that CMA is interested in conducting voluntary research to address ATSDR's data needs for vinyl chloride. In your letter, you indicated that a Memorandum of Understanding (MOU) to address these data needs will be executed by May 31, 1995. Also, you suggested that CMA and ATSDR scientists meet to discuss the design of a two-generation reproductive study by the inhalation route, however, we request that CMA take the lead role in developing the study protocol. Consistent with ATSDR's published procedures for conducting voluntary research (57 FR 54160), we ask that CMA submit a study protocol to be reviewed by Agency scientists and a panel of peer reviewers selected by the Associate Administrator for Science, ATSDR. At that time, it would be appropriate for the Agency to discuss the study plan with CMA including study protocol and time schedule. The Agency and CMA may then choose to enter into an MOU after agreeing upon an approved study plan. A copy of the Federal Register notice describing these procedures is enclosed for your information. With regard to ATSDR's data need for a 2-species developmental toxicity study via inhalation, please clarify the statement in your letter concerning the existing 2-species developmental study and other available developmental toxicity data. Specifically, we would like to know how such studies "might be R&S 152232 Page 2 - Hasmukh C. Shah, Ph.D. enhanced to include measures of developmental toxicity as an alternative to the two-species developmental toxicity referred to EPA." We look forward to our continuing dialogue with CMA leading to the signing of an MOU to conduct research to address ATSDR's data needs for vinyl chloride. If you have any questions, please contact me at 404-639-6300* Sincerely yours. Enclosure cc: Dr. Charles.Auer Christopher T. DeRosa, Ph.D, Director, Division of Toxicology R&S152233 34160 Federal Register / Vol. 57. No. 221 / Monday. November 16. 1992 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency tor Toxic Substances and Oisease Registry [ATSOR-611 FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas. Division of Toxicology. Research Implementation Branch. Agency for Toxic Substances and Disease Registry. Mailstop E-29. 1600 Clifton Road NE-. Atlanta. Ceorgia 30333. telephone 404-639-6306. Revised Procedures For Conducting Voluntary Research SUPPLEMENTARY INFORMATION: Background agency: Agency for Toxic Substances and Disease Registry (ATSDR). Public Health Service (PHS), Department of Health and Human Services (HHS). action: Notice. The Comprehensive Environmental Response. Compensation, and liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) (42 U-S.C. 9604(i}). requires that ATSDR: (1) summary: This Dotice announces 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. This notice describes the revised procedures. Oates: The ATSDR considers this voluntary research effort to be of significant importance to the continuing Develop jointly with the Environmental Protection Agency (EPA) a list of hazardous substances found at National Priorities List (NPL) sites (in order of priority), (2) prepare toxicological profiles of these substances, and (3) assure the initiation of a research program to fill identified data needs associated with the substances. 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 data 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 voluntarism, is being published in this issue of the Federal Register. Future Federal Register notices will announce development of the Substance-Specific ' the names of companies that have Applied Research Program. Therefore, volunteered to fill specific priority data public comments concerning this needs. 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 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 ME.. program will also provide data that can Atlanta. Georgia 30333. Requests for a be generalized to other substances 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 Comments on this notice will be range of data needs. available for public inspection at the Agency for Toxic Substances and Procedure for Conducting Voluntary Disease Registry. Building 4, Suite 2400. Research Executive Park Drive. Atlanta. Georgia (not a mailing address), from 8 a.m. until 4:30 p.m.. Monday through Friday, except for legal holidays. CERCLA. as amended in section i04(i)(5](D). states that it is the sense of Congress that the costs for conducting this research program be borne by the manufacturers and processors of the hazardous substances under the Toxic Substances Control Act (TSCA) and registrants under the Federal Insecticide. Fungicide, and Rodenticide Act (FIFRA). or by cost recovery from responsible parties under CERCLA. Furthermore, section lW(i)(5)(C) states that in developing and implementing the research program, the Administrator of ATSDR and the Administrator of EPA shall coordinate such program with the National Toxicology Program (NTP) and with programs of toxicological testing established under TSCA aDd FTFRA. To achieve this coordination, ATSDR established the Triageacy Superfund Applied Research Committee (TASARC) as a forum for ATSDR. EPA. and NTP to discuss and coordinate use of potential mechanisms for developing and implementing this CERCLA SubstanceSpecific Applied Research Program. Meetings of the TASARC are 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 idendfied in the Agency's Substance-Specific Applied Research Program. Toward that end. the procedures for conducting voluntary research, and the attendant Memorandum of Understanding, were developed by ATSDR and announced in the Federal Register on February 7.1992 (57 FR 4758). The Agency is aware of concents 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 comment on ATSDR's procedure for conducting voluntary research. Additionally, for each research project 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. ATSDR intends to enter into voluntary research projects in ways that lead only to high quality scientific work. This necessitates peer review of study prot cols and results consistent with CERCLA section 104(i)(13). CERCLA requires the peer review panel to consist R&S 152234 Federal Register / Vol. 57. No. 221 / Monday. November 16. 1992 / Notices 54161 P(three to seven peer reviewers who (a) The Agency is cognizant of the private Private sector organizations (companies) are 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 research on priority data needs are experts, (c) have a reputation tor voluntary research effort with ATSDR asked to submit to ATSDR. in writing, a scientific objectivity, and (d) lack which may be regarded as duplicative of brief statement that addresses the institutional ties with any person that effort. There are several safeguards priority data need(s) to be filled and the involved tn 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 many points: the review of ATSDR's address substance-specific data needs Federal agencies. As a result of 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 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 89-344. as amended. company, rather than to have the MOD 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 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 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 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 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 Organization for Economic Cooperation In these cases. EPA may exercise its company's statement. The Letter of and Development (OECD), less ngorous 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 review process will not supersede the It is generally the policy of ATSDR to ATSDR regarding the research plan to 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-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 Lntent will state that if the With respect to potential termination conducted under this program should be research plan is approved by ATSDR. of the MOD 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 that Information- If the company finds that research. 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, into discussions of alternative solutions, interested firms may elect to enter into within reasonable limits. However, decisions as to what constitutes a or may choose to terminate negotiations. collaborative efforts in pursuing one or Finally, in reference to research costs, more research projects, therefore, where breach of the MOU will be at the the direct and indirect costs 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 conducting research-.unexpected and unanticipated delays may occur and wherever possible this will be negotiated wtth the private sector organization m the spirit of mutual cooperation. incurred by the research sponsor and not by ATSDR. The Agency will assume responsibility for administrative costs including the cost of peer review as part of its overall program. The procedures for conducting voluntary research are described below. companies. Following the submission of the Letter of Intent and prior to the initiation of the research, the interested company will negotiate with ATSDR to agree upon an approved study plan including testing protocols and time schedules. R & S 152235 54-162 Federal Register / Vol. 57. No. 221 / Monday. November 16. 1992 / Notices The company snail submit to ATSDR a study plan for each test six weeks after submitting the Letter of Intent. The study plan shall include test protocols and a schedule with reasonable timetable and deadlines for initiation and completion of each test and submission of interim and final reports. The test protocols will be reviewed by an ATSDR-appointed peer review panel. If ATSDR disapproves the study plan, it will inform the company of the deficiencies of the plan. The company may request reconsideration of the study plan, resubmit a modified study plan, or eiect to terminate further discussion on the proposed research with no obligation of either party. In the event that the company resubmits a modified study plan and ATSDR disapproves it, the Agency may elect to terminate further discussion. If the study plan is approved by ATSDR upon the recommendations of the peer reviewers, die company will enter into an MOU with the Agency. The content of the MOU is described below; (1) Identification of the party or parties comprising the company which enters into the MOU--This section consists of the name and address of each party responsible for the conduct of the research. (2) Identification of the cubstance(s) subject to research requirements under the MOU--This section consists of the name and Chemical Abstract Service (CAS) Number of the chemical subs tance(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 that 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, 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 characteristics for which research is to be conducted under the MOU shall be listed. (4) Initiation of Research and Submission of Interim and Final Reports--The starting date of the research project may be negotiated depending on the type of research being conducted. However, as a general guideline, the research effort shall be initiated within eight weeks of the approval of the study plan and attendant test protocols, and the signing of the MOU. Written notification of the starting date of the test will be submitted to ATSDR by the company. The testing schedule and completion date of the study will be established from the approved study plan. Interim progress reports shall be submitted to ATSDR within six months after the initiation of testing and thereafter within six months after submission of each previous interim report. The final report an the results of testing shall be submitted to ATSDR no more than 20 weeks following the end of the study. Final reports will not be accepted if the data are designated Confidential Business Information (CBI) or otherwise restricted from public disclosure, with the exception of personally identifiable information on study subjects. Moreover. ATSDR's acceptance of the final report will be contingent upon approval by ATSDR following the peer reviewers' recommendations, consistent with CERCLA section 104(11(13) peer review requirements. All results of research conducted pursuant to the MOU and all supporting data associated with the research report will be provided to ATSDR and made available by the Agency to the public as part of its implementation of sections 104(iJ(3) and (5) of CERCLA. (5) Modifications of study plans, guidelines, and schedules--If a company intends to modify a 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 the modifications, the time schedule established for completion of the tests shall be re-negotiated and appended to the existing MOU. If ATSDR disapproves the company's request and the company does not accept ATSDR's decision to disapprove the modified study plan, the company may terminate the MOU. (8) 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 792. to the extent that such GLP standards apply. Should Good Epidemiology Practices ("Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research"--The Chemical Manufacturer Association's Epidemiology Task Group, journal of Occupational Medicine, Volume 33, 1221-1229,1991) be relevant to a research project, those Practices should be affixed to the study protocoL (7) Inspections--The company shall ensure that authorized employees of ATSDR are permitted, at reasonable times and in a reasonable manner, to (i) inspect any research or testing facilities that is conducting research pursuant to the MOU. and (ii) inspect (and in the case of records, copy) any records and specimens required to be maintained in connection with research performed pursuant to the MOU. (8) Submission and publication^ data--All data and reports submitted to ATSDR pursuant to the MOU shall be sent to ATSDR. in duplicate, at the address indicated in the addresses section. Final reports will not be accepted if the data is designated Confidential Business Information (CBI) or otherwise restricted from public disclosure. Furthermore, acceptance of the final report is contingent upon approval by ATSDR fallowing the peer reviewers' recommendations, consistent with CERCLA peer review requirements. The company maintains all rights to publication of data and results, however ail results of research conducted pursuant to the MOU and all supporting data associated with the final research report will be provided to ATSDR and made available by the Agency to the public as part of its implementation of section 3.04(11(5) of CERCLA. (9) Payments of costs and expenses-- Each company shall agree to pay all costs, direct and indirect, associated with the research programs. The Agency will assume responsibility for administrative costs including the cost of peer review as part of its overall program. (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 GLP standards, established test procedures or accepted practices of good science to the extent that these standards and practices apply: (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, shall constitute a breach of the MOU. In the event of a breach. ATSDR will not impose any claim to damages, but at the Agency's discretion may terminate the MOU. For research completed subsequent to termination of an MOU. or termination of negotiations in anticipation of an MOU, companies may not represent endorsement of such research by ATSDR based on ATSDR's approval of a study protocoL plan or other aspect of the research. (11) Termination--Since the MOU is entered into voluntarily by ATSDR and the company, termination by ATSDR is R&S152236 Federal Register / Vol. 57. No. 221 / Monday. November 16. 1992 / Notices 54163 not considered reviewable agency their authority under any other action pursuant to the Administrative provision of law. or the response and Procedures Act or any other applicable abatement authorities of CERCLA. Federal law. and there will be no appeal As previously stated. EPA is not process beyond that set out in the MOU. currently planning to participate as a The company may elect to terminate the potential signatory in MOU negotiations MOU at any time. arising from this Notice. However, if (12) Statutory compliance--Consistent EPA were to participate, the contents with section 104(i](lZ) of CERCLA. as described above would need to be amended (42 U.S.C. 9604(i)(12)). nothing appropriately revised to reflect in the MOU shall be construed to delay commitments made by or to EPA. and or otherwise affect or impair the other matters deemed appropriate by authority' of the President the the parties. Administrator of ATSDR or the The results of the research via this Administrator of EPA to exercise any of ATSDR Substance-Specific Applied Research Program will be used for public health assessment purposes and to reassess ATSDR's substance-specific priority data needs. It is the intention of the Agency, at this time, to re-evaluate the priority data needs for the listed hazardous substances every three years. Dated: November 6.1992. William L. Roper. Administrator; Agencyfor Toxic Substances and Disease Registry. [FR Doc. 82-27639 Filed 11-13-92; 8:45 am| SILLIHO COOC 41*0-70-*! R&S152237