Document kaD2V1Xa5MroNMYyDV0d5LBOO

MEMORANDUM OF UNDERSTANDING FOR VOLUNTARY RESEARCH PROGRAM Under Section 104 (i) (5) of CERCLA An agreement between THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY Division ofToxicology Research Implementation Branch and CHEMICAL MANUFACTURERS ASSOCIATION VINYL CHLORIDE PANEL June 26, 1996 CMA 113314 Table of Contents I. PURPOSE ............................................................................................................... 1 II. IDENTIFICATION OF THE PARTIES TO THIS MEMORANDUM OF UNDERSTANDING ............................................................................................... 2 III. IDENTIFICATION OF THE SUBSTANCE(S) SUBJECT TO RESEARCH REQUIREMENTS UNDER THIS MEMORANDUM OF UNDERSTANDING 2 IV. IDENTIFICATION OF THE EFFECTS OR CHARACTERISTICS FOR WHICH RESEARCH IS BEING CONDUCTED ................................................ 3 V. IDENTIFICATION OF STUDY PLANS AND TESTING PROTOCOLS AGREED TO BY ATSDR AND CMA PRIOR TO SIGNING OF MOU .......... 4 VI. SUBMISSION OF STUDY PLANS AND ESTABLISHMENT OF SCHEDULE FOR INITIATION OF RESEARCH AND SUBMISSION OF INTERIM AND FINAL REPORT............................................................. 4 VII. MODIFICATION OF STUDY PLANS, GUIDELINES, AND SCHEDULES .. 6 VIII. OBSERVANCE OF GOOD LABORATORY PRACTICES .............................. 6 IX. INSPECTIONS ....................................................................................................... 8 X. PAYMENT OF COST AND EXPENSES ............................................................ 8 XI. EVENTS CONSTITUTING A BREACH OF THIS MEMORANDUM OF UNDERSTANDING ................................................. 8 XII. FINAL REPORT - SUBMISSION AND PUBLICATION OF DATA............... 9 XIII. STATUTORY COMPLIANCE ........................................................................... 10 XIV. ADDRESSES ......................................................................................................... 11 XV. SIGNATURES ..................................................................................................... 11 CMA 113315 I. PURPOSE This Memorandum of Understanding (MOU) is entered into by the Agency for Toxic Substances and Disease Registry (ATSDR) and the private sector organization identified in Paragraph II below (hereinafter referred to as "CMA") in order to implement Section 104(i)(5) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA). These Congressional acts direct ATSDR to assure the initiation of a program of research designed to determine the health effects of hazardous substances for which adequate health effects information is not available. In order to facilitate the discharge of ATSDR's responsibilities under Section 104(i)(5) of CERCLA, and in recognition of the fact that CMA represents manufacturers of the hazardous substance(s) that is the subject of this MOU, ATSDR and CMA hereby agree as follows: CMA 113316 II. IDENTIFICATION OF THE PRIVATE SECTOR PARTIES TO THIS MEMORANDUM OF UNDERSTANDING The following trade association is a party to this MOU and, on behalf of the Health Committee of the Vinyl Chloride Panel, shall use its best efforts to ensure that the obligations and undertakings of the member companies under this MOU are discharged and carried out as provided herein: Name and Address of Participant Chemical Manufacturers Association Vinyl Chloride Panel Health Committee 1300 Wilson Boulevard Arlington, VA 22209 III. IDENTIFICATION OF THE SUBSTANCE(S) SUBJECT TO RESEARCH REQUIREMENTS UNDER THIS MEMORANDUM OF UNDERSTANDING The chemical substance that is the subject of this MOU is vinyl chloride (CAS No. 75-01-4). The chemical substance to be tested shall be as pure as reasonably can be attained. However, in certain circumstances, ATSDR recognizes that it may be more desirable to test mixtures or technical grade products. CMA 113317 rv. identification of the effects or characteristics for which RESEARCH IS TO BE CONDUCTED The health effects, environmental fate or other characteristics for which research is to be sponsored and funded by CMA under this MOU are listed below: Reproductive effects -- Inhalation Developmental effects -- Inhalation This research is intended to satisfy the priority data needs for vinyl chloride identified by ATSDR and the Environmental Protection Agency, as described at 59 Fed.Reg. 49934 (Sept. 30, 1994). ATSDR believes that the proposed research agenda addresses the Agency's priority data needs for vinyl chloride as follows: ATSDR has identified a priority data need for a multi-generation reproductive toxicity study by the inhalation pathway. The results of the attached study plan and protocol should meet this data need. ATSDR has identified a priority data need for a two-species developmental toxicity study by the inhalation pathway. The results of the attached study plan and protocol should meet this data need. -3;. CMA 113318 V. IDENTIFICATION OF STUDY PLANS AND T2STING PROTOCOLS AGREED TO BY ATSDR AND CMA PRIOR TO SIGNING OF MOl The research to be conducted on vinyl chloride pursuant to this MOU is described in detail in the study plan and the protocol Vinyl Chloride: Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats that was agreed to by ATSDR and CMA (Attachment 1 to this MOU). CMA agrees to sponsor and fund the performance of the research identified in Attachment 1 in accordance with the guidelines and schedules established pursuant to the study plan and testing protocols. VI. SUBMISSION OF STUDY PLANS AND ESTABLISHMENT OF SCHEDULE FOR INITIATION OF RESEARCH AND SUBMISSION OF INTERIM AND FINAL REPORT A. Prior to signing of this MOU, CMA shall have submitted to ATSDR the study plan and protocol for each test that is to be conducted pursuant to this MOU (see Attachment 1). B. Prior to entering into this MOU, the testing protocols and guidelines shall have been reviewed by an ATSDR-appointed peer review panel. Consistent with CERCLA Section 104(i)( 13), the peer review panel will consist of no fewer than three nor more than seven peer reviewers who (a) are selected by the Administrator of ATSDR; (b) are disinterested scientific experts; (c) have a reputation for scientific objectivity; and (d) lack institutional ties with any person involved in the conduct of the study under review. -4-. CMA 113319 C. The study shall be initiated within 8 weeks of the date on which ATSDR and CMA have signed this MOU. Written notification of the starting date of the test will be submitted to ATSDR by CMA. The completion date of the study will be established from the approved study plan. D. Unless modified pursuant to Paragraph VII, a final draft report on the results of testing conducted pursuant to the approved study plan and signed into agreement under this MOU shall be submitted to ATSDR within 26 weeks of the end of the study for ATSDR's peer review, consistent with CERCLA Section 104(i)(13). Following acceptance by ATSDR, upon recommendation by the peer review panel, CMA will submit a final report of the study to ATSDR within 6 weeks. Final reports will not be accepted if the data is designated Confidential Business Information (CBI) or otherwise restricted from public disclosure, with the exception of personally identifiable information on study subjects. E. Unless modified pursuant to Paragraph VII, interim progress reports on each testing program conducted pursuant to a study plan approved by ATSDR under this MOU shall be submitted to ATSDR within 6 months after the initiation of testing and, thereafter, within 6 months after the submission of each previous interim report. If the study is scheduled to be completed in one year, an interim brief letter addressing the status of the research must be submitted to ATSDR within 6 months of the initiation of the study. CMA 113320 VII. MODIFICATION OF STUDY PLANS, GUIDELINES, AND SCHEDULES A. If CMA seeks to modify a study plan, guidelines, or schedules that have been approved by ATSDR pursuant to this MOU, CMA shall notify ATSDR in writing of the proposed modifications and the reasons therefor. ATSDR shall respond in writing to the proposed modifications within 2 to 6 weeks either: (i) approving the modifications as proposed, (ii) approving the modifications as revised by ATSDR, or (iii) disapproving the modifications entirely. If ATSDR does not approve the modifications as proposed, CMA will have 2 weeks within which to: (i) accept ATSDR's decision and proceed in accordance therewith, (ii) request that ATSDR reconsider its decision, or (iii) withdraw from the MOU. ATSDR will respond to a request for reconsideration within 2 weeks (see Figure 1). B. If CMA submits a request for modification to ATSDR pursuant to Paragraph VII. A., the time schedule established for completion of these tests shall be extended by the length of time required by ATSDR and CMA to respond to and approve the modifications. VIII. OBSERVANCE OF GOOD LABORATORY PRACTICES CMA shall require its contractors) to conduct all research agreed to in this MOU in accordance with the EPA Good Laboratory Practice (GLP) standards codified in 40 C.F.R. Part 792, Subparts B, C, D, E, F, G, J, and L, to the extent that such GLP standards apply. Should Good Epidemiology Practices ("e.g., Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research" -- The Chemical Manufacturers Association's - 6 : CMA 113321 Epidemiology Task Group, Journal of Occupational Medicine. 33: 1221-29 (1991)) be relevant to a research project, those Practices should be affixed to the study plan. IX. INSPECTIONS CMA shall ensure that an authorized employee or duly designated representative of ATSDR is permitted, at reasonable times and in a reasonable manner, to (i) inspect any research or testing facility that is conducting research pursuant to this 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 this MOU. X. PAYMENT OF COST AND EXPENSES CMA agrees to pay all costs, direct and indirect, associated with the research program. ATSDR will assume responsibility for administrative costs including the cost of peer review as part of its overall program. XI. EVENTS CONSTITUTING A BREACH OF THIS MEMORANDUM OF UNDERSTANDING Failure by CMA to: i) initiate any test agreed to in the approved study plan appended to this MOU by the date established pursuant to the study plan; *8; CMA 113322 ii) adhere to GLP's or established test procedures to the extent that these standards apply; iii) submit any interim report required under this MOU by the date established pursuant to this MOU; or iv) submit any final report which receives ATSDR's approval following the peer reviewers' recommendations shall constitute a breach of this 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. Since this MOU is entered into voluntarily by both parties, termination by ATSDR is not considered reviewable agency action pursuant to the Administrative Procedure Act or any other applicable federal law, and there will be no appeal process beyond that set out in the agreement or otherwise mutually agreed to by the parties. XII. FINAL REPORT - SUBMISSION AND PUBLICATION OF DATA All data and reports submitted to ATSDR pursuant to this MOU shall be sent to ATSDR, in duplicate, at the address indicated in Paragraph XIV below. Acceptance of the final report is contingent upon approval by ATSDR following the peer review panel's recommendations, consistent with CERCLA peer review requirements. CMA maintains all rights of ownership and publication of data and results, however all results of research conducted pursuant to this MOU and all supporting data associated with the final research report will be made available by -9;. CMA 113323 ATSDR to the public as part of its implementation of Section 104(i)(5) of CERCLA. The final report will not be accepted if the data is designated Confidential Business Information (CBI) or otherwise restricted from public disclosure with the exception of personally identifiable information on study subjects. XIII. STATUTORY COMPLIANCE Nothing in this MOU shall be construed to delay or otherwise affect or impair the authority of the President, the Administrator ofATSDR, of the Administrator of EPA to exercise any authority of the President, the Administrator of ATSDR, or the Administrator of EPA under any other provision of law, including TSCA and FIFRA, or the response and abatement authorities of CERCLA. CMA 113324 XIV. ADDRESSES Any notifications, reports, or other written statements required to be submitted or sent to a part> to this MOU shall be sent by certified mail to the parties at the following addresses: Agency for Toxic Substances and Disease Registry Division of Toxicology, Research Implementation Branch Mail Stop E-29 1600 Clifton Road, N.E. Atlanta. GA 30333 Attention: Dr. William Cibulas Chemical Manufacturers Association Vinyl Chloride Panel Health Committee 1300 Wilson Boulevard Arlington, VA 22209 Attention: Dr. Hasmukh C. Shah Date: XV. SIGNATURES Agency for Toxic Substances and Disease Registry By: Typed Name: Title: 168368 Title: Controller -11 CMA113325