Document VJKYJdG0a7zbVxr8eBMg5L3kw

VINYL CHLORIDE HEALTH COMMITTEE PROPOSED 1995 PROGRAM Epidemiology Study Update Otto Wong ^ (1 KenMundt 3 50 (. [Synthesis of ,3C-vinyl chloride Q UNC Research Program O ENSR Data Transfer Cost <2.0 |C; Dow Monitoring Cost 3 t) Outside Counsel for TSCA Section 4 Rule 3 ^ cpiuenuuiugy Contract negotiations Work with ENSR for data transfer Contract management James Swenbeig Research program TSCA ATSDR communication EPA negotiations Risk Assessment Consultant Risk assessment workshop Agency and contractor communication Modification of Heast Table Contingency no R&S146698 ^4 o c ct Qyf\ 3 o tO f-or (v\_o5<5--' 6rtJsx<jK tfeP U^e^v(cJoe-- 13s~ 2 773 i'll 0 \, MOO \l 2-6 ^ 2, (><30 SiO \cJZTO n,97* / 6'7Hiqtfg I^SG /a 01 V oZ tZ-7S i>or e>s% 7'Zt |00-<VO R&S146699 /Budget $ y/400,000 V/' 30,000 60,000 / 10,000 ^ -IDOyCOO * t ^ \ ^jjS-y^tTD $ 625,000 Vinyl Chloride Health Committee Proposed 1994-1995 Budget Activity (Explanation Attached) Epidemiology Study Update Contractor Cost - $ 350,000 ENSR Data Transfer Cost - $20,000 ik' 'P. -7\ f'' j '/ f 3*V Dow Chemical's Monitoring Cost - $30,000 .o./ \ J Outside Counsel for TSCA Section 4 Prop. Rule The estimated cost of the EPA recommended testing program is $850,000. University of North Carolina Research Program Synthesis of 13C-vinyl chloride - $10,000 Determination of Half-Life of Etheno-Adducts in Animals & Determination of P-450 in Human Tissues at Diff, Ages - $50,000 _ Vinyl Chloride Risk Assessment Consultant for Modification of the Heast Table (R. Reitz) Consultant to Demonstrate a Biological Threshold for Vinyl Chloride Induced Liver Angiosarcoma and Absence of Cause-Effect Relationship Between Vinyl Chloride and Brain Cancers (C. Tamburo) International Workshop to be Sponsored by the Vinyl Chloride Panel to Assess Available Scientific Information and Review Work in Progress or Planned to Assess Vinyl Chloride Risk Administration Direct Time Oct.1994 - Dec.1995 - $90,000 (Based on Estimated Level of Effort of Four Days/Month) Travel and Miscellaneous - $10,000 Contingency TOTAL R&S146700 ' ~ y 75 1 P 'Y' C-j ff l 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 of Toxicology Research Implementation Branch and (Name ef Participating-Company) CHEMICAL MANUFACTURERS ASSOCIATION VINYL CHLORIDE PANEL (Bate of-signing this-Memorandum of Undefstanding) November 1995 R&S 146702 Table of Contents I. PURPOSE ............................................................................................................... 1 i II. IDENTIFICATION OF THE COMPANIES THAT ARE 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 TO BE CONDUCTED ................................................ 3 V. IDENTIFICATION OF STUDY PLANS AND TESTING PROTOCOLS AGREED TO BY ATSDR AND CMA THE COMPANY PRIOR TO SIGNING OF MOU ........................................................................................................ 3,4,5 VI. | SUBMISSION OF STUDY PLANS AND ESTABLISHMENT OF SCHEDULE FOR INITIATION OF RESEARCH AND SUBMISSION OF INTERIM AND FINAL REPORT............................................................. $6, 7 | VII. MODIFICATION OF STUDY PLANS, GUIDELINES, AND SCHEDULES . 18 | VIII. OBSERVANCE OF GOOD LABORATORY PRACTICES ............................. 18 IX. INSPECTIONS ...................................................................................................... 9 X. PAYMENT OF COST AND EXPENSES ............................................................ 9 XI. EVENTS CONSTITUTING A BREACH OF THIS MEMORANDUM OF UNDERSTANDING ............................................................................................ 10 XII. FINAL REPORT - SUBMISSION AND PUBLICATION OF DATA.............. 11 XIII. STATUTORY COMPLIANCE .......................................................................... 11 XIV. ADDRESSES ........................................................................................................ 12 XV. SIGNATURES .................................................................................................... 12 j Appendix 1 ............................................................................................ 13 R&S 146703 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(s) identified in Paragraph I below (hereinafter referred to as "CMA " the "company") 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 Reauthori2ation 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 j responsibilities under Section 104(i)(5) of CERCLA, and in recognition of the fact that CMA the j i company represents includes manufacturers and/or processors, or registrants of the hazardous substance(s) that is the subject of this MOU, ATSDR and CMA the company hereby agree as follows: 1 R&S 146704 II. IDENTIFICATION OF THE PRJVA TE SECTOR COMPANIES THAT ARE PARTIES TO THIS MEMORANDUM OF UNDERSTANDING The following trade association is a companies are party ies to this MOU and shall be responsible for ensuring that the obligations and undertakings of its member the companies under this MOU are discharged and carried out as provided herein: Names and Addresses of Participating-w/s Companies Chemical Manufacturers Association Vinyl Chloride Panel 2501 M Street, N. W. Washington, D.C. 20037 III. IDENTIFICATION OF THE SUBSTANCE(S) SUBJECT TO RESEARCH REQUIREMENTS UNDER THIS MEMORANDUM OF UNDERSTANDING The chemical substance(s) 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 under certain circumstances, ATSDR recognizes that it may be more desirable to test mixtures or technical grade products. [Note: Substitute alternative language when the subject of-the researc-h is a human-population as in epidemiologic studies|. 2 R&S146705 IV. 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 conducted by CMA the company under this MOU are listed below: 4-To be listed by the company -jReproductive effects -- Inhalation Developmental effects - Inhalation This research is intended to satisfy the priority data needsfor vinyl chloride identified by ATSDR and the Environmental Protection Agency, as described at 59 Fed. Reg. 49937 (Sept. 30, 1994). ATSDR believes that the proposed research agenda addresses the Agency's priority data needsfor vinyl chloride asfollows: ATSDR has identified cipriority data needfor a multi-generation reproductive toxicity study by the inhalation pathway. HSIA's proposal will meet this data need. ATSDR has identified a priority data needfor a two-species developmental toxicity study by the inhalation pathway. HSIA's proposal, combined with existing data, will meet this data need. 3 \ R&S146706 V. IDENTIFICATION OF STUDY PLANS AND TESTING PROTOCOLS AGREED TO BY ATSDR AND CMA THE COMPANY PRIOR TO SIGNING OF MOU The research to be conducted on vinyl chloride (name of chemical substance^ pursuant to this MOU is identified in Table 1 below. The study-plan, guidelines-and protocols are listed in I i Table 4 and described in detail in the study protocol Vinvl Chloride: Combined Inhalation . Two-Generation Reproduction and Developmental Toxicit\> Study in CD Rats that was were agreed to by ATSDR and CMA the company (Attachment 1 to this MOU). CMA The company i | agrees to perform-(or sponsor and fund the performance of) the research identified in Attachment Table 1 in accordance with the guidelines and schedules established pursuant to the study plan aid testing protocols agreed to prior to signing of-this MOU. 4 R&S 146707 TABLE 1 IDENTIFICATION OF STUDY PLANS AND TESTING PROTOCOLS AGREED TO BY ATSDR AND CMA THE COMPANY- PRIOR TO SIGNING OF MOU COMPANY TEST SUBSTANCE IDENTIFICATION OF STUDY PUN Title______________________ ID#______________________ TEST TO BE CONDUCTED TSCA' GUIDELINES Other EPA Guidelines Alternate Guidelines * Citation to 40 C.F.R. where appropriate 5 Ft&S 146708 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 the-company shall have submitted to ATSDR the protocol study plan for each test that is to be conducted pursuant to this MOU (see Attachment Appendix 1). B. Prior to entering into this MOU, the study plan including all testing protocols and guidelines shall have bten 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. C. The study shall be initiated within 8 weeks of the date on which ATSDR and CMA the company have signed this MOU. Written notification of the starting date of the test will be submitted to ATSDR by CMA the company. 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 20 weeks of the end of the study for ATSDR's peer review, consistent with CERCLA section 104(i)(13). Following acceptance by ATSDR, upon 6 R&S 146709 recommendation by the peer review panel, CMA the company will submit a final report of the study to ATSDR within 4 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. {Note: When the MOU covers-multiple tests, different final report-periods could be estoblished-for the different tests]. 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. 7 R&S146710 VII. MODIFICATION OF STUDY PLANS, GUIDELINES, AND SCHEDULES A. If CMA the compart)' seeks to modify a study plan, guidelines, or schedules that have been approved by ATSDR pursuant to this MOU, CMA the company 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 the company 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 request for reconsideration within 2 weeks (see Figure 1). B. If CMA the company 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 the company to respond to and approve the modifications. VIII. OBSERVANCE OF GOOD LABORATORY PRACTICES All research agreed to in this MOU shall be conducted in accordance with the Good Laboratory Practice (GLP) standards 8 R&S146711 R&S146712 Company alaeta to Figure 1. REQUEST FOR MODIFICATION OF STUDY Company Review of Revision ATSDR revision Approval ATSDR Review of Request Disapproval o 5 !* ^....... - Withdraw from MOU C0 1 ma c0 oEo 2 Disapproval Continue Research 11 5 | $ ATSDR Re-revlew Company procaada with original MOU I Company Review of Disapproval Company raquaata ra conaldaratlon Company elects to terminate MOU 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 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 plan. IX. INSPECTIONS CMA The company 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 T-he company agrees to pay all costs, direct and indirect, associated with the research programs. 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 10 R&S146713 Failure by CMA the company to: i) initiate any test agreed to in any the approved study plan, appended to this MOU, by the date established pursuant to the study plan; 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 Procedures 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 11 R&S146714 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 The company maintains all rights to 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 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 of ATSDR, or 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. 12 R&S146715 XIV. ADDRESSES Any notifications, reports, or other written statements required to be submitted or sent to a party 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 Company I Chemical Manufacturers Association Address Vinyl Chloride Panel 2501M Street, N.W. Washington, D.C. 20037 Attention: Dr. Hasmulch C. Shah Company II Address Attention: _j Date: Date: XV. SIGNATURES Agency for Toxic Substances and Disease Registry By: Company--)-. Chemical Manufacturers Association By: 13 R&S146716 Date--------------------- - Gompany-fl. By*-------------------------------------------------- -- R&S146717 14