Document reRq369943VekJJkRxaE2obqV

NOU-21-19S4 lb: 55 UHtnSTHK 2026674756 r. 024-'-21^ CHEMICAL MANUFACTURERS ASSOCIATION u Vinyl Chloride Panel Health Committee Fax November 21, 1994 TO: Jam^s Bajrter . JZd,iUm ' PPG GEON 412/434-2137 216/447-6459 C-RoJj, Gilbert Westlake 713/963-1540 - Mark Gruenwald Borden 614/431-6611 James Knaak OxyChem 716/286-3141 , Patrick Logue Georgia Gulf 504/687-0294 ' Dave Penney Vista 512/331-2387 David Pun Formosa 201/716-7283 Jonathan Ramlow Dow 517/636-1875 FROM: - Has Shah RE: CONFERENCE CALL ANNOUNCEMENT M^ C.j\< 1 r- ^ This is to confirm that the conference call to discuss the enclosed agenda items is scheduled for Tuesday, November 22, 1994 at 11:30 a.m., EST. Please review the enclosed information prior to the call. Jonathan Ramlow will discuss item two. If you have any questions, please call me at (202) 887-1192. Thanks. PAGES; 12 (including cover) SENDER: Kim Reed PHONE: (202) 887-1191 250i M Street, NW. Washington, DC 20037 Telephone 202-867-1100 Fax 202-887-1237 NOU 21 '94 15=53 BFG 00131 ResponsibleCare" njOKCUXnamreern PAGE.01 NDU-21-1994 lb :5b L'HbnbTRR 2026874756 P.002/012 CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Panel Health Committee Tentative Agenda Conference Call DATE: TIME: November 22, 1994 11:30 a.m., EST yf^O 2.0 Discussion of Response to ATSDR/EPA Request for Proposal ? \ A. *' * * v Discussion of a (Proposal/ from Carlo Tamburo Regarding a Brain Cancer Case Control Studyd/' tec- fA / 2- i 0^ -r * A~ V 3.0 5.0 Update on Revised Proposal from Kenneth Mundt for Update of Vinyl Chloride Epidemiology Study MA fr t1 *' - *0 t.h* O A Financial Discussion *^-v Set Date for Next Meeting^) A -^-6 a-4-* f A* V ... a. >. / -*-X*.**.A gf/-: Subject to Approval Hasmukh C. Shah, Pb.D. Manager, Vinyl Chloride Panel if f /Mi NOU 21 '94 15=54 BFG 00132 PAGE.02 NOU-21-1994 15=56 CHEN5 FAR 202887475b P.006/012 M/21/A4 DRAFT Christopher T. DeRosa, Ph.D. Diroctor Division of Toxicology Agency for Toxic Substances and Disease Registry 1600 Clifton Road Atlanta, Georgia 30333 Charles M. Auer Director Chemical Control Division Environmental Protection Agency 401 M Street S.W. Washington, D.C. 20460 Re: Data Needs for Vinvl Chloride Dear Dr. DeRosa and Mr. Auer: In 1992, the Agency for Toxic Substancoe and Disease Registry (ATSDR) identified final priority data needs for 38 priority hazardous substances, including studies of the reproductive and developmental toxicity of vinyl chlorida by tho inhalation route. 57 Fad. Reg. 54150 (Nov. 16, 1992). More recently, ATSDR solicited voluntary research proposals to meet the Identified data needs, and indicated that it had referred the two data needs described above to the Environmental Protection Agency (EPA) for addition to Its master testing list, tho first step in tost rulo development under Soctlon 4 of the Toxic Substances Control Act. 59 Fed. Reg. 11434 (March 10, 1994), EPA has now issued a notice inviting manufacturers and processors of nine of the chemicals roforred by ATSDR to negotiate enforceable consent agreements (ECAs) with EPA for tosting to fill those data needs. 59 Fed. Reg. 499934 (Sept. 30, 1994) (the 'solicitation notice"). In certain cases, EPA has included testing to satisfy requests from its own program offices or from other agencies that are additional to tho data needs referred to it by ATSDR. For vinyl chloride. EPA has added an inhalation neurotoxicity study to tho data needs referred to it by ATSDR. On November 18, our counsel received from you a policy statement concerning the respective roles of ATSDR and EPA with regard to voluntary testing for four of the chemicals that are the subject of the solicitation notice, including vinyl chloride. This statement has been quite helpful to us in responding to the solicitation notice. N0U 21 `94 15=55 BFG 00136 PAGE.06 nuu-21-1994 ib*56 CHEnSTRK 2028874756 -2 P.007/012 The Vinyl Chloride Panel represents the U.S. producers of vinyl chloride. On their behalf. I am writing to express our intent to work with ATSDR to develop a voluntary testing program that would satisfy the two data needs for vinyl chloride it identified and reforred to EPA. In this regard, we propose a meeting between scientists from our member companies and ATSDR scientific staff In the first half of December to discuss the design of an inhalation multigeneration reproductive toxicity study and to discuss, as an alternative to the two-spocies developmental toxicity study referred to EPA, a one-species Inhalation developmental study that could be compared to data from the Inhalation developmental study on vinyl chloride already in the scientific literature. Once we have reached agreement on the testing program, the Panel would propose to move forward with ATSDR to negotiate and exacute, by May 31. 1995, a memorandum of understanding (MOU) to address these date needs for vinyl chloride. We understand that, should EPA decide that our voluntary research agreement with ATSDR will not address ell the testing needs for vinyl chloride identified in the solicitation notice, EPA may proceed to negotiate an ECA or propose a test rule to meet such unaddressod tasting needs. According to the policy statement, EPA will proceed with development of an ECA or test rule for vinyl chloride if an MOU between the Panel and ATSDR has not bean executed by May 31, 1995. If possible, the Penel would prefer that any voluntary testing program it develops address the data needs for vinyl chloride that have boon identified by EPA as well as the two studios proposed by ATSDR. We believe that it may be possible to design the reproductive toxicity study in such a way that ft Includes measures of neurotoxicity. Accordingly, we propose that solentf&ts from our member companies meet with EPA scientific staff at or shortly after the meeting with ATSDR scientific staff proposed above, to discuss the rationale for the neurotoxicity data need identified by EPA and how It might be addressed. According to tho policy statement, ATSDR will within 30 days notify EPA of the terms of any voluntary testing agreement it might enter into with the Panel on vinyl chloride, and EPA will then decide whether the agreement addresses all the testing needs identified in the solicitation notice. We are not at this time in a position to Judge whether EPA would decide that our voluntary research agreement with ATSDR will address ell the testing neods for vinyl chloride identified in its solicitation notice. As described above, it will be necessary in this regard to have further discussions with EPA and ATSDR scientific staff and to see how our voluntary testing program develops. Accordingly, we request that the time for submission of a proposal to EPA to NQU 21 '94 15=55 BFG 00137 PAGE.07 NOU-21-1594 15:57 CHtnSTRR 2028874756 -3- P.008/012 conduct testing of vinyl chloride undor an ECA for any testing needs identified in the solicitation notice but not Included under a voluntary resoarch agreement with ATSDft be extended until June 30, 1995, We look forward to working with you. Please do not hesitate to call If you wish to discuss any of the points in this letter. Sincerely* Hesmukh Shah Managor cc: Brian P. Riedel, Esq. W. Caffey Norman, Esq. EPA Dockot OPPTS-42052P; FRL-4756-6 Kinn Cm BFG 00138 PAGE.08 NUU-21-1994 1^:57 CHfcHbiRR 202S8Y4756 ! .009/012 UNITED STATES ENVIRONMENTAL PROTECTION AQCNCV WASHINGTON. D.C. 20460 NOV 18 1994 W. Caffey Norman, Esq. Patton, Boggs & Blow, L.L.P. 2550 M Street, N.w. Washington, D.C- 20037 rmwmtMVKDnuc TOMCBUCTAMOCI Dear Mr. Norman: in the interest of coordinating the processes and clarifying several issues associated with the voluntary research program of the Agency for Toxic Substances and Disease Registry (ATSDR) and the Enforceable Consent Agreement (EGA)/test rule program of the Environmental Protection Agency (EPA), we have developed and plan to follow the approach outlined in the enclosed policy statement. Ae the policy Indicates, the testing proposals under the ATSDR voluntary testing research program or under SPA'a ECA program must address all testing needs identified in the solicitation notice of September 30, 1994 or SPA intenda to proceed with a teat rule to meet these needs, The chemical endpoints identified for testing in the solicitation notice are the product of a considerable amount of coordination among EPA programs and Federal Agencies. ATSDR and EPA strongly encourage submission of testing proposals under either program and look forward to working with you. Sincerely Enclosure Dr. Christopher DeRosa Director, Division of Toxicology Agency for Toxic Substances and Disease Registry Charles M. Auer Director, Chemical Control Division Environmental Protection Agency N0U 21 '94 15:55 BFG 00139 PAGE.09 NUU-21-19y4 lb:57 CHEMSTHR 2028874756 jit-1 c. j.*r. Development and Finalization of Agreements .under_ the Voluntary Research Program of the AgencY fOE_ Toxic Substances and Disease -Registry (AT3CR) Yeraus Development and Submittal to the Environmental Pro&ectigp..taanc.Y (EPA) of Proposals for Enforceable Consent Agreements LECAsl in Response to EPA's 9/30/9* notice of Solicitation Section 104 (i) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) provides that ATSDR will develop a substance-specific research program to fill data needs identified for chemicals that are most commonly found at Superfund sites and that are posing the most significant potential threat to human health. Under CSRCLA, section 104 (i) (5) (D), Congress contemplates that authorities under the Toxic Substances Control-Act (TSCA) would be utilized to collect needed health effects data. in October, 1992, ATSDR referred 38 chemicals to EPA for testing under TSCA authorities, Notice, Status of the Superfund Substance-Specific Applied Research Program,- Federal Register. March 10, 1994 (59 FR 11434-11435). As required under CERCLA, section 104 (i), ATSDR's substance-specific research program was coordinated with testing programs under TSCA/Federal Insecticide, Fungicide, Rodenticide Act and with the National Toxicology Program. Such coordination was required "to avoid duplication of effort" and to assure that the chemicals are tested "thoroughly at the earliest practicable date." ATSDR also considered the recommendations of the Interagency Testing Committee established under TSCA, section 4(e) on the types of research to be done, as required under CERCLA. In addition, EFA considered and coordinated the data needs of its program offices and other Federal Agencies on these chemicals. Thue, the resulting list of chemicals and endpoints identified by EPA for testing under TSCA is the product of considerable coordination and represents the current federal testing priorities for these chemicals. On September 30, 1994, EPA published a notice in the Federal Rec:ster 59 FR 49934) soliciting testing proposals from manufacturers and processors that wish to participate in negotiations for an ECA on chemicals which ATSDR referred to EPA for testing under TSCA. These chemicals are vinyl chloride, benzene, trichloroethylene, tetrachloroethylene, hydrogen cyanide, sodium cyanide, toluene, methylene chloride, and chloroethane. NOU 21 '94 15=56 BFG 00140 PAGE.10 NQU-21-1394 15=58 CHEM5TRR 2028874756 P.011/012 EPA understandB that ATSDR is anticipating concluding voluntary agreements for testing of certain chemicals listed in the solicitation. ATSDR and EPA agree that the scope of each agency's testing program should be clearly defined. Accordingly, ATSDR and EPA have developed the following approach to meeting the identified testing priorities for the chemicals on the solicitation list: Application. This policy applies to development of testing proposals on methylene chloride, trichloroethylene, tetrachloroethylene, and vinyl chloride. Testing proposals for the other chemicals on the solicitation list will fall under the auspices of EPA* s' testing program and will be governed by the procedures set forth in the solicitation notice. Methylene Chloride. The Halogenated Solvents Industry Alliance, Inc. (HSIAJ has submitted a voluntary research proposal to ATSDR on methylene chloride and, as of this date, is revising the proposal to meet ATSDR*s concerns. If HSXA concludes a Memorandum of Understanding (MOU) with ATSDR for voluntary testing of methylene chloride by December 30, 1934, ATSDR will within 30 days notify EPA of the specific testing included in the voluntary agreement. In considering whether to remove methylene chloride from the solicitation list EPA will consider whether the ATSDR voluntary research agreement addresses all testing needs identified in the solicitation notice. Pursuant to the process described in the solicitation notice, HSXA may submit a proposal to conduct testing of methylene chloride under an ECA for testing needs identified in the solicitation notice but not included under the voluntary research plan. HSIA may request a reasonable extension for such submission. If HSIA and ATSDR do not conclude a MOU on methylene chloride by December 30, 1994, EPA will proceed with development of an ECA or, if an acceptable response to the solicitation notice has not been received, with a test rule. NOU 21 Trichloroethylene Tetrachloroethylene. and Vipvl Chloride. In order to participate in ATSDR*s voluntary research program for trichloroethylene, tetrachloroethylene, or vinyl chloride, a party must submit, by November 29, 1994, a "statement of intent" to enter into a MOU with ATSDR for voluntary testing of trichloroethylene, tetrachloroethylene, or vinyl chloride. If a party and ATSDR conclude a MOU for voluntary testing of trichloroethylene, tetrachloroethylene, or vinyl chloride by May 3i, 1995, ATSDR will within 30 days notify EPA of the specific testing included in the voluntary agreement. In considering whether to remove trichloroethylene, tetrachloroethylene, or vinyl chloride from the solicitation list EPA will consider whether the ATSDR research proposal addresses all testing' needs identified in the solicitation notice. Pursuant to the process, described in the solicitation notice, a party may submit a testing proposal to conduct testing of trichloroethylene, tetrachloroethylene, or vinyl chloride under an ECA for testing needs Identified in the solicitation notice but not included* '94 15=56 PAGE.11 BFG 00141 NUV-21-1SS4 15:58 ' / CHEHSTAR 2028874756 l ! P.012/012 ' under Che voluntary research plan. A> party may .request; a . reasonable extension, for such submission. x a.party does not submit a statement of intent* by November'29/ 1994, or does not enter into a MOT with A2SD& by Hay 31/ 1995/ * 8S& Will proceed * with development of an SCX or, if an acceptable response to. the . solicitation notice'has not been received. With*a teat rule. -X I Kim \ z>^ 'Q4 iq; teuinl Tice Nov. [8. 4:'24P2T - ' Print Time BFG 00142 Nov. 18. 4:Z6P!T ' * TOTAL P.012