Document aJXwb10GpB7Q5kn3jLzQJ5LGY
CHEMICAL MANUFACTURERS ASSOCIATION
Vinyl Chloride Health Committee
Record of Conference Call
Date:
November 22,1994
Time:
11:30 a.m.
List of Participants:
James Barter Ed Beeler Ron Gilbert Mark Gruenwald Frank Hawk James Knaak Dan Kracov Patrick Logue Caffey Norman David Penney Jonathan Ramlow
PPG Industries The GEON Company Westlake Polymers Borden Chemicals and Plastics Borden Chemicals and Plastics Occidental Chemical Patton Boggs LLP Georgia Gulf Corp. Patton Boggs LLP Vista Chemical Dow Chemical
Has Shah
CMA
1.0 The Committee discussed the ATSDR/EPA request for an Er Agreement research program to fill vinyl chloride data needs identified by EPA in the September 30,1994 Federal Register. Caffey Norman reviewed the ATSDR/EPA policy statement of November 18,1994, that indicated that any testing proposal under the ATSDR voluntary testing research program or under EPA's Enforceable Consent Agreement must address all testing needs identified in the solicitation notice of September 30,1994, or EPA intends to proceed with a test rule to meet these needs. For vinyl chloride these include:
a two-generation reproduction study;
a teratogenicity study in two species; and,
a neurotoxicity study.
Any voluntary program that addresses the above data needs must be approved by the ATSDR/EPA in a Memorandum of Understanding. Such an MOU must be executed by the Panel and ATSDR/EPA by May 31,1995.
The Committee agreed to pursue a voluntary testing program with ATSDR that includes a two-generation reproduction study. For the teratogenicity study, the Committee agreed to discuss with ATSDR the adequacy of existing data to fill its
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data needs. For neurotoxicity studies, the Committee agreed to discuss with EPA the rationale for the neurotoxicity data needs.
Mr. Norman will draft a letter to ATSDR/EPA indicating the Committee's intent to enter into negotiations that would lead to a Memorandum of Understanding by May 31,1995.
2.0 Jonathan Ramlow briefly reviewed his conversation with Carlo Tamburo of the University of Louisville regarding the brain cancer case control study of vinyl chloride workers. Dr. Shah will invite Dr. Tamburo to the next Committee meeting to discuss his proposal.
3.0 Dr. Shah reported that a revised cost proposal from Applied Epidemiology Inc. has been received. The revised cost for the epidemiology study update is approximately $335,000. Drs. Ramlow and Shah plan to meet with key staff from Applied Epidemiology Inc. in the beginning of December to discuss the AEI proposal and to receive a demonstration of its ProQuest software program for epidemiology study information management.
4.0 The conference call was concluded at approximately 12:30 p.m.
Subject to Approval
Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel
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