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- fv Dear Vinyl;Chloride Health Committee Members:
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The next conference call for the Vinyl Chloride Health Commttteeisschedxded for Thursday, October 9* from 10:00 a.m. to 12 noon. An agenda and packet of supporting materials is attached.
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Following up on last week's conference call on the CAA Section 112(k) comments, Caffey Norman was able to access TRI data for vinyl chloride and the other chemicals we discussed. However, Caffey is still looking for information on uses of vinyl chloride and emissions from sources other than chemical plants (see memorandum to the VCHC, dated October 3,1997, with attachments). Since we have only one week to finish preparing these comments, please take a moment to review the memo and determine if you can access any of the requested information. I plan to have a first draft of the comments to you prior to the October 9,1997 conference call.
Also on Thursday we need to finalize the Committee's budget for 1998. Attached is an updated version of the proposed budget that we discussed on our July 30th conference call. The proposed budget would use the balance of $107,000 plus interest to cover administrative costs for 1998. An additional commitment of $150,000 would cover activities such as funding for J. Swenberg, updating the risk assessment for vinyl chloride, legal budget for outside counsel and some additional contingency budget. To estimate individual company commitments I calculated pro-rata shares of the 1998 budget using 1995 name plate capacity. On the last conference call the committee agreed to update name plate capacity to reflect 1996 data.
In preparation for our budget discussion, I arranged a conference call with Dr. Jim Swenberg on September 22,1997. The purpose of the call was to discuss the status and future plans for his DNA adduct research on vinyl chloride. C. Park, M. Gruenwald and E. Beeler also participated in the call. To facilitate our discussion of Dr. Swenberg's work I have attached a "calendar of events" of future research activity (dated September 22,1997) and a copy of the Research Report and Budget Request (dated July 28,1997) that you received prior to the last conference call.
Regarding the two-generational study at Huntingdon, I am preparing to send a status report update to ATSDR prior to the end of this month. The draft developmental study will soon be available for committee review. We need to discuss a timeline for receiving and commenting on the report to allow it to be finalized by the December 1997 deadline. For your information, a copy of the revised (April 22,1997) study plan is attached.
Finally, in response to a request from the Vinyl Institute, I put together a one-page summary of activities that the VCHC supports financially. The summary, entitled "Vinyl Chloride Health Committee Activities" is attached. Frank Borelli and I have discussed die studies, and the Vinyl Institute has inquired about the committee's plans to present the finalized studies at appropriate industry forums.
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Innovation, Technology and Responsible Care At Work
---------------------------------------------------------- ------ - ------------------------ ^^Responsible Care' 1300 Wilson Blvd., Arlington, VA 22209 Telephone 703-741-5000 Fax 703-741-6000 i f A RnlicCommitment
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For your information, I am also enclosing the following: two letters from D. A. White, UNC, thanking the committee for their gift to Dr. Swenberg; letter from ATSDR to W. Sherman, dated July 28,1997, re: acknowledging the update on the two-generational study; and an article on potential contamination of NTP bioassays with Heticobaiter hepaticus.
As always, if you have any questions, I can be reached at 703/741-5639.
Sincerely,
Enclosures
Wendy K. Sherman Manager, Vinyl Chloride Health Committee
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STUDY PLAN (Revised April 22,1997)
COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXIOTY
TESTING OF VINYL CHLORIDE
I. Test Requirements Contained in Study Plan
Inhalation Two-Generation Reproduction Study of Vinyl Chloride in Rats
Inhalation Developmental Toxicity Study of Vinyl Chloride in CD Rats
II. Administrative Official and Project Manager:
Wendy K. Sherman Manager, Vinyl Chloride Panel Chemical Manufacturers Association 1300 Wilson Boulevard Arlington, VA 22209
Phone: 703/741-5639 Fax: 703/741-6091
III. Testing Facility:
Huntingdon Life Sciences, Inc. P.O. Box 2360 Mettlers Road East Millstone, NJ 08875
Study Director:
Raymond E. Schroeder M.S.
Phone:
908/873-2550 (ext. 2910)
IV. Professional Qualifications
Curriculum Vitae (C.V.) providing the training and experience of each professional involved in this study were provided as an attachment to the original study plan. Copies of those C.V.s are available upon request from Ms. Sherman.
V. Identity of Test Substance
An analysis of the material which is being used in the studies was conducted and the results are available from Huntingdon Life Sciences, Inc.
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VI. Study Protocol
The protocol for the combined inhalation two-generation reproduction and developmental toxicity testing was included as an attachment to the original study plan. A copy of the protocol is available upon request from Ms. Sherman.
VII. Test Schedule
Developmental Toxicity Study:
In-life phase starts: In-life phase completed: Progress report: Progress report Final report:
October, 1996 April, 1997 April, 1997 October 1997 December, 1997
Reproduction Study:
In-life phase starts: In-life phase completed: Progress report: Progress report: Progress report: Final report:
October, 1996 September, 1997 April, 1997 October, 1997 April, 1998 July, 1998
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