Document ZzazpyvGExZrGBxzygpwYZBZ

I FAX Transmission PATTON BOGGS, L.L..P. 2550 M Street, N.W. Washington, D.C. 20037 (202) 457-6000 CLIENT NUMBER: 4590.102 Please deliver the following TO: Has Shah FAX NO.: FROM: DATE: 703-741-6091 Tom Downs February 26, 1996 TOTAL NUMBER OF PAGES (including cover page): PLEASE NOTE: The information contained in this facsimile is confidential and is intended only for the use of the person named above. If this facsimile has come to you in error, please call the sender or operator at the number given below. Any distribution or copying of this facsimile is strictly prohibited. Our telecopier direct line is: (202) 457-6315. OPERATOR: OPERATOR NO.: Atherine Jackson 457-5291 COMMENTS: This fax transmits draft comments on the AT3DR Medical Managem nt Guidelines for Vinyl Chloride. Let me know if you have comments or proposed revisions. Thank you. CMA113544 February 26, 1996 Ms. Jennifer Heise Peer Review Coordinator ERG 110 Hartwell Avenue Lexington, MA 02173 Re: ATSDR Medical Management Guidelines for Vinyl Chloride Dear Ms. Heise: This letter transmits the Chemical Manufacturers Association (CMA) Vinyl Chloride Panel's comments on the Medical Management Guidelines for Vinyl Chloride under development by the Agency for Toxic Substances and Disease Registry (ATSDR). At the request of Scott Wright of ATSDR, CMA is submitting these comments directly to you. Please call me at (703) 741-5637 if you have questions or need additional information on the enclosed comments. Very truly yours Enclosure Hasmukh C. Shah, Ph.D. Managertjfr? (Vinyl Chloride Panel CMA 113545 CMA 113546 Comments of the \j Cftefficgl Manufacturers Association on the Agency for Toxic Substances and Disease Registry's Proposed Medical Guidelines for Vinyl Chloride Introduction The Agency for Toxic Substances and Disease Registry (ATSDR) recently requested review and comment on proposed Medical Management Guidelines for Vinyl Chloride. The Chemical Manufacturers Association (CMA) Vinyl Chloride c ^r page i, rcoute ot exposure, mnaianon The fifth sentence (beginning "Occupational exposures have resulted") should be revised to read as follows: "Occupational exposures well above the current threshold limit value (TLV) have resulted in the occurrence of a syndrome consisting of acroosteolysis, scleroderma-like skin changes, and Raynaud's phenomenon." The last sentence (beginning "Chronic exposures have led to cancer") should be revised to read as follows: "Chronic exposures (well above the current TLV) have led to increased risk of cancer, particularly of angiosarcoma of the liver. Increased risks of cancer of the lung and brain have been reported out not substantiated." Page 3, Health Effects, boxed text The third sentence (beginning "Vinyl chloride has been shown") should be revised to read as follows: "Vinyl chloride has been shown to induce CMA 113547 ? ?5r's |V| gjL-- -ft>c vVn71 Ke^^U/" C/v\A- (UjifJr-. 4, ^ <rh n'J^ 6 angiosarcoma of the liver in humans and in laboratory animals with chronic exposure." 1 The fourth sentence (beginning "Immunological effects") should be revised to read as follows: "Immunological effects and effects on reproduction have not been conclusively demonstrated in humans or animals." Page 3, Acute Exposure, Cardiovascular The last sentence (beginning "Chronic exposure to vinyl chloride") should be removed from the Acute Exposure section and placed under Chronic Exposur , on page 4. The sentence also should be revised to read as follows: "Chronic exposure to vinyl chloride (well above the current TLV) can cause a syndrome consisting of acroosteolysis (dissolution of the bones of the terminal phalanges of the fingers, toes, and sacroiliac joints), Raynaud's phenomenon, and scleroderma-like skin changes." Page 4, Chronic Exposure, Carcinogenicity This paragraph should be revised to read as follows: "The Environmental Protection Agency has classified vinyl chloride as a known human carcinogen. Vinyl chloride has been shown to induce cancer of the liver (angiosarcoma) in humans and laboratory animals when they are exposed for long durations above the current TLV. There is inconsistent and inconclusive evidence suggesting that vinyl chloride exposure also may be associated with cancer of the lung, brain, and central nervous system." Page 5, Reproductive and Developmental Effects The first paragraph should be revised to read as follows: "Occupational vinyl chloride exposure has been reported to result in decreased sexual performance both in men and women, although this theory has not been substantiated in controlled epidemiologic studies. In men, occupational exposure has been reported to be associated with decreased libido, impotence, and decreased testosterone production. In women, vinyl chloride exposure has been reported to result in decreased sexual function and elevated blood pressure and edema during pregnancy (i.e., pre-eclampsia). The reports of these findings largely have been based on individual random cases, and are not considered strongly suggestive of vinyl chloride's health effects. Animal studies have not conclusively demonstrated the presence or absence of vinyl chloride reproductive toxicity, but additional studies currently under way should clarify these issues." 2 CMA113548 Supplem ntary mat rial The information that follows should be added to the Chronic Exposure section or possibly to a new section entitled "Occupational Exposure": ANGIONEUROTIC DISORDERS IN THE HANDS AND FEET (RAYNAUD'S PHENOMENON) exposure criteria: minimum intensity of exposure: confirmed occupational exposure, assessed if possible by: - anamnesis and study of exposure conditions - and, if appropriate, atmospheric sampling ACRO-OSTEOLYSIS IN THE UNGUAL PHALANGES OF THE HANDS AND FEET May accompany angioneurotic disorders confirmed by X-ray (loss of substance from bones) exposure criteria: minimum intensity of exposure: confirmed occupational exposure, assessed if possible by: - anamnesis and study of exposure conditions - and, if appropriate, atmospheric sampling DISTAL SKIN DISORDERS Pseudosclerodermal syndrome with penetration of the skin, possibly accompanied by general symptoms (arthralgia, myalgia); follows on from angioneurotic disorders. exposure criteria: minimum intensity of exposure: confirmed occupational exposure, assessed if possible by: - anamnesis and study of exposure conditions - and, if appropriate, atmospheric sampling LIVER FIBROSIS WITH PORTAL HYPERTENSION Portal Hypertension syndrome fibrosis confirmed by endoscopy or histology or indirectly by echography. exposure criteria: minimum intensity of exposure: confirmed occupational exposure, assessed if possible by: - anamnesis and study of exposure conditions - and, if appropriate, atmospheric sampling 3 CMA113549 1 VaJUf' ANGIOSARCOMA angiosarcoma, usually hepatic exposure criteria: minimum intensity of exposure: confirmed occupational exposure, assessed if possible by: - anamnesis and study of exposure conditions - and, if appropriate, atmospheric sampling 4 CMA113550