Document ymvEYnwvEgjnewGNoNJr9RDa2

IlFGoodrich INTER-ORGANIZATION CORRESPONDENCE TO FROM SUBJECT CPSC Members Marie Schmiederer FIELD POINT OR DEPT. & BLDG. NO. FIELD POINT OR DEPT. & BLDG. NO. D/5428 Consumer Product Safety Committee October 31, 1977 DATE YOUR LETTER DATE THIS LETTS? 11/2/77 Present: W. C. Becker/R. B. Downey/D. L. Kent/F. Krause/J. F. Malone/ R. D. Savage/M. Schmiederer/R. Steller/G. Albers/R. MacCuspie/ J. Tanzi111 Absent: C. Blackfan/N. G. Duke/J. P. Morrill 1. Virginia Toxic Substances Act -- Reporting requirements have been for mulated for legislation similar to the Federal TOSCA. If we choose to respond, we can either reply to the customer or to the State of Virginia directly. The Marketing Directors will be able to react to the rules before the BFG position is established. 2. Michigan Critical Materials List -- Harold Fast has suggested that BFGCD respond to inquiries in the interest of good customer relations. It is still not clear as to how much information we need supply. It would be beneficial if all the information required were in one package, such as a materials safety sheet. 3. Canadian Birth Defects Study -- Dr. Theriault of Laval University reports a significantly higher rate of birth defects in Shawinigan, a city which contains a PVC polymerization plant, than in Drummondville, a city without such a plant. Despite the apparent link, serious questions have been raised by Dr. Theriault himself and other scientists regarding the significance of the findings. Dr. M. Johnson will attend Dr. Theriault's presentation at the annual meeting of the American Public Health Association. Hill and Knowlton will be prepared with a statement. 4. SPI Board Meeting -- a. OSHA Cancer Policy -- SOCMA will be the chemical industry voice for constructive criticism. We will seek to extend the one month comment period to three months. It appears that EPA, CPSC, and FDA will use the same basic policy. H. Waltemate and R. Hinderer will participate in a BFG position meeting on November 8. b. SPI Fire Safety Policy -- A statement of recommended procedure for SPI Operating Groups has been drafted. J. Malone would like to see wide dissemination of this policy, within BFGCD. c. Acrylonitrile bottles -- The ban on AN for bottle use could well affect the PVC bottle issue. Current FDA thinking tends toward a ban.if the potential for any residual VCM and resulting migration - more BFG22236 t: TOOTfceg; Page 2 exists. If financial support from the bottle faction comes through, SPI may take the AN bottle issue to court. d. Vinyl acetate -- SPI will recommend further study into the potential for carcinogenicity. 5. Combustibility-- BFG Efforts and Objectives-- Since the early 1970's and the formation of the National Fire Prevention and Control Administration (NFPCA), there has been increased emphasis on the fire problem. Thus far,combustibility studies have concentrated on the composition of materials, as opposed to end product use. BFG efforts have focused on: 1. Understanding the potential fire hazards of any of our products: flammability, smoke generation, combustion gases. 2. Developing improved materials through new additive formation. 3. Understanding the significance of different test protocol and their results. 4. Impacting on regulations and code recommendations. 5. Helping to develop an industry awareness of the problem and organizing for reasonable solutions. We are concerned with maintaining our market position for such products as PVC. * NEXT MEETING -- MONDAY, NOVEMBER 14 AT 9:00 A.M., ROOM 3A Marie Schmiederer MS/tp cc: W. C. Becker/C. Blackfan/N. G. Duke/J. P. Morrill/R. D. Savage/ R. B. Downey/D. L. Kent/F. E. Krause/J. F. Malone/R. L. Steller/ G. Albers/R.MacCuspie/J. Tanzilli BFG22237 zmvrtzz Page 4. October 17, 1977 FOOD CHEMICAL NEWS Page 56) will-Include hearings to be held In California and in Georgia. He said a Federal Register document dealing with the proposals and the hearings is imminent. 1 The State proposals would determine compliance with net weight statements at the retail level. FDA and USDA policy, upheld by the U.S. Supreme Court, peg compli ance to the met weight of products as they leave the plants. The Commissioner commented that he can appreciate the problems faced by a large, dry State such A California, indicating that California products could more easily comply with net weight requirements at retail than food products packed in more moist climates and\hipped across the country. He also noted that more consumers may be checking netVeights in their own kitchens, commenting that consumer confidence "may be at stake here." \ FDA Seeks Modest Nutrition Research Role, Kennedy Says \ The Commissioner stressed that FDA is not seeking to become the "lead agency" in the government's nutrition research program-, but wants only a "modest" but "solid" program in "specific areas" relating to its "regulatory mission" (See FOOD CHEMICAL NEWS, Sept. 26, Page 29). \ \_ Kennedy said a "lead agency" -- not iRDA -- would coordinate nutrition research efforts by FDA, USDA, and the Nationahlnstitutes of Health. Concentrating on nutrition labeling and fortification policy he continued, FDA would have "a rather modest slice of the whole nutrition education pie." \\ Noting that FDA's nutrition budget -- $4.5 million -- is tiny compared to those of NIH and USDA, Kennedy said USDA is showing interest in nutrition research. He commented that the Department of Health, Education and Welfare -- which houses both FDA and NIH -- should be "excited and hopefbl" about this development. FDA's interest should be focused on nutrition interaction, nutrition toxicity, fortification, nutrition labeling, and information on which action levels may be established, Kennedy said. BFG22238 Asked about alternatives to the current nutrition labeling format (See FOOD CHEMI CAL NEWS, Oct. 3, Page 23), the Commissioner said he would like to encourage an effort to bring "applied social sciences" to bear on how best to present nutrition information. He said that little serious research has gone into the problem, and that FDA has not exhausted possible styles of presenting nutrition information. Acrylonitrile Order Will Lead to "New Era." Kennedy Says Kennedy said the recent FDA order banning acrylonitrile bottles (See FOOD CHEMICAL NEWS, Sept. 26, Pages 47, 50, and 53) will lead to a "new era" of consideration of indirect additives, adding that this will go along with further consideration of all poisonous and deleterious substances. Although the Commissioner said he does not want to make any more trouble for the packaging industry than is necessary, he predicted that many polymers will turn out to be carcinogenic. The future of plastic food packaging materials will depend s October 17, 1977 Page 5 FOOD CHEMICAL NEWS in part on what Congress does about the Delaney anti-cancer clause and In part on changes in the sensitivity of analytical methods, he said. Acrylonitrile will trigger policy decisions in "an area in which we'll be devoting " more time," the Commissioner said. He said the order paves the way for "a broadly based consideration of what we want to do in that area." Kennedy also said FDA will consider the Society of the Plastics Industry's petition for use of a sensitlvityof-method approach to indirect additives and will respond to it. Increased FDA Interest in Food Ad Claims Stressed 7 Saying that "the regulatory process must at least protect the quality of information available to consumers," Kennedy stated that FDA's "tools fordoing that with respect to labeling are arguably adequate, but in the case of advertising they are clearly not." He noted that FDA is working with FTC on the problem of ad and label claims for over-the-countel drugs, and commented, "... This is very much a part of my own philosophy for foodsjas well as drugs." "I believe that nutrition is so vital as a health determinant that advertising claims for foods should be just as accurate, responsible, and carefully-worded contributions to health education als those made for drugs," Kennedy said. He continued: "Nutrition is too Important a subject to mislead people about. The food industry is in a great position at this time to capturevwide public support and confidence: It' has done much t^> buoy this nation's international economic position, to anchor consumer expenditures against infla tion, and to improve the quality and convenience of America's diet. Positive and voluntary steps now in the areas of labeling an^ advertising would serve the industry well, and would make^a critical contribution to the public health." \ Discussing food ad claims, Kennedy noted an ad that appeared in the Oct. 10 Washington Post, with the headline "Apple Jacks Cereal has no more sugar than the apple." He said: \ 2642008 "The text goes on to say, in pertinent part, 'To make sure that nutrition gets eaten, \prne of our cereals are ready-sv/eetened. How much? Jot as much as you may think. A medium-size apple contains about 17 grams of sugar. A one-ounce serving of (our)\oereal has about 16 grams of sugar.' There is more, but I<11 spare you. Any reader who gets past line one, in whlc\ nutrition Is referred to as something that gets eaten, will conclude that a compar ison of sugar concentration is being mad\. But the reader is not told that the apple weighs five ounces, not one, and that there is actually five times as much\dded sugar in the apple. Furthermore, the clear implication Is that the apple refers somehow to the apples used in me manu facture of that portion of the cereal in which theJsugar is BFG22239 October 31, 1977 Page 25 FOOD CHEMICAL NEWS The danger from a carcinogen is not immediate, he said, adding that higher life expectancy has resulted from use of food additives. He said, therefore, it is a value judgment whether to use an additive or not. Stumpf concluded by saying that when other substances are available which cause no risk, there should be a ban of the suspect additive. He urged an assessment ranking of the safety before deciding if an additive should be allowed. FDA TASK FORCE CONSIDERING INDIRECT ADDITIVE REGULATION A Food and Drug Administration task force is preparing a paper on agency policy for regulating packaging materials in light of the sweeping final order concerning acrylonitrile beverage containers. Commissioner Donald Kennedy recently said the acrylonitrile policy will usher in a "new era" (See FOOD CHEMICAL NEWS, Oct. 17, Page 3). The report of the task force is expected to be ready for the Commissioner in midNovember. It will deal, in part, with non-beverage container uses of acrylonitrile and with uses of polyvinyl chloride. The paper may go beyond those two specific materials and discuss future regulation of all plastic food-packaging materials. C The task force also will prepare a paper -- due in about a month -- concerned with the lifting of the "housewares exemption" from food additive regulation (See FOOD CHEMICAL NEWS, Jan. 10, Page 36). It is expected that assertion of regulatory power over housewares as indirect food additives could strain the agency' resources, and the task force will consider this issue. A third indirect additive problem being confronted involves the Society of the Plastics Industry's petition for FDA to adopt a principle of toxicological insignif icance in regulating packaging materials (See FOOD CHEMICAL NEWS, Sept. 5, Page 50). Although FDA declined to adopt such a principle in dealing with acrylonitrile bottles, the agency indicated it would consider the proposal. It appears likely that FDA will hold an open meeting in late January for discussing the SPI petition. Chairman of the task force is Richard J. Ronk, Director of the Division of Food and Color Additives in the Bureau of Foods. Other task force members are: FDA attorney Stuart Pape; Thomas C. Brown, of the Division of Food and Color Additives; Dr. Robert C. Livingston, of the Division of Chemistry and Physics; Dr. Albert Holtz, of the Division of Chemistry and Physics; Dr. Krishna P. Misra of the Division of Toxicology; and Dr. Jeffrey Staffa, of the Office of Science. ,2642009 BFG22240 FDA ASKS SULFONAMIDE NADA HOLDERS TO LENGTHEN WITHDRAWAL PERIOD The Food and Drug Administration has sent letters to holders of New Animal Drug Applications for sulfamethazine-containing products to lengthen the withdrawal peric from 10 riavfi to IS Ha vs .