Document 4RrEjZgV52bYe3GQDmeo464V

ENVIRONMENTAL DEFENSE FUND 1525 18th STREET, NW, WASHINGTON, D.C. 20036/202 833-1485 January 28, 1974 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville, Md. 20852 RE: FDA Proposed Rulemaking relating to Asbestos Particles in Food and Drugs (F.R. Sept. 28, 1973) Dear Sir: The above-noted proposal invited comments from interested parties on or before December 27, 1973. The Environmental Defense Fund and the Center for Science in the Public Interest did file such comments before that date. Since that time, we have had the opportunity to consider the Comment of 12/21 filed by Johns-Manvilie (J-M) on the same proposal. As a result, we are now submitting a supplemental comment with the hope that it, although late, can be considered as well. This comment can be summarized by two statements: a) We do not object to the described use of asbestos-containing talc for pitch control in food and drug papers if it is shown that such talc does not migrate into food or drugs with which the pa per is in contact; and b) the use of additional asbestos-contain ing talc for brightness filling or any other purpose should not be acceptable in food and drug wrappings. - There are a number of statements in Section 3 of the J-M Comment (Health Hazard of Ingestion) to which we would take strong exception. We do not wish any of the statements which we make here to indicate agreement that asbestos ingestion can be assumed to be harmless. We do not believe that such an assumption is just ified. However, this question is not relevant to any use of talc which does not give rise to asbestos ingestion. OFFICES IN. EAST SETAUKET, NY (MAIN OFFICE); NEW YORK CITY (PROGRAM SUPPORT OFFICE); WASHINGTON, DC; BERKELEY, CALIF.; DENVER, COI Printed on 100% Recycled Paper # 2 We have considered the matter of talc use in the manufac ture of paper used for food packaging. J-M states that talc which contains up to 5% tremolite by volume and is used for pitch control becomes "locked into place in the paper" and will not migrate into food with which it is in contact. J-M further main tains that due to talc's unique surface properties, no equivalent substitutes are known and that surface active agents, if used as an alternative to talc, are a cause of pollution at pulpmills. We are now making our own appraisal of the environmental impact of talc and non-talc systems for pitch control. However, it is our preliminary opinion that the advantages of the use of talc for pitch control need not be sacrificed if, as J-M's tests indicate, the incorporated talc does not migrate from papers to food. It is our understanding that talc for pitch-control is added during pulping in amounts up to 1.5%, with further addition of as much as 2% during paper making. These figures were given by Johns-Manville in their December 21, 1973 Comment to you. If testing by procedures approved by the FDA does establish that no tremolite will migrate from paper to any food or drug during forseeable conditions of use, we would not object to this use of talc containing up to 5% tremolite by volume, in the amounts noted above, for the purpose of pitch control. Use of talc for other purposes in food and drug wrappings should not be allowed. For example, Johns-Manville also sells a 20 to 30% tremolite talc for use as a "functional filler" in paper making, and says that such filler is used little in making food papers. Normal rates of talc addition for this purpose exceed the combined amounts used in pitch control, and serve only an admittedly cosmetic purpose. Where manufactures require such brighteners for food or drug wrappings, substitutes for talc such as titanium dioxide can be used. As the use of 5 to 15 percent talc containing 20 to 30% tremolite constitutes a relatively massive amount of tremolite added, we believe that the use of talc for brightness filling in food and drug papers should be prohibited immediately. It is unlikely that papers with such high talc loading would completely retain their talc during the tearing, abrasion, and repeated foldings to which some food papers are subjected. J-M states that the use of such high-talc papers for food and drug packaging would be unusual due to high cost. Nevertheless, we believe that such use should be explicitly prohibited in the regulation to be promulgated by FDA. #* 3 We are unable to comment on the acceptability of talc-treated recycled paper since we have no information as to how much talc is retained after the waste pulp stock is reclaimed, whether it is more or less securely "locked in" than talc added for pitch control, and to what extent recycled paper is used for direct wrapping of food and drugs. We are aware that recycled paper is apt to contain other contaminants (i.e. PCB's)which can make it unsuitable for food and drug wrapping. We urge FDA to clarify these points before approving the use of recycled paper for direct contact with food and drugs. Sincerely yours Lucile F. Adamson, Ph.D. Environmental Defense Fund LFA/BC:mew Center for Science in the Public Interest