Document MMgb2XxgjaR8rBn93NaRo27QM

*r CELLULO COMPANY t 33-41 NEWARK STREET, HOBOKEN, NEW JERSEY 07030 IN. J.) 2 0 1 -6 5 9 -3 0 6 0 IN .Y.) 2 1 2 -9 4 3 -0 9 7 5 PLANTS -- SANDUSKY, OHIO AND FRESNO, CALIFORNIA SUHS'C Axl Of fn m a t * . a;b, " Performance-Proved Filters and Filter Media . . . Since 1919'' Registered -4 ; Return Receipt Requested December 21, 1973 The. Hearing oierk Food and;Drug, Administration Room 6-86 /5600 Fls||efAliane Rockvi 1 .;sMaryland, 20852 Ref: 1 ' Department of Health, Education and Welfare Fd -aiid, Drug Administration 21 CFR; Parts 121, 128, 133 Pr.pp^S;^' Rule Making on Asbestos Particles in Drugs As Printed in Federal Register Volile, No. 188, Friday, September 28, 1973 Gentlemen:!, . I"fe would Tik. make comments with regard to the proposed rule making in view of our company's long range involvement with chrysotile asbestos fiber for filtration purposes. We-assume that'other interested parties will submit comment to yoh perhaps with more emphasis on areas of their particular expertise.^ We would like to comment on the overall filtration practices in th chemical, food, beverage, and pharmaceutical {industries Which we serve. We are aware f FDA's interest in assessing the extent of the lise of^.ashestoS;; by such industries and we were privileged to attend such a, Weting in January of 1972 in Washington. That particular meeting did in fact indicate that asbestos was con sidered a vital filter ingredient by a large number of companies in a wide variety of industries. Asbestos fiber when used in industrial filtration is considered a depth type.,filter media, whether it is used in the form of an asbestos/Oellulose pad or in the form of loose fibrous product slurried in a.liquid to form a filter mat on the leaves of large pressure filters. or 2- Hearing Clerk Food and Drug Administration Rockville, Maryland, 20852 December 21, 1973 Large precoat filter installations and pad filters presently installed in these diverse industries represent a staggering total of capital investment. Procedures have long been established for filtering this enormous national capacity of various liquids to provide the consumer with a cleaner product than previously available prior to the large scale use of asbestos in combination with such other materials as wood cellulose, cotton linters, diatomaceous earth, perlite, etc. The chrysotile asbestos which we supply for these various uses has many of the unique advantages that are not character istic of substitute fibers. Primarily unique are the small fiber diameter characteristics and the Zeta potential exhibited. Consequently, such depth filters offer finer filtration due to the smaller diameter fibers in the filter matrix and the ad sorption characteristics due to Zeta potential enabling par ticles smaller than the filter interstices to be retained. Some measure of the economics of such depth filtration are graphically illustrated on page 11 of Millipore Corporation Bulletin MB404 attached herewith. Too often people have suggested alternate methods of filtration for specific products without full knowledge of the practicality of these suggestions. Screen or membrane filters retain contaminants on the surface with resulting limited particle holding capacity and consequent short filtration cycles resulting in cost factors being raised as high as a thousand-fold when depths filters are not employed prior to such membranes. The mass production of certain drugs may never have been possible without the use of various asbestos bearing depth filters. The retention of asbestos fibers in the filter housing have long been a consideration of pharmaceutical manufacturers and they do an excellent job in protecting contamination of the final filtrate, not only from asbestos fibers, but other depth filter media in gredients vital to the practical production of the drug. The exclusion of asbestos fibers from the final filtrate is not limited to membranes, but is accomplished also by a number of other septums classified as non-fiber releasing. We would there fore suggest that under Paragraph 133.8 be amended to allow the use of such asbestos containing filters with a suitable screentype after filter properly employed. Hearing Clerk Food and Drug Administration Rockville, Maryland, 20852 December 21, 1973 Some of the proponents of the banning of asbestos for all and sundry purposes may fall into the category of what have been referred to as the good guys in the so-called Age of the Antagonist. "The Age of the Antagonist" was the title of an address given by Daniel C. Searle, Chief Executive Officer of G. D. Searle Company on October 25th at the Chicago Section of the American Chemical Society. In it, he had made some worthwhile remarks with regard to this overall problem. Permit me to quote from this speech: "My company and others in the pharmaceutical industry make medicines that restore or preserve health for millions of people, but the state of science and technology does not now and never will enable us to make medicines entirely safe and effective for all people under all conditions. Thus, in the Age of the Anta gonist, we are bad guys." Unfortunately, it has become fashionable to form instant ex pert consumer protection groups who are automatically put in the category of the good guy. Any society, regardless of its purpose or tactics, which espouses ecological causes is usually likewise labeled "good guys". Presently, scientists who caution us about being careful in cleaning up environmental situations for fear that we may precipitate more biological and ecological damage by removing so-called "pollutants" below a critical level, are also cast as "bad guys". However, the scientific community points out that while large concentrations of certain elements can be injurious, trace concentrations are absolutely necessary for life. We have had the opportunity to talk with some of our customers who have made attempts to convert from asbestos bearing filter media to non-asbestos substitutes. Results have been unsatis factory from a total efficiency standpoint. In such cases where industry has attempted to move in this direction, they had indicated the move has not been considered for fear of any medical hazard, but rather concern for reaction in the market place. Certain zealous self-appointed protection groups have indicated that boycotts should be placed on foods and beverages processed through asbestos-bearing filters without giving a scientific conclusion as the reason, but rather appealing to the general public on a total emotional approach to the matter. *# Hearing Clerk Food and Drug Administration Rockville, Maryland, 20852 December 21, 1973 Unfortunately, many industrialists are reluctant to come for ward and publicly be counted onthe side of those advocating the use of asbestos filters due to possible future economic considerations in the market place. We assume that with all of the information input that we and other companies have made to FDA, you are fully aware of the international trade implications in banning the use of asbes tos in this country for filtration purposes. Considerable economic damage to this country is a possibility. We appreciate the cooperation that has been shown over these past months in sharing information on the subject and have faith that you will come to the proper conclusion in this matter. Very truly yours JJMcH:kk Enel.