Document BRdawBK19aL8xGqB96LYYp1RE

/ \ .Scott Laboratories, Inc. * 860 South Nineteenth Street Richmond, California 94804 Phone (415) 232-8288 December 5, 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville, Maryland 20852 Subject: Proposed Rules - Asbestos in Food and Drug Federal Register, Volume 38, Number 188, September 28, 1973 Dear Sir: For a number of years we have manufactured filtering materials for the valuable liquid industries in North America. A large segment of our business has been with the food and beverage industries. The filter sheets which we have supplied have contained asbestos. They are happy to report that they have worked very well. On September 28, the Commissioner answered certain requests for rules regulating filtering materials,with proposed rules of his own. On first reading, we were pleased that the Commissioner followed the overwhelming weight of evidence and did not by direct regulation disallow the use of asbestos for filtration of food and beverages. In practical reality, however, by not making a strong affirmative statement favor ing the continued use of asbestos bearing filter media, even with certain limitations such as after filters, etc., the Commissioner has left the industries producing food and bever ages to the mercy of legislation by headline and non-scientific rule making such as that recently proposed in House Bill 1559, State of Pennsylvania. Secondly, the proposed rules which apply directly to filtration of parenteral drug products and by default, as mentioned above, to filtration of orally ingested products, refer to asbestos only because of the wide publicity given this subject. Asbestos is already being replaced in certain filter media by micro glass fibers. These are not soft and flexible. These have no chance of dissolving in the human stomach. Many scientific studies qt>P*DoUe( # Hearing Clerk Food and Drug Administration December 5, 1973 Page 2 have proved that these fibers are perfectly capable of producing human health problems. This could be more true where the glass fibers have had a zeta potential impressed on them to simulate asbestos in function. We sincerely believe that unless the Commissioner's final regulations take this into account, his regulations will really have an adverse effect on human health m America. Yours truly, I Hearing Clerk Food and Drug Administration December 5, 1973 Page 2 have proved that these fibers are perfectly capable of producing human health problems. This could be more true where the glass fibers have had a zeta potential impressed on them to simulate asbestos in function. We sincerely believe that unless the Commissioner's final regulations take this into account, his regulations will really have an adverse effect on human health in America. Yours truly, RSS:lw