Document EvvGg2DQ8DVkvbxbwo9JzaQJ4

FILE NAME Talc TALC DATE 1973 Oct 17 DOC TALC082 DOCUMENT DESCRIPTION Memo RE Asbestos Fibers in Food and Drugs SU oO ETAL re ETAL , oy, fae Se 1525 1525 18th A by STREET N.W. WASHINGTON D.C. 20036/202 833-1435 October 17 1973 MEMORANDUM To MEMORANDUM Rod Camerch and Lucile Adamson the Bob Executive Harris Committee . From Scott II Lang Re Asbestos fibers in food and drugs A. FDA Notice of ProposedProposedRulemaking Rulemaking on asbestosasbestos filters finally proposed regulations and talc containing asbestos in response to the petition filed in the Public Interest and last June by EDF the Center for Science a set of 28th the CSPI FDA published ED's ED's proposed proposed regulations plus in September 28th Federal Regis- regulations its own proposed ter a copy of which is enclosed EDF and CSPI regulations If adopted which 1 a court suit we almost entirely have been wholly like this proposed had the petitioned FDA's the agency for four separatseeparate regulations are think is the best we can hope will have been granted one of for without our requests partially two others denied The and the fourth will scorecard looks essentially EDF& CSPI Proposed Regulations FDA Proposed RegulationsRegulations 1. Prohibit the use of asbestos filters in food and processing the use of parenteral 1. No action proposed 2. Same as COPI with some minor exceptions exceptions procedures 3. Same except under FDA's 3. Establish a zero toler some for asbestos fibers testing ance in talc used as a food most fibers would es- . ' cape detection additive CIFICES IN LAST SETAUKET SETAUKET SETAUKET NY MAN OFFICE ) OFFICE NEW This thr is YOAK CHY recy recy to P COPAM COPAM SUPPORT SUPPORT OFFICE protect protect the enslerament enslerament PINGTON DC PERSILLYPERSIL Y PERSILLY Regulations Regulations a 4. Establish zero tolerance for asbestos fibers in talc used as a component of drugs 4. Same except under FDA's testing procedures some most fibers would cape detection es- . The FDA had proposed such a zero tolerance regulation in the Federal Register on August 12 1972 more than 14 months ago In our petition we asked the agency to promulgate a final version of that regulation immediately Instead the FDA has proposed it but in a slightly weakened version In addition we had argued in our petition that since asbestos is carcinogenic when inhaled when injected and probably when ingested it should be prohibited from food and beverages by the Delaney Caluse The FDA responded in its introductory statement by minimizing the potential carcinogenicity of asbestos fibers in food and drugs without taking any position on the health effects of ingesting asbestos and without mentioning the Delancy Clause It decided to regulate asbestos in food and drugs as part of good manufacturing practices rather than because of a risk to health This is disappointing because we had hoped to have the FDA record that asbestos may be carcinogenic when ingested to help us in the Reserve Mining case in which the ingestion of asbestos is a central issue The FDA's proposed regulations will not be much assistance to either side however since the agency conspicu- ously avoided taking a position on this issue The FDA's caution was probably dictated not only by the impact its den decision might this might put have on the Reserve trial but on its own regulatory program also by the bur- If asbestos in food is considered carcinogenic then water used in food process- ing that contains be a carcinogenic Duluth is not the asbestos fibers such as Duluth water would also food additive in violation of the Delaney Clause only major metropolitan area where millions of asbestos fibers per liter have been detected in the water supply All food processed in these areas using public water could be contaminated Thus both FDA and EPA would face severe regulatory crunches if either were to publicly acknowledge that asbestos is just as lethal when ingested as when inhaled or injected This factor has not been overlooked by top officials of cither agency I can assure you B. EDF and CSPI Response EDF and CSPI must now decide what responsers esponses if any to make to the FDA's counterproposals Comments are due by December 27 The ing Center has asked Ventions a private laboratory specializ- in electron microscopmeicroscope research to assist us in our comments a Jim Turner lawyer specializing in FDA matters has offered to on consult with us legal strategy Turner is a member of EDF's Environmental Health Program Advisory Committee There are several significant deficiencies in the FDA's counterproposals which in my opinion deserve a strong response the 1. Asbestos to prohibit Filters Xs use of The FDA has not proposed any rregulateions gulations asbestos filters in processing foods and beverages This isarguably a violation of the Delancy Clause However that issue need not necessarily be reached The regu- lation of filters used in processing foods and beverages is also arguably compelled bythe FDA's own policy statement on good manufacturing practices contained in the preamble to the FDA's proposed regulations on talc and parenteral drugs It is therefore reasonable precautions to be taken in to require the manu- facture of food and drugs as part of practices good that manufacturing the to assure amount of asbestos fibers in any food or drug is reduced to the minimum feasible level 38 Fed Reg 27079 emphasis added. The and failure to apply beverages is to this policy to say the least the use of filters for food arbitrary and capricious 2. Talc More than 14 months have elapsed since the FDA initially proposed to take talc contaminated with asbestos off the GRAS list and to 1972 nothing advance the eliminate its prior sanction This new proposal proposal carcinogenicity of does nothing when 37 Fed to Reg ingested 16407 August 12 the ball Although not been positively carcinogenicity asbestos has established there is certainly evidence to show that it does the criteria enough not not meet GRAS list i.e. it it is is generally recognized among experts qualified by uate its safety as having procedures " . to be safe and scientific training been adequately shown experience to ovalthrough scientific under the conditions of its intended intended intended u use se use 21 U.S.C. 321 FDA regulations further specify that when the is safety of a substance previously listed as GRAS under investig tion he initial results of a new investigation even if not convincing with respect to the potential harm may establish that the substance in question can no longer be considered as GRAS 21 C.F.R. C.F.R. 121.3 This would appear to apply to our case Although there is considerable room for the exercise of adminis- trative discretion in applying the above criteria discretion must be based on reason and we can make a very strong showing that there is no sound reason for permitting tale containing asbestos to remain on the GRAS list or to retain its prior sanction any longer The FDA's claim that it is conducting a study to determine an appropriate testing procedure is not a valid reason for delay since the FDA has claimed to be conducting such an investigation for more than 14 months already At some point the administrative process must arrive at a conclusion 3 Test asbestos Procedures Talc The test procedures for detecting fibers in tale proposed in 121.2006 are deficient in several respects Counting fibers more than 5 microns in length under a light microscope is hopelessly inadequate In the Reserve Mining case for example EPA studies indicate that virtually all of the asbestos fibers involved were less than 5 microns long and require sophisticated electron microscopes for detection FDA's proposal is based on an AOAC Association of Official The Analytical Chemists method that certainly has with the recent rapid developments in asbestos not kept pace detection techniques Lucile Adamson and I believe there is a sound alternative to the approach taken by FDA Not all talc deposits are contaminated with asbestos Some are relatively pure deposits Therefore it might make more sense to require certification of deposits of talc which can be used for food and drug processing rather than require inadequate and expensive monitoring of each product or component This does not conflict with our original proposal since we did not address the question of the appropriate test methodology in , our petition During the next discussed above and few the weeks we will be exploring the possible alternative courses of Your individual or collective comments are most welcome welcome depend try to complete any comments we submit to the FDA prior the Washington office at the latest by DecembeDecembrer 1st take this further and go into court will depend at least to some extent on whether we can interest other staff attorneys or perhaps perhaps pro bono attorneys in the suit Jim Turner thinks this may be a suitable case against the AOAC which Turner says is controlled FDA the AOAC office is at FDA's headquarters and frequently c.g. used by FDA to justify the adoption of antiquated testing procedures as the one proposed here This is an issue Lucile and I would have missed which demonstrates the importance of having the right people on EDF's program advisory committees