Document pLdmmK1002p7eZ6xOqag1p66

FILE NAME: Talc (TALC) DATE: 1973 Oct 17 DOC#: TALC082 DOCUMENT DESCRIPTION: Memo RE Asbestos Fibers in Food and Drugs i r ' K : S ln - T N.W., WASHINGTON!, D.C. 20036/202 83J-1485 October 17, 1973 MEfiORAN DUM ' To: Rod Garnercc and the Executive Committee, . Lucile Adamson, Bob Barris * From: Scott II. Lang Re: Asbestos fibers in food ana drugs . A . FDA Notice o .. The FDA has finally proposed regulations on asbestos and talc containing asbestos, n* _re^pon~- ro unu ^ . , - \ ,,,,u ( 1cv. -I- t>v* J"0'b* i' C J 011. C 0 x n t l x G - last June by ^ ^ proposed regulations plus a filters Tnt-rept - x * -r ^ ^ - set of its own propose regulacionu in the - - ter, a copy of which is enclosed. ,?nP Prd r q DJ r e a X t G n " If -do" S uhi rh 1 S c o f i : b , we alncXeloLly, have' been wholly had petitioned the agency for four separate the FD.V, counter-proposed regulations are think is the best R can hope for without will have been granted one of our reguests two others partially, and tho fourth will denied. The scorecard loo. essential!, like this : `DF V CSPI Proposed Regu 1ation s ___ __ FDA P'roposed Reaulations 1 . Prohibit the use of acjbos tos fi1ters in processing food and beverages. 2 . Prohibit the use of asbestos filters in p reoaring parc-^ ra1 drugs. 3. Establish a zero toler ance for asbeu tos lib c r in talc used as a .i.ood additive.* ' 1. No action proposed. 2 . Serre as EDF/CGPI,_with some minor exceptions. Same , cxcept uncle r FD A 'a testing procedures, some (most?) fibers would es cape de te ct i o n . c. nfpc in gar,IWTAi'f'rr.ni (t'-'r.1 'iiy (!'.pm'\\i`"b"oe; (vrint,'.vvonc * V) / at'. ; f ;hn cot/. t'h' h 'll. -2 EDF ~sT c 5P Proposed R .3 g illat i o n s_____ FDA Proposed Re gu 1a ti o ns__ 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 es cape detection. ' *The FDA had proposed such a ero tolerance regulation in the Federal Register on Augusl . 12, 1972, more than 14 months ago. In our petition we askec . the agency to promulgate a final version of that regulati on immediately. Instead, the FDA has re-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 in gested, 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 i.ibeis m food and drugs, without taking any position on the health effects of inaesting'asbestos, and without mentioning the Delaney Clause. It decided to regulate asbestos in food and drugs "as part of good manufacturing practices," rather than because of a risk to healtn. This is disappointing, because we had hoped to^have the DA-on record, that asbestos nay 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 b e _ much assistance to either side, h o w e v e r s i n c e the agency conspicu ously avoided taking a position on this issue. The FDA's caution was probably dictated not only by the impact its decision might have on the Reserve trial, but also by the bur den this might put on its own regulatory program. ^ if asbesuos^xii food i s .considered carcinogenic, then water used in food process ing that contains asbestos fibers, such as Duluth water, would a..so be a carcinogenic food additive in violation of the Delaney Clause. Duluth is not the only major metropolitan area where millions of asbestos fi*o rs per liter have been detected in the water suppJ.y. All food processed in t.hese area: using public water could be contaminated. Thus, both FDA and EPA would face severe regula tory crunches if either were to publicly acknowledge u m . asoes tos is just as lethal when ingested as when inhaled OL _injected. This factor has not been overlooked by top officials of C X b i l G x agency, I can assure you. -J- B, BDP and CSP1 Response EDF and CSP1 raust now decide what; response: ; if any, to make Bo tl f o ; s co un to rp ropo sol Comments arc due by December 27, ri'he Center has asked EM~Vont.ions , a private laboratory spoor aliz- ing in electron microscope research, to assist us in our common fa Jim Turnery a lawyer specializing in FDA matters, has offered to' consult with us on legal strategy. (Turner is a member of E D F 1s Environmental Health Program Advisory Committee.) There are several^ significant deficiencies in the FDA *s counterproposals which, in my opinion, deserve a strong response: 'fjie IDA has not proposed any regulations to pronibit the use of asbestos filters in processing joods and beverages. This is arguably a violation of the Delano/ Clause.. However, that issue need not necessarily be reached, '.The regulation of filters useci in processing- foods and beverages is also arguably compelled by the FDA 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 to require precautions to be taken in the manu facture of food and drugs, as part of good manufacturing practices, to assure that the amount of asbestos fibers in any food or drug is reduced to the minimum'"feasible level. 38 Fed. Reg. 27079 (emphasis added). The failure to apply' this policy to the use of filters for food and beverages is, to say the least, arbitrary and capricious. 2. T a lc. More than 14 months have elapsed since the FDA .initially proposed to take talc contaminated with asbestos off the GRAS list and to eliminate its prior sanction. 37 Fed. Reg, 16407 (August 12, 19 72). This new proposal does nothing to advance the b a l l ."a .L-,,ho eg a the carcinogenicity of. asbestos when ingested has not been positive iy established, there is certainly enough evidence to show that it doe s not meet the GRAS list criteria, i .o ., "it is not generally r a c o o n ::od among experts qualified by scientific training and experience to ov al- \ r shown th roup h 0c-ILQV-tX 1` 1 C procedures. . . to be safe under the cot It ions of its in 1c.-G 21 U.S.C. 32.1 (s). FDA regulations furl;] specify that V h n saf ot.y of a subs l;ance pre vious 1y 11 sted .hr GRAS is undo l inV t i o n , [tjno initial results or a new invesstt-iiggaatciroonn, eveon itr not convincing with respect to the potential haarITmT,., may oes ttoabllish tha! the substance in question can no longer be considered as GRAS." 21 C.F.R. 121.3(f). This would appear to apply to our case. Although there is considerable room for the exorcise of adminis trative discretion in applying the above criteria, discretion must 4- he based on eason, and wo can mako a very trong shewing th at there i; no sound reeaason for permitting talc con to inina acbo tO to remain on the GRAS list or to retain JLJu- ->, pri or oon c t.ion air.v longer. The FDA's claim that it is con_duct.! xv' a study to do1er rajne an appropriate testing procedure i': not. a Vca.l le reason for delay, since the FDA has claimed t:.oo be conducting suec!h an xnves tigation for more than 14 months already. At some point the administrative process must arrive at a conclusion. 3. Test Procedures for.Talc. The test procedures for detecting asbeslTos'Tlliirs in'talc proposed in 121.2006 (c) _are deficient in several respects,. Counting fibers more than o raLairons in ^^9 -^ under a light microscope is hopelessly inadequate. In true Reserve Mining case, for example, FPA studies indicate that v n tualxy at. of the asbestos fibers involved were less than 5 microns long ane require sophisticated electron microscopes for detection. The FDA's proposal is based on an AOa C (Association of O^j-.u -a U j. Analytical Chemists) method that certainly has not kept pace with the recent rapid developments in asbestos detecLion t e c h n i q u e s .* Lucile Adamson and I believe there is a sound aitentative to the approach taken by FDA. Not all talc deposits ore contaminated with asbestos. Some are relatively pure deposits.^ Thoyerore,jm might make more sense to require certification ox deposits oj. '~ar 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 ciia not address the question of the appropriate test methodology m our petition. ' During the next few weeks, we will be exploring the issues discussed" above and the possible alternative courses o.: action. Your individual or collective comments are most welcome. 1 wi.. try to complete any comments we submit to the FDA prior tot yyvin, the Washington office, at the latest by Decemcor lse. take this further and go ..into court will depencx ac lec.su yo yunyy_ extent on whether we can interest ocher sto..-..)- at Loj. < .j <- a. p L pro bono attorneys in the suit. *Jim Turner thinks this may be a suitable case to laurcn aaainst the A O A C , which Turner says is controlled by FDA the AOAC office is at FDA's headquarters) and frequently FDA to justify the adoption of antiquoted testing as the one proposed here. This 3.s an issue Lucilty c-.ne I have missed, v;hich demonstrates the importance of navxng right people on E D F 's program advisory committees. an acucei (e.g , used by ym 1 wo^.-Le the