Document vKVQjwLv5XrZXLbmpKJzypy8

O0 SEPTEMBER 1970 MONS 032568 "We are carefully to preserve that life which the Author of nature has given us, for it was no idle gift." ummf w. wu,,, mt-mo Father of the Federal Food end Drugt Act of 1909 Pram M* ewtmtRMnint adorns *'Ut Mttf lh Owning Tim*'' Hanover Celia#*. 1M7 lthough the present degree of concern over A chemical contamination of the human environ ment has been with us only a few years, chemical con tamination of one pari of the environment, the food wc cal, has been one of PDA's major concerns for a great many years. During these years l*T)A, under general and .sjuvilic statutes, has dcvclo|>cd clbcienl regulatory and scientific methods for protection of the consumer from toxic chemicals in or on his food. But this methodology has involved mainly those foods that might be reasonably expected to become contami nated under given conditions. Thus these methods have involved such chemicals as pesticides used in producing, processing, and storing foods; drugs used in foodproducing animals; and direct or indirect food addi tives. Little attention has been -given to other ways that toxic chemicals used chiefly in industrial processes may find (heir way into food through contamination of the earth, bodies of water, and the atmosphere, when considered in context with the ecological patterns of plunt and animal life that may tend to concentrate these chemicals in hitherto unsuspected food sources (see page 8). More study is needed on the kinds of industrial chemicals that pose a threat to human health when loosed in the environment; the nature and extent of the threat; the legal, regulatory, ami educational safeguards needed to protect the public health; and the scicnliAc methods needed to detect, identify, and measure these chemicals in foods. . i j M0IS 03i569 FDA Paptra / Sfpieinbrr 1970 l l oo j| n ono instance, in (lie objections filed lo our .jt. impli'iiu'iiKiiion of the NAS-NKC rccoinmcn- J.iiioii';, iluu' k.is MilmiiiU'd ;i Mm of more than loo so vmMi-J si'ii'otilu' `.Indies :m<l rcpoils pur- j'oiiioi* to show snniclhin- roj'.iirdinj* u particular dint'.. Ii look cnnsideinhlc time for our leo.a) ;imi ss'uniiiie stalls lo osOiblish (hat tliis evidence w.is mostly irulev:ml :nul obviously iiuidcquttlc. ''Stic!) it submission does a ili^scxvice lo llu! I o<h| iiotl AilminisOiiiion (even if we pre- n.iiD. lo you who are upholding professional si.iml.iol.. ami to the public for whom we should a/l be spending our lime more productively, and linally to the drug industry." /.'/m A!./>., As.\i\iant lo the Commissiottrr far Mutual A ihiir.K, at tin 93rd Annua) Meeting of the American liar Association, Si. Louis, Missouri, August Ii, 1970. ,i linn he GRAS list has been the point of focus -- for concerns over food safety. The cyclamute incidcni ol hist October heightened (his con* cent. In its wake, the President directed the Agency lo review the entire list to be assured that consumer safety is being adequately protected. There will, no doubt, be n harder look at these food additives. Thcic will, no doubt, be some deletions from the list. But the list is not a hiding ground for a variety of chemicals of unknowns or uncertain toxicity. Il includes nu trients, such as ascorbic acid. ' What is needed right now is for the producers ami 'he users of these substances to take a care ful look at the evidence of safety on which they market or use the ingredients. Just us the evi dence to support drug promotional claims is thin in many instances, the evidence to support GRAS status of several substances is likely to be equally thin at least in some instances. Industry ought to take the initiative here. But will it? Or wilt it wait to react to the processes of public examina tion of its practices?" William W. Goodrich, Asnstant General Counsel, Food, ))rut;, and Environment/.! flrallh Division, DUEW, ol tin 9/rd Annual Meeting1 ol Ihe American Bar As sociation, Si. Louis, Missouri, August 13,1970, eml l. ntehardiaa S-oruiy. u ! Oecsilme-nt Hrtllh, and Ri) O. {|ibif|, M O. Av.t f>r*r irlaiy Uit Health and CcM.l.c Altana Chart** C. !>! M.o, (..iniiiMtiiMii i.l limit ,,<j 0>VD* Howard II. IMAII Am.I .<n*ninM'iiif Inr | .tin niton Mini lnlitlMlftlKin Harald C. HaphlhtrCdilonal Diracior Jaaae M. Nkhl,/A**t AM Director Oan 0'r**i#/i'hou>9'ps( Jaan M. Oillw|itM4na{lfi| Cdltor rrcdarlch L. Tawnahand/Piodiietton Mgr, PHOTOnnAAItn nifteh film, boimm inlt a, a. I, tit, >7: NAfCA, I|f t!-, Cfimrl I inter CiUrn, Onltam #, tap 11; l'tnn*|>l*ft,<l'i Uf'imomriftl l Health, 10; Framant Dnvll Ucmnto Oorvico, centar II; fOA. FOA PAPERS, the off'CAl mngAr.nn of H*o Food end Drug Arimmitlnilion. * poUhahrU monthly, CKCOpl >oi combined July-August And Deenmhar* Jsnunry tnuns Subscriptions mny be ordered Irom Ihe Supnrtnlrmlt'ni ol Document*, Oovninmnnl Pimlmo Oihro WAt>hmi|inn. 0 C >0(0?. I SC.00 A yoft> (St LO adrlihvft.il tor loiaign mailing) Addret* far edtlnrial mittorti fOA PAPERS. CE-20, Food and Drug Administration. $600 Fisher* Lana. Rockville, Md. JCSW. Articles publlshnd in PDA PAPERS aro In the public domain and taut may be republiaoed without permission. Use ol funds lor printing this publication approved by Director of the Bureau of tha Budget August IS, 1966. Section 705|375J of (he Food. Drug, and Cosmetic Act. (a) The Secretary shell cause to be published from time to limo reports summarinng all judgments, decrees, and court orders which have been rendered under this Act. including tha natura ol tha charga and the disposition thereof. (b) The Secretary may also causa to be disseminated information regarding food, drugs doviees. or cosmetics in situation* involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shait be construed to prohibit the Secretary from eoltecting, reporting, and illustrating the results of tha investigations ol tha Department. Advisors so the Editor* K. Nelson Fltton, Department ol Agriculture; Qeorgt Creel, Department ot Housing and Urban Development; William J. Colter, Post Otlica Dapartmant; Htnry Scherer, Department ot Commerce; Dr. Milner B. Schaefer, Dapartmant ot tha Interior; Dr. Bam Helm, Veterans Administration; Or. Pater V. Siegel, Federal Aviation Agency: Or. Spotlord O. English, .United Stelae Atomic Energy Commission; Dr. Harra J. Carlson, National Science Foundation; Howard A Lewie, National Academy ol Sciences; Arthur Ssttol, Bureau of Cuaioma. 'The fees a*e D've Adniai*te#nea Ii tout* ,apa**<bla <a> Ik, nlcnli a* IDA Willi. Tha Aeviiari ih Ediier h* canHHtanu an mailer* WSline I* *h hmeiien* l Mw Faetrat OaparWwnW one Afltneter us*e HONS 032570 o > Industrial Chemicals and FDA by Henry Fischbach, Ph.D Those responsible for (he public health have good rea son for their increasing concern about chemical subsianecs that may pollute the environment and, among other things, ultimately find their way into man's food. The recent discovery of toxic amounts of mer cury in fresh water fish as a result of contamination of bodies of fresh water is a ease in point. Re cently there also has been steadily growing concern about the release of polychlorinated biphenyls (or PCD's) in the environment and speculation about why and how these chemical substances enter the environment and eventually man's system through the food chain or through other means. To assure the safety, purity, and wholcsomcncss of our food supply, FDA has directed its regulatory and scientific activities to those areas where the possibilities of contamination arc most apparent. As new formula tions ami uses of pesticides and other economic poisons were introduced for agricultural and health purposes, the Agency has concentrated on detecting and identify ing these substances in or on foods. Under its food additive regulations, FDA has sought to asMiic that substances used in formulating, proc essing, and packaging foods do not contaminate the food with toxic amounts. Through its responsibility for foods in interstate commerce and imported foods, FDA has inaugurated regulatory, educational, and scientific safeguards to assure that food products in storage or transit arc not contaminated by toxic chemicals. The development of highly sensitive instrumenta tion and ingenious physico-chemical techniques has enabled man to detect, identify, and measure minute residues of chemicals, both in his own body tissues and elsewhere in (he environment and of particular interest in FDA's ease, in foods. That these residues exist is a reflection of man's genius for synthesizing new chemical substances to advance his many tech nologies. Until recent years little consideration has been given to thfe potential impact of these chemicals on our iota) environmental cycle. But as these sub stances become ever more sophisticated and continue to proliferate, it has become essential that man, in his decisionmaking, take into consideration a factor that becomes more and moijc obvious: these chemicals, many of them in highly Stable forms and many others in forms that may combine with other chemical substances to produce' toxic materials, cannot be dispersed from ^ur planet and thus must become a p;m of the environment. Earth and its atmospheric envelope is a dosed system! In this country our control over industrial chemicals is largely in the field of pesticides and food additives simply because of (he statutory powers conferred on (he U.S. Department of Agriculture and the Food and Drug Administration in these areas. Because of these obligations, the FDA in particular has developed highly sensitive and characterizing methods and equipment with which to monitor pesticides in foods. K is thus mainly in the food area that we have some data on the extent of pesticide residues in our environment as well as some rather incomplete data about residues in the tissue of man. Little is known about the many residues that result from processing the industrial chemicals used in modern industry, simply because man has not looked for such residues; nor has he developed the appropriate, sensitive me thodology by which they can be detected and identified. Much of the publicly voiced concern over the past years has been aimed at reducing the "known" toxic residues in the environment. This concern is certainly appropriate ami efforts are being made to minimize these potential hazards (see article, February 1970 issue, FDA Pai'HRS, about the report by the Secretary'* Commission on Pesticides and Their Relationship to Environmental Health). It is an essential activity, but at least of equal concern should be the planning and deliberation needed to minimize future contami nation of the environment. Chemical substances that arc neither pesticides nor food additives arc present in our environment and may cause hazardous residues in food and feed. Since some of these industrial chemicals are closely related in chemical structure to stable pesticides and may interfere with our measurement of pesticide residues, the FDA must maintain an owarcncss of this potential interference and continue evaluating the validity of its methodology for detecting, identifying, and measuring pesticide residues in food. We must recognize that any stable industrial chemical related in structure to the stable pesticides and used in significant tonnage in industrial processes will become a part of the environment and is likely to find its way into food. Aside from man, I consider fish end the sedentary shellfish to be the greatest bio concentrators of certain chemicals. We must determine the nature and extent of this potential hazard and. if necessary, act to minimise it. L A pertinent example of such industrial chemicals i in the environment is the PCB's, manufactured by the . Monsanto Chemical Company under the trade name, / Srptrmlvr IV70 / FDA toptn MOMS 03257^ Sv\i'i>il tiilu-i companies in tUnopo inamt- i.umiiu' similar piodueis under >lhor trade names. ! I hew imlvisdi.il chcmieals haw certain valuable at- liibnic* that arc attractive lo the many technologic?; developed by modern man: low vapor pressure, high iliclccdic constant. Ivneliehd How property, lire rctiirdmicc, high stability. he. I Iiiik these chcim.'iils haw ninny uonug.ijculininl uses: In paints, tr.mslouner lluitls. plastics. mllu'sivcs, asphalt, tile. etc. With such, wide usage it should Ire expected that traces of these chemicals will enter our watersheds ami become concentrated in lish as do * such other related chemical structures as DDT. The 1* widesptcad presence of PClt's in our environment has been established. They were first reported in fish* I eating birds amt now have been found in fish in the Great I alecs ami. in a few instances, in milk and dairy products ami even in human latty tissues, PCll's are only one of the many industrial organic chemicals undoubtedly present in our environment in such quantity or under such conditions ns lo cause residues in food ami in man himself. We should con* sider ways to collect sound scientific information on these materials so that decisions can be made based on the net "beniTil" to man versus the "deficit." Among the industrial organic chemicals requiring scrutiny, perhaps the halogcnatcd compounds, such us those containing chlorine, should be studied first. For example, the chlorinated naphthalenes and chlorinated paraffins arc widely used in much the same way as PCIi's. An FDA food additive regulation (121.2572) pci mils the use of chlorinated paraffins as cross-linking agents in resins used in coating packaging materials for dry foods. Many other chlorinated industrial chemicals are widely used. Chlorothiophcnes, chlori nated pyridincs. and chlorinated phlhalatc and phos phate esters arc only a few. The Federal Register of April 15, 1970, carried an FDA notice that a food additive petition (FAPOH2519) has been filed by Dow Chemical Company for 2.3,5,6-tctrachloro4-(mcth- ylsulfonyl) pyridine as a preservative for food-packaging adhesives. There is an existing fx>d additive regulation (121.2520) permitting use of tri-8-chlorocthyl phos phate in adhesive^ uspd in food packaging. Hcxnchloro- pentadione is a building block for chemical compounds that imparl fire-retardant features. Chlorcndic anhy dride in resin-based laminates suppresses combustion and imparts self-extinguishing properties to nonflaming, film-forming resins. Such compounds reduce ihc hazard to man from fires resulting from an electrical short circuit that starts a blaze ip a primed circuit board. On the other hand, these compounds arc related to such pesticides ns d^ldrin and cmlrin and should be evaluated from the standpoint of a future hazard in the environment, namely, their net benefit or deficit lo man. A host of chemicals arc used as plasticizers, a use which seems a very likely source for residues eventu ally becoming part of the food supply. The leaching of pl.isiiL-izcrs from plastic (objects in trash disposal Q .. ' TniiM i f TBfciii*** ill i ` i --------- * HONS 032572 FDA Papers / September 1970 / 9 o0 files ami volatilization when plastics arc incinerated may result in contamination of streams through scrubbing of (he atmosphere by rains, ami residues may thm enter the food chain. Many plasticizers are rather stable derivatives of phlhalic acid. Almost 784 million pounds of phthalic anhydride esters were produced for plasticizer use in the United States in 1967, according to the U.S. TarilT Commission report, "Synthetic Organic Chemicals," for 1967. A variety of phosphates and other chemicals arc also used. Another likely source of environmental contamina* tion and subsequent residues in the food supply is chemicals used in rubber processing. Aside from waste from processing plants, rubber worn from tires on the highways and subsequent washing of the additive chemicals into storm sewers and streams may result in eventual residues in our food chain. Production of rubber processing chemicals in the United States in 1967 amounted to 264 million pounds, according to the Tariff Commission report. Examples: Total pro* duction of thiazolc derivatives for this use was over 56 million pounds. Total Ihiurnm derivatives (related to pesticides) was over 14 million pounds. Only n few examples of widely .used Industrial organic chemicals have been cited. In 1967. U.S. production of all synthetic organic chemicals totaled almost 105 billion pounds. Of this total, pesticides and related products constituted less than l percent, or about one billion pounds. This leaves n huge quantity of synthetic organic chemicals with a wide variety of industrial uses. * Except for PCB's, about which only limited informa* tion is available, essentially nothing is known about possible residues of these many nonpcsticidal industrial chemicals in man's food supply and in man himself. Furthermore, there is a dearth of information, on the toxicology of these chemicals. In most eases, little is known about the toxic effects of low levels ingested over long periods. The only other group for which adequate pharmacology is available is the synthetic t-J` 10 l Scplrmbrr 1970 / FDA topers HONS 032573 o l--a& i\V` -.... jo f>.i i :: ^.warj - ^^ . . , /-|* }* ** i' ... .1# t; >*** Honry Fischbseh. Ph D., director tine* February 1970 of Iho Otlioo of Poatlcidao ami Prodpei Safety. Ouroau of Foods and PoaUeldoa. Joined FDA in the New Orleans District fn 1930. * Ik. luMteuf 'V'.. ' '.* ...... - , t'- -S-~/................ - - - medicinal chemicals. hul Ihc mini 1967 production of these chemicals (active ingredients) was only 1R0 million pounds, less than 0.2 percent of mini U.S. organic chemical production. The evolving PCB's situation is tin example of the potential environmental problems associated with man's rapid strides in various technologies. In evaluating the full extent of such ecological complexities, 1 (eel that all available information should be assembled on the volume of use. chemical stability, and toxicity of industrial chemicals related to pesticides. The initial efforts might be directed at the hnlopcnatcd cyclic chemicals since we have methodology based tin years of work detecting pesticide residues comaininc such compounds. lTrom this information a knowledgeable selection might be made of the chemicals most likely to cause hazardous residues in food, feed, or in man himself. At this point the chemical and physical properties of these chemicals should he evaluated, methods should Ik developed for measuring the residues in biologic material, and surveys should be made to determine the extent of (heir presence in the environment. If one of these industrial chemicals is found in food or feed, pharmacological studies at low levels would be essential to determine the potential hazard. The industrial and scientific community should con sider the development and adoption of a mechanism for pretesting new industrial chcmiculs prior to their introduction into the environment. Stable chemicals that may be used in significant tonnage should be scrutinized by an appropriate panel for their net "benefit** to society when the proposed new chemical is presented to the U.S. Patent Office. Such an evaluation at this point in lime should fit into the framework of our economic system with n minimum of disruption. j ! -- ' | FDA Puperi / Srptrmkrr 1970 / II HONS 03257<