Document dQeXnvQ75MoVwb2dbVYXBKEZR

ElNAlt T. WUEFSBERG CONSULTANT. GOVERNMENT.INDUSTRY RELATIONS '' sets WILLIAMssuno OLVD. ARLINGTON. VA. 22207 (7091 a44 April IS, 1972 Hearing Cleric Department of Health, Education and Welfare Room 6-88 . 5600 Fishers Lane Rockville, MD 20852 - Reference: Department of Health Education and Welfare Food and Drug Administration 21 CFR Parts, 3; 121; 122; 128 Polychlorinated Biphenyls, Notice of Proposed Rule Halting Federal Register, Vol. 37 No. SU, Saturday March 18, 1972 Dear His3 McCullar: As an interested person and private citizen, I wish to protest this proposal on the grounds that the course of action chosen by the Commissioner is not in concord with the authority granted him under the FD&C Act. How ever well intentloned the proposal and despite ray whole-hearted agreement with his concern over the problem of contamination of food with poly chlorinated biphenyls, I believe the objectives can be attained without doing violence to the FD&C Act. X am further of the opinion that the inter ests of consumers and producers can and must be protected within a frame work of law and that it is the burden of the agencies of the Executive Department to act at all times within the authorities granted by the applic able laws of Congress. Objection is taken to the proposals for amendment to the Code of Federal Regulations, Title 21 Paragraph 3.__, Formal Statements of Policy or Interpretation. As I understand these statements they are intended to reflect the opinions of the Commissioner or declare his position in a given matter. For that purpose they are very valuable instruments. In 0054ill5 >2< a practical way thssa statements are highly regarded and may be commonly observed as if they were law. However they are not substantive regula tions and aro inappropriate vehicles for mandates such as Par. 3. Use of polychlorinated biphenyls (PCB's) in the production and storage of animal feed, "(b)(3) Within 30 days follovlr.g the effective date of this order, the management of establishments producing animal feed shall: (l) Have the heat exchange fluid U3sd in existing equipment or machinery sampled and tested etc. etc. (li), (ill), and (iv)." Presuming non-compliance, what law ha3 been violated? What prohibited act has been committed? What charge will be brought? What penalties have been provided? With but a modest knowledge of the Food, Drug and Cosmetic Act, I fail to find that an authority for such mandates has been granted to the Secretary or his delegate, or that failure to comply is a prohibited act. The same considerations are applicable to the proposal: Par. 3__ Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (b)(l) and (b)(2). These mandates are without authority and non-compliance i3 not a prohibited act within the language or intent of the Food, Drug and Cosmetic Act. As to the proposal to add Section 128.U, Equipment and Utensils, I agree that the so-called "Current Good Manufacturing Practice Regulations" provide for the industries a valuable expression of what the Commissioner believes should characterize various commercial operations. I do not believe these statements have the stature of substantive regulations and they are inappropriate as vehicles for the mandates provided in this pro posal. '- It is my opinion that, phrased as Formal or Informal Statements 's of Policy or Interpretation the guidance provided by these proposals would TOWOLDMON0055436 be most valuable to all concerned. Under the authority granted In Sec. I1O6, FD&C Act, 21 VSC 3h6, the Commissioner proposes to add a new Part 122 to the Code of Fbdoral Regul ations. Of significance to this objection is the proposed Par. 122.10 Tolerances for Polychlorinated biphenyls (PCB's). It may be noted that the proposed tolerances are temporary. The Commissioner's office has advised that these are to be further reduced to the extent practical as the elimination of PCB's from food and food-packaging materials pro gresses. The question here is not the benevolence of the Commissioner's intent to eliminate PCB's from foods and food-packaging materials. No one who believos in the virtue of pure food can dis;jree with such purpose. To understand what is happening in these proposals and the subtle violence being done to the FD&C Act requires a careful analysis. Without the credentials to interpret law, I may indeed be rushing in where wise men fear to tread. However, I believe that scientific truth supports these arguments and that the issue in essence has been litigated in the case called Lexington Mill and Elevator Co. That was done in a strict judicial and scientific climate whereas today's political and emotional climate tends to prevail over strict adherence to scientific fact. First there is no question of the authority of the Commissioner to propose tolerancos under Sec. 106. The question is whether or not the proposed tolerances meet the criteria intended by law. Once the require ments of public procedure are complete, tolerances under Sec. 1*06 become regulations having the force and effect of criminal law. Upon a determination OOSMlH tit: that any one of the tolerances have been violated the Commissioner Is required to charge that the offending articles are unsafe, to remove them from commerce, enjoin against further violations and/or prosecute those who commit the prohibited act. Classically the removal from the channels of commerce is accomplished by selsure action charging under Sec. Ii02(a) (2)(A) that the food is adulterated in that it bears or contains a sub stance which is unsafe within the meaning of Section lt06. Section I1O6 provides that for any poisonous or deleterious substance which cannot be avoided by good manufacturing practice or is required in the production of the food, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary to protect tho public health. Nowhere do we find In the language or Intent of the Food, Drug and Cosmetic Act that the Secretary has the authority to set tolerances more restrictive than those necessary to protect the public health nor to use soma othr basis for tolerances in these sections of the Act which relate to Sec. b02(a)(l) "adulterated and unsafe". Thus the charge, "adulterated and unsafe" within the meaning of Section U06 must moan what it says. The offending article may not arbitrarily be deemed unsafe because the. producor or manufacturer did not meet a tolerance based on what the Commissioner believes can bo attained. The determination of "unsafe"i3 to be arrived at in view of the other ways in which the consumer may be affected by the offending substances or other poisonous or deleterious substances^ but 1. Sec. h06 .... In determining tho quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which tho consumer may be affected by tho sane or other poisonous or deleterious substances. 00541X6 thesa provisos do not altar the meaning of the tern. This sane guidance Is restated In Sec. h08 and Sec. ItO? . In brief the contention is that Tolerances under Sac. 1*06 must cleave between that which must be deemed unsafe and that which must be deemed safe and not between vh-.t manufactur ers or producers can reasonably achieve and what would be so severe as to cause undue hardship. Neither does the Commissioner have authority to propose tolerances which are more lenient than those necessary to protect the public health. To do so subjects the consumer to food in the market place which is unsafe, or which in view of th;- sum of all of the vectors by which the offending substance and its pharmacological counterparts affect man, must be deemed to be unsafe. It follows that tolerances established oannot be temporary v.'.th the intent of proposing lower tolerances at an appropriate time. The Commissioner's only choico is to propose tolerances which with the best toxicological advice available condemns that which mu3t bo deemed to be unsafe and permits that uhich must be deemed to be safe. Exception to the rulo might be noted in time of food shortage or famine when a higher tolerance is recognised as a Justifiable risk. Likewise, tolerances may be raised or lowered with tha advent of new Information concerning toxicity, mutagenicity, teratogenicity or other health facet, also with 2. Sec. UOtf lb) . T* . . In establishing any such regulation, tha secretary shall give appropriate consideration, among other relevant faotors, (1) . . . . (2) to the other ways in which the consumer may be affected by the same pesticide chemical or by other related sub stances that are poisonous or deleterious. 3. Sec. L09(c)(5) In determining, for the purposes of this section, whether a proposed use of a food additive- is safe, the Secretary ehall consider among other relevant factors--(a) the probable consumption of the additive and of any substance forced in or on food because of the U3e of.the additive; (b) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or sub stances in such dlot; and (c) safoty factors which in tha opinion of exports qualified by scientific training and experience to evaluate tha safety of food additives are generally rocognisod as appropriate for the use of animal experimentation data. \ '\ *6* ' changes in par capita ingestion of the concerned substance from all known sources and also as other new facts provide a better sciontifio basis for docision. To be between the horns of this dilerana nay be unpleasant for the Commissioner and his advisors but both producers and consumers of food are entitled to a just decision based on the best scientific advice available. This objection to the proposed tolerances. Sec. 122.10 is based on the contention that the tolerances do not dolineate between that which must be deemed unsafe or safe but that thsy attempt to identify temporarily the current goals for ind.rtry practice. They reflect the Corsaissioner's opin.' on as to what food and food-packaging producers can achieve for the present. In other words the proposed tolerances are based on the chemistry of the problem and are not the product of a toxicological determination that a violation mu3t be deemed to be unsafe in the same sense the term is doflned in Sec. L[06 and further elucidated in Soc. U03 and Sec. tt09. The question arises why should the Commissioner be constrained by considerations of hazard to health in his sincere and praiseworthy effort to reduce the amount of a poison in food to the least amount tech nologically possible. The emotionally unpalatable answer lies in the fact that in the strict scientific 8ense there are no poisonous or deleterious substances but only poisonous or deleterious amounts of substances. Below the level at which health hazard begins, a substance is neither poisonous or dsletorious. Emotionally it may be impossible to accept the concept that a highly toxic substance or even a moderately toxic substance such as PCB's are not poisons. Scientifically there is no question. In some amount every substance is safe and in another amount every substance is poisonous and deleterious. Nothing is of itself safe and nothing is . 005*120 TOWOLDMONOQ55440 V *7 * I ~' of Itself poisonous.This observation has b8n nada ^ tha National Academy of Science s^*'' and repeatedly by othar responsible persons at least since the time of Paracelsus, (ca 1530 A.D.) To me what is required in the promulgation of a toleranco under Sec. Ii06 is a toxicological conclusion based on today's knowledge (not including soma future undefined concern as to mutagenicity and teratogenicity) that defines the point at which the beat scientific advice the Conmis3ioner can command, says the article of food must be deemed unsafe. By public procedure these conclusions are exposed to tha boat scientific minds in the nation for comment. Out of such deliberations come the levels (tolerances) at which the Commissioner may and must seise and destroy offending articles of food. There is some apparent support for the Per Se Poison Theory in portions of the toxt of the Food, Drug and Cosmetic Act. Section li06 begins with a condemnation of "Any poisonous or deleterious substance lu Chemicals are used in various phases of food production and technology. Those that occur in the food as the result of such use are termed "chemical additivos". The regulation, in the interest of public health, of the extent of occurrence of these chemicals in food la based in part on the established toxicologic principle that there is a "safe level" of intake for any chemical. An additional principle, which has not been generally recognized or, in fact, stated, enters into such regulation. This prin ciple permits the ignoring of the presence of known, finite quantities of chemicals in food as though there were none present. There has bean sons tendency to use the term "zoro" to Include such finite, though ignorable, amounts. It seems preferable to recognize that these amounts are finite but that they are insignificant or inconsequential Insofar as public health is concerned. Statement by the Food Protection Committee, Food and Nutrition Board, National Academy of Sciences, tlatj.on.U Research Council, Food Drug Cosmetic Law Journal, Coraiorco Clearing House, Inc. Chicago, July 1958 p.U77 5. For every compound there is a level of intake below which there is no discernible effect upon health. In toxicologic testing, a level of intake of a compound having no demonstrable effect upon at least two species of animals when fed over a long period is generally referred to as a "no-offect level". Extrapolation frc: the "no-effect level" in animals has been successful in defining a level of intalca which has a negligible probability of injuring any individual in ths population. This level is commonly referred to as tha "Bafe level" for use by man. Ibid p. l7o 00S*12i TO VVOLDMONOQ55441 added to any food .... shall be deemed to be unsafe . . ." Ibis simplistic language, probably expedient politically for the passage of the Act, was repeated In adding to the law, the Pesticide Amendment, Sec. 1>08, and the Food Additives Amendment, Sec. Ii09. Other phrases in the FD&C Aot seemingly support the Per Se concept unless they are read in the context of the scientific fact that no substance is poisonous or deleterious except in the amount sufficient to enable it to be poisonous or deleterious. In the immediate instance PCB's are not poisonous or deleterious in any amount but only in that amount in which they may be harmful to man under the comprehensive guidelines provided in Sec. lOS and further amplified in Sec. 1)08 and Sec. 1)09. It may be proposed that in the Food, Drug and Cosmetic Act of 1938 the Congress chose to renounce or relinquish the intent of the prior Act and espouuo the Por Se Poison concopt by law. Certainly the casual reading of Sec. 1)06 would suggest that. This would thsn vest in the Commissioner the power to identify an offensive substance as Poisonous or Deleterious, to seize and destroy offending articles of food as "deemsd unsafe", to set successively more rigorous tolerances until the affected industry or agriculture had reached the limit of technological capability to exclude it. In a popularity contest managed by skillful promoters in today's highly emotional climate there is no telling how loudly the clamor for this view might become. The problem is that not even tha Congress can invalidate what scientific experience shows to be truth nor was it ever their intention to do so. ` In addition to what I believe can be logically deduced, two matters compel this difference of opinion with the Food and Drug Administration. First, the charge that food is adulterated and unsafe must result in the 0054122 9 seizure of property and in the instance at hand the destruction thereof by some means that will not contaminate another facet of the environment with PCB's. To quote Chief Justice Warren, "When society acts to deprive one of its members of his life, liberty or property, it takes its most awesome steps .... The methods we employ in the enforcement of our criminal law have aptly been called the measures by which the quality of our civilization may be judged.",6 I do not believe that the Congress in the Food, Drug and Cosmetic Act intended to grant to the Commissioner the power to seize a man's property as adulterated and unsafe for viol ation of a limit that reflected the Commissioner's Judgement of what was possible. On the other h.nd the Commissioner should have little choice but to seize property that contains an amount of soma substance which a carefully considered toxicological opinion must regard as unsafe. Secondly, the concept of a constraint on the Commissioner's authority to limit an offensive substance in food has been considered in the case 7 of US vs Lexington Hill and Elevator Co. . Though there is no case history of litigation directly on the Per Se Poison Theory for the reason that scientific fact does not lend itself to litigation, i.e, whether or not Arsenic is Per Sa poisonous or deleter ious to man is not a question of law. In the matter cited, the govemmsnt seized flour under libel charging adulteration with "nitrites or nitrite reacting matorial, nitrogen peroxide, nitrous acid, nitric acid and other poisonous and deleterious substances which might render the flour injurious to health." S. Coppedgo vs United States ?32 US 399 7. Klelnfeld, Vlncont A. and Dunn, Charles We3loy, The Federal Food Drug and Cosmetic Act 19L9-50, Commerce Clearing Houso, Chicago pages 51-55 8. Ibid p.5l 005*123 llO The trial court (in error) charged the jury as follows: "The fact that poisonous substances aro to be found In the bodies of human beings. In the air, In potable water, and in articles of food, such as ham, bacon, fruits, certain vegetables, and other articles, does not justify the adding of tte same or other poisonous substances to articles of food such as flour, because the statute condemns the adding of poisonous substances. Therefore the court charges you that the Government need not prove that this flour or foodstuffs made by the use of it would injure the health of any consumer. It is the character--not the quantity--of the added substance, if any, which is to determine this case." ^ The Circuit Court of Appeals held that the trial court erred in instructing the jury that the addition of a poisonous substance in any amount would adulterate the article for the reason that "the possibility of injury to health due to the added ingrodlent and in the quantity in 10 which it ie added is plainly made an eesential element of the prohibition." Upon a writ of certiorari the Supreme Court upheld the Court of Appeale. Though the use of the words poisonous or deleterious in this opinion have overtones of the Per Se Poison Theory the court recognized clearly the intent of Congress to condemn food containing an added poisonous or deleterious ingredient only when such addition might render the article of food injur ious to health. 10. Ibid p.52 11. If it can not by any possibility, whon the fnct3 are reasonably considered, injure the health of any consumer, ouch flour, though having a email addition of poisonous or deleterious ingredients, may not bo condemned under the act. Ibid p.5U \ Ills i Whether or not the proposed tolerances (FR March 18, 1972) in fact delineate between that which must be deemed unsafe and that which must be deemed safe is a question for scientists with appropriate credentials. What levels the industries can "live with" now (temporarily) and attain later with diligent effort is irrelevant. If food in the market place is unsafe by virtue of PCB's it must be removed from the channels of commerce. If food in the market place is safe the proposed tolerances should be recon sidered and any unfortunate incidents or accidents corrected by FDA And USDA as heretofore. The Commissioner states that "the current dietary level is not considered an immediate hazard to the public health." By deleting the word immediate, we have a more forthright statement, "the current dietary level of PCB's is not considered an hazard to the public health." In view of the fact that thevproduction and use of PCB's in the U.S. have within the past two years been drastically curtailed and controlled there is little reason to expect that the situation will worsen. Are there more effective way3 in which the objective of further reducing the level of PCB's in animal feeds, feed components, and food for human use can be achieved even though the the current dietary levels present no hazard to the public health? The fact that there are ways to accomplish the objective has been aptly put in a recent presentation by Richard J. Bonk before the 15th Annual Educational Conference of the Fbod and Drug Law Institue and the Food and Drug Admin istration, "It is recognized that the integrity of the product is the undiluted responsibility of the manufacturer. However the ultimate solution to these problems whero contaminants are Incorporated and concentrated from the hnvironment will require the concerted effort of consumers, industry, 9 and government?. 9. Ronk, Richard J. Chemical Fbdd Contamination and Product Integrity, Food Drug Cosmotlc Law Journal, Commerce Commerce Clearing Rouse, Inc. Chicago Vol. 27 No. 2, Fobruary 1972, p.96. 005*125 TOWOLDMONOQ55445 subsequent decision in Bristol-Myers Co. v. FTC, 424 F.2d 935 (D.C. Cir. 1970), where it was even suggested that "substantial delay in * * * achieving such disclosure as the statute requires" would authorize the courts to "con sider the propriety of granting temporary relief" against further proceedings on a notice of proposed rule making V (424 F.2d at 940), . Moreover, we have not yet received the statement required by Section 102 (2)(C) of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4332 (2) (C)) on the environmental impact of the proposed rules, which, according to Associate Commissioner Fine's letter of April 6, 1972, is currently in the drafting stage. The mandate of NEPA is that environmental values be given full consideration by agency officials "at every distinctive and comprehensive stage of the .[agency] process beyond the staff's evaluation and recom mendation." Calvert Cliffs' Coordinating Committee, Inc, v. AEC, 449 F.2d 1109, 1119 (D.C. Cir. 1971). Compliance with that mandate, as the Court of Appeals recently indicated, 1/ The rule making in Bristol-Myers was pursuant to Section 4 of the Administrative Procedure Act (5 U.S.C. 553), rather . than in a two-stage procedure such as Section 701(e) of the Food, Drug & Cosmetic Act (21 U.S.C. 371). The princi ple is thus plainly applicable to all aspects of the present rule making proposal and not merely to those subject to Section 701 (e). . 005*12** It would saem that tha PCB problem must be in Its final stages. Somewhere between 1929 when PCB's were first produced and Aug. 1970 when sale for open system usages ceased, the exposure of the American consumer to PCB's reached its zenith. Recently thoro were accidonts involving poultry feed quickly controlled by FDA and BSDA. Meanwhile the Commissioner has repeatedly assured the public that no hazard to health exists. As a measure of prudence toward eliminating long term low level human exposure the further removal of PCB's from our environment would appear best served by the cooperative efforts of government, business, and industry. There yet remain PCB's which can be physically aggregated and destroyed which otherwise by the nature of their usage may reasonably be expected to be dissipated into the environment to ulti mately affect water and food. In addition to a search of the industrial loca tions as proposed, which may yield PCB's, consideration cn be given to suitable destruction of the PCB type self-copying paper. Personal experience loads me to believe that there are still sizeable quantities of this type of copy paper in business firms, public institutions and government which can be identified, collected and destroyed as a wholesome gesture toward the purity of our ecology, water supply, food and animal feed. At 30,000 parts per million even the ordin ary handling of this paper must result in some exposure. Only very recently have I encountered PCB type paper as follows: (1) receipt for deposit at a federal credit union, (2) roceipt for fare paid for a sight-seeing trip by bus, (3) order pad used by waitress in a restaurant. (U) self copying adding machine tape in a bank ($) hotel statement on check out. Newer forms of self-copying paper are available, nevertheless the PCB type is still in use and can be seg regated and collected for controlled incineration as the only practical known means of destroying the PCB's. Respectfully submitted, Einar T. Wulfsberg/ 005A12B