Document Rp5nYN630z5751KejGqLe5M7n

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N W. WASHINGTON, D. C. 20009 (202)483-6126 W. A. K. DEC 1 9 1974 December 16, 1974 TO: Food, Drug, and Cosmetic Chemicals Committee SUBJECT: Poisonous or Deleterious Substances in Foods Members: Attached is a copy of the notice on the above subject which appeared in the December 6 Federal Register (pages 42743 - 42748) . The Legislative and Regulatory Subcopanitree is to consider this proposal at its January 14,-''1975 meeting. If you have any comments on it, please be sure to send them to Mr. Sunshine (copy to me) prior to this meeting. Sincerely yours. , MMH:sh Attachment Distribution "B" M. yf. Hoover, Secretary Food, Drug, and Cosmetic Chemicals Committee ASI 00003424 Copied by MCA December 16, 1974 PROPOSED RULES M. M. Hoover 42743 [ 21 CFR Part 122 ] POISONOUS OR DELETERIOUS SUBSTANCES IN FOOD Notice of Proposed Rule Making Elsewhere In this issue of the Federal Register the Commissioner of Food and Drugs la Issuing proposed regulations 1 Copies mar be obtained from: Association of official Analytical Chemists, P.O. Box 540. .Benjamin Franklin Station, Washington, DC 20044 concerning permitted levels of mercury for food substances referenced In section in fish and shellfish (mollusks and crus 402(a) (2) of the act and was retained taceans) , lead in evaporated milk and from the Food and Drugs Act of 1906 evaporated skim milk, and aflatoxin in because its language had been construed shelled peanuts and peanut products used by the Supreme Court in United States as human foods. The Commissioner has v. Lexington Mill & Elevator Co., 232 concluded that Part 122, promulgated in U.S. 399 (1974). See Hearings on S. 2800 an order published in the Federal Reg Before the Senate Committee on Com ister Of July 6, 1973 (38 FR 18096), merce, 73d Cong., 2d Sess. 530 (1934). should be expanded to deal with all Its broad scope is shown by the fact that poisonous or deleterious substances in the related provisions in sections 406, food, including food-contact surfaces, pet 408(a), 409(a), and 512(k) of the act food, and animal feed, to implement sec exempt a substance from section 402(a) tions 402(a) and 406 of the Federal Food, (1) only if a regulation has been promul Drug, and Cosmetic Act. gated under the authority of those other Section 402(a)(1) of the act provides sections. that a food shall be deemed to be Section 402(a) of the act distinguishes adulterated: between naturally occurring and "added" If it bears or contains any poisonous or substances and sets different standards deleterious Bubstance which may render It for each. Naturally occurring substances Injurious to health; but in case the sub are prohibited only If they render the stance Is not an added substance such food shall not be considered adulterated under this clause If the quantity of such substance In such food does not ordinarily render It Injurious to health. food "ordinarily" Injurious to health. Added substances are prohibited if they "may" be Injurious to health; if such substances are necessary or unavoidable, special procedures are established by Section 402(a)(2) of the act provides which they can be regulated. that a food shall be deemed to be "Added" is a statutory term of art en adulterated: compassing all ingredients which are not (A) If It bears or contains any added poi inherent and Intrinsic parts of a food. sonous or added deleterious substance (other The term "added" was introduced into than one which Is (1) a pesticide chemical in or on a raw agricultural commodity; (11) a food additive; (ill) a color additive; or (iv) a new animal drug) which Is unsafe within the meaning of secton 406, or (B) if it Is a raw agricultural commodity and It bears or contains a pesticide chemical which is un Federal food law in the drafting of the 1906 act when the U.S. Department of Agriculture (USDA) opposed a provision defining a food product as adulterated if it was injurious to health. The De partment noted that such a provision safe within the meaning of section 408(a); would outlaw coffee, tea, and other foods or (C) If it Is, or It bears or contains, any food additive which is unsafe within the meaning of section 409: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 403 and such raw containing deleterious ingredients as natural constituents. See the testimony of the Commissioner in Hearings on H R. 6906, H.R. 8805, H.R. 8941, and S. 5 Before A Subcommittee of the House Committee on Interstate and Foreign agricultural commodity has been subjected Commerce. 74th Cong., 1st Sess. 58 to processing such as canning, cooking, freez (1935). To exempt such foods containing ing, dehydrating, or milling, the residue of such pesticide chemical remaining In or on such processed food shall, notwithstanding the provisions of sections 406 and 409, not be deemed unsafe If such residue In or on the raw agricultural commodity has been re naturally occurring deleterious ingredi ents, the Senate committee considering the bill in 1906 adopted' the word "added." See 40 Cong. Rec. 897 (1906). (Although the word chosen Implies that moved to the extent possible In good manu the statute is concerned with the act of facturing practice and the concentration of addition, the legislative history makes such residue In the processed food when ready to eat Is not greater than the tolerance proscribed for the raw agricultural commod ity; or (D) If It Is, or It bears or contains, a new animal drug (or conversion product thereof) which Is unsafe within the meaning of section 513. clear that the term seeks rather to estab lish a standard based upon the necessary and Inherent normal nf fho foodTr Actions of the USDA after enactment of the 1906 act demonstrate that all Section 406 of the act permits the establishment of tolerances for added poisonous or deleterious susbtances In food: section 408 of the act permits the establishment of tolerances for pesticide chemicals In or on raw agricultural com modities; and section 409 of the act per mits the establishment of tolerances for food additives. The basic provision of the act dealing contamination was regarded as "added." In 1914, the USDA announced that It had been Investigating the presence of lead and arsenic in food, noting that such contaminants were "usually intro duced into such products through the use of impure raw materials or trnmlhe apparatus nr~ utensils pmplnverf in the processes nf mnnufartnva.:.* The an nouncement further stated that "this bureau holds that food containing with poisonous or deleterious substances arsenic or lead, added In any manner, is in food is section 402(a)(1) of the act, adulterated, In that if contains an added which applies to all poisonous or deleteri poisonous or deleterious ingredient which ous susbtances, whether they are nat urally occurring or added. It is deliber ately cumulative with the provisions may render the product injurious to health." U.S. Department of Agriculture, Bureau of Chemistry, Service and Regu latory Announcements 312-313 dated relating to establishment of tolerances June 23, 1914. FEDERAL REGISTER, V L 39, N . 235--FRIDAY, DECEMBER 6, 1974 ASI 00003425 42744 PROPOSED RULES Throughout the hearings leading to the 1938 act, it remained clear that sub-, stance was "added" within the meaning of the statute whenever it was not inher ent in nature, and not just when it was purposefully added. Thus, in explaining a proposed provision equivalent to the present section 402(a)(1) of the act, which removed the 1906 act's limitation to added ingredients, the Commissioner testified that the effect of eliminating the reference to added ingredients was to include deleterious ingredients "nor mal to the food product." Hearings on S. 2800, supra, at 528. The Commissioner's-examples of added substances clearly included environmental and industrial contaminants. One example given of food containing an added poisonous sub stance was sugar contaminated by smoke from a nearby smokestack. Lead pipes, lead manufacturing equipment, and lead containers were also identified as sources of added poisonous substances. Hearings on H.R. 6906, supra, at 59-60; Hearings on S. 1944 Before a Subcommittee of the Senate Commerce Committee, 73d Cong., 2d Sess. 25, 27 (1933). The Commissioner testified at one point that some added poisonous or deleterious substances were "more or less universal," and at another time that "ttlhcre are very few things * * * in which you will not find contam inating products in some small degree." Hearings on S. 1944, supra, at 18; Hear ings on H.R. 6906, supra, at 59. This em phasis on the ubiquity of added poison ous or deleterious substances clearly demonstrates that the term was under stood to include all food contaminants. The legislative history also identifies examples of foods naturally containing poisonous or deleterious substances and thus not subject to the "added" provi sions of section 402(a)(1) of the act. These examples are Burma beans, which contain a glucoside that yields prussic or hydrocyanic acid; rhubarb, which contains oxalje acid; and coffee and tea. See Hearings on S. 1944, supra, at 17; Hearings on S. 2800, supra, at 29; Hear ings on H.R. 6906, supra, at 58. Except for substances whose deleterious nature is Inherent to the natural state of the food, and thus similar in origin to these examples, all poisonous and deleterious components are "added" within the meaning of the act. Moreover, when a naturally occurring poisonous or dele terious substance is increased to abnor mal levels through mishandling or other intervening act, it is "added" to the ex tant of such increase. Judicial decisions have recognized that the scope of the "added" provisions of the law extends to all poisonous or deleterious substances not inherently a component of the food. In United States v. 1,600,800 Pounds of White Com, Civil No. T-4173 <D. Kan., Dec. 18, 1970), the court held that afiatoxin in com was an added poisonous or deleterious substance within the meaning of the act since aflatoxin is not a natural constituent of com. In United States v. 1200 Cans, Pasteur ised Whole Eggs, 339 F. Supp. 131, 136 (N.D. Ga. 1972), the court recognized that salmonella in eggs is an added poi sonous or deleterious substance. Section 406 was Included in the 1938 act to permit the establishment of toler ances for added poisonous or deleterious substances which are required in the pro duction of food or otherwise cannot be avoided by good manufacturing practice. A limitation may be placed upon such substances to the extent necessary for the protection of the public health. Al though formal tolerances under section 406 have not been used by the Food and Drug Administration, except for the tol erance for PCB's published in the Fed eral Register of July 6, 1973 (38 FR 18096), informal action levels have fre quently been utilized to implement this provision of the law and a number of those action levels exist today. In the past, such action levels have been issued through press releases and other public announcements but have not been pub lished in the Federal Register or codified as regulations. Section 408 was added to the act in 1954 to permit the establishment of toler ances for pesticide chemicals in or on raw agricultural commodities. This pro vision of the law was administered by the Food and Drug Administration (FDA) until the establishment of the Environ mental Protection Agency (EPA) in 1970. In 1958, Congress enacted the Food Additives Amendment, which affected the legal status of some of the contam inants previously regulated only as added poisonous or deleterious substances. The legislation was basically in two parts: first, a broad definition of "food addi tive" and a general prohibition of food additives not demonstrated to be safe; and second, a procedure by which the use of safe food additives could be ap proved. This two-part approach was the congressional answer to what was identi fied as a "dual problem." See H.R. Rep. 2284, 85th Cong. 2d Sess. 1 (1958). The first part of the problem was that under section 402(a) (1) and (2) (A) of the act, the burden is on the Government to show that a food substance is poisonous or deleterious. As the House Commerce Committee noted, "to prove an untested substance poisonous or deleterious may require approximately 2 years or more of laboratory experiments with small ani mals and during this period the Govern ment cannot prevent the use of such a substance in food." The amendment therefore shifted the burden of proof in enforcement actions brought against food containing poisonous or deleterious substances to the food manufacturer. The definition of "food additive" estab lished in section 201(e) of the act is not limited to intentional additives. The breadth of the language in section 201 (s) of the act Includes any food substance, and excludes only those substances which cannot reasonably be expected to become a component of food. The statutory defi nition thus includes what are referred to as "incidental additives" as well as "in tentional additives". See HR. Rep. No. 2284, supra, at 3. Any added poisonous or deleterious substance in food, unless ac cidental and unforeseeable or specifically exempted by section 201 (s) of the act, is a food additive. A food naturally con taining a poisonous or deleterious sub stance becomes a food additive if it is not generally recognized as safe and is added to other food or undergoes processing. Food-packaging material may also con tain food additives. The broad scope of section 201 (s) of the act has been judi cially recognized in United States v. Ewig Bros. & Co., Nos. 73-1008, 73-1454 (7th Cir,, Aug. 28, 1974), and United States v. City Smoked Fish Co,, Civil No. 33989 (ED, Mich. 1970, 1972) in which DDT in smoked fish was held to be a food additive. The court In United States v. Articles of Food, 370 F,, Supp. 371 (E.D. Mich. 1974), held that substances migrat ing from pottery plates are food addi tives. The Food Additives Amendment of 1958 was also intended to rectify the sec ond part of the dual problem which was that "present law entirely prohibits the use of these additives even if their use at safe levels would advance our food technology and increase and Improve our food supplies." H.R. Rep. 2284, supra, at 1-2. Section 409 of the act was enacted to permit issuing a regulation prescribing the conditions under which an additive may be safely used. Eefore any such regu lation can be issued, the statute requires that the safety of the food additive be demonstrated. The statute also requires that the food additive accomplish a phys ical or other technical effect and requires the regulation to restrict use of the food additive to the lowest level necessary foi that purpose. When the Food Additives Amendment of 1958 was enacted, the provisions of sec tion 406 of the act were not repealed. Al though all added poisonous or deleterious ingredients are food additives, except when they appear In food accidentally and unforeseeably or are exempted under section 201 (s) of the act because they are otherwise regulated under the act, the tolerance-setting provisions of section 406 of the act were left Intact to deal with those unavoidably added poisonous or deleterious ingredients that could not meet the high standards for Issuance of a regulation under the authority of sec tion 409 of the act. A number of added poisonous or deleterious substances, which are also food additives within the meaning of section 201 (s) of the act, are unavoidable but cannot meet the require ments for a section 409 regulation because their safety cannot be demonstrated and because they serve no functional purpose. A prominent example is lead, which was one of the contaminants most frequently mentioned in the legislative history of the 1938 act and one of the prime contami nants with which section 406 was enacted to deal. Lead cannot be the subject of a food additive regulation under section 409 of the act even at trivial levels be cause It serves no functional purpose. Section 406 of the act, therefore, remains In force to control the use of such sub stances, since there would otherwise br no statutory means available to recognlz ASI 00003426 FEDERAL REGISTER, V L 39, N . 236--FRIDAY, DECEMBER A, 1974 PROPOSED RULES 42745 their unavotdability and to exercise rea for regulating use of such substances re may nevertheless still be appropriate to sonable control over their presence. mains unchanged, and regulations issued take some formal regulatory action to Thus, there Is nothing In the language under that authority are set forth in 21 control use of a substance. In such cir of section 402(a)(2)(A) of the act to prevent issuance of a regulation under section 406 of the act for an added CFR Part 121. However, when a food contaminant is unavoidable but cannot be approved under the criteria of sec cumstances, the Commissioner will con sider promulgating an action level under authority of sections 306, 402(a), and poisonous or deleterious substance that is also a food additive and for -which no food additive regulation has been or can be promulgated. Section 402(a)(2)(A) of the act deems a food adulterated "if it tion 409 of the act, a formal procedure is being proposed to control its use under authority of sections 306, 402(a), and 406 of the act. When a tolerance is established under 406 of the act. Such action levels are similar to a formal tolerance in basis and effect. In setting an action level, the Commis sioner considers evidence indicating bears or contains any added poisonous or added deleterious substance (other than one which is * * (ii) a food addi tive * ) which is unsafe within the meaning of section 406". If the paren thetical exception had been meant to prohibit issuance of section 406 toler ances for food additives, the exception would have been placed in section 40G of the act. Instead, the language of section 406 of the act allowing the Secretary of Health, Education, and Welfare to promulgate tolerances remains in full effect. Section 406 of the act must, of course, be read as having equal force and effect as the other parts of the statute. The parenthetical exception was placed in section 402 of the act. the sec tion dealing with the legal definitions of adulteration, rather than in section 406 of the act, the authority to promulgate tolerances, because the intention was to exempt a food additive from the pro visions of section 406 of the act once a section 409 regulation has been promul gated. The parenthetical exception is thus similar to the language in sections 406, 400(a), 409(a), and 51200 of the act granting an exemption from section 402 (a)(1) of the act if a regulation under one of those sections is in effect. the provisions of section 406. the act requires it to be set at the level necessary for the protection of the public health taking Into account the extent to which the substance cannot be avoided and the other ways in which the consumer may be affected by the same or other poison ous or deleterious substances. At times it will not be appropriate to establish a formal tolerance. The Com missioner Is not required tp establish a tolerance for every added poisonous or deleterious substance, as is indicated by the language of section 406 of the act recognizing that an adulteration charge can be made under section 402(a) (1) of the act when no tolerance is in effect. Section 306 of the act has long been in terpreted to permit the Pood and Drug Administration to establish action levels in implementing the adulteration provi sions of the act. See United States v. Goodman, 486 P. 2d 847 (7th Cir. 1973); United States v. Thriftimart, Inc., 429 F,2d 1006, loll (9th Cir. 1970); United States v. 1500 Cases More or Less, Tomato Paste, 236 F. 2d 208, 211-12 (7th Cir. 1956): United States v. 449 Cases Containing Tomato Paste, 212 P. 2d 567, 572-73 (2d Cir. 1054); United States v. 133 Cases of Tomato Paste, 22 F. Supp. when the presence of an added poisonous or deleterious substance may render food injurious to health, which is the stand ard in section 402(a) (1) of the act. In addition, the Commissioner takes into account the question of its unavoid ably, a policy embodied in section 406 of the act. Thus, an action level is based on the same criteria as a tolerance, ex cept that an action level Is temporary until the appearance of more stable cir cumstances makes a formal tolerance appropriate. Particular problems are raised with re spect to the use of pesticides, which fre quently result in environmental con tamination. Tolerances under section 406 of the act may be issued by EPA which allow for residues of pesticides in food, even though the pesticide itself is not registered by EPA for use with that par ticular crop. An action level may also be established for a pesticide for which the EPA has not Issued a tolerance under section 406 of the act. Because of their joint pesti cide responsibilities under the act, the EPA and the FDA agree that both agen cies have definite roles in respect to ac tion levels for pesticides. Since action levels are an exercise of enforcement dis cretion, and since FDA is responsible for The correctness of that interpretation 515, 516 (E.D. Pa. 1938); cf. United enforcement under the Executive Order Is confirmed by the language of the pro viso in section 402(a) (2) (C) of the act. States v. Ewlg Bros. & Co., supra. When the factors required to be con establishing EPA, FDA is responsible for determining when an action level for a That proviso creates an exemption from sidered prior to promulgation of a sec pesticide should be established and issu the food additive provisions of the act for a pesticide in a processed food under tion 406 tolerance are rapidly changing, it would be inappropriate to set such ing such actions levels as regulations. Since action levels are similar to a formal certain circumstances. In doing so, the a formal tolerance. The procedures re tolerance in basis and effect, and since proviso refers to both sections 406 and 409 of the act. A reference to section 406 quired by section 406 of the act, includ ing a public hearing and requirement of EPA has the expertise to establish pes ticide tolerances, EPA is responsible for of the act would obviously not have been necessary to exempt a substance from the provisions of the act applicable to food additive if the language of sec tion 402(a)(2)(A) of the act made the provisions of section 406 of the act inap substantial evidence to support the tol erance.' contemplate ample evidence to consider, and a relatively stable situa tion where the evidence will be of more than transient significance and where the tolerance eventually promulgated determining, upon request from FDA, the appropriate level at which a pesticide ac tion level is to be set. Such tolerances or action levels properly recognize the problem of envi ronmental contamination caused by drift plicable to food additives. Instead, be cause the proviso deals with a situation in which no section"409 regulation will be issued, the reference to section 406 of the act is necessary to afford complete exemption. will be appropriate for a relatively long period of time. Por example, if industrial practices are improving so quickly that the extent to which the substance is unavoidable changes significantly from year to year, there is little justification of a pesticide from one area to another, or the persistence of the chemical In the environment over a period of time. In no instance, however, does any such action level or tolerance itself authorize use of any pesticide on a food crop for which Similarly, when a tolerance for an for use of section 406 procedures. Sim it has not been registered by EPA. Ex unavoidable pesticide cannot be issued ilarly, if toxicological data are scanty cept in the limited instances discussed under the criteria of section 498 of the or conflicting, but additional data are below, no action level or other adminis act, section 406 is available to control being developed. It would serve no good trative action will be taken to permit the its use. Under theExecutive Order estab purpose to labor over an assessment of sale of food contaminated with a pesti lishing it, the EPA promulgates toler the existing data in a public hearing cide that has been used in any manner ances under sections 406, 408, and 409 while Ignoring the prospects of addi other than in strict accordance with the of the act for pesticides In or on food, tional studies. The Commissioner there label directions approved by EPA. and the FDA is then responsible for fore concludes that the structure and enforcing those provisions. criteria of section 406 of the act indi The establishment of a tolerance or an action level does not authorize use of The Commissioner proposes to estab cate it is to be used primarily in rela the particular poisonous or deleterious lish procedures for controlling all poison tively static circumstances. substance Involved, or mean that any ous or deleterious substances. Basic re When It is not appropriate to pro product containing up to that level of liance on the provisions of section 409 mulgate a tolerance under section 406, It contamination is necessarily a lawful FEDERAL REGISTER, VOL 39, NO. 236--FRIDAY, DECEMBER 6, 1974 ASI 00003427 42746 PROPOSED RULES product. The failure to comply with the requirements of section 402(a) (4) of the act, which prohibits the preparation, packaging, or storage of food under in sanitary conditions, is a separate viola tion of the act. even if the food itself does not violate any tolerance or action level for added poisonous or deleterious substances. Similarly, blending a con taminated food with a noucontaminated food, to produce a final product that falls within a tolerance or action level, is un lawful under tho act and is prohibited by the proposed regulations. The proposed principles and proce dures sot forth in Part 122 apply equally to imported food. An? food additive or pesticide intentionally used in or on im ported food must be the subject of a regulation issued under section 408 or 400 of the net. Unavoidable added poi sonous or deleterious substances may be the subject of a tolerance or action level issued under Part 122. Because of enforcement practicalities, tolerances and action levels for imported food must be the same as for domestically produced food, although levels of un avoidable contamination may differ from country to country. For example, some pesticides are approved for use abroad because of conditions which justify their use, but are not registered for use in this country because those conditions do not exist here. In such a case, a regulation issued by EPA under section 408 or 409 of the act would apply to any food on which the pesticide was intentionally used. A tolerance may be issued by EPA or an action level by FDA, however, to be applied to food unavoidably contami nated by the pesticide. That tolerance or action level will be set at a uniform level for all food, Including domestic food. The establishment of the tolerance or action level would not authorize any use of the pesticide in this country, however. The Commissioner intends to issue, by publication in the Federal Register, all existing action levels for unavoidable poisonous or deleterious substances as regulations in Part 122. In the interim, these publicly known action levels will continue in effect. Although the Commis sioner Intends to issue as regulations all new action levels as well, circumstances may require use of informal action levels pending Issuance of final regulations. Such informal action levels will continue to be announced to the public. Finally, the Commissioner recognizes that there may be some circumstances where it will be in the public interest to permit the marketing of food that is con taminated with a poisonous or deleteri ous substance, even though the contami nation may have occurred through unlawful or other avoidable misuse of the substance and thus the food would not be eligible for a tolerance or action level. This would occur where a large amount of food is contaminated, result ing in a substantial adverse impact on the national food supply, and all avail able toxicological data indicate that no significant health hazard is involved. Ac cordingly, the proposed regulations pro vide a public procedure whereby, under such circumstances, the Commissioner may permit the marketing of such food, as an exemption from the usual rules that would be applicable. Any such ex emptions would be limited to a single oc currence and would be decided on an ad hoc basis after public consideration of the issues involved. The proposal also prescribes a method of issuing regulations to deal with foods containing naturally occurring poisonous or deleterious substances. Where appro priate, the Commissioner may identify foods which, because of their inherent components, are deemed to be adulter ated within the meaning of section 402- (a)(1) of the act. These regulations would, of course, not constitute a com plete list of such foods. In the Federal Register of Septem ber 23, 1974 (39 FR 34172), the Commis sioner consolidated existing regulations on substances prohibited from use in food in a new 5 121.106 (21 CFR 121.106). Prohibited food additives will continue to be listed in Part 121, and Part 122 will be used only to identify foods prohibited even when not used as food additives. Since neither of these lists is exhaustive, the appearance of a food or of a poison ous or deleterious substance on one of the lists while not on the other does not con stitute a determination that it should not appear on the other. In addition, the proposal creates a method whereby Interested persons can petition the Commissioner to establish a tolerance, action level, or other regula tion under this part. Petitions adequately supported would be published In the Fed eral Register for comment. No action Is proposed for polychlori nated biphenyls (PCB's) (21 CFR 122.10) except recodification as 122.100. The renumbered section is set forth in its entirety as part of the revision for the convenience of the reader. Additionally, paragraph (a) (9) of that section was stayed by an order published in the Fed eral Register of August 24, 1973 (38 FR 22792). Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 306. 402(a), 406. 408, 409, 701 (a), 52 Stat. 1045-1046 as amended, 1049, 1055, 68 Stat. 511 as amended; 72 Stat. 1785-1788 as amended; 21 UjS.C. 336, 342(a), 346,346a, 348, 371(a)) and under authority delegated to him (21 CFR 2.120), the Commissioner proposes that Part 122 be revised to read as follows: PART 122--POISONOUS OR DELETERI OUS SUBSTANCES IN FOOD AND FOOD-PACKAGING MATERIAL Subpart A--Definition* and Procedure* Sec. 122.3 Definitions. 122.4 Establishment of regulations. I22JS Petitions. 122.G Added poisonous or deleterious sub stances. 122.7 UnavotdabUlty. 122.8 Exemptions. Subpart B---Tolerances for Added Poisonous or Dtletsrlous Substances 123.100 Polychlorinated biphenyls (FOB'S). Authobitt: Secs. 306, 402(a), 406, 408. 409, 701, 82 Stat. 1045-1046 as amended, 1049 1055-1066 as amended, 68 Stat. Sii, a amended; 72 Stat. 1786-1788 as amendeo (21 UJ3.0. 336, 343(a), 346, 346a, 348, 371), Subpart A--Definitions and Procedures 122.3 Definitions. (a) "Act" means the Federal Food. Drug, and Cosmetic Act. (b) The definitions of terms contained In section 201 of the act are applicable to such terms when used In this part. (c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inher ent natural constituent of a food and is not the result of environmental, agri cultural, industrial, or other handling or contamination. (d) An "added poisonous or deleteri ous substance" is a poisonous or deleteri ous substance that is not a naturally occurring poisonous or deleterious sub stance. When a naturally occurring poisonous or deleterious substance is in creased to abnormal levels through mis handling or other Intervening act, it is an added poisonous or deleterious sub stance to the extent of such increase. (e) "Food" includes human food, sub stances migrating to food from foodcontact articles, pet food, and animal feed. 122.1 Establishment of regulations. (a) When appropriate under the cri teria of 122.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be estab lished by regulation in Subpart B of thi. part under the provisions of section 406 of the act. A tolerance may be estab lished at the level of zero. ,, (b) When appropriate under the cri teria of 9 122.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in Subpart C of this part to define the level of contam ination at which a food will be deemed to be adulterated under section 402(a) (1) of the act. An action level may pro hibit any detectable amount of the sub stance in food. <c) A regulation may be established in Subpart D of this part to Identify a food containing a naturally' occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a) (1) of the act These regu lations do not constitute a complete lisT of such foods. g 122.5 Petitions. The Commissioner of Food and Drugs, either on his own Initiative or on behalf of any interested person who has sub mitted a petition, may issue a proposal to establish, revoke, or amend a regula tion under this part. Any such petition shall Include an adequate factual basis to support the petition, shall be in the form set forth in 9 2.65 of this chapter, and will be published In the Federal Register for comment If it contains reasonable grounds for the proposed regulation. 00003428 ,FEDERAL REGISTER, VOL 39, NO. 234--FRIDAY, DECEMBER 6 1974 PROPOSED RULES 42747 122.6 Added poisonous or deleterious substances. (a) Use of an added poisonous or dele terious substance, other than a pesticide chemical, that is also a food additive will be controlled by a regulation issued under section 409 of the act when possible. When such a use cannot be approved un der the criteria of section 409, or when the added poisonous or deleterious sub stance is not a food additive, a tolerance or action level may be established pursu ant to the criteria established in para graphs (b) and (c) of this section. Use of an added poisonous or deleterious sub stance that is also a pesticide chemical will ordinarily be controlled by a regula tion issued under section 406, 408, or 409 by the U.S. Environmental Protection Agency (EPA). When such a regulation has not been issued, an action level for an added poisonous or deleterious sub stance that is also a pesticide chemical may be established at a level specified by EPA pursuant to the criteria established in paragraph (c) of this section. ( b) A tolerance for an added poisonous or deleterious substance in any food may be established when the following criteria are met: (1) The substance cannot be avoided by good manufacturing practice. (2) The tolerance established is suffi cient for the protection of the public health, taking into account the extent to which the presence of the substance cannot be avoided and the other ways in which the consumer may be affected by the same or related poisonous or delete rious substances. f3) No technological or other changes arc foreseeable in the near future that might affect the appropriateness of the tolerance established. Examples of changes that might affect the appro priateness of the tolerance include antici pated improvements in good manufac turing practice that would change the extent to which use of the substance is unavoidable and anticipated studies ex pected to provide significant new toxico logical or use data. (c) An action level for an added poisonous or deleterious substance in any food may be established when the criteria in paragraph (b) of this section are met, except that technological or other changes that might affect the appro priateness of the tolerance are foresee able in the near future. An action level shall cease to be enforced and shall be revoked when a tolerance for the same substance and use has become effective. <d> Tolerances will be established un der authority appropriate for action levels as well as under authority appro priate for tolerances. In the event the effectiveness of a tolerance is stayed pur suant to section 701(e) (2) of the act by the filing of an objection and request for hearing, the order establishing the toler ance shall be deemed to be an order establishing an action level until final action is taken upon such objection. 122.7 Unavoidability. (a) Tolerances and action levels to this part are established at levels based on the unavoidability of the poisonous or deleterious substance concerned and do not establish a permissible level of contamination where it is avoidable. (b) Compliance with tolerances and action levels does not excuse failure to observe either the requirement in section 402(a) (4) of the Federal Food, Drug, and Cosmetic Act that food may not be prepared, packed, or held under insani tary conditions or the other requirements in this chapter that food manufacturers must observe current good manufactur ing practices. Evidence obtained through factory inspection indicating such a vio lation renders the food unlawful, even though the amounts of poisonous or del eterious substances are lower than the currently established tolerances or action levels. The manufacturer of food must at all times utilize quality control proce dures which will reduce contamination to the lowest level currently feasible, (c) The mixing of a food containing a poisonous or deleterious substance in an amount above the tolerance or action level with another lot of food is not permitted and renders the final food un lawful regardless of the amount of poisonous or deleterious substance in the final food. 122.8 Exemptions. (a) The Commissioner may exempt from regulatory action and permit the marketing of any food that is unlawfully contaminated with a poisonous or delete rious substance ill (1) He determines (1) based upon all available scientific evidence, that the food is safe for consumption and (11) that destruction or diversion of the food in volved would result in a substantial ad verse impact on the national food supply. (2) Such determination is published as a proposal in the Federal Register, with time for public comment whenever feasible. The time permitted for comment shall depend upon the degTee of urgency required by the specific matter involved. In the event that no time for comment is feasible, the exemption may' be issued as a final determination rather than as a proposal. (3) The determination identifies the level of contamination allowed by the ex emption, and the food to which It applies (e.g., the specific growing area or other identifying information). The exemption shall not apply to any other food pro duced in any other area or at any other time. Contaminated food not subject to the exemption will remain subject to regulatory action. (b) Any person responsible for con tamination of the food involved, or ship ment of any such food in interstate commerce prior to the Issuance of an ex emption pursuant to this section, shall remain subject to regulatory action pur suant to sections 302 (Injunction pro ceedings) and 303 (penalties) of the act, (c) In the case of a poisonous or dele terious substance which is a pesticide chemical, the level of contamination allowed by the exemption shall, upon re quest of the Food and Drug Administra tion, be specified by the Environmental Protection Agency pursuant to para graph (a) (1) (1) of this section and pro mulgated by the Commissioner. No ex emption for a pesticide chemical shall be promulgated without the concurrence of the Environmental Protection Agency. Subpart B--Tolerances for Added Poisonous or Deleterious Substances 9 122.100 Polychlorinated biphenyls (PCB's). () Polychlorinated biphenyls (PCB's) are toxic, Industr ,d chemicals. Because of their widesprt. u, uncontrolled indus trial applications, PCB's have become a persistent and ub uultous contaminant in the environment. As a result, certain foods and animal feeds, principally those of animal and marine origin, contain PCB's as unavoidable, environmental contaminants. PCB's are transmitted to the food portion (meat, milk, and eggs) of food producing animals Ingesting PCB contaminated animal feed. In addition, a significant percentage of paper foodpackaging materials contain PCB's which may migrate to the packaged food. The source of PCB's in paper food-pack aging materials is primarily of certain types of carbonless copy paper (contain ing 3 to 5 percent PCB's) in waste paper stocks used for manufacturing recycled paper. Therefore, temporary tolerances for residues of PCB's as unavoidable en vironmental or Industrial contaminants are established for a sufficient period of time following the effective date of this paragraph to permit the elimination of such contaminants at the earliest prac ticable time. For the purposes of this paragraph, the term "polychlorinated biphenyls (PCB's)" is applicable to mix tures of chlorinated biphenyl compounds, irrespective of which mixture of PCB's is present as the residue. The temporary tolerances for residues of PCB's are as follows: (1) 2.5 parts per million in milk (fat basis). (2) 2.5 parts per million in manufac tured dairy products (fat basis). (3) 5 parts per million in poultry (fat basis). (4) 0.5 parts per million in eggs. (5) 0.2 parts per million in finished animal feed for food-producing animals (except the following finished animal feeds: feed concentrates, feed supple ments, and feed premixes). () 2 parts per million In animal feed components of animal origin, .including fishmeal and other by-products of ma rine origin and in finished animal feed concentrates, supplements, and premixes Intended for food producing animals. (7) 5 parts per million in fish and shellfish (edible portion). The edible por tion of fish excludes head, scales, viscera, and inedible bones. (8) 0.2 parts per million in infant and junior foods. (9) 10 parts per million in paper food packaging material intended for or used with human food, finished animal feed and any components Intended for animal feeds. The tolerance shall not apply to FEDERAL REGISTER, VOL 39, NO. 234--FRIDAY, DECEMBER A, 1974 ASI 00003429 42748 paper food-packaging material separated from the food therein by a functional barrier which is Impermeable to migra tion of PCB's. (b) A compilation entitled "Analytical Methodology for Polychlorinated Elphenyls. February 1973" for determining compliance with the tolerances estab lished in this section is available from the Hearing Clerk, Department of Health, Education, and Welfare, Room 4-63, 5600 Fishers Lane, Rockville, MD 20852. Interested persons may, on or before i March 6, 1975, file with the Hearing Clerk, Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20G52, written comments (preferably In qulntuplicatei regarding this proposal. Received comments may be seen in the above office during working hours, Mon day through Friday. Dated: November 20, 1974. A. M. Schmidt. Commissioner of Food and Drugs. IFR Doc.74-23407 Filed 12-2-74:8:45 am] PROPOSED RULES ASI 00003430 FEDERAL REGISTER, VOL 39, NO. 236--FRIDAY, DECEMBER 6, 1974