Document MJZd2RvoreDDkNJ43ZmezmkvV

JOSEPH E. HELLER JEROME H BECKMAN CHARLES M MEEHAN WILLIAM H. SOSOHBSANI, JR. ROBERT R. TIF.HNAN WAYNE V. BLACK DAVID L. HILL MARTIN W, BERCOVICI MARC K SHAVE LEI.AND J. BLAIR PETER M. MEHIOV law orncBs Kelleb and Heckman 1180 17TS STREET, N. W. SUITE IOOO WASHINGTON, D- C- SOO30 March 20, 1972 TELEPHONE CABLE ADDRESS "KELMAN" TO: All Members of the SPI Food, Drug and Cosmetic Packaging Materials Committee RE: PCB Tolerances Matter Gentlemen: Following up on the report on the PCB situ ation which I gave you at the Food, Drug and Cosmetic Packaging Materials Committee meeting last week, I am herewith enclosing reproductions of pages 5705 and 5706 from the March 18 Federal Register. As you will see, the Food and Drug Administration has now issued a Notice of Proposed Rule Making on the PCB question. The most important part of the Notice is the proposal to establish tolerances for PCB content in foods and food packaging materials. The proposal does not reference specific methodology whereby compliance with the tolerances may be determined but this omission is not unusual and merely implies that FDA will allow the use of any method ology deemed appropriate in specific cases to determine PCB content. You will recall that, at our meeting, the Technical Information Subcommittee was given the task of considering and possibly developing additional suit able methodology for the testing of packaging materials for PCB content. Obviously, this was a timely move on the part of the Committee and it is to be hoped that it will be productive. We would recommend that all members of the Committee review the enclosed Notice of Proposed Rule Making promptly and advise us as soon as possible if they believe that formal comments of any type should be mASI-pr 0001550 March 20, 1972 Page Two filed with respect to the same. Our understanding is that comments will be received for a period of 60 days under the new general Food and Drug Administration comment procedural rules. We shall be looking forward to having your thoughts on this matter at your convenience. Enclosure *SI'P* 0001SS1 PROPOSED RULE MAXING 570-' the time prescribed In the notice posed rule making and who desire to present oval comments at such hearing should by May 12, 1972, submit an out line of the topics and the time they wish to devote to each topic. Such outlines should be submitted to the Commissioner of Internal Revenue, Attention: CC: IiR:T, Washington, D.C. 20224. Persons who desire a copy of such written comments or suggestions or out lines and who desire to be assured of their availability on or before the begin ning of such hearing should notify the Commissioner, in writing, at the above address by May 17, 1972. In such a case, unless time and circumstances permit otherwise, the desired copies are deliv erable only at the above address. The charge for copies is twenty-five cents (50.25) per page, subject to a minimum charge of $1. Lee H. Henkes, Jr., Acting Chief Counsel. JFR Doc.72--221 Filed 3-l7-72;8:53 am] EDUCAIEGM, AUG WELFARE Food ond Drug Administration 121 CFR Parts 3, 121, 122, 128 1 POLYCHLORINATED BIPHENYLS Notice of Proposed Rule Making The Commissioner of Food and Drugs is concerned about the problems of con tamination of food with polychlorinated biphenyls (PCB's) arising indirectly from the use of PCB-contaniinated animal feed, from Industrial and environmental sources, and from the use of FCB-contaminated paper food-packaging ma terials. No authorization has been granted under the Federal Food, Drug, and Cosmetic Act for any use of FCB's which results, either directly or indi rectly, in FCB's becoming a component or otherwise affecting the characteristics of food for man or other animals. FCB's have been produced since 1929 and have been employed in a wide range of industrial uses including heat ex change liquids in pasteurization equip ment; formulations in lubricants and hydraulic fluids; and ingredients of paints, plastics, resins, inks, waxes, ad hesives, rubber, asphalt, and various building materials. FCB's are toxic sub stances which are very stable and highly persistent In the environment. Because of their widespread use, PCB's have been found in food as a result of avoidable industrial accidents and of environmen tal or industrial contamination. Although it Is not possible to remove PCB's from the environment, the Com missioner of Food and Drugs is taking all reasonable steps to limit the ways in which PCB's may otherwise contaminate food and to limit the level of PCB's in foods containing unavoidable PCB resi dues from environmental or industrial sources. The Food and Drug Administration" liction in the PCB concentrations of has been conducting a national survey to paper-packaging materials. For exam determine the extent and levels to which ple, data on recycled paperboard cur complete animal feeds are contaminated rently being produced shoe/ that 95 with PCB's. The survey results available percent of the samples examined con to date show that less than 5 percent of tained less than 5 parts per million: data the animal feeds sampled contain PCB's. on the same type of material manu Levels range from no detectable contam factured during 1970 and 1971 show that ination to a maximum PCB level of (M> only 18 percent of the samples examined part per million. It appears that complete contained less than 5 parts per million. animal feeds are not a significant source Other investigations show the pres of PCB's for food-producing animals and ence of PCB residues in fresh water fish that PCB contamination of feeds for and in some foods of animal origin. The food-producing animals can generally be source of these residues is attributed in attributed to avoidable industrial acci part to environmental contamination dents and practices. Investigations by such as discharges of PCB waste effluents FDA have revealed the use of PCB's in into water and air. heat exchange fluids used in certain pasteurization equipment. Although heat exchange fluids in such equipment are considered to be in "closed systems," ac cidents have occurred that resulted in di rect contamination of animal feed with PCB's and subsequently in contamination of food products such as poultry and eggs intended for human consumption. The use of PCB-containing coatings on the inner walls of silos has resulted in the contamination cf silage which has in turn caused PCB residues in the milk of dairy cows. It is suspected that other in dustrial uses of PCB's have also resulted in the PCB contamination of animal feed and food for human consumption during processing and manufacturing. Investigations have also revealed PCB migration to food resulting from the use of PCB-containing paper foodpackaging material. This problem is be ing intensively studied by EDA and the paper and food industries. These studies show that paper for food-packaging ma terials, whether manufactured from re cycled paper or virgin stock, may contain PCB's. The source of PCB's in recycled paper is attributed to the use of certain kinds of copying paper and printing ink. While the source of PCB's in virgin stock is not as well defined, it is generally attributed to the presence of PCB's in the equipment, machinery, and water used for the manufacturing of these ma terials and to environmental contamina tion. Based on FDA total diet studies, the dietary intake of PCB's appears to be of a l'ow order. The 900 food composites analyzed for PCB's in the total diet mar ket basket samples for the past 21/years showed 54 of the food composites to contain PCB residues. Calculated on the basis of dietary intake, the average PCB level found in the market baskets was less than 0.007)1 milligram per kilogram~oTbbdv~ weight- ner day. The mar ket basket samples represent a high consumption diet whiqh is approxi mately twice the normal diet. Knowledge of the toxicological effects of PCB's is limited at this time. Avail able information indicates that PCB's are classified as being of moderate acute toxicity. As a point of comparison, DDT has a higher acute toxicity than PCB's. In contrast to the recognized moderate acute toxicity of PCB's, the aspects of, PCB-chronic toxicity, including muta genicity and teratogenicity are at present not well defined and thus are potentially of greater concern. The chronic toxicity of PCB's is being extensively studied by the Government, industry', and the scien tific community. Preliminary reports and observations indicate that it would be prudent to reduce and, wherever possible, eliminate long-term, low-level human exposure to PCB's. On the basis of these Investigations and other available information, includ ing the report of the Interdepartmental PCB Task Force, the current dietary foods from packaging materials is de pendent upon many factors (e.g,, levels of PCB's in food-packaging materials, type of food, length of storage). This is shown by the results of a national survey conducted by FDA, which revealed that even though 67 percent of the complete food packaging tested contained PCB's aUevels as high as 338 parts Per million, only 19 percent of tire foods in these packages contained PCBls. The average PCB concentration in food was 0.1 part isKljoLPClxis .tiotjeoasidgisd-an Im mediate hazard. tQ-the nubile health. However, the Commissioner concludes that the sources and levels of PCB's in animal feeds, feed components, and food for human use can and should be signifi cantly reduced or eliminated so as to minimize the overall long-term human exposure to PCB's. Accordingly, the Commissioner makes the following pro posals: 1. Part 3 should be amended to (a) fier million, and the maximum PCB level provide special provisions to preclude the ound wiis 5 parts per million. Tire sur direct accidental PCB contamination of vey further showed that 75 percent of animal feed, and (b) to provide special the food product in packaged Infant provisions to preclude the direct acci cereal samples contained PCB's. The dental FCB contamination cf food-pack average PCB concentration in the cereal aging materials. was 0.2 nart ner million, and the maxi 2. Section 128.4 should be amended mum PCB level found was 1 part per by adding special provisions to preclude million. the direct accidental PCB contamina Other information which became tion of food. available subsequent to the FDA survey 3. Section 121.254G should be amended shows a continuing and substantial re to exclude pulp from reclaimed fibers FEDERAL REGISTER, VOL 37, NO. S4--SATURPAV, MARCH IS, 1973 ASI-PR 0001552 5706 PROPOSED RULE MAKING containing poisonous and rkdetertous tained in cei'.c.in pasteurization equip substances which may migrate to food ment u.ed in processing animal Iced, Al from use in the manufacture of food though lit at exchange fluids in such packaging material.,. equipment are considered to be in ''closed 1. A temporary to'e.aucc of 5 parts system'," accidents have occurred that PCI million in .jacor rood-packaging resulted in direst contamination of ani materials should be ejl-blished permit mal feeds with PCBs and subsequently ting unavoidably PCB residues in these in PCB contamination of human food. products for a sufficient period of time The use of I-CB-containing coatings on to provide an opportunity for ttic orderly the inner walls of silos has resulted in elimination of FCB-contaiuing raw the contamination of silage which h=*s materials used in the manufacture of in ton carped PCB residues in the milk food-packaging materials. There are nol of daily cows. Other industrial uses of provisions for permissible uses of PCB'sl PCB's include, or did include in the past, Sunder 21 CFR 121.2523 or 121.2571. This! their use in formulations .as lubricants temporary tolerance is not to provide and_hy_drauUc_fluids and their use as "in for direct uses under the above regula gredients of paints, plastics, resins,jnks, tions. Immediate elimination of all food waxes, adhesives, rubber, asphalt, and packages containing PCB's would dis various building m'a'lcrToIs. rupt the nation's food packaging and (bT Tire following special provisions distribution system and is not warranted are necessary to preclude accidental PCB by the hazard to human healtli. contamination of animal feed: 5. It is recognized that nationwide controls in the uses of PCB's will reduce the unavoidable contamination of foods. Therefore, although a temporary toler ance cannot be established for all foods, regulations should be promulgated pro viding the following temporary toler ances permitting unavoidable residues for a sufficient period of time to permit elimination of such residues at the ear liest practicable time: Parts per / (1) Coatings or paints for use on the contact surfaces of feed storage areas may not contain PCB's or any other harmful or deleterious substances likely to contaminate feed. / (2) New equipment or machinery for handling or processing feed in or around an animal feed producing establishment shall not contain PCB's, (3) Within 30 days following the effec tive date of this order, the management of establishments producing animal feed million shall: (a) Milk (fat b?.ri3) 2.5 Ai) Have the h t exchange fluid used (b) Dairy products (fat basis)________ 2.6 in existing equipment or machinery for (c) Poultry (fat basis)________________ 5.0 handling and processing feed sampled (d) Eggs........................................ (e) Finished animal feed_____________ (f) Animal feed components (includ ing fishmeal) (g) Fish (edible portion),___________ (h) Infant and junior rood?__________ (1) Food-packaging material_________ 0.5 0. 5 5.0 5.0 0.1 5,0 Since PCB's are very stable and highly persistent in the environment, any disposal of PCB's should be accomplished by appropriate high temperature degra dation or other appropriate means in order to avoid any environmental con tamination which could affect food sub ject to the Federal Food, Drug, and Cos metic Act or which could otherwise ad versely affect the environment. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 402(a), 406, 409, 701, 52 Stat. 1046 as amended, 1049, 1055-56 as amended by 70 Stat. 919 and 72 Stat, 948, 72 Stat. 1785-68 as amended: 21 U.S.C. 342(a), 346, 348, 371) and under author ity delegated to him (21 CFR 2.120). the Commissioner proposes to amend Parts 3, 121, and 128 and to establish a new Part 122, as follows: and tested to determine whether it con tains PCB's. or verify the absence of PCB's in such formulations by other ap propriate means. Within the 30 days specified above, any such fluid formu lated with PCB's must be replaced with a heat exchange fluid that does not con tain PCB's or any other harmful or deleterious substances. /(iii Eliminate from the animal feed producing establishment any PCB-containing fced-contnct surfaces of equip ment and utensils and any PCB-conlaining lubricants for equipment or machinery that are used for handling or processing animal feed. /(iii) Eliminate from the animal feed producing establishment any other FCBcontaining materials, whenever there is a reasonable expectation that such ma terials could cause animal feed to become contaminated with PCB's cither as a re sult of normal use or as a result of ac cident, breakage, or olher mishap. y (iv) Eliminate the use of any feed packaging materials that contain in ex cess of the 5 parts per million temporary tolerance for PCB's established in 5 122.10 of this chapter. PART 3--STATEMENTS OF GENERAL (c) For the purpose of this section, POLICY OR INTERPRETATION the term "animal feed" includes all arti cles used for food or drink for animals 1. By adding the following new sec other than man. tions to Part 3: 3__ Use of polyrhhii-iiritod biphenyl- .1___ Pui of polychlorinated biphenyl., (Pfilt's) in i-M.iblidimenl** niauufai;- in the production and t>tor- Uir'm" (oud-iin:*ka<:iug nnitciiuts. tigc of oiiinud feed. (a) PCB contamination has been de ta) Investigations by the Food and tected In paper food-packaging mate Drug Administration have revealed use rials. Such contamination may have in of PCB's in heat exchange fluids con some cases resulted from the use of PCB's in heat exchange fluid., or other PCB-containing materials used in the establishment manufacturing focd-packaging materials. (b) Hie following special provisions are necessary to preclude the accidental FCB contamination of food-packaging materials: '/<1> New equipment or machinery for manufacturing food-packaging materials shall net contain or use PCB's. (2) Within 30 days following the ef fective date of this order, the manage ment of establishments manufacturing food-packaging materials shall: ' <i> Have the heat exchange fluid used in existing equipment for manufacturing food-packaging materials sampled and tested to determine whether it contains PCB's, or verify the absence of PCB's in sucli formulations by other appropriate means. Within the 30 days specified above, any such fluid formulated with PCB's must be replaced with a heat ex change fluid that does not contain PCB's or any other harmful or deleterious substance. Aii) Eliminate from the establishment any other PCB-containing materials Wherever there is a reasonable expecta tion that such materials could cause food-packaging materials to become contanunated with PCB's either as a result of normal use or as a result of accident, breakage, or other mishap. PART 121--FOOD ADDITIVES 2. In Part 12f by revising g 121.2546 (b) in subparagraphs (!) and_(2), as follows: 121.2.>4(i I'uijj from m-biimetl fiber. ***** (b) * ' * (1) Industrial waste from the manu facture of paper and paperboard prod ucts excluding that which bears or con tains any poisonous or deleterious sub stance which is retained in the recovered puip and that migrates to the food. (2) Salvage from used paper and paperboard excluding that \vhic.h (i) beais or contains any poisonous or dele terious substance which is retained in the recovered pulp and migrates to the food or (ii) has been used for shipping or handling any such substance. PART 122--UNAVOIDABLE NATURAL, ENVIRONMENTAL, OR INDUS TRIAL CONTAMINANTS IN FOOD AND FOOD-PACKAGING MA TERIAL Subpart A--Definitions and Proce dural and Interpretative Regula tions 3. By adding a new Part 122 consist ing initially of two sections, as follows: 122.1 Ihfinilioiis uni! inIoipii.:;itioii. (a) The definitions and interpreta tions of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable to such terms whan used in this part. FEDERAL REGISTER, VOL. 37, NO. 54--SATURDAY, MARCH 13, 1972 AS1-PR 0001553