Document gE3kvJ3zVmG3ebvNq2yXpzXk3

Monsanto MONSANTO INDUSTRIAL CHEMICALS CO. 800 N. Lindbergh Boulevard St. Louis, Missouri 63166 Phone: (314) 694-1000 August 3, 1973 Dear Sir: In February, 1971 we announced the reformulation of our PydraulR industrial fluids to eliminate the use of poly chlorinated biphenyls (PCBs) as components of these fluids. Since then we have reviewed our formulations and taken further steps to remove all chlorinated compounds from our PydraulR fluids. PydraulR fluids containing chlorinated materials have not been sold since mid-1972. Recently the Food and Drug Administration published in the Federal Register (Vol. 38, No. 129, pgs. 18096-18104, July 6, 1973) a final rule-making order regulating the sources by which polychlorinated biphenyls (PCBs) may ' contaminate animal feed, food, and food-packaging materials during manufacturing, handling and storage, and limiting the levels of PCBs that may be present in animal feed, food, and food packaging materials as a result of unavoidable, environmental contamination. Attached is a copy for your use. Because you may have purchased PydraulR fluid prior to our changeover activities in mid-1972 which may have contained PCBs, you may wish to review your procedures and inspect your facilities at this time to insure that your operations are in compliance with the new regulation. To assist you in any investigations you may care to conduct, I have attached a list identifying the PydraulR fluids which contained chlorinated ingredients and those which do not. Proper disposal of chlorinated materials requires high temperature incineration. Monsanto has installed a facility at its Sauget, Illinois plant and has made this service available to its customers. Information relating to this service is attached to help you should you decide to dispose of such materials in this manner. 2 DEPOSITION | EXHIBIT I9 Banageorgo E 57 0003572 WATER PCB-SD0000039946 -2- Our current line of Pydraul^ fluids which do not contain chlorinated materials do not require this method of disposal. I hope this information is useful to you. If I can be of further service please let me know. /pep Enclosures Cumming Paton Product Manager Fluids 000.3573 WATER PCB-SD0000039947 pydraulrfluids which contained chlorinated ingredients PydraulR 90 PydraulR 135 PydraulR 135A Pydraul R 150 PydraulR 150A PydraulR 230 PydraulR 23OA PydraulR 280 PydraulR 312 PydraulR 312A PydraulR 540 PydraulR 540A PydraulR 540B PydraulR 625 PydraulR 625A PydraulR AC PydraulR AC-A PydraulR AC-A Winter Grade PydraulR AC Winter Grade PydraulR A-200 PydraulR A-200A , PydraulR A-200B PydraulR F-9 PydraulR F-9A CURRENT PYDRAULR FLUIDS (DO NOT CONTAIN CHLORINATED INGREDIENTS) PydraulR 10E (formerly PydraulR 60) PydraulR 29E LT PydraulR 30E PydraulR 50E Pydraul 230C PydraulR 65E . Pydraul 312C PydraulR 90E Pydraul' 540C PydraulR 115E Pydraul MC (formerly MCS 1330) 0003574 WATER PCB-SD0000039948 MONSANTO INDUSTRIAL CHEMICALS CO. 800 N. Lindbergh Boulevard St. Louis, Missouri 63166 Phone: (314! 694-1000 INCINERATION SERVICE FOR PYDRAULR FLUIDS This will confirm our conversation concerning incineration of your fluids. Enclosed are pre-addressed drum return labels marked "Disposal Only". The drum contents must be clearly indicated on each label. To prevent leakage, please use return drums which meet DOT 17E specifications (55 gallon drums, 18 gauge, 2 bung head; 5 gallon drums, 24 gauge minimum). The outside of the drums must be clean, free of fluid and not leaking. Cleanup or other costs affecting the carrier which are related to fluids leaking from drums will be charged to the shipper. Please show Monsanto Identification Number on the bill of lading and on each drum. The freight classification is Hydraulic System Fluid other than Petroleum and the release value is 50(^ per pound. Please ship all drums freight prepaid to: Monsanto Industrial Chemicals Co. Department 246, Incinerator Sauget, Illinois 62201 Incineration charges for Pydraul R fluids are 5^ per pound. Please advise if you want us to invoice these charges against a specific purchase order number. g -n-t o* v to C o r 3 * 0003575 WATER PCB-SD0000039949 Solids such as sawdust, rags or sludge and aqueous fluids cannot be handled in our incinerator. For these materials we suggest you check local authori ties and your own environmental department for an approved disposal method. Personnel in our Sauget, Illinois, plant have been instructed to refuse receipt of drums containing these materials and to return them to the sender at the sender's expense. Thank you for your cooperation. If you have additional questions, please phone me (314) 694-3354, or contact me by letter at the above address. _ Sincerely, Enclosures W. N. MADDOX Supervisor Customer Service Center 0003576 WATER PCB-SD0000039950 J FRIDAY, JULY 6, 1973 WASHINGTON, D.C. Volume 38 Number 129 PART II DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration POLYCHLORINATED BIPHENYLS Contamination of Animal Feeds, Foods, and Food Packaging Materials and . Availability of Supplement to Environmental Statement on Rulemaking 0003577 WATER PCB-SD0000039951 18096 RULES AND REGULATIONS Title 21--Food and Drugs b. One comment argues that electrical CHAPTER I--FOOD AND DRUG ADMINIS TRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE , SUBCHAPTER A--GENERAL capacitors and transformers should be exempt from the requirement that new equipment and existing equipment in es tablishments engaged in the processing of animal feed, human food, or packag SUBCHAPTER B--FOOD AND FOOD PRODUCTS ing materials shall not contain PCB's, POLYCHLORINATED BIPHENYLS (PCB's) since no known substitute is available Contamination of Animal Feeds, Foo<js, and Food-Packaging Materials In the Federal Register of March 18, 1972 (37 FR 5705) a notice of proposed rule making was published limiting the which offers the proper balance of char acteristics (e.g., Are safety and design efficiency). In support of the comment, it is stated that both capacitors and transformers are constructed in sealed metal cases and are not normally in sources by which polychlorinated bi stalled in equipment or located in such a phenyls (FCB's) may contaminate ani manner as to be in direct contact with mal feed, food, and food-packaging ma terials during manufacturing, handling, and storage, and limiting the levels of PCB's that may be present in animal feed, food, and food-packaging materials as a result of unavoidable, environ the material being processed. The Com missioner of Food and Drugs agrees that there should be an exemption for the safe use of PCB's in electrical capacitors and transformers. The final order has been amended in {135.113(c), { 3.93(c) mental contamination. The notice pro and {128.4(b) (3), to provide an exemp vided for the filing of comments within tion for electrical capacitors and trans 60 days after the date of publication and this was extended to July 16, 1972 by a formers. c. One comment contends th' at an notice published May 18, 1972 (37 FR effective date of 90 days following publi 10003). . , cation of the Anal order should be estab stances for use in the manufacture of food-packaging materials and, to the extent necessary, to prevent contamina tion of the packaged food product with these substances. Therefore, the regula tion precludes the necessity of establish ing tolerances for the packaged food product. The Commissioner agrees, how ever, the clarification of the amendment is needed In order to be consistent with regulations which permit the presence of what could otherwise be regarded as poisonous or deleterious substances at levels that have been proved to be safe in food-packaging materials. Therefore, the order is amended in 121.2546 by adding the phrase "except as provided in regulations promulgated under Sec tions 406 and 409 of the Federal Food, Drug, and Cosmetic Act." 3. Part 122, The notice included the proposal to establish temporary toler ances under Section 406 of the Federal Food, Drug, and Cosmetic Act for un avoidable PCB residues in animal feed, certain foods and food-packaging mate rials as a result of environmental con tamination. In response to the notice, ninety-three lished since this time period would be comments were received from members required for the modification of existing of Industry, trade associations, consumer plant equipment to accommodate PCB groups and individual consumers. replacements. The Commissioner con The following is a summary of the' cludes that there is no Justification for a. One comment recommends that a zero tolerance for PCB's in foods and feeds should be established. The Com missioner rejects this recommendation. Animal feeds, certain foods, and paper provisions contained in the notice and extending the effective date and the final food-packaging materials contain PCB's the comments on these provisions re order establishes an effective date of 30 which, under present conditions of envi ceived by the Food and Drug Adminis days from the date of publication in the ronmental contamination, are unavoid tration: Federal Register. able. Current toxicological information 1. Sections 3.93,128.4, and 135.113. The d. One comment contends that with does not support the necessity of estab notice included provisions which would, the replacement of PCB formulated heat lishing zero tolerances for these articles prohibit the use of FCB-containing ma exchange fluids with non-PCB fluids, in order to protect public health since terials and equipment in animal feed, in some level of PCB residue is likely to re human exposure to dietary sources of food, and in food-packaging material main in certain equipment. Therefore, PCB's is usually sporadic, non-system- manufacturing, handling and storage the comment continues, the Food and atlc, and occasional. The "finite" tempo establishments, in order to preclude di Drug Administration should initiate rary tolerances being established will rect, accidental PCB contamination of studies for the purpose of establishing a provide the assurance that significant animal fee.d, food, and food-packaging finite allowable residual level. While it PCB levels are not contained in food and materials. is true that some residue of PCB may re that human exposure to PCB's from a. One comment suggests that since most industrial chemicals can be inter preted to be "harmful or deleterious", the phrase should be deleted as a crite rion for PCB replacement. The Commis-1 sioner concurs with deleting the phrase "harmful or deleterious". The toxicity and other characteristics of fluids se lected as PCB replacements must be adequately determined so that the least potentially hazardous replacement is used. In making this determination with respect to a given fluid, consideration should be given to (l),its toxicity; (2) the maximum quantity that could be' spilled onto a given quantity of food before it would be noticed, taking into account its color and odor; (3) possible signaling devices in the equipment to in dicate a loss of fluid, etc.; and (4) its environmental stability and tendency to survive and be concentrated through the food chain. The judgment as to whether a replacement fluid is sufficiently nonhazardo.us is to be made on an indi vidual installation and operation basis. Accordingly, the appropriate amend ments have been made in 135.113(b) (3) main in certain equipment, if the change is made in a reasonable manner and in good faith there should not be significant concentrations of PCB remaining. With out additional data it is not possible to set any specific limit for PCB concentra tion in the equipment fluids. Further more, the Commissioner has determined that no reasons exists for FDA to initiate studies to determine the extent of resid ual levels of PCB's in heat exchangers or to specify by regulations finite tolerances for such residual material at this time. 2. Section 121.2546. The notice in cluded an amendment to the existing food additive regulations (21 CFR 121. 2546) so as,to exclude from use in food packaging materials pulp from reclaimed fibers containing poisonous and deleteri ous substances which may migrate to, the packaged food. a. One comment contends that the lan guage of the amendment is incomplete since it does not establish a limit or toler ance for poisonous or deleterious sub stances, such as PCB's, which may ulti mately be found in the packaged food product. The Commissioner disagrees be dietary sources will be maintained at safe and minimal levels. Zero tolerances, therefore, are unwarranted and would unnecessarily deprive the consumer of a portion of his food supply and disrupt the Nation's food distribution system be cause a portion of fish, poultry, eggs, and milk and packaging .used for food would be violative. b. A consumer group's comment rec ommended lowering the PCB tolerances for human foods by a factor 5-10; while another comment recommended that the temporary tolerances should be based on toxicological data which would allow a level that is deemed safe rather Lhan al low a level that can be reasonably achieved. The Commissioner disagrees with both recommendations. Section 406 of the act, which is the authority for es-, tablishing the temporary tolerances for PCB's, states that where the addition of a poisonous or deleterious substance to food cannot be avoided the Secretary shall promulgate regulations "limiting the quantity therein or thereon to such ex tent as he finds necessary for the protec tion of the public health", and also spe cifically states that the Secretary in (21 CFR 135.113(b)(3)), {3.93(b)(2) (21 cause the purpose of { 121.2546 is to setting such a tolerance shall take into CFR 3.93(b)(2)), and {128.4(b)(2) (21 regulate the use of reclaimed fibers con account the extent to which use of the CFR 128.4(b) (2)). taining poisonous or deleterious sub substance "cannot be avoided". The fact FEDERAL REGISTER, VOL 38, NO. 139--FRIDAY, JULY 6, 1973 0001511R WATER PCB-SD0000039952 RULES AND REGULATIONS 18097 that the tolerances are termed "tempo ' Incident). Since PCB's probably have a vironmental contamination, which as a rary" is recognition that, in the future, long biological half-life in man, an alter practical matter are presently unavoid there should be less PCB contamination native toxicological analysis of the hu able. Those foods, for which, temporary which "cannot be avoided" and the Com man data may be based on the assump tolerances are being established, include missioner is authorized to reduce the tion that ingested PCB's would continue milk and dairy products, poultry, eggs, tolerance levels accordingly. The tempo to accumulate in tissues for a long fish, and infant and junior food. Infants rary tolerance levels are based on an period of time. Since 2,000 mg was re and young children consume a greater analysis of .animal and human toxico ported to be the average total dose caus amount of food per kilogram of body logical data and data on the occurrence ing an effect in the Japanese, it is possi weight and thereby have a proportion of PCB's in the food supply as follows: ble that 200 mg total' dosage PCB's ately greater exposure than do adults. (1) Animal toxicological data. Data (applying a safety factor of 10 to 1 as A separate temporary tolerance for in from long-term animal studies are avail above) may be tolerated over a much fant and Junior food, therefore, reflects able to show that the no-effect level in more protracted period of time without the possibility that undesirable ex rats and dogs (for PCB's with 42, 54, and overt adverse effect if daily exposure is posures could result if combinations of 60 percent chlorination) is 10 parts per held to minimal levels. It would take 22 certain PCB-contamlnated foods com million (ppm). Employing a 100 to 1 months of daily Ingestion of 300 meg of prise a major portion of this age group's safety factor, the "no-effect" level for PCB's to arrive at a total ingestion of diet. In order to minimize the overall man would be 2.5 microgram (meg)/kilo 200 mg. This would permit ingestion of dietary intake of PCB's, individual gram (kg) body welght/day based on 4 meg/kg/day as derived from a 70 kg sources of PCB contamination must also data drived from dogs, or 3 meg/kg body- man. Since the lowest total dose pro be appropriately minimized. PCB's have welght/day from rats. Therefore, based ducing an effect in man was 500 mg, a been shown to occur in packaged food on long-term animal studies, the allow similar analysis leads to an allowable as a result of the PCB contamination of able level of PCB ingestion in man would protracted ingestion of 1 meg/kg/day as paper food-packaging materials. Limi-. be approximately 175 meg/day for a 70 derived from a 70 kg man. tations on the levels of PCB's in paper kg individual. (2) Human toxicological data. Human intoxication with Kanachlor 400, a PCB manufactured in Japan with 48 percent chlorine was noted when a heat ex changer leaked fluid into rice oil and was consumed by Japanese families in 1968. About 1,000 people were eventually afTected. Typical clinical findings in cluded chloracne and increased pigmen tation, visual Impairment due to hyper secretion of the Meibomian glands, and systemic gastrointestinal symptoms that (3) Dietary sources of PCB's. The re sults of FDA total diet studies for fiscal years 1970-1972 show that quantitatively measurable residues of PCB's are equiv alent to an intake of approximately 0.06 meg/kg/body weight/day (or 4.2 meg/ day for a 70 kg man). Because of the sensitivity of the analytical methods used. PCB's may be present at levels too low to be detected, If lower levels could be measured, the dietary intake of PCB's from the total diet studies would prob ably show an'increase. It should be rec food-packaging materials are, therefore, necessary to minimize the amount of PCB's which may migrate to the pack aged food. Since PCB's can be trans mitted to and concentrated in edible portions of food-producing animals in gesting PCB-contamlnated feed, animal feed represents another source of PCB's In the food supply. Limitations on the levels of PCB's In animal feeds and ani mal feed components are necessary, therefore, to minimize the frequency and magnitude of PCB residues In foods of included abdominal pain and disturb ognized, however, that in rare instances animal origin. ances in liver function. A few babies some people could have more systematic The Commissioner concludes that the were bom with decreased birth weights exposures to PCB's in foods than those temporary tolerances being established and skin discoloration which slowly re gressed as the children grew in size, although the growth rate of males ap peared to be somewhat slower than nor mal. Adult patients had protracted expected' by eating a moderately well balanced diet such as represented by the total diet samples. Hence, there is a need for minimizing potential human expo sures. The total diet studies indicate that will protect the public health from PCB's In food, but cautions that the temporary tolerances are not to be con strued as "guidelines" permitting the consumption of foods containing these clinical disease with very slow regression of symptoms and signs, suggesting slow metabolism and excretion of this PCB in humans, probably involving a long bio logical half-life. Exposure levels to the oil were calculated to approximate, on the average, 15,000 mg per day. The oil itself was reportedly contaminated at a level of about 2,000 ppm. This level was derived from the known organic chlorine content of rice oil related to the known organic chlorine content of Kanachlor 400. The average total dose of PCB's causing an effect in the Japanese was reported to be 2,000 mg. The human data published by Karatsune, et al., Fukuoka Acta. Med. 23:117 (1971) established that the lowest level of PCB that pro duced an effect in man (using a 50 kg man) was 500 mg consumed over a pe riod of 50 days at a rate of approxi mately 200 meg/kg body weight/day. Tire effect level was based on overt symptoms rather than sensitive bio chemical tests that might have demon strated some effects at even lower levels. Employing a safety factor of 10 to 1 to go from an effect level in man to a per missible no-effect level in man allows for an ingestion of 20 meg/kg body PCB's most frequently occur in the food composite consisting of meat, fish and poultry (experience has shown that most of the PCB residues in this composite are in fish and, to a lesser extent, poultry) and'in the food composite con sisting of grain and cereal products (ex perience has shown most of the PCB residues in this composite are derived from paper packaging materials). FDA's food surveillance activities have shown that PCB's also occur in dairy products, eggs, and packaged foods, in addition to packaged cereal products. (4) Temporary tolerances for PCB's. Using the human toxicological data de scribed above, FDA concludes that for the short term, based on the lowest total dose producing an effect and estimated biological half-life of PCB's, current levels of PCB's in the diet represent no Immediate hazard. This is also true for the average total dose causing an effect in the Japanese for long-term exposure. However, based on the most sensitive "Japanese patient" (l.e., lowest total dose producing an effect), the possibility of potential long-term hazards necessi tates reduction of the levels of PCB's in food as soon as possible. In the interim, amounts of PCB's on a regular and con sistent basis. Further, the temporary tol erances will be lowered as experience In dicates that lower levels can be attained. c. One comment recommends that FDA Issue warnings to pregnant women who breast feed their babies to restrict their Intake of fish to species that have been thoroughly monitored by FDA and found to be uniformly within the temporary tolerance. The basis for this recommen dation is that consumption of PCB-containing fish and, for that matter other foods, may result In transfer and storage of PCB residues In human milk which in turn, the comment contends, would present a hazard to breast fed babies. The Commissioner concludes that such a warning is not warranted. On the basis of available, but limited monitoring data, most of which is unpublished, it appears that PCB levels in human milk would generally be less than approximately 0.05 ppm (whole product basis). Anal ysis of available toxicological data in volving multigeneration reproduction studies in rat indicates that this level presents no immediate hazard to Infants. Furthermore; this level is substantially less than the level of PCB's FDA will per weight/day; or 1.4 mg/day for a 70 kg temporary tolerances are necessary to mit in the milk of dairy cows. The tem man based on a total period of exposure limit human exposure to those foods that porary tolerance being established for of 50 days (equivalent to the Japanese may contain PCB's resulting from en milk is 2.5 ppm (fat basis), which is FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6, 1973 0003578 WATER PCB-SD0000039953 18098' RULES AND REGULATIONS equivalent to 0.1 ppm (whole product one sample of milk in 520 tested con tains acceptable levels of PCB's, irre basis). Therefore, a public warning as tained more than 2.5 ppm PCB in the spective of whether the whole tissue is recommended is not supported by the fat, l.e,, 0.2 percent of the total sam consumed or the fat is consumed as a scientific facts available at this time. ples. Evidence also indicates that higher separate food. d. One comment recommends clarifi levels may be generally attributed to 6. Section J22.10(a)(S) and (6). The cation of the term "PCB's" so as to avoidable sources of contamination, notice included the proposal to establish' distinguish between PCB-compounds of such as the use of PCB coatings in temporary tolerances for PCB's in fin different chemical composition. The diary farm silos which caused PCB con ished animal feeds at 0.5 ppm and ani basis for this comment is the fact that tamination of silage for diary cows with mal feed components (including fish PCB's are mixtures of chlorinated bi- subsequent transmission of PCB's to the meal) at 5 ppm. phenql compounds. Each component of milk of these cows. a. One comment recommends that the the PCB mixture is a specific chemical b. One comment recommends the PCB term "finished animal feed" be changed compound having the basic biphenyl tolerance be expressed on an "as is" to "complete animal feed" since some moiety and one to ten chlorine atoms. basis because the fat content of dairy finished feeds are further mixed with There are 209 different chlorinated bi products varies and these foods are con grains, by-products of grains, and other phenyl compounds. Each component of sumed "as is". The Commissioner re feed Ingredients of plant origin before manufactured and sold in the United jects this recommendation. The butter- feeding. The Commissioner agrees that States under the registered trade name of fat is generally considered the most val certain finished animal feeds such as Aroclor, followed by a four digit number uable constituent of milk. PCB's are fat feed concentrates, premixes, and supple (l.e,, 1242; 1248; 1254; etc.). The term soluble, and in'the manufacture of vari ments, often contain high levels of PCB's Aroclor signifies that the product con ous dairy products from milk, remain at because they consist of a high percent sists of chlorinated biphenyls, chlori a nearly constant concentration in the age of animal-derived Ingredients. At nated terphenyls, or a mixture of these fat. The fat basis tolerance is therefore time of use, however, these articles are compounds. The first two digits of the necessary to govern the level of PCB's mixed with plant-derived ingredients numerical part of the trade name indi cate the molecular type (1200 signifies chlorinated biphenyl), while the last two digits give the weight percent of chlorine (42 signifies 42 percent chlorine). Since the physical and chemical properties of each Aroclor vary, the analytical be havior of each Aroclor will also vary. For PCB residue analysis, it is customary to determine the amount of PCB residue found by comparing the residue to a known quantity of the Aroclor it most nearly matches when separated into multicomponents on a gas chromato graph. Therefore, the Commissioner agrees that clarification of the term "PCB" is necessary for the analysis of food, animal feed and paper food-pack aging materials for PCB residues. The compilation of FDA analytical methods to be used for enforcing the PCB toler ance that is available upon request con tains instructions regarding this aspect of the re'commendation. The Commis sioner does not agree, however, that the tolerances for PCB's should distinguish between PCB-compounds of different chemical composition because toxicologi cal data do not support the nged to establish separate tolerances for each Aroclor, Therefore, the temporary toler ances will apply to the term "PCB" ir respective of which Aroclor or mixture of Aroclor is present as the contaminant. 4. Section 122.10(a)(1) and (2). The notice included the proposal to establish a temporary tolerance for PCB's in milk and dairy products at 2.5 ppm (fat basis). a, One comment recommends that since FDA's previous action level for PCB's in milk and dairy products, which was set at 55 ppm (fat basis), was stated as adequate for protecting public health, the temporary tolerance for milk and' dairy products should be kept at the same level. The Commissioner concludes that there is no justification for raising the proposed tolerance from 2,5 ppm to 5 ppm in the fat of milk and dairy prod ucts. The 2.5 ppm temporary tolerance takes into account current toxicological data and the level of PCB residues that in such products in preparing some other type of food. For example, butter (about 80 percent fat) made from milk contain ing levels of PCB's below tolerance would also be acceptable since the PCB concen tration in the fat would be unchanged, 5. Section 122.10(a) (3). The notice in cluded a proposal to establish a tempo rary tolerance for PCB's in poultry at 5.0ppm (fatbasis). a. One comment recommends that since FDA's previous action level for PCB's in poultry, which was set at 5 ppm on the edible tissue, was stated as ade quate for protecting public health, the temporary tolerance should be kept at that same level. The Commissioner re jects this recommendation. PCB con tamination of poultry at levels in excess of the temporary tolerance being estab lished has been attributed to the use of animal feed contaminated with PCB's as a result of industrial accidents, e.g., leakage of PCB's onto feed components. The Commissioner concludes that there is no justification for establishing a tol erance level that accounts for avoidable sources of contamination. The tempo rary tolerance of 5 ppm (fat basis) takes into account that this level of PCB is generally unavoidable because some poultry feeds contain unavoidable PCB residues that will transfer to and con centrate in the fat of poultry. Further more, current toxicological data sup ports this tolerance level. ' b. One comment recommends that the tolerance for poultry be expressed on an "as is basis" since this would more closely relate to the total PCB intake from this food than would a tolerance established for poultry on a "fat basis". In response, the Commissioner finds that although the dietary intake of PCB's re sulting from contaminated poultry was considered on an "as is" basis (whole tissue) in the development of the tem porary tolerance level, expressing the tc: cporary tolerance on a fat basis is preferred since PCB's are fat soluble and fat derived from poultry can be used as a separate food (e.g., soups, gravies, etc.). which are not expected to contain PCB's. Thus, the final ration for the animal would not contain excessive levels of PCB's. The Commissioner concludes that for purposes of the PCB tolerance for animal feeds, clarification of the term "finished animal feed" is needed rather than a change in terminology. Therefore, the order is amended in J 122.10(a) (5) (21 CFR 122.10) so that the temporary tolerance for PCB's is applicable to fin ished animal feeds, except feed concen trates, supplements, and premixes. b. One comment recommends a PCB tolerance of 1.0 ppm be established for animal feed components which are not of animal or marine origin. Since there has been no reported finding of PCB's (other than that which may be due to avoidable contamination during process ing, handling, or storage) in animal feed components such as grains and by-prod ucts of grains, the Commissioner con cludes there is no need at this time to establish a separate tolerance for PCB's in this category of animal feed compo nent. c. One comment recommends that the term "animal feed components" be quali fied by the expression "including fish meal and concentrates, premixes, and supplements''. The Commissioner agrees with this recommendation and the order is amended in 5122.10(a) (6) so that the temporary tolerance for PCB's is appli cable to animal feed components of ani mal origin (including fishmeal and other marine by-products) and animal feed concentrates, premixes and supplements. d. The Commissioner finds that al though there was no comment to change the proposed tolerance levels of 0.5 ppm for finished animal feeds and 5 ppm for animal feed components, current infor mation indicates a lowering of these tol erance levels is warranted for the follow ing reasons: (1) Data from FDA conducted feeding studies show that the proposed tempo rary tolerance 0.5 ppm for finished ani mal feeds is incompatible with the tem porary tolerances for poultry, White leg is presently considered unavoidable. A The fat basis tolerance, therefore, pro horn hens exposed to a diet containing recent FDA survey revealed that only vides the assurance that poultry con 0.5 ppm PCB's (Aroclor 1254) for 8 weeks ,FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6 1973 0003579 WATER PCB-SD0000039954 RULES AND REGULATIONS 18099 contained residues in excess of 5 ppm sion of PCB's to the edible portion of (fat basis) in the muscle (breast and animals Ingesting PCB contaminated thigh), dissectable fat, and liver of these 'feed constitutes a potential hazard to animals. At a 0.2 ppm feeding level, the human health. Further, the comment concentration of the PCB tissue residues makes a reasonable recommendation in poultry was less than 5 ppm (fat since some pets may be able to safely basis). Data further indicate that con consume levels of PCB's higher than 0,5 tinuous feeding of Aroclor 1254 at 0.5 ppm. However, on the basis of available ppm from day three to day forty-three toxicological information, there is insuf post initial egg production can result in ficient data for FDA to establish a toler PCB residues only slightly less than 0.5 ance for PCB's in feed for all types of ppm in the eggs. (2) Data from FDA surveillance pro grams and from industry reports indi cate that PCB levels in finished animal feeds and in animal feed components are generally substantially less than the pro posed tolerance limits. (a) Last year FDA conducted a survey of finished animal feeds for PCB's. The survey consisted of 1274 sample examinations representing various categories of animal feeds. The results show that 4.4 percent of the sam ples contained PCB residues. The highest reported level was 0.6 ppm PCB in feed intended for beef cattle. Ihe average level for all samples tested was less than 0.1 ppm and the average level of the 56 samples that contained reportable levels of PCB's was less than 0.2 ppm. About 1 percent of the samples exceeded 0.2 ppm. (b) Animal feed components of animal and marine origin are expected to con tain PCB's as a result of environmental contamination. During the past year, 32 pets and for other non-food producing animals, For this reason, studies will be initiated to obtain this information and, if warranted, FDA will issue a proposal to limit the level of PCB's in this category of finished animal feed. In the interim, the order is amended so that the tem porary tolerance in 122.10(a) (5) is ap plicable to only food-producing animals. 7. Section 122.10(a) (7). The notice in cluded the proposal to establish a tem porary tolerance for PCB's in fish (edible portion) at 5 ppm. a. One comment recommends that a temporary tolerance be established for shellfish. The Commissioner agrees with this recommendation because shellfish also have been found to contain PCB's as a result of unavoidable, environmental contamination and it is also in the in terest of public health to limit the level of PCB's in this food. Therefore, 122.10 (a) (7) is amended to include shellfish under the temporary tolerance of 5 ppm. samples of imported fishmeal were ex 8. Section 122.10(a) (S). The notice in amined by FDA for PCB's. The results cluded the proposal to establish a tem show that about 37 percent of the sam porary tolerance for PCB's in Infant and ples contained PCB residues. The highest junior foods ad, 0.1 ppm. level reported was 0.47 ppm. In addition, a. One comment states that the level 153 fishmeal samples of domestic origin proposed cannot be achieved because of were examined during this period. The trace quantities of PCB's in certain foods results show that about 48 percent of the and in p'aper food-packaging materials. samples contained PCB residues. The The Commissioner concurs with this highest level reported was 2.1 ppm and statement because information Indicates the average was less than 1 ppm. (c) In that this level of PCB's cannot be avoided the fall of 1971, industry conducted a and that current analytical methodology survey of the PCB levels in rendered ani is insufficient to enforce a tolerance of mal by-products used for feed ingredi 0.1 ppm. Therefore, the final order is ents such as hydrolyzed feather meal; amended by revising the temporary tol meat and bone meal; fats and greases; erance for PCB's in Infant and junior and poultry by-product meal. The results foods to 0.2 ppm.. of this survey which were published in "Feedstuffs," issue of July 3, 1972, show that of the 438 samples tested, the high est level of PCB found was 1.6 ppm in fat and greases. The average PCB level for the samples tested was less than 1 ppm. Other data that the FDA has received on the levels of PCB's in rendered animal by-products essentially confirms the re sults of this industry survey. Therefore, on the basis of the above, the Commis sioner concludes that available evidence requires and justifies a reduction in the PCB tolerances for animal feeds and animal feed components. The order is thus amended in J 122.10(a)(5) and (6) to establish temporary tolerances for PCB's in finished feeds at 0.2 ppm and in animal feed components at 2 ppm. e. One comment recommends that a tolerance of 5 ppm be established for PCB's in pet food. The Commissioner agrees in part with the comment. The proposal to establish a tolerance for ani mal feed was directed toward food- 9. Section 122.10(a) (9). The notice in cluded the proposal to establish a tem porary tolerance for PCB's in food-packaging materials at 6 ppm. a. One comment recommends that plastic and other non-paper food-pack aging material be exempt from the tem porary tolerance. The Commissioner agrees with this recommendation because there is no evidence to indicate that PCB's occur in plastic or other non-paper food-packaging materials as a result of unavoidable contamination. For this reason, no basis exists for establishing a tolerance under Section .406 of the Fed eral Food, Drug, and Cosmetic Act for these articles. Therefore, the wording of 8 122.10(a) (9) is revised to apply only to paper food-packaging materials. This exemption means that no PCB's what ever may be present, either as a result of purposeful addition or industrial acci dents, in plastic and other non-paper food-packaging materials. The provisions in the Statement of General' Policy or producing animals because the transmis Interpretation under Part 3, which pro hibits the use of PCB-containlng equip ment and materials, are applicable to those establishments engaged in thp manufacture, handling, and storage of plastic and other non-paper food packaging materials. b. One comment contends that no au thority exists under Section 406 'of the Federal Food, Drug, and Cosmetic Act for the establishment of temporary tol erances for PCB's in food-packaging materials. The Commissioner concludes that the establishment of temporary tol erances for PCB's in food-packaging ma terial is consistent with the language and purpose of Sections 402(a) (2) (A) and 406 of the Federal Food, Drug, and Cosmetic Act. , c. One comment recommends the temporary tolerance be applied to the packaged food, rather than the. food packaging material. The Commissioner rejects this recommendation for the fol lowing reasons; (1) Since the transfer of PCB's from packaging material to the food is de pendent on time and conditions of ex posure, tolerances based solely on the food would not provide adequate pro tection to the consumer. A packaged food analyzed at the time of packaging may be entirely free of PCB's, but by the time it reaches the consumer and is finally consumed it may have accumulated con siderable quantities of PCB's if the packaging material is contaminated. A tolerance system in which analytical findings are so dependent on many vari ables such as time of sampling would not be reasonable or adequate. (2) In order to achieve compliance with a tol erance for packaged food, the level of PCB in the packaging has to be taken into account and liniited to preclude the potential transfer of quantities of PCB's to the food that would cause the food to exceed its tolerance level. The fact that the level of PCB in packaged food is related to the level of PCB in its pack aging, in effect, necessitate tolerance for both the food and its packaging. This would represent an obvious redundancy. (3) Establishing a tolerance for pack aged food would be inconsistent with the intent and meaning of section 406 of the Federal Food, Drug, and Cosmetic Act. The packaged food does not contain un avoidable PCB residues. The principal source of the PCB contamination of packaged food is the paper food-pack aging material, which contain the un avoidable contamination. As such, the tolerance should deal with this article. Therefore, this source of food contam ination should be limited so as to minimize the levels of PCB's that may migrate to the packaged food. (4) Fail ure to limit the level of PCB's in food packaging materials would perpetuate the use of a known, avoidable source of PCB contamination of food. d. One comment received from indus try and related trade associations argues that the temporary tolerance for PCB's in food-packaging materials should be deleted or postponed until; (1) quality control test' procedures and adequate analytical methods are developed to reg ulate production and insure compliance, FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6, 1973 0303580 WATER PCB-SD0000039955 18100 RULES AND REGULATIONS and (2) migration rates are established clor 1242 are metabolized in biological 5 122.10(a). Omitting the methodology to take into account barrier effects, type systems more rapidly than the higher from toe regulation will permit easier of food, and package weight to food chlorinated Aroclors, there is no Infor adoption of improved procedures as they weight ratio. In response, the Commis sioner finds that: (1) Although a trade mation available which describes the composition, toxicity, and fate of the are developed while having the analytical methods readily available to all inter association submitted data which they metabolic products. The absence of Aro ested parties. claimed indicates a lack of reliability in clor 1242 residues in human and other h. One comment states that the tem analyses of paperboard material, the data failed to show that uniform test animal tissue and in the environment is not a sound basis from which to argue porary tolerance for PCB's for paper food-packaging materials will be detri methods were employed by the partici that no hazard exists from the inges mental to solid waste disposal programs, pating laboratories or that these tests were performed by laboratories with tion of Aroclor 1242. The possibility ex ists that Aroclor 1242 is converted to al increase food packaging costs and result in an insufficient supply of packaging demonstrated capabilities in trace re sidue analysis, further, an interlabora tory study conducted under the aus pices of another trade association using FDA analytical methodology, supports the conclusion that current methodology is adequately sensitive and reproducible from laboratory to laboratory in order to Insure compliance with the tolerance. (2) It is recognized that migration rates (actual level of PCB in food resulting from the use of contaminated packag ing) are affected by factors such as bar riers, type of food, package weight to food weight ratio, and time and condi tions of exposure. Since FDA's primary concern is not the fact that paper food packaging materials contain FCB's, but the fact that PCB's can migrate to the food from the packaging, the use of bar riers which prevent migration is an ac ceptable alternative to limiting the PCB content of paper food-packaging mater ial. For this reason, the final order is amended in 122.10(a) (9) to exempt paper food-packaging materials from compliance with the temporary tolerance if the paper food-packaging material is separated from the food by a functional barrier impermeable to PCB migration. Metal cans and glass bottles are obvious examples of what constitutes a func tional barrier impermeable to PCB mi gration. Data from industry sponsored studies have shown that materials such as polyvinylidene coated paper and glassine can, to varying degrees, prevent or reduce PCB migration under test condi tions which would favor migration. FDA would not object to the use of flexible materials and other materials as bar riers provided there is no evidence of migration of PCB's to the food. At this time, however, there is insufficient in formation for FDA to list as part of the regulation those materials that are con sidered functional barriers. The other factors mentioned above which affect migration rates may also be important considerations and should be thoroughly studied. In the interim, the temporary tolerance for paper food-packaging materials and the exemption to this temporary tolerance are considered nec essary to assure the consumer that pack aged food is not being contaminated with PCB's to an avoidable degree. teration products which may be more toxic than the original compounds, but which are not detectable by current ana lytical methods. Further, available data from chronic feeding studies with rats and dogs fail to substantiate claims that Aroclor 1242 does not represent a toxic substance or that it differs in toxicity from the higher Aroclors. The Commis sioner concludes that the temporary tol erance for paper food-packaging mate rials will apply to the tern "PCB" irre spective of which Aroclor is present as the contaminant. f. Several manufacturers and trade as sociations recommended that the tempo rary tolerance for PCB's in food-packag ing materials be modified so that the tolerance is expressed as "0.265 meg/ square centimeter in that portion of the package from which migration to the food can reasonably be expected", rather than using "parts per million" terminol ogy. The Commissioner believes that this would not be a practical alternative be cause: (1) Expressing the tolerance for the weight of PCB residues in terms of unit area of packaging material rather than unit weight of packaging material assumes that PCB's are uniformly dis tributed throughout the food package and that any area of toe packaging ma terial selected for PCB analysis would be representative of the entire package. It is generally recognized that this as sumption is not valid. (2) The migration of PCB from package material to food is considered to be chiefly a vapor phase phenomenon which is related to the con centration of PCB's in toe packaging material. It is therefore not possible to ascertain which portion of toe package would be expected to contribute to toe PCB contamination of the packaged food. For these reasons, it is necessary to take into account the paper food-packaging material in its entirety as a potential source for the PCB contamination of toe packaged food. Therefore, expressing the tolerance in terms of weight of PCB's per weight of packaging material as "parts per million" is a practical means to measure the "average" PCB level in the packaging. g. One comment recommends that FDA include in the final regulation PCB analytical procedures employed by FDA materials due to limitations of raw? ma terials, and thus will significantly affect the quality of the human environment. The underlying basis for this statement is the fact that PCB's may occur in re cycled paper because of toe inclusion of some types of carbonless copy paper con taining 3-5 percent PCB's into w'astepaper stocks used in the manufacture of recycled paper. The comment contends that the temporary tolerance, will have an adverse effect on the recycled paper industry and thus will cause the above environmental consequences. In re sponse, FDA prepared in accordance with the National Environmental Policy Act of 1969 an environmental impact state ment on the proposed rule making. FDA issued a Draft Environmental Impact Statement on May 11, 1972, a Final En vironmental Impact Statement on De cember 21,1972, and a Supplement to toe Final Environmental Impact Statement (published concurrently with this order). In these statements, FDA asserted that information on toe toxicity of PCB's ne cessitates limiting toe levels of PCB's cur rently present in certain foods as a re sult of environmental contamination, as well as levels of PCB's in certain un avoidable sources of food contamination, i.e., PCB contaminated paper foodpack aging materials. FDA also asserted that toe public health benefits derived from the rule making would outweigh any benefits that might be derived from in dustry-recommended alternative courses of action. These alternatives, which were considered and rejected by FDA as in effective consumer protection measures, included: (1) The alternative of not reg ulating toe PCB content of food-pack aging materials: (2) The alternative of exempting Aroclor 1242 from the regula tion: and (3) The alternative of regulat ing the packaged food rather than the packaging. FDA concluded in toe state ments that the rule making would have a significant, beneficial effect on toe quality of toe human environment. FDA did, however, re-evaluate the proposed level of 5 ppm as the temporary toler ance for PCB's in paper food-packaging materials. Data from toe FDA survey of PCB's in foods and food packaging showed that the food portion of toesamples with 5-10 ppm in paper food packaging contained the same range of e. One comment states that the estab in determining the extent of compliance PCB levels (0.1-0.6 ppm) as toe food por lishment of temporary tolerance for PCB with the established temporary tolerance tion of the samples with 0-5 ppm in paper in paper food-packaging materials is un for paper food-packaging materials. The packaging. Samples with more than 10 warranted for public health reasons be Commissioner concurs in part with this ppm in the packaging contained higher cause available scientific evidence shows recommendation and FDA will provide levels in the food, ranging up to 3.7 ppm, that Aroclor 1242 (predominant PCB upon request the analytical methods to The Commissioner concluded that this found in paper) is not persistent and cu be used for enforcing the temporary was the only acceptable alternative mulative. and thus will not present a tolerances for PCB's in paper food-pack available and stated in the Final Envi chronic toxicity problem. Although data aging materials and the other articles for ronmental Impact Statement that the indicates that some components of Aro which tolerances are established in temporary tolerance for PCB's in paper FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6, 1973 $035si WATER PCB-SD0000039956 RULES AND REGULATIONS 18101 food-packaging materials would be1 cant percentage of paper food-packaging changed to 10 ppm. (This order amends material contains PCB's which can mi 5 122.10(a) (9) to reflect this change.) grate to the packaged food. The origin Data provided by industry shows that of PCB's in such material is not fully (c) The provisions of this section do not apply to electrical transformers and condensers containing PCB's in sealed containers. levels of PCB's in paper food-packaging understood. Reclaimed fibers containing materials have diminished during the carbonless copy paper (contains 3 to 5 PART 121--FOOD ADDITIVES past year to the point that 93 percent or more of this material will contain 10 ppm or less PCB's. Therefore, FDA con cluded that the temporary tolerance of percent PCB's) have been identified as a primary source of PCB's in paper prod ucts. Some virgin paper products have also been found to contain PCB's, the 2. In Part 121, 121.2546(b) is amended by revising subparagraphs (1) and (2), as follows: _ 10 ppm and the exemption to this toler source of which is generally attributed 121.2546 Pulp from reclaimed fiber. ance for paper food-packaging materials to direct contamination from industrial separated from the packaged food by a functional barrier will protect the public, while minimizing or negating the impact of the rule making on recycling pro grams. Furthermore, FDA indicated in the Supplement to the Final Environ mental Impact Statement that it will ex plore with other federal agencies meas ures for eliminating PCB-containing carbonless copy paper from existing in ventories. If feasible, this action would reduce the primary source of PCB's found in paper food-packaging materials per mitting FDA to reduce the temporary tolerance, and eventually to eliminate the need for regulating this unavoidable source of PCB's in food. Accordingly, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 402(a), 406, 409, 701, 52 Stat, 1046 as amended, 1049, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948, accidents from the use of PCB-containing equipment and machinery in food packaging manufacturing establish ments, Since PCB's are toxic chemicals, (b) * * " (1) Industrial waste from the manu facture of paper and paperboard products excluding that which bears or contains the PCB contamination of food-packag ing materials as a result of industrial accidents, which can cause the PCB con any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food, except as tamination of food, represents a hazard to public health. It is therefore necessary to place certain restrictions on the in dustrial uses of PCB's In establishments manufacturing food-packaging mate rials. (b) The following special provisions are necessary to preclude the accidental PCB contamination of food-packaging materials: (1) New equipment or machinery for manufacturing food-packaging materials shall not contain or use PCB's. (2) On or before August 6, 1973, the . management of establishments manu provided in regulations promulgated under sections 406 and 409 of the Federal Food, Drug, and Cosmetic Act. (2) Salvage from used paper and paperboard excluding that which (i) bears or contains any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food, except as provided in regu lations promulgated under sections 406 and 409 of the act or (ii) has been used for shipping or handling any such sub stance. * * * * 72 Stat. 1784-1788 as amended; 21 U.S.C. facturing food-packaging materials 342(a), 346, 348, 371) and under au shall: . PART 122--UNAVOIDABLE CONTAMI thority delegated to the Commissioner (i) Have the heat exchange fluid used NANTS IN FOOD AND FOOD-PACKAG (21 CFR 2.120) Parts 3, 121, 128, and 135 in existing equipment for manufacturing ING MATERIAL are amended and a new Part 122 is added, as follows: PART 3--STATEMENTS OF GENERAL POLICY OR INTERPRETATION 1. The following new section is added to Part 3: food-packaging materials sampled and tested to determine whether it contains PCB's pr verify the absence of PCB's in such formulations by other appropriate means. On or before Sept. 4, 1973, any such fluid formulated with PCB's must to the fullest extent possible commen 3. A new Part 122 is added as follows: Subpart A--Definitions and Procedural and Interpretive Regulations Sec. ' 122.1 Definitions and Interpretations. 122.2--122.9 [Reserved] g 3.93 Use of polychlorinated biphenyls (PCB's) in establishments manufac turing food-packaging materials. (a) Polychlorinated biphenyls (PCB's) represent a class of toxic industrial chemicals manufactured and sold under a variety of trade names, including: Aroclor (United States); Phenoclor (France); Colphen (Germany); and Kanaclor (Japan), PCB's are highly surate with current good manufacturing practices be replaced with a heat ex change fluid that does not contain PCB's. (ii) Eliminate to the fullest extent pos- . Subpart B--Industrial Contaminants In Food and Food-Packaging Material 122.10 Temporary tolerances for polychlortnated biphenyls (PCB's). sible commensurate with current good Acthoritt: Secs. 402(a), 406, 409, 701, 62 manufacturing practices from the estab lishment any other PCB-containing equipment, machinery and materials wherever there is a reasonable expecta Stat. 1046 as amended, 1049, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948, 72 Stat. 1785-1788 as amended; 21 DB.C. 342(a), 346, 348, 371. tion that such articles could cause food Subpart A--Definitions and Procedural packaging materials to become contam and Interpretive Regulations stable, heat resistant, and non-flamma ble chemicals. Industrial uses of PCB's Include, or did include in the past, their use as electrical transformer and capaci tor fluids, heat transfer fluids, hydraulic fluids, and plasticizers, and in formula tions of lubricants, coatings, and inks. Their unique .physical and chemical properties and widespread, uncontrolled industrial applications have caused PCB's to be a persistent and ubiquitous inated with PCB's either as a result of normal use or as a result of accident, breakage, or other mishap. (iii) The toxicity and other charac teristics of fluids selected as PCB replace ments must be adequately determined so that the least potentially hazardous re placement is used. In making this deter mination with respect to a given fluid, consideration should be given to (a) its toxicity; (b> the maximum quantity that 122.1 Definitions and Interpretations, (a) The definitions and interpretations of terms contained in section 201 of the Federal Food,' Drug, and Cosmetic Act shall be applicable to such terms when used in this part, (b) Unavoidable natural, environ mental, or Industrial contaminants in clude any poisonous or deleterious sub stance added to any food Where such contaminant in the environment, caus ing the contamination of certain foods. could be spilled onto a given quantity of food befoi'e it would be noticed, taking substance cannot be avoided by good manufacturing practice. In addition, incidents have occurred in which PCB's have directly contaminated animal feeds as a result of industrial accidents (leakage or spillage of PCB fluids from plant equipment). These ac into account its color and odor; (c) pos sible signaling derices in the equipment to indicate a loss of fluid, etc.; and (d) its environmental stability and tendency to survive and be concentrated through Subpart B--Industrial Contaminants in Food and Food-Packaging Material 122.10 Temporary tolerances for poly, chlorinated biphenyls (PCB's). cidents in turn caused the contamina the food chain. The judgment as to (a) Polychlorinated biphenyls (PCB's) tion of food products intended for human whether a replacement fluid is suffi are toxic, industrial chemicals. Because consumption (meat, milk and eggs). In ciently non-hazardous is to be made on of their widespread, uncontrolled indus vestigations by the Food and Drug Ad an individual installation and operation trial applications, PCB's have become a ministration have revealed that a signifi basis. persistent and ubiquitous contaminant in FEDERAL'REGISTER, VOl. 38, NO. 129--FRIDAY, JULY 6, 1973 0303582 WATER PCB-SD0000039957 38102 RULES AND REGULATIONS the environment. As a result, certain 128.4 Equipment and utensil*. that such materials could cause food to 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 animaj feed. In addition, a significant percentage of paper food packaging 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). (a) General. All plant equipment and utensils should be (1) suitable for their Intended use, (2) so designed and of such material and workmanship as to be ade quately cleanable, and (3) properly maintained. The design, construction, and use of such equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other con taminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. . (b) Use of polychlorinated biphenyls in food plants. Polychlorinated biphenyls (PCB's) represent a class of toxic indus trial chemicals manufactured and sold under a variety of trade names, Includ ing: Aroclor (United States); Phenoclor (France); Colphen (Germany); and Kanaclor (Japan). PCB's are highly stable, heat resistant, and non-flammable chemicals. Industrial uses of PCB's in clude, or did include in the past, their use as electrical transformer and capacitor fluids, heat transfer fluids, hydraulic fluids, and plasticizers, and in formula tions of lubricants, coatings, and inks. TTieir unique physical and chemical properties and widespread, uncontrolled become contaminated with PCB's either as a result of normal use or as a result of accident, breakage, or other mishap. (lv) The toxicity and other charac teristics of fluids selected as PCB replace ments must be adequately determined so that the least potentially hazardous re placement is used. In making this deter mination with respect to a given fluid, consideration should be given to (d its toxicity; (b) the maximum quantity that could be spilled onto a given quantity of food before it would be noticed, taking into account its.color and odor; (c) pos sible signaling devices In the equipment to indicate a loss of fluid, etc.; and (d) its environmental stability and tendency to survive and be concentrated through the food chain. The Judgment as to whether a replacement fluid is sufficiently non-hazardous is to be made on an in dividual installation and operation basis. (3) For the purposes of this section, the provisions do not apply to electrical transformers and condensers containing PCB's in sealed containers. PART 135--NEW ANIMAL DRUGS 5, The following new sectloh is added to Part 135, Subpart B: l2) 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). (6) 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). TTae 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 industrial applications have caused PCB's to be a persistent and ubiquitous con taminant in the environment and caus ing the contamination of certain foods. In addition, incidents have occurred in which PCB's have directly contaminated animal feeds as a result of industrial ac cidents (leakage or spillage of PCB fluids from plant equipment). These accidents in turn cause the contamination of food intended for human consumption (meat, milk, and eggs). Since PCB's are toxic chemicals, the PCB contamination of food as a result of these accidents rep resents a hazard to human health. It is therefore necessary to, place certain re strictions on the industrial uses of PCB's in the production, handling, and storage of food. The following special provisions are necessary to preclude accidental PCB contamination of food; (1) New equipment, utensils, and machinery for handling or processing food in or around a food plant shall not contain PCB's, (2) On or before September 4, 1973, the management of food plants shall: 135.113 Use of polychlorinated bi phenyls (PCB's) in the production, handling, and storage, of animal feed. (a) Polychlorinated biphenyls (PCB's) represent a class of toxic industrial chemicals manufactured and sold under a variety of trade names, including-: Aro clor (United States); Phenoclor (France); Colphen (Germany); and Kanaclor (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's in clude, or did include in the past, their use as electrical transformer and capaci tor fluids, heat transfer fluids, hydraulic fluids, plasticizers, and in formulations of lubricants, coatings, and inks. Their unique physical and chemical properties and widespread, uncontrolled industrial applications have caused PCB's to be a persistant and ubiquitous contaminant in the environment, causing the contam ination of certain foods. In addition, in cidents have occurred in which PCB's have directly contaminated animal feeds as a result of industrial accidents (leak paper food-packaging material separated (1) Have the heat exchange fluid used age or spillage of PCB fluids from plant from the food therein by a functional in existing equipment or machinery for equipment). These accidents in turn barrier which is impermeable to migra handling or processing food sampled and cause the contamination of food intended tion of PCB's. tested to determine whether it contains for human consumption, (meat, milk, (b) A compilation entitled "Analytical PCB's, or verify the absence of PCB's in and eggs). Investigations by the Pood Methodology for Polychlorinated Bi such formulations by other appropriate and Drug Administration have revealed phenyls, February .1973" for determining means. On or before Sept. 4, 1973, any that heat exchange fluids for certain compliance with the tolerances estab such fluid formulated with PCB's must pasteurization equipment used In proc lished in this section is available from be replaced with a heat exchange fluid essing animal.feed contain PCB's. Al the Hearing Clerk, Department of that does not contain PCB's. though heat exchange fluids in such Health. Education, and Welfare, Room (ii) Eliminate from the food plant any equipment are considered to be in "closed 6-88, 5600 Fishers Lane, Rockville, MD PCB-containing food-contact surfaces of systems", leakage has occurred that re 20852. ' PART 128--HUMAN FOODS; CURRENT GOOD MANUFACTURING PRACTICE equipment or utensils and any PCB-con taining lubricants for equipment or machinery that is used for handling or sulted in direct contamination of animal feed with PCB's and subsequently re sulted in the transfer of PCB's to human food produced by animals consuming the (SANITATION) IN MANUFACTURE, processing food. contaminated feed. The use of PCB-con PROCESSING, PACKING OR HOLDING (ill) Eliminate from the food plant any taining coatings on the inner walls of 4. In Part 128 by revising 128.4 to other PCB-containing materials wher silos has resulted in the contamination of read as follows; ever there is a reasonable expectation silage which has In turn caused PCB FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6, 1973 0003583 WATER PCB-SD0000039958 RULES AND REGULATIONS 18103 residues in the milk of dairy cows con suming the contaminated silage. Since PCB's are toxic chemicals, the PCB con tamination of food as a result of these and other Incidents represent a hazard to public health. It is therefore necessary to'place certain restrictions on the indus trial uses of PCB's in the production, handling, and storage of animal feed. (b) The following special provisions are necessary to preclude accidental PCB contamination of animal feed: (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 establishment producing animal feed shall not contain PCB's. (3) On or before Sept. 4, 1973, the management of establishments produc ing animal feed shall: (i) Have the heat exchange fluid used In existing equipment or machinery for handling and processing feed sampled and tested to determine whether it con tains PCB's, or verify the absence of PCB's in such formulations by other appropriate means. On or before Sept. 4, 1973, any such fluid formulated with PCB's must to the fullest extent pos sible commensurate with current good manufacturing practices, be replaced with a heat exchange fluid that does not contain PCB's. (ii) Eliminate to the fullest extent possible commensurate with current good manufacturing practices from the animal feed producing establishment any PCB-containing lubricants for equipment or machinery used for han dling or processing animal feed. (iii) Eliminate to the fullest extent possible commensurate with current good manufacturing practices from the animal feed producing establishment any other PCB-containing materials, whenever there is a reasonable expecta tion that such materials could cause ani mal feed to become contaminated with PCB's either as a result of normal use or as a result of accident, breakage, or other mishap. (iv) The toxicity and other charac teristics of fluids selected as PCB re placements must be adequately deter mined so that the least potentially haz ardous replacement should be used. In making this determination with respect to a given fluid, consideration should be given to (a) its toxicity; (b) the maxi-, mum quantity that could be spilled onto' a given quantity of food before it would be noticed, taking into account its color and odor; (c) possible signaling devices in the equipment to indicate a loss of fluid, etc.; (d) and its environmental stability and tendency to survive and be concentrated through the food chain. The Judgment as to whether a replace ment fluid is sufficiently non-hazardous is to be made on an individual installa tion and operation basis. . (c) For the purpose of this section, the provisions do not apply to electrical transformers and condensers containing PCB's in sealed containers. (d) For the purpose of this section, the term "animal feed'' includes all articles used for food or drink for animals other than man. . Any person who -will be adversely af fected by the provisions of } 121.254b and 122.10 of the foregoing order may at any time on or before August 6, 1973 file with the Hearing Clerk, Department of Health, Education, and Welfare, Boom 6-88, 5600 Fishers Lane, Hockville, MD 20852, written objections thereto. Objec tions shall show wherein the person fil ing will be adversely affected by the order, specify with particularity the provisions of the order deemed objection able, and state the grounds for the ob jections. If a hearing is requested, the objections shall states the issues for the hearing, shall be supported by grounds factually and legally sufficient to justify the relief sought, and shall include a de tailed description and analysis of the factual Information intended to be pre sented in support of the objections in the event that a hearing is held. Objections may be accompanied by a memorandum or brief in support thereof. Six copies of all documents shall be filed, Received ob jections may be seen in the above office during working hours, Monday through Friday. Effective date. This order will become effective for foods, feeds, and paper food packaging materials initially shipped in commerce after Sept. 4 1973 except as to any provisions of if 121.2546 and 122.10 that may be stayed by the filing of proper objections. Notice of the filing of objections or lack thereof will be an nounced in the Federal Register. In the event S 122.10 is stayed by valid objec tions, pending a final regulation the Food and Drug Administration will enforce the levels stated in 122.10 by seizing pursuant to sections 301 and 304 of the Act any food, feed, or paper food-pack aging material shipped in commerce con taining higher than the specified level of PCB's as adulterated in violation of sec tion 402 of the Act. (Secs. 402(a), 406, 409, 701, 52 Stat. 1046 as amended, 1049, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948, 72 Stat. 1765-1788 as amended: 31 UA.C, 342(a), 346, 348, 371) Dated: June 21,1973. Sherwin Gardner, Acting Commissioner of Food and Drugs. [FR DOC.73-13549 FUed 7-5-73:8:45 am] No. 120--Pt. II-----2 0003584 FEDERAL REGISTER, VOL. 38, NO. 129--FRIDAY, JULY 6, 1973 WATER PCB-SD0000039959 1S104 NOTICES ' DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration POLYCHLORINATED BIPHENYLS Availability of Supplement To Final Environmental Impact Statement The Commissioner of Pood and Drugs published a notice in the Federal Regis ter of December ?1, 1972 (37 FR 28201) announcing that, a statement entitled "Final Environmental Impact State- ment--Rule Making on Polychlorinated Biphenyls" had been issued by the Pood and Drug Administration. Notice is hereby given that a statement entitled "Supplement to the Final Envi ronmental Impact Statement--Rule Making on Polychlorinated Biphenyls" has been issued by the Pood and Drug Administration. Copies of the supplement are available from the Office of the Assistant Commissioner for Public Af fairs, Room 15B-42, or the Office of the Hearing Clerk, Room 6-88, 5600 Fishers Lane, Rockville, MD 20852. This notice is Issued pursuant to pro visions of the National Environmental Policy Act of 1969, Public Law 91-190 (sec. 102(2) (c), 83 Stat. 853; 42 U.6.C. 4332), and under authority delegated to the Commissioner (21 CFR 2.120). Dated: June 21,1973. 8am D. Fine, . Associate Commissioner for Compliance. [FR Doc.73-13548 Filed 7-5-73;8:45 am] FEDERAL REGISTER, VOL 38, NO. 129--FRIDAY, JULY 6 1973 0003585 WATER PCB-SD0000039960