Document QMyX5jjRK13jnGJNYXe06kgG6

SUPPLEMENT TO IBB FINAL ENVIRONMENTAL IMPACT STATEMENT KOLB MAKING OH POLYCHLORINATED BIPHENYLS Pood and Drug Administration i Dapartmant of Haalth, Education, and Welfare Sam D. Pina Aaeoclate Cn--1aalonar for Compliance July 2, 1973 MONS 043313 Title_ CONTENTS I. Introduction II. Summary of the Problem of PCB'a Food Contaminants; Rule Making on PCB's and Related Environmental Iaaues ................................ III. Baaia for Establishing the PCB Temporary Tolerances ........................................................................ IV. Alternatives to the PCB Temporary Tolerances........................................................................ V. Environmental Impact of the PCB Rule Making.................................................................... Appendix; Comments Received on Draft F.nvlroomantal Impact Statement I 3 6 I] 21 Page MQNS 043314 I. INTRODUCTION The Commiesloner of Food end Drugs published In the FEDERAL REGISTER of March 18, 1972 (37 F.R. 5703) a notice of proposed rule caking to licit hucan exposure to polychlori nated biphenyls (PCB's) froa dietary sources. Since It was Interpreted that lcplenantatlon of certain provisions of the proposed rule caking cay significantly affect the quality of the hucan envlronaant, the Food and Drug Administra tion (FDA) prepared. In accordance with the National Envlroncental Policy Act of 1969, an environmental Impact statement on the proposed rule caking. Accordingly, FDA Issued a Draft Environmental Iapact Statement on the proposed rule caking on May 11, 1972, and a Final Environmental Impact Statement on December 18, 1972. These statements addressed the following aspects of the PC8 rule making; Background; description of rule caking; envlroncental Impact of rule making; alternatives to rule caking; emulative, long-term effects; and Interagency review of rule making. In addition, the Final Statement included a summary of proposed rule caking and evaluation of the comments received on the Draft Statement and notice of proposed rule caking. Subsequent to the Issuance of tha Final Statement, tha Council on Environmental Quality advised FDA that the consents received on tha Draft Statement should be appended to the MONS 043315 l 2 Final Statement. The Council on Environmental Quality alao suggested that certain laauea FDA Intended to addreae In the final order of Che PCB rule making are also appropriate considerations under the National Environmental Policy Act and as such should also ba Included in the Final Statement. Therefore. FDA has prepared this Supplement to the Final Environmental Impact Statement, which provides additional Information relative to the PCB rule making. The Council on Environmental Quality further advised FDA that the provision In Its guidelines promulgated under the National Environ mental Policy Act, which requires that a final environmental Impact statement.be Issued at least 30 days prior to the time the action It governs Is taken, need not apply to this Supplement. Therefore, pursuant to provisions of the National ' Environmental Policy Act of 1969 (sec. 102(2)(c), 83 Stat. 833; 42 U.S.C. 4332(2)(c)), and under authority delegated to him (21 CFK 2.120), the Commissioner of Food and Drugs Issues this Supplement to the Final Environmental Impact Statement - Rule Making on Polychlorlnatad Biphenyls. HONS 043316 -3- II. SUMMARY OF THE PROBLEM OF PCB'a AS FOOD CONTAMINANTS; RULE MAKING ON PCB'a AND RELATED ENVIRONMENTAL ISSUES Polychlorinated biphenyls (PCB'a) represent a claaa of toxic lnduatrlal chemicals, which ara highly stable, haat raalatant, and nonflammable. The industrial applications of PCB'a include, or did include in the past, use aa electrical transformer and capacitor fluids, heat transfer fluids, hydraulic fluids and plasticizers; and use in formulations . of lubricants, plasticizers, coatings, and inks. PCB's have been shown to occur as chemical contaminants in foods from the following sources: A. Because of their unique chemical and physical properties and their widespread, uncontrolled industrial uses, PCB'a have become a persistant and ubiquitous con taminant in the environment, resulting in the contamination of certain foods. B. A number of incidents have occurred in which PCB's have directly contaminated animal feed aa a result of lnduatrlal accidents l.e., leakage or spillage of PCB's from plant squlpment. C. PCB contaminated papar food-packaging materials made from recycled paper containing waste carbonless copy paper, in which 3-5 percent PCB's are used to encapsulate ink, has led to the contamination of foods as a result of migration of MONS 04331V 4 PCB's from the packaging Co the Food contained In the package. The use of recycled paper Is not, however, the only source of PCB'e in paper food-packaging materials. Some paper made from virgin pulp has been shown to contain PCB's. The contamination probably occurred during processing. The presence of PCB's In food and the sources by which PCB's may contaminate foods represent a potential hazard to public health. For this reason, PDA published a notice of proposed rule making in the FEDERAL REGISTER of March 18, 1972 (37 P.R. 570S) to Halt human exposure to PCB's from dietary sources by dealing with known sources and causes of PCB contamination of food. The proposed rule making Included the following provisions: A. Restrictions on the Industrial uses of PCB's In establishments manufacturing, handling, or storing animal feeds, food, or food-packaging materials, In order to preclude the direct, accidental PCB contamination of these articles. B. Amendment of food additive regulation I 121.2546 to allov for food-packaging use of pulp from reclaimed fibers containing unavoidable poisonous or deleterious substances, providing these substances do not migrate to the food. MOWS 043318 -5- C. Establishment of temporary tolerances limiting the level of PCB'e In animal feed, certain foods, and paper food-packaging materials as a result of unavoidable, environmental contamination. On May 11, 1972, FDA made available Its Draft Environmental Impact Statement which addresaed the Impact the proposed rule making on PCB'e may have on the quality of the human environment. This Impact Included: A. Potential adveree effects on the environment from Improper disposal of PCB'e as a result of requiring removal of PCB's from the FDA-regulated industry. B. Potential adverse effects on recycled paper activities as a result of implementing the tolerance for paper food-packaging materials. C. Beneficial affects on human health as a result of controlling the contamination of food with PCB's. A 60-day period was provided for Interested parties to comment on the Draft Environmental Impact Statement. Comments on the Draft Statement were received from the U.S. Department of Agriculture, the Environmental Protection Agency, the U.S. Department of Coamerce, end the American Paper Institute. Copies of these comments are Included in the eppendlx to this Supplement. The Final Statement included FDA's evaluation of these comments. Further MQNS 043319 6 discussion with respect to these comments, as well as other Information on the PCB rule making, ia provided in this Supplement. III. BASIS FOR ESTABLISHING THE PCB TEMPORARY TOLERANCES Section 406 of the Federal Food, Drug, and Cosmetic Act is the authority for establishing the temporary tolerancaa for PCB1s In animal feed*, certain foods, and paper food packaging materials. It states that where the addition of a poisonous or delaterloua substance to food cannot be avoided the Secretary shall promulgate regulations "limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health," and also specifically states that the Secretary shall take into account the extent to which use of the substance "cannot be avoided." This same authority la also applicable to food packaging materials. , The fact that the tolerances for PCB'a are termed "temporary" is recognition that in the future there should be less PCB contamination which "cannot be avoided," and the Commissioner la authorized to reduce the tolerance levels accordingly. HONS 043320 -7- The temporary tolerances for PCB'e are baaed on both an analysis of available data on the toxicological effects of PCB'e and an analysis of reported levels of PCB'e In the food eupply. A. Toxicological Bffacta of PCB'e. The toxicity of PCB'e hae baen under study for the past several yeara. The Pood and Drug Administration's evaluation of the significance of PCB'e on human health and the develop ment of allowable dietary Intakes of PCB'e wee based on an analysis of both animal and human toxicological data and la unmerited ae follows: 1. Animal Toxicological Data. Available data from long-term animal studies shows that the no-effect level in rata and doge (for PCB's with 42, 34, and 60 percent chlorination) la 10 ppm. Employing a 100 to 1 safety factor, the "no-effect" level for man based on data derived from dogs would be 2.5 microgram (meg) par kilogram (kg) body weight per day, or from rata, 3 meg per kg body weight per day. Therefors, based on long-term animal atudlea, the allowable level of PCB Ingestion In man would be approx imately 0.175 milligrams (mg) par day for a 70-kg Individual. HONS 043321 -8- 2. Hunan Toxlcololcl Data. Human Intoxication with Kanachlor 400, a PCS that la oanufacturad In Japan and that contains 48 parcsnt chlorlna was noted In 1968 when a heat exchanger leaked fluid Into rice oil and was consumed bp Japanese families. About 1,000 people were eventually affected. Typical clinical findings Included chloracne and Increased pigmentation, visual Impairment due to hypersecretion of the Meibomian glands, and systemic gastrointestinal symptoms that Included abdominal pain and disturbances in liver function. A few babies were born with decreased birth weights and with skin discoloration which slowly regressed aa the children grew In slaa. However, the growth rate of males appeared to be somewhat slower than normal. Adult patienta had protracted clinical disease with very slow regression of symptoms and signs, suggesting slow metabolism and excretion of this PCB In humans, probably Involving a long biological 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 Kanachlor 400. The average HONS 043322 -9- total dose of PCB's causing an affact In the Japanese was 2/ reported to be 2,000 ag. The human data astabllahad that the lowest level of PCB that produced an affect In nan (using a 50-kg man) was 500 ag consumed over a period of 50 days at a rate of approximately 200 meg per kg body weight per day. The affact level was baaed on overt symptoms rather than sensitive biochemical tests that might have demonstrated some effects at even lower levels. Employing a safety factor of 10 to 1 to go from an effect level In man to a permissible no-effect level In man, allows for an lngaatlon of 20 meg per kg body weight per day, or 1.1 mg par day for a 70-kg man, based on a total period of expoeure of 50 days (equivalent to the Japanese incident). Since PCB's probably have a long biological half-life In man, an alternative toxicological analysis of the human data may be based on the assumption that Ingested PCB's would continue to accumulate In tissues for a long period of time. Since 2,000 mg was reported to be the average total dose causing an effect In the Japanese, It Is possible that 200 mg total dosage PCB's (applying a safety factor of 10 to 1 as abova) may be tolerated over a much more protracted period of time without overt adverse affect if dally exposure la held to minimal levels. It 2/ Kanatsune, at,, al., Fukuoka Acta. Med. 23:117 (1971) HONS 043323 10 would cake 22 months of dally Ingestion of 300 meg of PCB's to arrive at a total Ingeation of 200 mg. This would permit Ingestion of 4 meg per kg body weight per day In a 70-kg man. Since the lowest total dose producing an effect in nan in the Japanese incident was 500 mg, a similar analysis leads to an allowable protracted ingestion of 1 meg per kg body weight per day aa derived from a 70-kg men. B. Dietary Sources of PCB's. The results of FDA total diet studies for fiscal years 1970-72 show an intake of approximately 0.06 meg per kg body weight per day (or 4.2 meg per day for a 70-kg man). Because of the degree of sensitivity of the analytical methods used, PCB's may be present at levels too low to ba detected. If lower levels could be quantitatively measured, the dietary Intake of PCB's from the total diet studies would probably show an Increase. It should be recognised, however, that in rare instances soma paopls could hava more systematic exposures to PCB'a in foods than those expected by eating a moderately well balanced diet such ea represented by the total diat samples. Hence, the need for minimising potential human exposures. The total diet studies indicate that PCB's most frequently occur in the food coapoelte consisting of meat, fish, and poultry (experience has shown that moat of HONS 043324 + 11 - the PCB residue* la this composite are In fish and, to a laaaer extant, poultry) and In the food coaposlte consisting of grain and caraal products (experience has shown aost of tha PCB residues In this composite are derived from paper packaging materials). PDA's food surveillance activities have shown that PCB's also may occur in dairy products, eggs, and packaged foods. In addition to packaged cereal products. C. Temporary Tolarancas for PCB's. Using the human toxicological data described above, FDA concludes that for the short term, based on the lowest total dose producing an offset 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 sn effect In tha Japanese for long-term exposure. However, based on the most sensitive "Japeneee patient" (l.e., lowest total dose producing an effect), the possibility of potential long-term hazards necessitates reduction of the levels of PCB'e In food aa soon as possible. In the Interim, temporary tolerances srs necessary to limit human exposure to those foods that may contain PCB's resulting from environmental contamination, which aa a practical matter are presently unavoidable. Those foods for which temporary tolerances ars being established Include milk and dairy products, poultry, eggs, and fish. In addition, other Information necessltatas axtendlng the temporary tolerances to other Items, as described below: MONS 043325 - 12 - . 1. Infants and young children consume s greater amount of food per kilogram body weight and thereby have a proportion ately greater exposure chan do adults. A separata temporary tolerance for PCB'a In Infant and junior food, therefore, reflects the possibility that undesirable exposures could result if combinations of certain PCB-contamlnated foods comprise a major portion of this age group's diet. 2. PCB's In paper food-packaging materials represent a aource of human exposure to PCB's In the diet. The FDA survey of the PCB food-packaging material problem showed that 67 percent of tha packaging portions of the samples examined contained PCB's. The highest level was 338 ppm. Analysis also showed that 19 percent of the food portions of the samples contained PCB residues and that there was an average PCB concentration In the food portions of 0.1 ppm. The maximum level of PCB'a found In food was 5 ppm. Either limiting tha PCB level of paper food-packaging material to 10 ppm or requiring the use of a functional barrier which Is Impermeable to PCB migration provides the necessary means for limiting this source of PCB contamination of food. 04332b mons - 13 - 3. Sine* PCB'a art tranimittad to and concantratad In odlbla portions of food-producing animals which lngaac PCBcontamlnatad faad, animal faada rapraaant anothar aourca of PCB'a In tha human dlat. Tharafora, temporary tolarancaa for PO'a In animal faada and animal faad componenta ara nacaaaary to mlnlmlxa tha frequency and magnitude of PCB realduaa In fooda of animal origin. PDA concludaa that the temporary tolarancaa being aatabllahed will protact tha public health, but cautlona that theaa temporary tolarancaa ara not to be conatruad aa guidellnee permitting tha conaumptlon of fooda containing theaa amounta of PCB'a on a regular and conalatant baala. Further, tha temporary tolarancaa will be lowered aa experience indicates that lower 1avals can ba attained. IV. ALTKBHATITO TO TBS PCB TSMPORASY TOLKKAHCBS Tha Pinal environmental Impact Statement Included a dlacuaalou of tha alternative couraaa of action available to FDA for each provision of the rule making. Tha following la a discussion of other alternatives which were suggested by consumer groups and by Industry la thalr coaments to tha FDA on tha notice of proposed rule making. MONS 0b33d7 A. Enforce Zaro Tolerances for PCB'a In Animal Feeds Certain Poods. and Paper Food-Packaging Material!. Animal feeds, certain foods, and paper food-packaging materials contain PCB'a, which undar praaent condltlona of environmental contamination ara unavoidable. Currant tox icological Information doea not aupport tha necessity of astabliahlng zaro tolerances for those items in ordar to protect public health, since human exposure to dlatary sources of PCB'a is usually sporadic, nonsyatematlc, and occasional. Tha "finite" temporary tolerances being established by FDA will provide tha aaaurance that signi ficant PCB levels ara not contained in food and that human axpoaure to PCB'a from dietary sources will ba maintained at safe and minimum levels. Zaro tolarancaa, therefore, are unwarranted and would unnecessarily deprive the consumer of a portion of hla food supply and would disrupt tha Nation's food distribution system, because certain quantities of fish, poultry, eggs, milk, and food-packaging material would be violative. B. Impose No Tolerances for the PCB Contamination of Animal Feeds. Certain Foods, and Paper Food-Packaalna Materials. This alternative was explored by FDA and rejected for tha following reasons: MONS 0433ZB - 15 - 1. No authorization haa baan granted undar tha Fadaral Food, Drug, and Coaaatlc Act paraittlng FCB'a aa conponanta of food or aa aubatancaa otharviee affaetlng tha charactarlatlca of food. Tha fact la, however, that FCB'a ara coaponanta of fooda aa a raault of unavoldabla, environmental contamination. Analyaia of currant toxicological data daaonatrataa a potaotlal hazard to hunan haalth If dietary axpoauraa to FCB'a ara not controlled. Therefore, aa polaonoua or dalatarloua aubatancaa, FCB'a In anlaal faada, fooda, and paper food packaging materlale render auch artlclaa adulterated undar tha Fadaral Food, Drug, and Coaaatlc Act. Failure to Initiate poaltive action, l.e., aatabllah llalta on tha PCB content of thaae artlclaa and remove from conauaar channala thoaa artlclaa containing FCB'a In exceaa of tha aatabllahad llalta, uould be contrary to tha lntereate of public haalth and contrary to congraaalonal aandata. 2. In tha abaanca of tolarancaa for FCB'a In fooda, FDA haa uaad "action laval guldallnea" for dataralnlng tha level of PCB contamination at which regulatory action la to be initiated. During tha paat 3 yaara, FDA, the U.S. Departmane of Agriculture, and State and local aganclaa have uaad thaaa action lavele aa tha baala for ranovlng PCB-contaalnated fooda froa coaaarclal channala. Tha FCB temporary tolarancaa now being aatabllahad ara MONS 043329 - 16 generally comparable to these action lavela both In terns of the level et which regulatory action Is taken and the reason for taking regulatory action, l.e., protection of public health. The aajor distinction la that the tolerances are Issued as a proposed regulation upon which all Interested parties are Invited to comment. Once established as a regulation, tolerances provide guidance to all regulatory agencies end to Industry In order to assure efficient and equitable enforceaant and consumer protection. C. Establish Tolerances for Packaged Foods Rather Then Paper Food-Packaging Materials. This alternative, which tha paper Industry recommended, was considered by FDA and rejected for the following reasons: 1. Since the transfer of PCS'e from packaging material to the food Is dependent on time and conditions of exposure, tolerances baaed solely on the packaged food would not provide adequate protection to the consumer. A packaged food analysed at the time of packaging may be entirely free of PCB's, but by tha tine it reaches the consumer and Is finally coneumad It may have accumulated considerable quantities of PCB's If the packaging material le contaminated. A tolerance aystem in which analytical findings are so dependent on many variables uch aa time of sampling would not be reasonable or adequate. MONS 043330 - 17 - 2. In order to achieve compliance with a tolerance for packaged food, the level of PCB'a In the packaging hae to be taken Into account and Halted In order to preclude the potential tranafer to the food of quantItlae of PCB'e that would cauea the food to exceed lte tolerance level. Since the level of PCB'e la packaged food la releted to the level of PCB'e In Its packaging, tolerances for both the food and lte packaging would be necessary. This aaounta to an obvious redundancy. 3. Establishing a tolerance for packaged food aloae would be Inconsistent with the Intent and aeanlng of Section 406 of the Federal Food, Drug, and Coanetlc Act. The packaged food by Itself does not contain unavoidable PCB residues; the principal source of the PCB contamination of packaged food la the paper food-packaging naterlal, which contains the unavoidable contenlnetlon. Accordingly, the tolerance should deal with this naterlal. Therefore, this source of food contamination ehould ba United so as to nlnlnlaa the levels of PCB'e that nay migrate to the packaged food. 4. Failure to Halt the level of PCB'a In paper food packaging materials would parpetuata the use of a known, avoidable aourca of PCB contamination of food. MONS 043331 18 - D. Exempt Aroclor 1242 from tha PCB Temporary Tolerance for Paper Food-Packaging Hatarlala. Thl* eltemetlve, which FDA lnveetlgeted and raj acted, waa alao recommended by the paper Induetry. The paper lnduetry comaanta atate that Che aatabllahment of the PCB tolerance for paper food-packaging matarlala la unwarranted for public health raaaona, bacauaa available aclentlflc evidence ahowa that Aroclor 1242 (the predominant PCB found In paper) la not parelatanc and cumulative, and thua will not preaant a chronic toxicity problem. Although data lndlcatea that aome componanta of Aroclor 1242 are metabollxed In biological ayatema more rapidly than tha other higher chlorinated Aroclora, there la no Information available which daacrlbea tha compoeltlon, toxicity, and fata of tha metabolic producta. The abeence of Aroclor 1242 reelduaa In human and certain animal tlaaue and In tha environment la not a aound baala from which to argue that no hazard axlata from the lngeatlon of Aroclor 1242. The poaalblllty exlata that Aroclor 1242 la converted to alteration producta which may ba more toxic than the original compounda, but which are not detectable by currant analytical methode. Further, available data from chronic feeding atudlea with rata and doge fall to aubatantlata clalne that Aroclor 1242 doea not rapreaent a toxic aubatanca or that It dlffara In toxicity - 19 - from other Aroclors. Therefore, the Comslssloner concludes that the temporary tolerance will apply to the tern "PCB" lrreapective of which Arodor la present as the contaadnant. E. Postpone the PCB Tolerance for Taper Food-Packaalna Materials Until Certain Infometlon Is Developed. Cosaents received fron Industry and related trade associa tions argued that the taaporary tolerance for TCP's In food packaging materials should be delated or postponed until: (1) quality control test procedures and adequate analytical nethods ere developed to regulate production end insure conpllanca, and (2) migration rates are established to take Into account barrier effecte, type of food, and the ratio of package weight to food weight. PDA considered these coaaente and concluded that the astabllshaent of the tolerance should not ho postponed for the following reasons: 1. Although a trada association subalttad data which It dalaed Indicates a lack of reliability la analyses of paper board naterlal, the data failed to show that unifora test aathoda were employed by the participating laboratories or that these teats were performed by laboratories with demon strated capabilities In trace residue analysis. Further, an Interlaboratory study that was conducted under the auspices of another trade association sad that utilised FDA analytical HONS 043333 - 20 - methodology supports the conclusion that current methodology la adequately aenaltlve and raproduclbla from laboratory to labora tory to Insure compliance with the tolerance. 2. It le recognized that migration rates (actual level of PCB'a In food resulting from the uaa of contaminated packaging material) are affected by factors such as barriers, type of food, the ratio of package weight to food weight, and exposure time and conditions. Since FDA's primary concern Is not the fact that paper food-packaging materials contain PCB's, but the fact that PCB'a can migrate to the food from the packaging, then the use of barriers which prevent migration Is an accept able alternative to limiting the PCB content of paper food packaging material. For this reason, the proposed rule making has been ravlaqd In the final order In I 122.10(a)(9) by exempting paper food-packaging materials from compliance with the temporary tolerance If tha paper food-packaging material le separated from tha food by a functional barrier Impermeable to PCB migration. Metal cans and glass bottles are obvious examples of what constltues a functional barrier Impermeable to PCB migration. Data from industry-sponsored studies have shown tha materials such polyvinylldene-coated pspsr and glasslne can, to varying degress, prevent or reduce PCB migration under test conditions which would favor migration. HONS 043334 - 21 - FDA would not objoct to the uao of flexible materials and other materials as barrlara, provided there la no evidence of migration of PCB'e to the food. At this time, however, there le Insufficient Information for FDA to list as part of the regulation those materials that are considered functional barrlara. The other factors mantloned above ' which affect migration rates may alao be Important considera tions 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 necessary to assure the consumer that packaged food Is not balng contaminated with FCB's to an avoidable degree. F. Establish a Hlsher Tolerance for Paper Food-Pachaalna Materlala. The notice of proposed PCB rule making Included the proposal to astabllsh the temporary tolerance for FCB's In paper food packaging materials at 5 ppm. In exploring alternative courses of action regarding this regulation, FDA reevaluated the 5 ppm tolerance level. Deta from the FDA survey of FCB's la foods and food-packaging material showed that the food portion of the samples with 5-10 ppm FCB's In paper food-packaging material contained the same range of PCB levels (0.1-0.6 ppm) as the food portion of the samples with 0-5 ppm in paper food packaging material. Samples with more than 10 ppm In the HONS 0A3335 22 packaging contained higher lavala in the food, ranging up to 3.7 ppm. On the baaia of thia information, the FDA concluded that the final order of the PCI rule making ahould ba changed to incorporate a revieion la the temporary tolerance for PCB'* in paper food-packaging material* from 5 ppm to 10 ppm. Thia revlelon in the tolerance vaa aleo etated in the Final Environmental Impact Statement on the PCB rule making. V. ENVIRONMENTAL IMPACT OF THE PCB RULE MAKING Since the PCB rule making will reduce human expoaure to dietary eourcee of a toxic, chemical contaminant, FDA concluded in lte Final Environmental Impact Statement chat the rule making will have a beneficial effect on the quality of the human environment. The Final Statement aleo included a dlecueelon concerning potential advaraa affacta the rule making may have on the quality of the human environment. The following la additional information relative to thia matter: A. Environmental Imcact of PCB Replacement or Subetitutee. During the development of the provlelone of tha rule making, conalderatlon vae given to tha poaalbla adveree effecta on the environment of thoee chemical* which may be uaed ae replacement* or aubetltutee for thoea lnduatrlal uaea of PCB'a prohibited by HONS 04333b - 23 - the rule making. FDA was and continues to be concerned that the regulation could have the effect of causing the use of chemicals which would pose a threat to tha environment and to human health. For this reason, a requirement In the final order of the rule making will call attention to this potential problem In order to reduce the likelihood of Introducing a new "PCB-type problem." This requirement Is as follows: "Tha toxicity and other characteristics of fluids selected 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: (1) its toxicity; (2) tha maximum quantity that could be spilled onto a given quantity of food before it would be noticed, taking Into account the fluid's color and odor; (3) possible signaling devices In the equipment to Indicate a loss of fluid, etc.; and (!) its environmental stability and tendency to survive and be concentrated through the food chain. The judgment aa to whether e replacement fluid la sufficiently aon-hazardous Is to be made on an Individual Installation and operation basis." Furthermore, tha numerous PCB-assoclated "accidents" that have occurred In the past and the provisions of tha rule making Itself will sarva as Incentives to prevent future MONS 043337 problems from occurring. Industry should b mors cognizant of tha aarloua repercussions that can result from the Indis criminate uaa of toxic chemicals and from accidents of this type, such as adverse effects on human health and the environment, adverse publicity, criminal and civil penalties, end substantial financial losses. In addition to these considerations, there Is information which Indicates that leas toxic, biodegradable PCS replacements have been developed and are being used for heat transfer systems and other Industrial applications that have caused past environmental problems. In conclusion, FDA can only apaculata that some PCB replacements or aubatltutaa may present future environmental problems. However, It le known with certainty that the continued use of PCB'a by tha regulated Industries presents a definite hazard to man and hla environment. Therefore, FDA's action to restrict tha use of this contaminant In feed, food, and food-packaging material manufacturing establishments Is clearly more beneficial to the quality of the human environment than allowing the continued uaa of PCB'a. B. Impact on Rscvcllng Activities. In commenting on the notice of proposed rule making, the paper Industry and Its trade associations have stated that the temporary tolerance for PCB'a In paper food-packaging materials would be detrimental to tha Nation's commitment to utilize recycling In solid waste disposal programs. This alleged MQNS 043338 - 25 - adverse environmental Impact Is based on the paper lnduatry's contention that the tolaranca would place severs economic hardships on recycling mills, as follows: 1. "Significant" quality control costs would be required to assure compliance with the tolerance; and 2. Financial losses would be Incurred when products which contain PCI's in amounts above the tolerance are rejected. The paper Industry concludes that these Increased costs In pro duction would cause the closing of some recycling mills and thus result In the adverse environmental impact cited above. This aspect of the rule making was addressed in the Final Environmental Impact Statement. FDA concluded that the revision In the tolerance level and allowing an exemption to tha tolerance would reduce or eliminate tha alleged adverse affects on recycling programs. First, Increasing the tolerance for paper food-packaging materials from 5 ppm to 10 ppm Is expected to reeult In only a low percentage of paper products being excluded from use for food-packaging purposes. This conclusion was baaed on Industry survey data which showed that 20 percent or more of paperboard saaplea tasted contained FCB levels In excess of 5 ppm, while about 7 percent exceeded tha tolaranca level of 10 ppm. Second, tha exemption from tha tolerance when a functional barrier la used will serve to further reduce tha percentage of paperboard that would be unacceptable (l.e., containing PCI's In an amount above tha tolerance level) for food-packaging use. MONS 043339 - 26 - In addition, the Final Statement statad that racyclad paper products ara not being singled out aa objects of thla tolaranca. Virgin papar producta hava baan ahown to contain PCB'a and, for thla raaaou, tha antIra papar Industry will hava to baar addad coata of lnplanantlng quality control procaduraa. In thla raapact, recycling nllla ara not balng placad at a coapatltlva dlaadvantaga. Furthermore, thaaa addad coata ara fully warranted and Justified bacauaa of the public health banaflta that will ba derived froa regulating thla source of food contamination. As a possible means of reducing tha Incidence of food packaging aatarlala that exceed tha tolerance level for Peg's, tha Environmental Protection Agency stated In Its coumants on the Draft Environmental I^sct Statement that consideration should ba given to removing from existing Inventories carbonless copy paper that contains PCB's. In tha Pinal Statement, FDA responded to tha EPA comment by stating that It lacks jurisdiction to Implement this aotlon. This continues to be the reason FDA does not consider thla approach an affective and realistic alternative to tha temporary tolaranca for PCB'a In paper food-packaging materials. However, FDA does recognise that It may be feasible to some degree to control the flow of PCBcontmining carbonless copy paper Into waste paper channels, and thus lessen any Impact tha PCB rule making may hava on racyclad HONS 043340 - 27 - paper programs* In this regard* FDA haa contacted the Environ mental Protection Agency and requested Its aaslatance In exploring possible procedures for Implementing the Environmental Protection Agency's suggestion. C. Economic Considerations. The U.S. Department of Conmerce, In Its comments on the Draft Statement, ateted that a coat/benefit analysis relative to the PCS rule making should be conducted. The Pinal Statement responded to thla comment by stating that since a cost/benefit analysis la an economic consideration. It la not a proper subject of an environmental impact statement. The Counsel on Environmental Quality advised PDA that economic conslderstlons should be eddreeeed elong with the environmental considerations under the Netlonel Environmental Policy Act. PDA la In agreement and retracts Its previously ststed position on this natter for the following reasons: 1. The position Is contrary to the Netlonal Environmental Policy Act. 2. The position la not an accurate reflection of the considerations given by PDA to the economic Impact of the PCI problem. ' t MONS 043341 - 28 - FDA recognized thee because PCB's are widely used and important industrial chemicals and ubiquitous environmental contaminants, any action taken would have adverse economic consequences. FDA also recognized that because PCB's ere toxic substances, not taking action with respect to the sources of PCB contamination of the food supply would have adverse consequencee on human health. In the development of the PCB rule making, FDA fully considered consequences In terms of both the cost of compliance and the health benefits derived from minimizing human exposure to PCB'e. The rule asking reflects a balance between these consequences, l.a., the regulations are not more restrictive than le necessary to protect public health. This fact Is exemplified In the proposed rule making, wherein It was stated: "Immediate elimination of all food packages containing PCB's would disrupt the Nation's food packaging and distribution system and Is not warranted by the hazard to human health." The Draft and Final Environmental Impact Statements on the PCB rule making contained similar examples of FDA's considerations relative to the cost/benefit aspects of the rule making. In addition, this Supplement responds to Industry coamenta that the rule making will cause a severe economic Impact on the recycling Industry. HONS 043342