Document Eydmgq7g03pgdD23kpbDRGRL

PINAL ENVIRONMENTAL IMPACT STATEMENT RULE MAXING ON POLYCHLORINATED BIPHENYLS Pood and Drug Administration Dapartaant of Haalth, Education, and Halfara Saa D. Pina Aaaoclata Coadaalonar for Compliance Dacaabar 18, 1972 MONS 0A2775 CONTENTS Fm I. SuiKimry of Proposed Rule Making and Evaluation of Cooaenta on Draft F.ivlr <nnGn tal Iapact Stataaant and Notice of Propoaed Rule Making ................................... 1 II. Background 7 TII. P.-ccrIptlon of Rule Making ........................................... 12 IV. ruvltonmental Iapact of Rule Making ........................... 18 V. Altcrnatlvaa to Rule Making ......................................... 22 VI. Cumulative, Long-Tarn Effecta ..................................... 28 VII. Interagency Review of Rule Making ............................. 29 MONS 0k2776 FINAL ENVIRONMENTAL IMPACT STATEMENT RULE MAKING ON POLYCHLORINATED BIPHENYLS I. SUMMARY OF PROPOSED RULE MAKING AND EVALUATION OF COMMENTS ON DRAFT ENVIRONMENTAL IMPACT STATEMENT AND NOTICE OF PROPOSED RULE MAKING The Coimalssloner of Food and Drugs published In Che FEDERAL REGISTER of March 18, 1972 (37 F.R. 570S) a notice of proposed rule making to limit human exposure to poly chlorinated biphenyls (PCB'e) from dietary sources. The proposed rule making would: (1) Prohibit the use of certain PCB-contalnlng materials and equipment In animal feed. In food, and In food-packaging material manufacturing, handling and storage establishments to preclude direct accidental PCB contamination of animal feed, food, and food-packaging materials; (2) exclude from food-packaging materials the uee of pulp from reclaimed fibers containing poisonous and deleterious substances which may migrate to food; and (3) establish temporary tolerances for unavoidable PCB residues in food-packaging materials and for unavoidable PCB residues In certain foods as a result of environmental contamination. HONS -2- In the FEDERAL REGISTER of Hey 11, 1972 (37 F.R. 9503), the Commissioner published s notice of availability of the draft environmental impact statement Issued by the agency on this notice of proposed rule making. Comments from the public, consumer Interest groups, Industry, trade associations, and State and Federal agencies were received concerning both the notice of proposed rule making and the draft environmental Impact statement. The comments received on the draft environmental impact statement and those received on the notice of proposed rule making which deal with the environmental Issues are considered together for the purposes of this final environmental Impact statement. The Department of Agriculture supported the environmental Impact statement, commenting that the proposed rule making will considerably reduce accidental contamination and long-term exposure of man to PCB's In the United States, and that widespread occurrence of PCB's In the environment makes It highly desirable to set temporary tolerances for PCB's as proposed until the unavoidable background levels are reduced. The Environmental Protection Agency recoonended that the environmental Impact statement emphasize concern over the ultimate PCB content of packaging material rather than the MQNS 042778 -3- level In the aource material in order to alleviate any potential impression that contaminated pulp can only come from recycling. The agency further recommended that the impact statement should detail the justification for the tolerance level of S parts per million (ppm) for food-packaging material. The agency also recommended that the Impact statement should Include consider ation of the removal from existing Inventories of carbonless copy paper containing PCB's as an additional method'to reduce the level of PCB's in food packaging. It also recommended that the Impact statement should include an examination of data on use of barriers with respect to migration of PCB's to food from food packaging. The Department of Commerce recommended that discussion of the following be Included in the impact statement: Toxi cological effects of PCB's on human health; the 30-day time period required for compliance with the regulations; a statement as to whether materials which would replace PCR-contalnlng materials will be the subject matter of an environmental Impact statement; the need for or existence of rules controlling removal and disposal of PCB-contalnlng materials, regardless of FDA's Jurisdiction over this issue; the effect of the regulations on recycling programs; a cost-benefit analysis; the expected duration of the tolerances, considering an HONS 042779 -4- adjustment of the llalts once the toxicological effects of PCB's have been adequately determined. Consents from the paper Industry and related trade associations which were received on the notice of proposed rule making reflected Industry's concern that the proposed temporary tolerance of 5 ppm PCB's for food-packaging materials would be detrimental to the paper recycling Industry and to solid waste disposal programs. Industry commented that the proposal is contrary to sound national objectives on resources recovery, particularly to the recycling of residential, commercial, and Industrial solid waste. It stated that the major Impact of compliance with this proposal would fall on combination paperboard mills which perform vital environmental functions of recycling waste paper. The consents maintained that these recycling mills would suffer losses resulting from their inability to sell for nonfood purposes paperboard that Is custom-made to food-packaging specifications and that la rejected as exceeding the tolerance. It added that the use of food packaging materials made from recycled waste paper would be curtailed because sharply higher costs arising from compliance with the tolerance would stimulate demand for alternative materials. Industry anticipates that a number HONS 042780 -5- of the recycling Bills would close if the 5 ppm tolerance Is implemented and that such closing would entail adverse envi ronmental consequences. The American Paper Institute recommended against simul taneous publication of the final environmental impact statement and the final rule making order. The Coramlssloner* having considered the comments received and other relevant material, concludes as follows: A. The regulations will have a beneficial effect on the quality of human environment in that they are designed to minimize and eliminate human exposure to PCB's from dietary sources by regulating identified sources or causes of PCB contamination of food. B. Information on the toxicity of PCB's, which is included In the final environmental Impact statement, supports the need to limit the level of PCB's in certain food-packaging materials that may migrate to packaged food. C. The final order establishes the temporary tolerance for paper food-packaging materials as 10 ppm, rather than the proposed temporary tolerance of 5 ppm. It includes an exemption from this tolerance of paper food-packaging material which is separated from the packaged food by a functional barrier impermeable to PCB migration. HONS -6- D. These revisions of the proposed tolerance for paper food-packaging material will reduce or eliminate the alleged adverse effects on recycling programs. E. While establishing the 10 ppm tolerance for PCB'a In paper food-packaging material to reduce the PCB level in paper food-packaging material, the Food and Drug Administration lacks Jurisdiction to require removal from existing inventories of carbonless copy paper containing PCB's. F. The 30-day time period for compliance and the recommended cost-benefit analysis are economic considerations. They ere not the proper subject of an environmental Impact statement under the National Environmental Policy Act. G. A decision as to whether extensive disposal of animal feed, food, and paper food-packaging material containing excessive amounts of PCB's should be the subject of an environmental impact statement vlll be made should the agency receive data indicating the existence of such extensive disposal. H. A decision aa to whether the use of non-PCB replacement materials will be covered by an environmental Impact statemant la relevant neither to the PCB final environmental Impact statement nor to the PCB rule asking order. MONS 042782 -7- I. The toxicological Information and other related Information on PCB's supports the need to set for certain foods containing unavoidable PCB residues* temporary tolerances that are as low as practicable. The FDA does not expect nor Intend for these foods to normally reach the established tolerance levels. The tolerance levels are to serve as limiting values to prevent foods containing excessive levels of PCB'e from reaching consumer channels. J. The final rule making order shall be published in the FEDERAL REGISTER no sooner than 30 days after this final environmental impact statement Is made available to the public. 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 the guidelines of the Council on Environmental Policy published In the FEDERAL REGISTER of April 23* 1971 (36 F.R. 7724)* and under authority delegated to him (21 CFR 2.120)* the Commissioner of Food and Drugs Issues this Final Environmental Impact Statement relating to the notice of rule making on polychlorinated biphenyls. II. BACKGROUND Polychlorinated biphenyls (PCB's) are toxic chemical substances which have been shown to occur as contaminants In food. They were first manufactured commercially in 1929 MONS 042783 -8- and. because of their chemical and physical properties, their industrial applications have become widespread. PCB's have been used principally In electrical capacitors, transformer fluids, plasticizers, hydraulic fluids and lubricants, and heat transfer fluids. The identification of PCB's as potential food contaminants was first reported in 1966 when they were discovered in fish from Swedish waters. Subsequent investigations established several sources by which foods may become contaminated with PCB's. The identifiable sources of PCB contamination of food are as follows: Industrial accidents such as leakage, spillage, or other direct contact of PCB-contalnlng materials with animal feeds or food; PCB migration to food packaged In PCBcontaminated paper products; and anvlronmental contamination due to the presence of PCB'a in water and air. A. Industrial Accidents. A number of Industrial accidents have occurred involving the direct PCB contamination of animal feeds which, in turn, have caused human food to become contaminated. Some of these are as follows: 1. Poultry and eggs became contaminated as a result of the leakage of PCB heat transfer fluid during the pasteurization of fish meal. The contaminated fish meal was used as a component of poultry feed. MONS 042784 -9- 2. PCB residues in milk have occurred becauee PCBcontalnlng coatinge were ueed aa sealants on the lnalde walla of ailoa containing dairy fead allage. The PCB'a migrated to the allege and PCB-contanlnated allege contaalnated dairy harda. 3. The uae of apent PCB tranaforaer fluid aa an herbicide epray vehicle waa auapectad to have contaminated dairy cattle grazing areaa, thereby caualng PCB realduea in allk froa theae cattle. *. The grinding of bakery producta, including wrappera that aay have contained PCB'a. for uae aa anInal feed la auapectad to have cauaed the contamination of poultry. Other alallar incidents during the paat aeveral yeara have resulted in the contamination of large quantltlee of food. Extensive investigations failed, in some instancea, to dlscloaa the exact source or cauae of the PCB contamination. However, on the baals of the exceeslve levels of PCB'a found In the contaalnated food or feed, there waa a likelihood that leakage, spillage, or other direct contact with PCB-containlng materials had takan place. B. Paper Food-Packaalna Material. In 1971, food-packaging material was identified as a source of PCB contamination of fooda. Investigations Indicate MONS 042 785 10- that a significant percentage of papar food-packaging aatarlal containa PCS'a and that thla can raaulc in Che Migration of low levela of PCB'a Co the packaged food. The origin of PCB'a In auch paper Material la not fully underatood. Reclaimed pulp containing carbonleaa copy paper haa been Identified aa a primary aource of PCB'a In paper producta. Carbonleaa copy paper containa between 3 and 5 percent PCB'a. Virgin paper producta, however, have alao been ahown to contain PCB realduea. The aource of PCB'a In virgin paper producta la generally attributed to the uae of PCB-contalnlng equipment and Machinery that la uaed In the papar Mill or In the eatabllahnent where the package la aanufaeturad. Direct contamination from lnduetrlal accidents similar to those associated with anlaal feeds may occur In these establishments. Environmental sources of contamination, such as PCB's In water uaed In processing, may also be contributing to the contamination of virgin pulp. In the fall of 1971, the FDA Initiated a natlonwlda aurvay to determine the extent of the PCB food-packaging problem. The survey Included analysis for PCB's In all the paper food packaging components and the packaged food portions of IS selected food categories. The survey showed that 67 percent of the packaging portione of the samples examined contained HONS 042786 -11- PCB residues* Iha highest levsl encountered ves 318 ppm. Analysis also shoved that 19 percent of the food portions of the samples contained PC9 residues and thera was an average PCS concentration of 0.1 ppa. Ihe maximum PCB level found In food vas 5 ppn. C. Environmental Contamination. Envlronnental contamination of lakes, streams* and air as a result of effluent PCB waste discharges and various Industrial uses of PCB materials directly exposed to the environment has resulted In the Indirect, widespread PCB contamination of freah watar flah. In some Instances foods of enlmal origin* such as meat, poultry, eggs, and milk, contain low background levels of PCB's that may also be attributable to environmental sources of contamination. PCB's reach the environment from several sources, such as the following: open burning or Incomplete Incineration of municipal and Industrial solid waste; municipal and Industrial sewage; vaporisation from paints, coatings, and plastics; and accidental spills or Improper waste disposal practices. The dietary intake of PCB's, as shown In the PDA's total diet studies for the past 2 1/2 yaars, la of a low order (less than 0.0001 milligram per kilogram of body mqns qji2787 -12- weight per dap Id a high coneumpticm diet). There la, however. Halted knowledge of the effecta of PCS'a on huaan health even at low levala. Toxicological Intonation available lndicatea that the acceptable dally Intake of PCB'a, applying appropriate aafety factora, rangaa froa 0.17$ to 1.4 allllgraaa/day for an adult. The lower level la baaed on enlaal data; the upper level la baaed on human data which based the effect level on occurrence of overt ayaptoas. The lower level could be exceeded If a combination of chicken, allk, aggs, other dairy products, and flah containing the maxiaua allowable tolerance levels la regularly Ingested. PDA concludes that In no case should the daily PCB Intake froa all food aources exceed 1.4 milligram. III. DESCRIPTION OP RULE MAKING The notice of rule asking provides for comprehensive regulations designed to limit huaan exposure to PCB's froa dietary aourcea by dealing with known sources and causes of PCB contamination of food. It Includes provisions to preclude direct, accidental PCB contamination of animal feed, food, and food-packaging materials; to amend an existing regulation HONS 042788 -13- governlng the use of pulp from reclalasd fiber for food packaging use; and to establish temporary tolerances for unavoidable FCB residues In paper food-packaging material and In certain foods. On the basis of tha FDA's review and evaluation of the consents received and other Information pertaining to the draft envlronisental Isipact statement and the notice of proposed rule making, revisions have been made In these provisions and In the temporary tolerances. The description of the rule making reflects these revisions as follows: A. Animal feed establishments. Under 21 CFR Part 3, the rule making Includes the following provisions: 1. Coatings or paints for use on tha contact aurfacas of feed storage areas shall not contain PCB's. 2. New equlpmant or machinery for handling or processing feed In or around an animal feed producing establishment shall not contain PCB's. 3. The management of establishments producing animal feed shall eliminate to the fullest extant possible commensurate with currant good manufacturing practice tha following: heat exchange fluids formulated with PCI's, any FCB-contalnlng feed contact surfaces and lubricants, and any MONS 0A2J89 -14- other PCB-contalnlng materials that raaaonably could ba expected to causa anInal fead to bacon* contaminated with PCS'a. Tha management of such astabllshaents shall allnlnata ths usa of any feed-packaging material containing PCS'a In excess of 10 ppn. Paper feed-packaging material containing PCB's in excess of 10 ppa can be used, provided this material la separated from tha packaged feed by a functional barrier Impermeable to PCS migration. 4. Tha usa In thasa establishments of electrical transformers and capacitors that contain PCB's are not expected to cauaa tha contamination of animal feed In thasa establishments and are exempt from the above-mentioned provisions. B. food-packaging material establishments. Under 21 CPK Part 3, the rule making Includes the following provisional 1. New equipmant or machinery for manufacturing food packaging material shall not contain or use PCB's. 2. The management of establishments manufacturing food packaging material shall allmlnate to the fullest extant posalbla commensurate with good manufacturing practlca the following: heat exchange fluids formulated with PCS'a and any other PCB-contalnlng materials that reasonably could ba MONS 042790 -15- expected to cauoc food-packaging material to become contaminated with PCB'a. 3. Electrical tranaforaera and capacltora that contain PCB'a ara not expected to cauae the contamination of food- ' packaging material in theae eatabllahmenta and are exempt from the above-mentioned provlelona. C. Pood eatabllahmenta. Under 21 CFR Part 128, the rule making lncludee the following provlelona: 1. New equipment, utenalla, and machinery for handling or proceaslng food In or around a food plant ahall not contain PCB'a. 2. The management of food plante ahall eliminate to the fulleat extent poaalble coimensurate with good manufacturing practice the following: heat exchange fluids formulated with PCB's, any PCB-contalnlng food-contact surfacea and lubricants, and any other PCB-contalnlng materials that reasonably could be expected to cauae food to become contaminated with PCB'a. The management of auch establishments ahall eliminate the use of any paper food-packaging material containing PCB'a In excess of 10 ppm. Paper food-packaging material containing PCB's In excess of 10 ppm can be used, provided this material Is separated from the packaged food by a functional barrlar Impermeable to PCB migration. MONS 04*791 -16- 3. Electrical transformers and capaclcora that contain PCS'a are not axpocted to cauae the contamination of food in thaaa establishments and are exempt from the above-mantloned provialons. D. The amendment to food additive regulation 121.2366 does not allow the uae in food-packaging material of pulp from industrial waste or aalvaga that bears or contains any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food. E. Temporary tolerances ere established under the authority of section 606 of the Federal Food, Drug, and Cosmetic Act the establishment of temporary tolerancee for PCB's would permit unavoidable PCB residues in paper food packaging material and in certain foods. These temporary tolerances are established for a sufficient period of time to permit the elimination of such contaminants st the earliest practicable time and are based on currently avallsble information regarding the toxicity and the analytical behavior of FCB's, and the background levels of PCB's in these products. Uhera appropriate and necessary, new or additional Information on PCB toxicity, analytical behavior, and background levels may serve as the basis for changing the temporary tolerances. These tolersnces are* *0NS 06279^ -17- establlahed bacauss tha 7DA reeognlaaa that total, ljaaedlate allalnatlon of PCb'a In thaaa articles ia not poaalbla and that controls In uaaa of PCl'a will reduce nnavoldabla contamination of fooda. Tlis temporary tolarancaa, aapraaaad as parts par million, to ba Included In a now Part 122 ara >1 MU'* <l) J-'rf*?*-1) 2.) (2) Dairy products (fat basis) 2.9 O) Poultry (fat basis) 9.0 (4) tits (9) Couplet a and finished anlnel feeds 0.9 0.2 (6) Anlaal feed components < PI eh and shullflah (edible port Ion) 2.0 9.0 (> Infant and junior food () Paper food-packaging material 0.7 10.0 Tha tolerance for paper food-packaging materiel shall not apply to such notarial separated Iron the pat Itagad food by a functional barrier tapenaeable to P(.'g nitration. The Pood and Drug Adalnlatration will provide upon request the analytical Methods It will use lor enforcing tha taayorary tolarancaa. MQNS 0*2 793 -18- IV. ENVIRONMENTAL IMPACT OF RULE MAKING All avallabla Information lndicatea that the rule making for dealing with PCB'a In food will have a beneficial effect on the quality of the human environment. The rule making conslata of a aerlee of Individual actions aimed at limiting the ways In which avoidable industrial sources cause PCB contamination of food and animal faed and at limiting the level of PCB's In food. In feed, and in paper food packaging from unavoidable environmental sources. These actions will significantly minimise or eliminate the overall long-term human exposure to PCB's from dietary sources and will significantly reduce the potential for any possible chronic toxicological effects of PCB's on human health. The establishment of temporary tolerances for certain foods and for paper food-packaging material is directed toward FDA-regulated industries. However, the FDA asserts that. In order to reduce and eliminate the causes of unavoidable and Indirect environmental contamination of food, nationwide controls and preventive measures concerning the uses, handling, and disposal of PCB'a and PCB-containlng materials, other than regulatory actions by the Administration, must be Instituted by parties other than the FDA. This is the basis for establishing tolerances for a sufficient period MONS 04*794 19- of tine to permit elimination of PCB residues et the earliest practicable tine. If nationwide controls are instituted and Implemented, this will result in a lower concentration of PCB's In the ecological system and will reflect a diminishing expoeure of humans, wildlife, and fish and ocher marine life to all sources of PCB's. Compliance with the rule making will not be without potential adverse effects on the quality of the human environment. However, s clear understanding of the purpose and Intent of the rule making, combined with an exercise of caution end Judgment, will avoid these potential adverse effects. Important considerations are as follows: A. The provisions of the rule making require the elimination of moat PCB-contalnlng materials from animal feed, food, and food-packaging material establishments. The Improper removal and disposal of the PCB-contalnlng materials from these establishments could cause further environmental contamination. This potential adverse effect can be avoided by appropriate disposal, such as by hightemperature incineration (2,000 F. or above for 2 sec.) or other means whereby the PCB's are destroyed or degraded to chemical compounds of harmless composition and nonpolluting properties. HONS 042795 -20- B. The physical properties of PCB11, auch aa Chair being stable at high teaperatures and being nonflannable, have contri buted to their widespread industrial uses. Substitute or replacement chealcale for those uses of PCB's that are to be ellalnated In the regulated establishments may need to possess physical propertlea comparable to PCB'e. Otherwise, potential fire or explosion hazards say be possible In equipment operated at high temperatures and under other severe conditions. C. An exemption to the provisions eliminating certain Industrial uses of PCB's will permit the continued use In regulated establishments of certain electrical power equipment containing PCB's. This use of PCB's Is considered esaencial end presents only a minimal risk of accidental contamination of food and the environment. D. Industry opposed Che proposed amendment to food additive regulation 121.2546 and the proposed temporary tolerance for PCB's in paper food-packaging material ae being detrimental to the concept, purpose, and practice of the recycling waste programs. The Commissioner finds that the amendment and tolerance would not be detrimental to the recycling waste prograas. The aaendaent will prohibit the Inclusion In the recycling process of pulp that contains any poisonous or deleterious substance which may migrate to food MONS 042796 -21- from use In food-packaging. The FDA anticipates that tha effect of this amendment will be the exclusion of PCB- eontalnlng carbonless copy papers froa reclaimed and aalvaged fibers. The paper Industry is currently following this practice without any obvious detrimental effects on recycling prograas. It le recognised that some reclaimed paper will continue to contain unavoidable residues of PCB's. For this reason, the FDA Is establishing a temporary tolerance In paper food packaging materiel for a sufficient period of time In order to allow for the orderly elimination of PCB-containing raw materials used In the manufacture of food-packaging material. The temporary tolerance applies equally to virgin paper products, which also have been found to contain PCB's, and to recycled paper products. Therefore, recycled paper products are not being singled out as objects of this rule making; they should not be rejected as a form of food packaging material. Any paper food-packaging material not In compliance with the tolerance of 10 ppm PCB's will be usable for all ocher forms of packaging; it may also be used for food packaging when the material Is separated froa the packaged food by a functional barrier Impermeable to PCB . migration. 4 HONS 042797 -22- V. ALTERNATIVES TO RULE MAKING The FDA Is responsible for administering the Federal Food, Drug, and Cosaetic Act. No authorlxatlon has been granted under this act for any use of PCB's which results, either directly or Indirectly, In PCB's becoming components of food or otherwise affecting the characteristics of food. For the FDA not to take any positive action regarding the PCB contamination of food would be in violation of the Federal Food, Drug, and Cosmetic Act and would be contrary to the lnteresta of public health. The rule making represents positive action that the FDA concludes la appropriate end necessary for minimizing long term humen exposure to PCB's; the rule making notifies the regulated Industries of the actions that the FDA will require for reducing and eliminating PCB's In dietary sources. For each provision of the rule making alternative coureea of action are possible. These alternatives are as follows: A. Alternatives to eliminating Industrial uses of PCB's In regulated establishments. As described In Part II. BACKGROUND, the FDA has encoun tered numerous Incidents of direct, accidental PCB contamination of animal feed and human food. The FDA learned of these Incidents through its food Inspection and surveillance activities and through Information received from other HONS 042796 -21- government agencies and from Industry. In responae to thaaa Incidents, the FDA took appropriate atepa by exercising necessary controla and legal sanctions to minimize distri bution and consumption of the contaminated feed and food. As a result, substantial quantitlee of PCB-contamlnated animal feed and human food were seized, recalled from the market, or held under State embargo. The rule making has provisions to preclude this type of direct, accidental PCB contamination In those establishments Involved In the handling and procasslng of animal feed, food, and food-packaging material. An alternative to these provisions would be to Inform Industry of the potential, serious problem of PCB accidents and to permit the continued use of PCB materials In regulated Industries. As In the past, the FDA would exercise regulatory controls only when PCB accidents Involving feed and food occur. This alternative would not prevent the accidental PCB contamination of food; It would present a formidable taak requiring large expenditures of resources to locate, test, and taka regulatory action for the removal of food Implicated In these accidents; and It would not provide the assurance that all such accidents could be Identified prior to distribution and conauiq>tlon of the contaminated food. This alternative would not only expoae MONS 042799 -24- the public to an unwarranted risk, but alao It would not provide equitable regulatory control of an lnduatrywlde problen. B. Alternatlvea to amendment to food additive regulation 121.2546. The FDA Investigation showed that PCB'a In paper food packaging aaterlal are a source of PCB reslduea In packaged food. The presence of these residues results froe the use of food-packaging aaterlal made of both recycled peper and of virgin paper. As described In Part III. DESCRIPTION OF RULE MAKING, the FDA's rule asking provides two separate but related provisions concerning the subject, namely, an amendment of an existing regulation on the use of pulp froa reclaimed fiber and the establishment of a temporary tolerance for unavoidable PCB residues In paper food-packaging aaterlal. An alternative to the amendment of food additive regu lation 21 CFR 121.2546 would be the enforcement of the exiatlng regulation. This regulation permits salvage froa used paper end paperboard excluding that which bears or contains any poisonous or deleterious substance (Including PCB'a) which raasonably may be expected to be retained In the recovered pulp. The PDA's recent national survey on the occurrence of PCB'a In food-packaging material Indicates that moat aalvagad 042800 HONS paper and paperboard could ba expaccad to contain FCB'e and, therefore, theae materials would not be In coapllance with the preaent regulation. The FDA enforcement of the preaent regulation way have the effect of prohibiting the aanufacture of food-packaging Material froa salvaged or reclaimed paper. The FDA believes that this alternative course of action would not be in the Interests of the public. The intent of the rule naklng Is to reduce and avoid, insofar as Is posalbla, the dietary intake of PCB's. The primary concern Is not with low levels of PCB's In paper food-packaging material which do not Increase unavoldsble PCB levels currently In some food products; therefore, prohibiting all PCB-contalnlng paper food-packaging material regardless of level of PCB contami nation would be an unreasonable solution to the problem and would serve no useful purpose. Such action would also have an adverse lmpsct on recycling programs that would outweigh the beneficial effects. If any, that could be gained by a complete prohibition on the use of salvaged or reclaimed paper that contains low levels of PCB's. For these reasons, the FDA intends to amend food additive regulation 121.2546 as a means of dealing with this problem. The amendment vlll prohibit Inclusion of pulp from salvaged or reclaimed fibers contslnlng PCB's MONS 042801 -26- vtiich may al|nti to food. The temporary tolerance of 10 ppm PCS'a for paper food-packaging material or the functional barrier exemption vlll aerve aa the nachaniem for induetrywlde compliance with the amendment. Thla will permit the continued uaa of moat ealvaged or reclaimed fiber, while providing the aaaurance that fooda will not become contaminated with algnlflcant levela of PCB'a. C. Alternatives to the 10 ppm temporary tolerance for paper food-packaging material. An alternative to the 10 ppm temporary tolerance for paper food-packaging material would be the eatabllahment of PCS tolerancea for the packaged food. Toxicological Infor mation on the chronic effecta of PCB'a la not sufficient to aerve aa the baala for eetting tolerancea for all packaged fooda. Furthermore, thla alternative course of action would perpetrate the use of a known, avoidable aource of PCB contamination of food and would thua violate the Federal Food, Drug, and Coametlc Act. Xnveatlgatione Indicate that levela of PCB'a In paper food-packaging material have dlmlnlahed during the paet year to the point that 93 percent or more of paper packaging material Intended for food uee contains leea than 10 ppm PCB'a. The remaining 7 percent can be uaed either for nonfood Hons 0*^ao^ -27- purpoaea or for food-packaging tutorial that la aeparatad fron th* packaged food by a functional barrier Impermeable to PCB migration. Aa a reault of lnduatry controla and the FDA'a rule Baking, It la expectad that the levela will continue to be reduced ao that, In tine, the problen of PCB'a In paper food-packaging material nay be nonexletent. In the Interim, the 10 ppa teaporary tolerance for food-packaging aaterlala provldea neceaaary control for thla aourca of food contamination. D. Altematlvea to the teanorarv tolerancea for PCB'a In fooda. Section 406 of the Federal Food, Drug, and Coeaatlc Act provldea authority for promulgation of regulatlona limiting the quantity of unavoidable polaonoue or deleterioue aubatancaa In food. Acting on thla authority, the FDA la eatabllahlng temporary tolerancea for unavoidable PCB realduea in certain fooda. One alternative would be to refrain from promulgating a regulation governing the levela of unavoidable PCB realduaa In food. Aa a reault, food found to contain unavoidable PCB contamination would have to be regulated on a caae-bycaaa baala regarding lta acceptability for human and anlaal conaumptlon. Another alternative would be to declare any food containing unavoidable PCB realduea Illegal. MONS 042803 -2Bt The** alternative* would eerve no uaeful purpoae. The promulgation of tolerance* for food* that have been ehown to contain FCB reelduea provide* guidance to Industry and to other Federal and Stata regulatory agencies concerned with the safety of food; such proaulgation notifies these agencies of level* of FCB contsalnatlon which will cause the FDA to remove foods froa Interstate coanerce. It will also provide the aesns for a uniform and equitable treatment of a national problem and will provide direction for minimizing the entry of FCB-contaalnated food Into consumer channels. VI. CUMULATIVE, LONG-TERM EFFECTS PCB's are highly stable and peralstent chemical coaq>ounda. FCB residues can be found in many forma of wildlife, In fish and other marine life and In other environmental substrates Including man. They are cusulatlve In animals; the exact biological effect of long-term exposure and accumulation of PCB's in living organisms Is generally unknown. The rule making will have the short-term effect of directly reducing and. In some Instances, eliminating the dietary sourcea of PCB's and the long-term effect of Indirectly reducing the levels of PCB's currently in the environment. As a result, this should enhance the quality of the human environment for succeeding generations. MOWS 042604 -29- VII. INTERAGENCY REVIEW OF RULE MAKING On February 29, 1972, the Interdepartmental Task Force on PCB'a, which vae aetabllehed In Septenber 1971 to coordinate a Government wide Investigation Into FCB contamination of food and food producta, received coplee of the draft notice of proposed rule making on FCB's and vaa briefed on the exact purpose and content of the proposed action. The Taak Force had no objections to the FDA propoaal. The report of the Task Force, entitled "Polychlorinated Biphenyls and the Environment," was made public in May 1972. The findings, conclusions, and recoamendatlons of the report supported the FDA rule making. The following organliatlona are represented on the Task Force: Office of Science and Technology, Council on Environmental Quality, Department of Agriculture, Department of Coaaerce (National Bureau of Standards and National Oceanic and Atmospheric Administration), Environmental Protection Agency, Department of Health, Education, and Welfare (Food and Drug Administration and National Institute of Environmental Realth Sciences), and Department of Interior. SUPPLEMENT TO THE FINAL ENVIRONMENTAL IMPACT STATEMENT RULE MAKING ON POLYCHLORINATED BIPHENYLS Pood and Drug Administration Dapartnant of Haalth, Education, and Walfara Saa D. Pina Aaaoclata Coaalaalonar for Co^llanca July 2, 1973 0^2806 MOMS CONTENTS TltU______________________________________________ I. Introduction II. Susury of tho Problem of PCS'* Food Contaminant*; Hula Making on PCS'a and Related Environmental Isauee ........................... III. Beale for Establlahlng the PCB Temporary Tolarancea .............................................................. IT. Alternative* to the PCB Temporary Tolarancea.............................................................. T. Environmental Impact of the PCB Rule Making.......................................................... Appendix: Comment* Received on Draft tavlronmantal Impact Statement 1 3 S 13 21 fm MONS 042807 I. INTRODUCTION Tha CoMiseloner of Food and Drugs published tn tha FEDERAL REGISTER of March 18, 1972 (37 F.R. 3703) a notlca of propoaad rula making to limit human axpoaura to polychlori nated biphenyls (PCB'a) from dietary aourcas. 8Inca It was lntarpratad that lmplamantatlon of cartaln provisions of tha propoaad rula making map significantly affact tha quality of tha human anvlronmant, tha Food and Drug Administra tion (FDA) praparad, in accordanca with tha Rational Environ mental Policy Act of 1989, an anvlronmantal Impact statement on tha propoaad rula making. Accordingly, FDA Issued a Draft Bavlronmantal Impact Statement on tha propoaad rula making on May 11, 1972, and a Final Environmental Impact Statamant on December 18, 1972. These statements addrassad tha following aspects of the PCI rula making: Backgroundt description of rula making; anvlronmantal impact of rula making; altaraatlyaa to rula making; cumulative, long-term affects; and lntsragancy ravlaw of rula making. In addition, tha Final Statamant Included a summary of propoaad rule making and evaluation of tha comments racalvad on tha Draft Statement and notlca of propoaad rula making. Subsequent to tha Issuance of tha Final Statamant, tha Council on Environmental Quality advlaad FDA that tha coamanta racalvad on tha Draft Statamant should ba appended to tha MONS 042808 -2- Final Statement. Tha Council on Environmental Quality alao uggaatad that curtain isauaa FDA intended to addraau in tha final ordar of tha PCI rula aaklng ara alao appropriate conuIdaratIona undar tha Rational Envlronnental Policy Act and aa auch ahould alao ba included in tha Final Statement. Therefore, FDA haa prepared thla Supplement to tha Final Environmental Impact Statement, which provide* additional information relative to the PCB rula making. The Council on Knvlrooaiental Quality further advlaed FDA that tha provlalon in it* guldellnee promulgated undar tha Rational Envlronmantal Policy Act, which raqulraa that a final environmental Impact atatemant be laaued at laaat 30 day* prior to tha time tha action it govern* la taken, need not apply to thla Supplement. Therefore, purauant to provlalona of tha Rational Environmental Policy Act of 1969 (aac. 102(2)(c), 83 Stat. 653; 42 O.S.C. 4332(2)(c)), and undar authority delegated to him (21 CFR 2.120), tha Coamlaalonar of Food and Drug* laauaa thla Supplement to tha Final Environmental Impact Statement - Rula Making on Polychlorinated Blphenyla. HONS 042809 -3- II. SUMMARY OF THE PROBLEM OF PCS'* AS FOOD CONTAMINANTS; RULE MAXING ON PCB's AND RELATED ENVIRONMENTAL ISSUES Polychlorinated blphenyla (PCI'a) rapreaant a claaa of toxic Industrial choalcalt, which ara highly atabla, haat raalatant, and nonflaaaabla. Tha lnduatrlal appllcatlona of PCB'a Include, or did lnduda In tha paat, use aa electrical transformer and capacitor flulda, haat tranafer fluids, hydraulic flulda and plasticizers; and use in foraulatlons of lubricants, plasticizers, coatings, and Inks. PCB'a hava been shown to occur as chanlcal contaminants In foods froa tha following sources; A. Because of their unique chanlcal and physical properties and thair widespread, uncontrolled Industrial uses, PCB'a hava bacons a persistant and ubiquitous con taminant In tha snvironnsnt, resulting In tha contamination of certain foods. - B. A nuabar of Incidents hava occurred In which PCB's have directly contaalnatad anlaal food as a result of Industrial accidents l.a., leakage or spillage of PCB'a froa plant equipment. . C. PCB contaalnatad papar food-packaging asterlala aada froa recycled paper containing wasta carbonless copy papar, In which 3-5 parcant PCB'a ara used to encapsulate Ink, has lsd to tha contamination of foods aa a result of migration of HONS -4- PCB' from the packaging to the food contained In the peckage. The uae of recycled paper la not, however, the only aource of PCB'a In paper food-packaging material*. Soma paper made froa virgin pulp haa bean ehovn to contain PCS'a. The contamination probably occurred during proceaalng. The preaence of PCB'a In food and the aourcaa by which PCB'a may contaminate food* rapreaent a potential hazard to public health. Tor thla raaaon, FDA publlahed a notice of propoaad rule Baking In the FEDERAL REGISTER of March 18, 1972 (37 P.R. 3705) to limit human expoaure to PCB'a froa dietary aourcaa by dealing with known aourcea and cauaea of PCB contamination of food. The propoaad rule making Included the following provlaiona: A. Raatrlctlona on the lnduetrlal uaea of PCB'a In aatabllahaanta manufacturing, handling, or atorlng animal faada, food, or food-packaging materlala. In order to preclude the direct, accldentel PCB contamination of theee article*. B. Amendment of food additive regulation I 121.2346 to allow for food-packaging uae of pulp from reclaimed flbera containing unavoidable polaonoua or delaterloue aubatancee, providing thaaa aubatancee do not migrate to the food. HONS 042811 -5- I C. Establishment of temporary tolerances limiting the b level of PCS'a In animal teed, certain foods, and paper food-packaging materials as a result of unavoidable, c environmental contamination. On Map 11, 1972, FDA made available Its Draft Environmental I Impact Statement which addressed the Impact the propoead E rule making on PCB's map have on the qualltp of the human environment. This Impact Included: A. Potential adverse effects on the environment from Improper disposal of PCB's as a result of requiring 1 removal of PCI'a from the FDA-regulatsd Industrp. I B. Potential adverse effects on racpdsd paper activities ss s result of Implementing the tolerance for paper I food-packaging materials. C. Beneficial affects on humsn health as a result of .1 controlling ths contsmlnatlon of food with PCB's. i A 60-dap period was provided for Interested parties to comment on the Draft Environmental Impact Statement. i Conenta on the Draft Statement ware received from the U.S. Department of Agriculture, the Environmental Protection I Agencp, the U.S. Department of Commerce, and the American ]l Paper Institute. Copies of these comments are Included in the appendix to this Supplement. The Final Statement l Included FDA's evsluatlon of these commente. Further HONS 042812 -6 - discussion with respect to those comments, ae wall as other information on the PCS rule making, is provided In this Supplement. III. BASIS FOR ESTABLISHING THE PCB TEMPORARY TOLERANCES Section 406 of the Federel Food, Drug, and Cosmetic Act le the authority for astabllshlng the temporary tolarancee for PCB'a In animal feada, certain foods, and paper food packaging materials. It etataa that where the eddltlon of a poisonous or deleterious 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 ehall take into account tha extant to which use of the substance "cannot be avoided." This same authority le also applicable to food packaging materials. The fact that the tolerances for PCB's are termed "temporary" is recognition that In the future there should be less PCB contamination which "cannot be avoided," and tha Commissioner is authorised to reduce the tolerance levels accordingly. MONS 042B13 - 7- I The temporary tolerances for PCS'a are baaed on both L ' an' analyala of available data on tha toxicological effacta of PCB'a and an analyala of reported levele of PCB'a In I tha food eupply. ' E A. toxlcoloalcal Effects of PCB'a. The toxicity of PCB'a haa bean under etudy for tha paat 1 aeveral years. The Food and Drug Administration'a evaluation of tha algnlflcanca of PCB'a on human health and tha develop t ment of allowable dietary Intakes of PCB'a vaa baaed on an I analyala of both animal and human toxicological data and la aimawrized aa follows: I 1. Animal Toxlcoloalcal Date. Available data from long-term animal atudias showa that the no-effect level In I rata and doga (for PCB'a with A2, 54, and 60 parcant [ chlorination) la 10 ppm. Employing a 100 to 1 aafaty factor, tha "no-effact" level for man baaed on data derived from E doga would be 2.5 microgram (meg) par kilogram (kg) body weight par day, or from rata, 3 meg par kg body weight par E day. Therefore, baaed on long-term animal studlea, the I allowable level of PCB Ingestion In man would ba approx imately 0.175 mllllgrama (mg) per day for a 70-kg individual. HONS 042814 2. H|nn Toxicological Data. Hunan Intoxication with Kanachlor 400, a PCI that la manufactured In Japan and that contains 48 parcant chlorine vaa noted In 1968 when a heat exchanger leaked fluid Into rice oil end was conaumed by Japanese families. About 1,000 people ware eventually affected. Typical clinical findings Included chloracne and Increased pigmentation, visual Impairment due to hypersecretion of the Meibomian glanda, 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 as the children grew In alee. However, the growth rate of males appeared to be somewhat slower than normal. Adult patients had protracted clinical disease with vary slow regression of symptoms and signs, suggesting slow metabolism and excretion of this PCB In humans, probably Involving a long biological half-life. Exposure levele to the oil were calculated to approximate, on the average, 13,000 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 MONS 042815 total doae of PCB's causing an affect In the Japanese was %! reported to be 2,000 mg. The human data established that (he lowest level of PCB that produced an effect in man (using a 50-kg man) was S00 mg consumed over a period of JO days at a rate of approximately 200 meg par kg body weight per day. The effect level was based 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 Ingestion of 20 meg per kg body weight per day, or 1.4 mg per day for a 70-kg man, based on a total period of exposure 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 tha 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 above) may be tolerated over a much more protracted period of time without overt adverse effect If daily exposure Is held to minimal levels. It 2/ , Kanatsune, et. al., Fukuoka Acta. Mad. 22:117 (1971) HONS 042816 10 - would taka 22 montha of dally lngeation of 300 meg of FCl'a to arrlva at a total ingaation of 200 mg. Thla would permit lngaatlon of 4 meg par kg body walght per day In a 70-kg man. Since the lowaat total doae producing an effect In aan In the Japaneae Incident waa 300 mg, a elmllar analyaie leada to an allowable protracted lngeation of 1 meg per kg body weight per day ea derived from a 70-kg man. B. Dietary Sourcaa of PCB'a. The reeulta of FDA total diet atudlea for flocal yeara 1970-72 ahow an Intake of approximately 0.06 meg per kg body weight per day (or 4.2 meg per day for a 70-kg man). Becauae of the degree of eenaltlvlty of the analytical mathoda uaad, PCB'a may be praaant at levela too low to be detected. If lower levela could be quantitatively meaaured, the dietary Intake of PCB'a from the total diet atudlea would probably ahow an lncreaae. It ahould be recognized, however, that In rare iuetancea eome people could have more ayatematlc expoauraa to PCB'a In fooda than thoae expected by eating a moderately wall balanced diet auch aa repreaented by the total diet aamplea. Hence, the need for minimizing potential human expoauraa. The total diet atudlea Indicate that PCB'a moat frequently occur In the food compoalte conalatlng of meat, flah, and poultry (experience haa ahown that moat of 042817 HONS - 11 - tha PCB residues In thli composite are in fleh and, to a leaner extant, poultry) and in tha food composite consisting of grain and careal products (experience haa shown aoat of tha PCB raslduei in this conpoelta are derived froa paper packaging materials). FDA'a food surveillance activities have shown that PCB'a alao may occur in dairy products, eggs, and packaged fooda, in addition to packaged cereal products. C. Temporary Tolerances for PCB'a. . Using the human toxicological data described above, FDA concludes that for the short term, baaed on the lowest total dose producing an affect and estimated biological half life of PCB'a, currant levels of PCB'a in the diet represent no immediate hasard. This is also true for tha average total dose causing an effect in the Japanese for long-term exposure. However, based on the most sensitive "Japanese patient" (l.a., lowest total dose producing an effect), the possibility of potential long-term hazards nacasaltatas reduction of tha levels of PCB'a in food as soon as possible. In the interim, temporary tolerances are necessary to limit human expoeure to those foods that may contain PCB's resulting from environmental contamination, which aa a practical matter are presently unavoidable. Thoae fooda for which temporary tolerances are being established include milk and dairy products, poultry, eggs, and fish. In addition, other information necessltataa extending tha temporary tolerancea to other ltema, aa described below: HONS 042818 - 12 - 1. Infant* and young chlldran consume a greeter aaount of food par fcllogran body waight and tharaby hav* a proportlonataly graatar exposure than do adulta. A aaparata temporary tolaranca for PCB'a In Infant and junior food, therefor*, raflaeta tba possibility that undaalrabla exposures could raault if combinations of certain PCB-contamlnated foods comprise a major portion of this aga group's dlat. 2. PCB'a In paper food-packaging materials represent a source of human exposure to PCB'a In tha dlat. The PDA survey of tha PCB food-packaging material problem showed that 67 percent of the packaging portions of the samples examined contained PCB'a. Tha highest level was 338 ppm. Analysis also showed that 19 percent of tha food portion* of tha samples contained PCB residues and that there was an average PCB concentration In the food portions of 0.1 ppm. Tha maximum level of PCS'* found In food was 5 ppm. Either limiting tha PCB level of paper food-packaging material to 10 ppm or requiring tha us* of a functional barrier which Is Impermeable to PCB migration provides tha necessary naans for limiting this source of PCB contamination of food. MOUs ^ai 9 - 13 - 3. Sine*' PCB'e are transmitted to and concantratad la -edible portlone Of food-producing antmale Which lngoat PCBcontaalnatad food, animal food* represent anothar aourca of PCS'a In tha huaan dlat. Tharafora, temporary tolaraneaa for PCB'a In animal faada and animal faad componenta ara neCeeaary to minimiaa tha frequency and magnitude of PCI raalduaa in fooda of animal origin. FDA concludaa that tha temporary tolaraneaa balng established will protact tha public haalth, but cautlona that thaaa temporary tolaraneaa ara not to ba conatrued aa guldallnaa paralttlng tha conauaptlon of fooda containing thaaa amounts of PCB'a on a ragular and conalatant baala. Purthar, tha temporary tolaraneaa will ba lowarad aa exparlance Indicates that lowar lavala can ba attalnad. IT. ALTEBHATIVKS TO TBB PCB TKMPORASY TOLEKABCIS Tha Final Environmental Impact Statement Included a dlacuaalon of tha alternative coureea of action available to PSA for each provlaloa of tha rule making. Tha following la a dlacuaalon of other altemativea which were auggaated by conaumer groupa and by lnduetry In thalr coamenta to the FDA on tha notice of propoaad rule making. 0^82 HONS - 14 - A. Enforce Zero loUrtncu for PCB' In Animal Feeds Certain Foods. end Pnner Food-Packaging Mnterlnle. Animal feeds, certain foods, and paper food-packaging materials contain PCB'a, which under present conditions of envlronasntal contamination are unavoidable. Current tox icological Information does not support the necessity of establishing taro tolerances for thsse Items In order to protect public health, since human exposure to dietary sources of PCB'a is usually sporadic, nonsystematlc, and occasional. The "finite" temporary tolerances being established by FDA will provide the assurance that signi ficant PCB levels are not contained In food and that human exposure to PCB'a from dietary sourcee will be maintained at safe end minimum levels. Zero tolerances, therefore, are unwarranted and would unnecessarily deprive the consumer of a portion of hla food supply and would disrupt the Ration's food distribution systaai, because certain quantities of fish, poultry, eggs, milk, and food-packaging material would be violative. B. Impose Mo Tolerances for the PCB Contamination of Animal Tends. Certain Foods, and Paper Food-Packaalna Materials. This alternative was explored by FDA and rejected for the following reasons: HONS 042821 15 - 1. No authorization hae bean grantad undar tha Fadaral Food, Drug, and toematic Act permitting PCB'a aa conpcnenta of food or a* aubatancaa otharwiee affecting tha characterlatlca of food. Tha fact la, hoveVer, that PCB'a ara componanta of fooda aa araault of unavoidable, anvlronaantal contaalnatlon. Ahalyeia of currant toxicological data damonatrataa a potantlal hazard to human health If dietary axpoeurea to PCS'a ara not controlled. Therefore, aa poiaonoua or delatarloua aubatancaa, FCB'a In animal feoda,fooda, and paper food packaging materlala render auch articled adulterated under tha Federal Food,'Drug, and Coamatic Act. Failure to Initiate poaltlve action, l.e., eatabllah llmlta on tha PCB content of thaaa artlcloa and renove from eonaumer channela thoaa drtlclea containing PCB'a in axcaaa of the eatabllahed llalta, aould ba contrary to tha lntereete of public health and contrary to congreeaidnal mandate.' ' ` ' 2. In thai abaance of tolerancea for PCB'a In fooda, FDA haa uaad "action level guldellnea" for determining tha level of PCB Contaalnatlon at which' regulatory action la to ba Initiated. During the paet'3 ycara, FDA, tha D.S. Department of Agriculture, and State and local agenelaa have uaad thaaa action lavele aa thd'baela for reviving PCB-contamlnated fooda Iron comearclal channela. the PCB temporary toleranced now'being'eatabllahed are HONS 042822 - 16 - generally comparable to thoao action lavela both in tana of tha laval at which ragulatory action la taken and tha raaaon for taking regulatory action! l.e., protection of public health. Tha major dlatlnctlon la that the tolerancaa are laaued aa a propoaad regulation upon which all lntareatad partlaa era Invited to comment. Once eatabllahed aa a regulation, tolerancaa provide guidance to all ragulatory agenclea and to lnduatry In order to aaaura officiant and equitable enforcement and eonaumer protection. C. Eotabllah Tolerancaa for Packaaed Fooda Rather Than Paper Food-Packaging Materlala. Thle alternative, which tha paper lnduatry racomended, waa conalderad by FDA and rajectad for the following reaeona: 1. Since the tranafar of PCB'a from packaging material to tha food la dependent on time and condltlone of expoeure, tolerancaa baaed aolely on the packaged food would not provide adequate protection to the eonaumer. A packaged food analyzed at the time of packaging may be entirely free of FCl'a, but by tha time it raachaa the eonaumer and la finally coneumed It may have accumulated eoneldarable quantltlee of PCB'a If the packaging material la contaminated. A tolerance eyetem In which analytical flndlnga are ao dependant on many varlablea auch aa time of eampllng would not be reaeonabla or adequate. 0<*282^ ttONS - 17 - 2. In ordsr to achieve compliant* with a tolerance for packaged food( the level of FCB'a in tha packaging has to ba takan Into account and limited in order to praduda tha potential tranefer to the food of quantities of FCB'a that would cauaa tha food to exceed lta tolerance level. Since - i , . <1 , . tha level of FCB'a In packaged food la related to tha level of FCB'a In lta packaging, tolataneaa for both tha food and lta packaging would ba necessary. Thle amount! to an obvloua redundancy. 3. Eatabllahing a tolerance for packaged food alone would be lnconeletent with tha Intent and naanlng of Section 406 of tha Federal Food, Drug, and Coametlc Act. The packaged food by ltaalf doaa not contain unavoidable FCB raalduea; tha principal aourca of the FCB conCaalnatlon of packaged food la tha paper food-packaging material, which contains tha unavoidable contamination. Accordingly, tha tolerance ahould deal with this material. Therefore, thla source of food contamination ehould be limited ao ae to minimise the levels of FCB's that may migrate to the packaged food. 4. Failure to limit tha level of FCB'e In paper food packaging materials would perpetuate the use of a known, avoidable source of FCB contamination of food. HONS 042824 - 18 - D. Exempt Aroclor 1242 from tha PCB Temporary Tolerance for Paper Pood-Packaging Hatarlale. Thie alternative, which FDA inveatigated and rejected, waa alao recommended by tha papar Induatry. Tha papar lnduatry commente atata Chat tha aatabllahmnt of tha PCB tolaranca for papar food-packaging materiala la unwarrantad for public haalth reaaona, bacauaa available aclantlflc evidence above that Aroclor 1242 (the predominant PCB found in paper) la not paralatant and cumulative, and thua will not preeent a chronic toxicity problem. Although data lndicatae that aoma eomponenta of Aroclor 1242 are metabolized In biological ayetema more rapidly than tha other higher chlorinated Aroelora, there la no Information available which deacrlbea the compoeltlon, toxicity, and fate of the metabolic producta. The abaanca of Aroclor 1242 reaiduea In human and certain animal tlaaua and In tha environment la not a aound baala from which to argua that no hazard exlata from the lngaatlon of Aroclor 1242. The poaalblllty exlata that Aroclor 1242 la converted to alteration producta which may be more toxic than the original compounda, but which are not detectable by current analytical mathode. Further, available data from chronic feeding etudlee with rata and doge fall to aubatantlete clalma that Aroclor 1242 doae not repreeaot a toxic eubatance or that It dlffera In toxicity mons 042825 - 19 - from other Aroclors. Therefore, the Commissioner concludes that the temporary tolerance will apply to the term "PCI" Irrespective of which Aroclor la present as the contaminant. E. Postpone the PCB Tolerance for Paper Food-Pachaalna . , Materials Pntll Certain Information le Developed. . Comments received from Industry and related trade associa tions argued thet the temporary tolerance. for.PCB's in food packaging materials should be deleted or postponed until: (1) quality control teat procedures and adequate analytical methoda are developed to regulate production and Insure compliance, and (2) migration rates are established to take Into account barrier effects, type of food, and the ratio of package weight to food weight. PDA considered these comments and condudad that the establishment of the tolerance should not be poetponed for the following reasons:. ., . 1.. Although a trade association submitted data which It claimed Indicates a lack of reliability In analysee of paper board material, the data failed to show that uniform teat methods were employed by the participating laboratories or that these tests.vers performed by laboratories with demon strated capabilities in trace residue analysis. Further, an Interlaboratory atudy that was conducted under the auspices of apother trade association and that utilised PDA analytical - 20 - methodology supports the conclusion that current methodology la adequately sensitive and reproducible from laboratory to labora tory to Insure compliance vlth the tolerance. 2. It Is recognised that migration rates (actual level of PCB's In food resulting from the use of contaminated packaging material) are affected by factors such as barriers, type of food, the ratio of package weight to food weight, and expoaure time end conditions. Since FDA's primary concern Is not the fact that paper food-packaging materials contain PCB's, but the fact that PCB's can migrate to the food from the packaging, then the use of barriers which prevent migration la an accept able alternative to limiting the PCB content of paper food packaging material. For this reason, the proposed rule making has been revlaed In the final order In I 122.10(a)(9) by exempting 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 bottlas are obvious examples of what constitues a functional barrier Impermeable to PCB migration. Data from lndustry-sponaorad atudiea have shown the materials such polyvlnylldena-coated paper and glasslne can, to varying degrees, prevent or reduce PCB migration under test conditions which would favor migration. MGNs I. I 1 E r B. I I I i i .t E * I - 21 - FDA would not object to the uae of flexible material! end other Material* ae barrier*, provided there la no evidence of migration of PCS'* to the food. At thl* time, however, there.1* inaufflclant Information for PDA to Hat aa part of the regulation thoae material* that are conaldered functional barrier*. The other factor* mentioned above which affect migration rata* map alao b* Important coneldera- tlone and ahould ba thoroughly studied. In the Interim, the temporary tolerance for peper food-packaging material* and the exemption to thl* temporary tolerance are conaldered naceaaary to aaeur* the conaumer that packaged food 1* not being contaminated with PCB'a to an avoidable degree. F. Eetablleh a Higher Tolerance for Paper Pood-Peckaalng Material*. The notice of propoeed PCB rule making included the propoaal to establleh the temporary tolerance for PCB'a In paper food packaging materlala at J ppm. In exploring alternative coureea of action regarding thle regulation, FDA reevaluated the S ppm tolerance level. Data from the PDA eurvay of PCB'a In fooda and food-packaging material ehowed that the food portion of the aamplaa with 5-10 ppm PCB'a In paper food-packaging material contained the aama range of PCB level* (0.1-0.i ppm) aa tha food portion of the eamplaa with 0-5 ppm In paper food packaging material. Sample* with more than 10 ppm In tha moms - 22 - packaging contained higher levala In the food, ranging up to 3.7 ppm. On the baala of thla Information, the FDA concluded that tha final order of the FCB rule making ehould be changed to Incorporate a revlelon In tha temporary tolerance for FCB'a In paper food-packaging matarlala from 5 ppm to 10 ppm. Thla ravlalon In tha tolerance waa alao atated In tha Final Environmental Impact Statement on tha FCB rule making. T. ENVIRONMENTAL IMPACT OF THE FCB RULE MAKING Since tha FCB rule making will reduce human expoaure to dietary aourcaa of a toxic, chemical contaminant, FDA concluded In lta Final Environmental Impact Statement that tha rule making will have a beneficial affect on tha quality of tha human environment. Tha Final Statement alao Included a diacuaalon concerning potential adveraa effecta tha rule making may have on tha quality of tha human environment. Tha following la additional Information relative to thla matter: A. Environmental Impact of FCB Replacement or Subatltutaa. During the development of tha provlalone of tha rule making, conelderatlon waa given to the poealble adverae effecta on tha environment of thoae chemicala which may be uaed aa replacemente or aubatltutaa for thoae lnduatrlal uaee of FCB'a prohibited by MONS 042829 - 23 - the rule making. FDA vaa and contlnuaa to ba coneatnad that tha regulation could have tha affact of causing tha uaa of chemlcala which would poaa a thraat to tha environment and to humanhealth. For this reason, a requirement In tha final order of the rule making will call attention to this potential problem In order to reduce the likelihood of introducing a new "PCB-typ* problem." This requirement la as follows: "The toxicity and other characteristic* of fluids selected a* FCB replacements must be adequately determined so that the leest potentially hazardous replacement Is used. In making this determination with respect to a given fluid, consideration should be given to: (1) Its toxicity; (2) the 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 (4) Its environmental stability and tendency to survive and be concentrated through the food chain. Tha judgment as to whether a replacement fluid is sufficiently non-haiardous is to be made on an Individual Installation and operation basis." Furthermore, tha numerous PCB-assoclatsd "Occidents" that have occurred In the past and tha provision* of the rule making Itself will serve as Incentives to prevent future mqns 0*d830 u- - problema from occurring. Industry chould be acre cognizant of tho serious repercussions that can raault fron tha lndlecrlalnata uaa of toxic chomlcala and from aeddanta of thla typo, auch aa advaraa offacta on hunan health and tha environment, adverae publicity, criminal and civil penaltlee, and aubatantlal financial loaaea. In addition to thaae conaldaratlona, chare la Information which Indicator that leaa toxic, biodegradable PCS replacemanta have bean developed and are being used for heat tranefer ayatama and other induatrlal appllcatlona that have caueed peat environmental problema. In conclualon, FDA can only apaculata that eoma PCB raplacamente or aubatltutea may preaent future environmental problema. However, it la known with certainty that tha continued uaa of PCB'a by the regulated lnduatrlee preaenta a definite hazard to man and hla environment. Therefore, FDA'a action to raatrlct tha uaa of thla contaminant In feed, food, and food-packaging material manufacturing aatabllahmenta la clearly more beneficial to the quality of tha human environment than allowing the continued uae of PCB'a. B. Impact on Recycling Actlvltleo. In commenting on the notice of propoaed rule making, the paper lnduatry and lta trade aeeodatlona have atated that the temporary tolerance for PCB'a In paper food-packaging materlala would be detrimental to the Nation'a commitment to utilize recycling In solid waete disposal programs. This alleged MGNS 042831 - 25 - adverse environmental impact la based on the paper Industry's contention that the tolerance would place severe economic hardships on recycling mill*, as follows: 1. "Significant" quality control coats would be required to assure compllence with the tolerance; and 2. Financial loasea would be Incurred when products which contain FCB'e In amounts above the tolerance are rejected. The paper Industry concludes that these Increased coeta In pro duction would cause the closing of soma recycling mills and. thus result in the adverts environmental Impact cited above. This aspect of the rule making was eddreaaed In the Final Environmental Impact Statement. FDA concluded that the revision In the tolaranca level and allowing an exemption to the tolerance would reduce or eliminate the alleged advaraa effects on recycling programs. Flret, Increasing the tolerance for paper food-packaging materials from 5 ppm to 10 ppm is expected to result In only a low percentage of paper producta being excluded from use for food-packaging purposes. This conclusion was bassd on Industry survey data which showed that 20 parcant or anre of paperboard samples tested contained FCB levels In excess of 5 ppm. while about 7 percent exceeded the tolaranca level of 10 ppm. Second, the exemption from the tolerance when a functional barrier is used will serve to further reduce the percentage of paperboard that would ba unacceptable (i.e., containing FCB'a In an amount above tha tolerance level) for food-packaging use. MOMS 042832 - 26 - Id addition, tha Final Statement atatad that recycled papar producta ara not being singled out aa objacta of thla tolerance. Virgin papar producta hava baan shown to contain PCS'a and, for thla raaaon, tha antlra papar Industry will hava to baax addad coata of Implementing quality control procaduraa. In thla raapact, racycllng ailla ara not balng placad at a conpatltlva dlaadvantaga. Furthamora, thsaa addad coata ara fully warranted and Juatlfied bacauaa of the public health beneflta that will ba derived from regulating thla aourca of food contanlnatlon. Aa a poaalbla naan* of reducing tha Incidence of food packaging materials that exceed tha tolerance level for FCB'a, tha Environmental Protection Agency atatad In Ita cowmanta on the Draft Environmental Inpact Statement that consideration should ba given to removing from existing Inventories carbonless copy paper that contains PCB's. In the Final Statement, PDA raepondad to tha EPA consent by stating that It lacks Jurisdiction to Implement thla action. Thla continues to be the reason FDA does not consider thla approach an effactlva and realistic alternative to the temporary tolerance for PCB's In papar food-packaging materials. However, FDA does recognise that It nay ba feasible to aoma degree to control the flow of PCBcontalnlng carbonless copy paper into wests papar channels, and thus lessen any Impact tha PCB rule making may have on recycled 0^2833 - 27 - paper program*. In thla regard, FDA haa contacted the Environ mental Protection Agency and rSquastad lta assistance in exploring poaalbla procedure* for Implamenting the Environmental Protection Agency'* *ugge*tlon. C. Economic Conaldaratlona. The U.S. Department of Commerce, In lta concent* on the Draft Statement, atated that a coat/banaflt analyala relative to the PCS rule making ahould b* conducted. The Final Statement responded to thl* comment by ateting that since a coat/benefit analysis 1* an economic conelderatlon, it la not a proper subject of an environmental Impact etatement. Tha Counsel on Environmental Quality advised FDA that economic consideration* should be addressed along with th* environmental conaldaratlona under the National Environmental Policy Act. PDA la In agreement and retracta Its previously stated position on this matter for the following reasons: 1. Tha position 1* contrary to tha National Environmental Policy Act. 2. Tha position 1* not an accurate reflection of tha considerations given by FDA to the economic Impact of th* FCB problem. MONS 04*834 - 28 - FDA rscognirsd that btcausa PCB'a are widely used and Important Industrial chemicals and ubiquitous environmental contaminants, any action taken would have adverse economic consequences. FDA also recognised that because PCB'a are toxic substances, not taking action with respect to the sources of PCB contamination of the food supply would have adverse consequences 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 minimising human exposure to PCB'a. The rule making reflects a balance between these conaequances, l.a., the regulations are not more restrictive than is necessary to protect public health. This fact is exemplified in the proposed rule making, wherein it was stated: "Ismediaea ellmlnetlon of all food packages containing PCB'a would disrupt tha Nation's food packaging and distribution system and is not warranted by the hasard 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 ths rule making. In addition, this Supplement responds to industry comments that tha rule making will cause a severe economic Impact on tha recycling Industry. HONS 042835 - 29 - Therefore, although not explicitly atatad In tha abova Stataaanta and propoaad rula making, IDA conductad a fora of a coat/banaflt analytic. Aftar full eonaldaratlon of altarnatlva couraaa of action, tha tosleologleal affacta of FCB'a on human haalth, and othar ralatad information, FDA concluded that each provlelon of tha rula making la necaaaarp in order to mlnlmlie human axpoaure to FCB'a from all dietary eourcea and that tha haalth benaflta derived outweigh any adverae economic conaequancee that may reault. HONS 042636 COMMENTS RECEIVED OH DRAFT ENVIRONMENTAL IMPACT STATEMENT MOMS 042837 DEPARTMENT OF AGRICULTURE office of the secretary WASHINGTON. D. C. 20250 October 18, 1972 Dr. L. L. Ramsey Aasoo. Director, Regulatory Programs Office of Compliance Bureau of Foods, FDA Washington, D.C. 20204 Dear Dr. Ramaeyi We have reviewed the document "Draft Environmental Impact Statement, Notice of Proposed Rule Making, Polychlorinated Biphenyls, May 8, 1972." The Department of Agriculture participated In the Interdepartmental Task Force on PCBs, which also received copies of the draft notice of proposed rule making on February 29. As Indicated on page 20, the Task Force, Including the U8DA representatives, found no objec tion to the IDA proposal. In addition, the Department formed Its own ad hoc group on PCBs which has prepared a report on "Agriculture's Responsibility Concern ing PCBs" (enclosed). This group also supports the FDA notice of proposed rule making. It Is believed that these proposed actions will considerably reduce the accidental contamination and long-term exposure of man to PCBs In the U.S. The widespread occurrence of PCBs In the environment already makes It highly desirable to set temporary tolerances for PCBs as proposed, until the background levels are reduced. This Department wishes, therefore, to support this environmental Impact statement. Appreciation Is expressed for the opportunity to review it. /4eRAU) F. CGMB8 ' Nutrition & Food Safety Coordinator Science and Education HONS 042838 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. O.C. 20460 SEP 1 4 1972 Bearing Clerk Department of Health, Education, and Welfare Room 6-B8, Parklawn Building 5600 Fishers Lane Rockville, Maryland 20852 * Dear Sir: We apologise for the delay In responding to the draft Environmental Impact Statement and to the Proposed Rule Making on Polychlorinated Biphenyls (PCB) of May 8, 1972, I hops It la not too'late to make use of our comments. the Environmental Protection Agency has no objection to the Intent of or principle behind the proposed rule making. We do feel, however, thae until a consistent dependable analytical method for PCB quantification Is developed that FDA sampling procedures be carefully structured to avoid any condemnation of packaging material that is based on only one or two samples. The proposed rule making and the draft environmental Impact statement should emphasize the concern over the ultimate PCB content of packaging material rather than the level In the source material. The E1S gives the Impression that contaminated pulp can only come from recycling. For example, Item A on page 7 of the EIS describes an amendment to the reg ulation which prohibits "reclaimed and salvaged fibers which would be used In food-packaging materials to include pulp that contains poisonous and deleterious substances which may migrate to food," (emphasize curs). A restructuring of this language would alleviate any potential discrimina tion against recycling. The data on migration of PCB'a from packaging to food In quantities needs further exploration In the use of barriers. Procedures for sampling and enforcement of this regulation should take Into consideration ths difficulties in accurately measuring PCB content. Moreover, no support is given In the statement or In the report of the Task Force for the 5 ppm tolerance level for food packaging. The statement should detail whatever Justification was used for this flguro. An additional method towards the reduction of PCB levels In food packaging which might norlt examination Is the removal of carbonless copy paper containing FCB'a from existing Inventories. If this Is MONS 042839 2 found economically feasible It would aid In eliminating the reappearance of PCB's In paperstock ueed for manufacturing paper board. He appreciate the opportunity to comment on the draft environmental Impact statemeui. and the proposed rule making. He look forward to receiving a copy of the final Impact statement. Please contect us If we can be of any further assistance. Sincerely yours, Sheldon Heyers Director Office of Federal Activities MONS OAiBiO September 15, 1972 THE ASSISTANT SECRETARY OF COMMERCE Washington. D.C. 20230 Mr. Robert C. Brandenburg Acting Deputy Associate Commissioner for Compliance Department of Health, Education and Welfare Public Health Service Food and Drug Administration Rockville, Maryland 20852 Dear Mr. Brandenburg: The draft environmental impact statement. Notice of Proposed Rule Making, Polychlorinated Biphenyls which accompanied your letter of August 21, 1972 has been received by the Department of Commerce for review and comment. Tho Department of commerce has reviewed the draft environ mental statement and has the following comments to offer for your consideration. We believe this statement should be redrafted and recirculated. General Comments 1. Little or no discussion of the toxicological effects of PCB's on human health or the effects of PCB's on biota is included in the statement, making it very difficult to appraise the relevance of and basis for the PCB levels proposed. Information on these subjects should be added to the statement. 2. The rules as stated in the statement are incomplete. The time required for compliance, the testing to determine the presence of PCB's and the verification of the absence of PCB's has been omitted and should be included for comment. The 30 day period for compliance as stated in the Federal Register, Volume 37, No. 54 of March 18, 1972, will pose ft1* 1 2 hardships to industry, especially if new equipment is required within this period. Further, it is unlikely that testing facilities and instrumentation are adequate to per form the work required by the rules in the necessary 30 day period. 3. While the general intent of the rules is clear, the ommission of coatings and paints from food-packaging material establishments and food establishments may make the interpretation and enforcement of "the elimination of any other PCB-containing materials wherever there is a reasonable expectation that such materials could cause food to become contaminated with PCB's" difficult. The same circumstances may also occur because the rules do not clearly cover machinery for manufacturing, processing, storing and handling consistently for all three categories of establish ments. Similarly, the statement does not address handling and storage for transportation and in-transit storage facilities or equipment. 4. While the environmental impact of the removal and dis posal of PCB-containing materials is discussed, no indication of the need for or existence of rules controling removal and disposal is made in the statement. This issue should be addressed irrespective of FDA's jurisdiction of it. 5. The statement indicates that some materials which would replace PCB-containing materials would have similar characteristics to those of PCB's because of the use condi tions. If it is implied that those replacement materials be subject to the Environmental Impact Statement review process this statement should clearly affirm or deny that implication. 6. In our judgment, this impact statement does not meet the NEPA requirement for "a detailed statement by the responsible official"; nor does it follow the format provided by NEPA. In particular, a cost/benefit analysis has been omitted. Not only is one required, but in this case, it is of HONS 042842 3 special importance because the impact statement contains no other economic or social information and the control of PCB's has potentially a considerable economic impact. Also, the health benefits have not yet been clearly established. A thorough and comprehensive cost/benefit rational and analysis should be included in the statement. 7. While the actions necessary to remove PCB's from equipment according to the proposed rules are reasonably clear, the discussion of the removal of PCB-containing materials from the waste recycling program is not clear or complete enough to appraise the effects of the proposed rules on industry. Seme 'carbonless" carbon paper may be being removed from the re cycling process now, but the extent of that practice through out that industry is not stated, nor is the effectiveness of that practice in reaching the temporary tolerance limit stated. Because such a very small quantity of carbonless carbon paper per ton of waste paper when recycled exceeds the proposed tolerances, it is unlikely that the tolerance limit can be met without significant additional costs to the recycling industry thus reducing its competitiveness in the market and its chances of survival. When carbonless carbon paper is combined with unknown materials containing PCB'a the problem is further compounded, making the tolerance limits even more difficult to achieve. The actions by the recycling industry necessary to meet the proposed rules are in the main different from and more difficult than those the virgin paper industry must take. While the intent of FDA is not to propose rules detrimental to the waste recycling program, that in fact may very well be the effect. The impact statement should address recycling in depth to protect against any economic and hence function dislocation of this important conservation effort. 8. The statement does not discuss the temporal aspects of the temporary tolerances, nor the ways by which a 'sufficient period of time to permit elimination of such (PCB) residues at the earliest practical time" is to be determined. These issues are components of the economic impact of the rules and information about the expected duration of the temporary tolerances and some definition of "sufficient" and "earliest practical time" should be included in the statement. MONS 042843 9. The rational for not egtablishing the PCB tolerance of the food itself described under Alternatives on page 16 is only valid because present information about the chronic toxicological effects of PCB's is not sufficient. This alternative is highly desirable, because it would provide the necessary incentives to the food packaging and processing industry to research and develop alternative solutions to the control of PCB*a in food from any source. It would further the development of not only new products but the development of new and improved tests and instru mentation as well as produce a better understanding of the chemical and physical composition and behavior of PCB's. conversely, prescriptive restrictions on products ancillary to the real purpose of the proposed rules serve only to discourage the type of technological invention that a rule on the PCB tolerance of food would foster. A part of the rational for not setting food tolerances should be amended in the statement so that once toxicological effects are adequately determined, limits could be adjusted accordingly. In summary, we believe the impact statement is not adequate for the type of balanced factual consideration expedited under NBPA and suggest that it be rewritten with more information and redistributed for comment. Sincerely, Deputy Assistant Secretary for Bnvironmental Affairs HUNS 042844 LAW OFFICE WALD, HARKRADER & ROSS NOSENT L. WACO CAKUCrOM A, HAMNMAPCK W8TMC.FWNAENNFIaC.LIOVCnSo,sJeN. 0ONALO M. MCIN SELMA N. LCVtNC TMOMAa e. MATTHEW*, JN. JOEL *. MOFFMAM IQMI A. AVENV ALCXANQCN W. SISNCK WTCILNLNICAMMCaC. A. MUNAMV WKtaaMAN STEPHEN M. TNUITT JAMES W. WHITE KEITH a. WATSON JAMES OOUOLA8 WELCH I. MICMACL SNECNSCNOS NHILlF ELMAN NEAL F. NUTLC UtO NINtTICNTH tTNCCT, N. W., WASMIMOTON, 0. C. 1001# mo coot aoa ss-tts* eAaLt AOencBai WALHAAK October (, 1972 Miaa Baryl MoCullar Hearing Clark Department of Haalth, Education and Welfare food and Drag Administration Kooa l-M SCOO Plshere Lana Rockville, Karyland 20992 Mb: In the Matter of POLYCHLORINATED BIPHENYLS Propoaal to Aaand 21 C.P.X. Parts 2, 121, 122, 129 Dear Mlaa MeCullari whan PDA'a final environmental Impact atatament relating to the proposed PCS regulations la laauad. It la likely that the American Paper Institute (API) will file ooaimenta during the thirty day period provldod for this purpose by the Guidelines ot the Council on Environmental Quality (CSQ). Soe 26 Fed. Peg. 7724, 7726 (April 22, 1971). It is API's position that both legal and policy consideration* require a period of at least thirty days for comment on the final environmental impact statement before the final regulation laauaa. The National Environmental Protection Act provides that both the final statement and the ccements of interested parties shall "accompany the propoaal through the existing agency review processes ... .* nepa S102(2)(c), 42 9.9.C. 94222(2)(C). The purpose of this provision is to assure agency consideration of ell environmental factors in the formulation of regulations. This would be impossible if final regulations were leaned in advance of the opportunity for oenmant on tha environmental atatament. HONS 042845 WALD, HARKRADER & ROSS ring Clark -2- (,October 1972 Koroover, the CCQ Guidelines ant the v.' precoduroe ot the Department of Health, Education and >.-Iface. (V, Iw!. p.,g. 23S7C-23679 (Pec. 11, 197133 spoil out a yi.-ci r." lahle to facilitate agenoy consideration of tho staten;c,>t sn<j . uMlc comments. Both Section 10(b) of tho CEO "uidi. line* and Section 20-is-bo(B) (3) of the HEW procodures, whit!'; at*-, a.i llcaele to 7DA, require on agoncy to issue its final erv ' i< >n...i ni.al Imi act statement 'at least thirty days before acting." '/rtlng' in thia context can have no meaning other than the affirmative stop by which the proposal ia formally enncU-d -- a Section 701(a)(1) order. Thia language clearly pj ><.icontemporaneous raleaso of the statement and the order, even if thu effective data of the regulations is postponed for t: I tty days. After thu tliirtieth day, tlie regulations would i 'cally Income effactivu without the need for further FDA action. Theee procedural requirements ar< .^signed in afford meaningful opportunity for interacted y-artiet. Including Industry and other governmental agencies, t.o corniier.t on the completed onvlronaiantal etatoment, and for t-V.; agency to consider these eoassenta before it finally commit* itself. The opportunity would lie seriously undermined if, as has been suggested, FDA iesuee the Impact statosMnt and Pen regulation* simultaneously. Sincerely yours. Mi/gv oc- M3. Fine Hr. Brandenburg Mr. Weasel Selma M. Levine Counsel foe American Taper Institute, Inc. MGNS 041846