Document 7zeMxKovVYYXZ6XZ2xGoZJ4e

f S409 PANEL ON REVIEW OF BACTERIAL^ VACCINES AND TOXOIDS Meeting Change Pursuant to the Federal Advisory Com mittee Act of October 6, 1972 (Pub. L. 92-463, 86 Stat. 770-776 (5 U.S.C. App. I)), the Food and Drug Administration announced in a notice published in the Federal Recister of February 23, 1976 (41 FR 7973), public advisory committee meetings and other required informa tion in accordance with provisions set forth in section 10(a) (1) and (2) of the act. Notice Is hereby given that the meeting of the Panel on Review of Bacterial Vaccines and Toxoids, scheduled for March 28 and 29, 1976, has been re scheduled to meet on March 27 and 28, 1976, with the open session beginning March 27 at 1:30 pan. Dated: February 19,1976. Sam D. Fete, Associate Commissioner ' - for Compliance. [FR Doc.76-5434 Filed 2-25-76:8:45 am] Food and Drug Administration [Docket No. 76N-0048] POLYCHLORINATED BIPHENYLS (PCB's) IN CERTAIN FRESHWATER FISH Statement of Policy The Food and Drug Administration is stating its policy in regard to the con tamination of freshwater fish with poly chlorinated biphenyls (PCB's). Although PCB's may not intentionally be added to food in any quantity, they are, at times, unavoidably present in cer tain foods as a result of environmental contamination. The Commissioner of Food and Drugs promulgated a regula tion under 8 122.10(a) (21 CFR 122.10 (a)) in the Federal Register of July 6, 1973 (38 FR 18096) that established lim its on the amount of PCB's that may lawfully be present in food as the result of such contamination. Among other things, the regulation set a temporary tolerance for fish of 5 parts per million (ppm) PCB's. Since the July 1973 tem porary tolerances were established, ad ditional toxicological data on PCB's have become available. These recently devel oped data have raised concern that PCB's may be more toxic than previously thought. The need to lower the tempo rary tolerances in light of these data, particularly the tolerance for fish, is under active consideration. Contempo raneously, sampling programs conducted by Federal and State authorities reveal that PCB's continue to be a significant contaminant of some species of fresh water fish taken from certain rivers and lakes in the United States. The Commissioner believes that the present situation warrants a statement of the policy of FDA regarding the prob lem of PCB contamination of freshwater fish ar -d the steps FDA has taken, or may Initiate, to deal with the problem. Fur thermore, the New York State Depart ment of Environmental Conservation has requested guidance from FDA as to what action, if any. Is necessary at this time to protect the public health in light of the recurrence of PCB levels in excess of the 5 ppm temporary tolerance in fish taken from certain waters in New York State. This notice responds to the re quest from the New York State authori ties for guidance and discusses the PCBin-fish problem generally. , Background . PCB's are a class of toxic industrial chemicals that are highly stable, heat resistant, and nonflammable. Prior to 1971, PCB's were used in a variety of applications, primarily because of their excellent chemical and thermal stability. It has been estimated that approxi mately 40 percent of the PCB's used in the United States prior to 1971 went into applications that resulted in loss into tlie environment. These applications in cluded use as plasticizers, pesticide ex tenders, microencapsulation of dyes for carbonless copy paper, and as compo nents of hydraulic fluids and lubricants, surface coatings, inks, sealants, and ad hesives, The bulk of the remaining 60 percent use of PCB's was in electrical transformers and capacitors (Ref. 1). By late 1971, it was apparent that the unique physical and chemical properties of PCB's and their widespread, uncon trolled industrial application had led to their becoming a persistent and ubiqui tous environmental contaminant. In 1971. the Monsanto Corp., the sole United States producer of PCB's, restricted sales for use only in closed-system elec trical application, e.g., transformers and capacitors. PCB use in the United States today is principally limited to such closed systems, which minimizes but does not eliminate the loss of PCB's into the en vironment (Ref. 2). One consequence of the contamination of the environment with PCB's was the indirect contamination of certain foods, principally those of animal origin. Al though only limited information on the toxicity of PCB's was available in late 1971 to 1972, there were sufficient data for the Commissioner to conclude that PCB's were a poisonous or deleterious substance, and that their presence in food posed a potentially serious health hazard. As a first step to limit human exposure to PCB's from dietary sources, FDA issued a notice of proposed rule making in the Federal Register of March 18, 1972 (37 FR 5705), indicating the agency's intentions under section 406 of the Federal Pood, Drug, and Cosmetic Act (21 U.S.C. 346) to restrict the level of PCE's that could lawfully be present In food. Temporary tolerances for PCB's In fish, milk, dairy products, eggs, poul try, animal feed and feed ingredients, and infant and Junior foods became ef fective in the final regulation of July 6, 1373. These tolerances are listed In 5 122.10 (a). An action level is also in ef fect for PCB's in paper food-packaging materials. In setting the temporary tolerances for PCB's, the Commissioner tool: i :`o ac count the extent to which a limit on PCB consumption was necessary for the protection of the public health, other ways in which the consumer mivfitbe ex posed to PCB's or other poisonous or de leterious substances, and the extent to which PCB contamination of food can not be avoided. Numerous safety factors were used to assure that the temporary tolerances provided an adequate safety margin for the consumer as long as ex posure to PCB's was sporadic and di minished with the passage of time. Surveillance data gathered by FDA and the U.S. Department of Agriculture subsequent to the effective date of the temporary tolerances (Ref. 3) have shown that, with the exception of certain freshwater fish, the presence of PCB's in those individual foods subject to the tolerances continues to be sporadic, and that there has been an overall and sub stantial decline in frequency and levels. These data further show that the aver age daily dietary'intake of PCB's is quite low and well within the margin of safety. PCB Contamination of Fish The Commissioner stresses that most fish intended for human - consumption come from salt waters. Sampling pro grams of FDA reveal that those fish are largely uncontaminated with PCB's (Ref. 3). Fish collected from commercial establishments contained an average of less than 0.2 ppm PCB's, substantially below levels that would pose a risk to health. However, considerably higher levels of PCB's are being detected in various species of freshwater fish-- particularly sport:,fish, e.g., coho and Chinook salmon, lake trout--fen sev eral areas in the United States. FDA is currently developing information to de termine the exact extent of the problem. The jurisdiction of FDA extends only to food in interstate commerce. For this reason, the agency cannot control direct ly sportsfishing or the consumption of PCB-contamlnated fish, unless such fish are being sold or shipped in interstate commerce. Nonetheless, the Commission er is concerned about the public health implications for sportsfishermen and others who may regularly consume fish that are caught from PCB-contammated waters. PCB Contamination of Fish in Certain ' _ New York State Waters On October 9, 1975, the New York De partment of Environmental Conserva tion formally sought the support of FDA with respect to specific actions it con templated to limit the consumption of PCB-conlaminated fish. This request by the Department was based on its finding that various fish species caught in the Hudson River and two species of salmon caught in Lake Ontario contained levels of PCB's well In excess of the FDA toler ance of 5 ppm. Specifically, the New York Department of Environmental Con servation was considering the following actions: . FEDERAL REGISTER, VOL. 41, NO. 39--THURSDAY1, FEBRUARY 76, 1976 DSW 323563 STLCOPCB4075211 8410 NOTICES 1. Banning all commercial fishing In final regulations on PCB's and in more ports were formally presented at the Na ' the Hudson River; recent statements by agency officials tional Conference on PCB's (Ref. 8). Tin 2. Advising the public not to consume (Refs. 5 and 6) supports the conclusion purpose of the FDA evaluation will be t< i. fish from the Hudson River and salmon tii at frequent consumption of fish con determine if the information containec from Lake Ontario: and taining PCB's above 5 ppm poses a risk in these reports indicates that a reassess - 3. Seizing any Hudson River fish in to public health. Therefore, on February' ment of the temporary tolerances is war intrastate commerce that contain PCB's 11, 1976 the Commissioner advised the ranted. As part of its current activities in excess of the 5 ppm temporary toler ance. On October 20. 1975, the New York Department of Environmental Conser State of New York that FDA fully sup ports the remaining proposals of the De partment of Environmental Conserva tion. Specifically, the Commissioner con the agency is also gathering and review ing data from different sources on tlu extent to which FCB's occur in fish anc other foods. This information is needed vation was informed that FDA would curs with the State of New York in its since section 406 of the act requires ai- initiate seizure of interstate shipm5nts proposals to: assessment of the impact on both human of fish found to exceed the temporary 1. Ban commercial fishing, except for health and the food supply that would tolerance and would support the State shad, from the Hudson River at or south result from any lowering of the current in taking similar action against intra of Fort Edward. temporary tolerances. Ii ! state shipments. The State was also ad vised that FDA would need to evaluate fully the results of surveys of fish taken from the Hudson River and Lake Ontario before it could determine the appro priateness of the other suggested actions. At that time, surveys were still being conducted by the State and by FDA: Subsequently, data from these surveys were submitted and have been evaluated by FDA (Ref. 4). The samples from the Hudson River included 17 species of fish collected from 18 points on the Hudson River between ' Glens Falls and Alpine, with 13 samples being collected at Glens Falls and 68 samples below Glens Falls. In summary, 2. Advise sportsfishermen and other persons not affected by the ban to restrict their intake of fish caught from these waters and to restrict their intake of salmon caught from Lake Ontario. When implemented, these actions will effectively eliminate the possibility that commercial fish contaminated with PCB's will enter interstate or intrastate commerce from these waters. An advisory to sportsfishermen and others who con sume fish caught from these waters is essential to alert them to the potential hazard of -consuming such fish, and is necessary since a" ban on commercial fishing does not directly protect such in dividuals. Should additional regulatory Additionally, on November 21, 1975 ths Environmental Defense Fund and the National Resources Defense Council pe titioned FDA to reduce gradually all the temporary tolerances for PCB's in foot to zero. This petition and supporting in formation will be given full consideratior and are Included In the current reviev. activities of the agency. If, on the basis of these reviews, lower ing any of the temporary tolerances i; warranted, the Commissioner will issue a proposal to amend the existing PCE regulations in the Federal Register, anc allow time for public comment prior tc implementing any revision. this evaluation showed that 53 out of actions become necessary in the future, References { i the 68 samples of fish collected at or below Fort Edward (approximately 7 miles below Glens Falls) contained PCB's in excess of 5 ppm. The average level of PCB contamination in these 68 samples was 31.3 ppm. In contrast, only trace levels were found in the 13 samples FDA will promptly take all appropriate steps, consistent with its statutory au thority. to protect the public from PCBcontaminated fish. Additionally, the State of New York plans to monitor closely the 1976 spring run of shad to determine what additional action may be A copy of each reference document is on file with the Hearing Clerk, Food and Drug Administration, Em. 4-65, 5600 Fishers Lane, Rockville, MD 20852, and may be seen during working hours, Mon day through Friday. obtained at Glens Falls. A high propor tion of flnfish and eels from all sampling points below Glens Falls contained PCB levels in excess of 5 ppm. The Fort Ed reauired for this species of Hudson River fish. The presence of significant levels of PCB's in freshwater fish is caused by the 1. World Health Organization, Interna tional Agency for Research on Cancer. "IARC Monographs on the Evaluation of Carcino genic Risk of Chemicals to Man," Vol. 7, 1974. 2. Statement by Russell R. Train. Adminis ward sampling point had the highest continued industrial discharge and dis trator, Environmental Protection Agency, at levels for the species examined, with in posal of PCB's Into the environment. The a Press Conference on PCB's. Monday, De i dividual samples ranging from 20.1 to 178 ppm. Twenty-eight of the 33 samples of coho and Chinook salmon from Lake Ontario exceeded 5 ppm, with a range from 2.1 ppm to 24.6 ppm. Of the 4 Commissioner emphasizes that the con tamination of fish with PCB's will persist unless controls are initiated to curtail pollution of the environment with PCB's. The Commissioner has, therefore, as sured the Environmental Protection cember 22,1975, Washington, DC. 3. "Levels of PCB's In the TJS. Food Sup ply," C. F. Jelinek and P. E. Corneliussen. Bureau of Foods, Food and Drug Adminis tration, November 25, 1975. 4. "Polychlorinated Biphenyls Residues In Fish from Lake Ontario and the Hudson samples of lake trout tested, results were in the range of 10 to 15 ppm. All other species of fish sampled from Lake Ontario were at 5 ppm or less PCB's. As a result of these findings, the Commlssioner has concluded that fish caught In the Hudson River south of Fort Ed ward are likely to contain excessive levels of PCB's. Similarly, coho and Chinook salmon caught in Lake Ontario are likely Agency (EPA) that the full scientific re sources of FDA continue to be available to assist in that agency's efforts to con trol PCB discharges. Similarly, FDA has provided, and will continue to provide, the full range of its scientific expertise in support of individual State actions aimed at controlling Industrial pollution of the environment with PCB's (Refs. 5 and 6). River," Bureau of Foods. Food and Drug Ad ministration, December 17.1975. 6. Testimony of Albert C. Kolbye, Bureau of Foods, Food and Drug Administration, before the Department of Environmental Conservation, State of New York, October 17, 1975. 6. Testimony of Henry Roberts, Minne apolis District Office. Focd and Drug Admin istration, before the Department of Natural Resources, State of Wisconsin, August 28. to contain excessive levels of PCB's. Since Status op Temporary Tolerances 1975. there are no data on current levels of For PCB's in Food 7. "FDA Regulation of PCB's In Food," PCB's in shad caught in the Hudson The preamble to the regulations on John R. Wcssel. Office of the Associate Com i , River, FDA is unable to make any conclu PCB's in the July 6, 1973 Federal Regis missioner for Compliance, Food and Drug sions about PCB contamination of that ter states that FDA will periodically re Administration, November 21,1975. t fish at this time. However, data obtained view and evaluate the appropriateness of 8. "Health Effects and Human Exposure." by the State of New York for past years, the temporary tolerances for PCB's. On Session I of the National Conference on while limited, indicate that shad may November 21, 1975, ft was announced PCB's, November 19 through 21. 1975. Chi contain relatively low levels of PCB's. (Ref. 7) at the National Conference on cago. Illinois. There are insufficient samples to make PCB's sponsored by EPA that FDA had any valid conclusions about lake trout initiated such a review. The scope of this Dated: February 12.1976. caught in Lake Ontario at this time. review includes an ln-depth evaluation A. M. Schmidt, The scientific evidence described in of recent scientific reports on various as Commissioner of Food and Drugs. the preamble to the July 6, 1973 FDA pects of the toxicity of PCB's. These re |FR DOC.76-46GG Filed 2-23-76:2:38 pm] FEDERAl REGISTER, VOl. 41, NO. 39--THURSDAY, FEBRUARY 26, 1976 DSW 323564 STLCOPCB4075212