Document mBMLdkR13wzQodwyDgdQ4Gb9O

December 1, 197 5 Pane 29 FOOD CHEMICAL NEWS There* seems to be some confusion about which products would remain under EPA control. Animal pesticides that do not clearly lit the definition of drug are still El'A's regulatory responsibility. There is also a difference of interpretation over which of the agencies; has regulatory responsibility for so-called "old drugs." KKEY PACKING POUND IN COMPLIANCE BY MPI COMPLIANCE STAFF A special review of Krey Pocking, also known as Kelly Foods, by the Compliance Staff of the Agriculture Department's Meat and Poultry Inspection Program, released last week, found that the firm lias corrected most of the deficiencies noted in on soil for report (See FOOD CHEMICAL NEWS, Nov. 17, Pago 35). In fact, the rcpoil concluded: "This plant, with minor exceptions has excellent foi mutation and thermal processing procedure:," which "for the most pen ` . . . uxeet ded the rcquiioments of the Federal MPI Regulations and Procedures." 'Tior.i Hit ovcia.1) appearance, the formulation, cooking, transporting, retooling, chilling, incubation and storage procedures were in accordance with the v.odUu piocodures described and recommended by the NCA (National Canncis Association)," the special review re port stated. The review of the pkc . by MFI's Compliance Staff was undertaken as a result of >\u euiliei rcpoil by Dr. J. C. Pruebu criticizing several of the firm's procedures. Tuo report said that "the deficiencies noted. . .had been corrected with roonmme`i<h>d chj.tii, piocc'dm cc and eonliols being implemented." I i A few of the deficiencies noted wei o not corrected, it stated. These included tin fact that no changes were made in the single bar spreader, and globe valves on vent lim s were not changed to gate valves. It was noted that MPI does not have requirements or specifications for either of these. The review ri port listed the deficiencies which wore corrected, including docunv .11<.- 1 ion of product preparation procedures; recordin j of initial tempo ulures and safi ue nd.-; against temperature variations; written out and uniform venting procedures; stric adherence to thermal pioeessiug procedures recommended by NCA; orderly main:* \><. c ol ran storage facilities? and installation of an air-vacuum type can cleaning devh (which, however, was not equipped with n malfunction alarm system, as recoi: rn d) It found that Kelly Foods had adequate product foimulalion cooking, Iranr porting, tilling and closing procedures; and had established incubation procedures and pr-vtnons for recalls. /*11/\C Kill) ON THREE FRONTS to induce ]Yolyclilorinalcd bjphcm^evels rcachcd a nrnr-fnvcr pitch la: i " ` with: (1) the tilinTTbl a ptM.'lUSn wjththc Food and Dilki j Administration to m dw HONS 032557 Page 30 December 1, 1975 FOOD CHEMICAL NEWS all tolerances for PCBs in foods; (?.) establishment of a Canadian guideline for PCBs in fish; and (3) introduction in Congress of a bill to ban all use of PCBs in the United States. The petition filed with TDA by the Environmental Defense Tund and the Natural Resources Defense Council (See FOOD CHEMICAL NEWS, Nov, 24, Page 2) would provide for a step-wise lowering of tolerances -- starting with fish -- until there are only zero tolerances for PCBs in foods. The two groups charged that FDA's current temporary tolerances "are completely Inadequate to protect human health and welfare." They said favorable action on the Joint petition "would significantly reduce human dietary exposure to PCBs.". Noting the reported carcinogenicity of PCBs, the groups said they are seek-ng "the establishment of a zero tolerance for. . .residues in food, to be achieved by means of a phased reduction to zero of appropriately set temporary tolerances." Conceding that a zero tolerance could not be established now "without condemning the nation's food supplies," EDF and NRDC said "that existing temporary tolerances can and should be substantially lowered immediately, to commence with a significant down ward revision in the tolerances for fish." The hazard from PCBs "is, of course, Increased if one considers the possibility of additive or synergistic toxicity with other fat soluble chemicals found in the same foods," the petitioners said. Avoiding specific tolerance level proposals, the two groups urge! that FDA use "the Mantel-Bryan or a comparable formula establishing risk probabilities for a carcinogen," with periodic downward revisions of the tolerances. The new, lower temporary tolerances, EDF and NRDC said, should be preceded in the regulations with the statement: "In keeping with the explicit legislative intent of 409 (the Food Additive Amendment.) of the Food, Drug and Cosmetic Act. . .to . prohibit carcinogenic food additives, and acting under the authority of 406. . .authorizing the establishment of tolerances for poisonous and deleterious substances in food, it is the express intention of the FDA progressively to reduce to zero tolerances permitted for PCB residues in food, downward revisions to occur as soon as is possible given the persistence of existing levels of PCBs in the environment The Canadian government announced that it had adopted a temporary enforcement guideline for PCBs in fish of 2 p.p.m., as expected (See TOOD CHEMICAL NEWS, Nov. 10, Page 39). In announcing the guideline, which is the first PCB limit established for fish in Canada, the Health Protection Branch of the Department of National Health and Welfare said that the decision was based on newly available toxicological data. It said the decision was made after consultation with Canada's Fisheries Inspection Branch. The U. S. tolcranc-o is 5 p.p.m. 032558 HONS December 1, 1975 Pago 3 I FOl'D CHEMICAL h . . S At tile recent National Conference on PCBs held In Chicago (See FOOD CHEMICAL NEWS, Nov. 24, Page 31), Canadian toxicologist Dr. D. L. Grant said that surveys of PCB residues in human adipose tissue conducted In Canada suggested that females have lower residues than males. He algo noted that residents of Central Canada (Manitoba and Saskatchewan) have lower levels than the rest of Canada and said that the majority of Canadians have an adipose tissue residue of 1-2 mg/kg. Grant not.ed that PCB residue In human milk of Ontario residents was found to be approxi mately 1 mg/kg fat. The bill introduced in th.e House (HR 10815) by Rep. Aspin (D-Wis.) called specliically for the prohibition of Introduction or delivery for introduction into commerce of the chemical compounds known as PCBs and was referred to the Committee on Interstate and Foreign Commerce. Aspin has been adding new sponsors to his proposal, and has introduced a number of Identical bills to ban PCBs. National Fisheries Institute Calls for Six Step Control for PCBs At a special night session of the PCB conference in Chicago, Lee J. Wed dig of the National Fisheries Institute, called for the following six steps to control the potential damage to the environment from continued use of PCBs: (1) A nationwide system for safe disposal of PCBs already in use; (2) passage of the Toxic Substances Control Act to avoid future problems with other chemicals; (3) retention of the FDA tolerance level for PCBs in fish at the present 5 p.p.m. , pending further investiga tion; (4) compensation to commercial fishermen whose livelihood is destroyed by prohibition of the sale of species of fish in which the level of PCBs exceeds the FDA tolerance: (5) Con gressional investigation of the Environmental Protection Agency to determine why EPA has net yet established effluent standards for PCB discharge despite a clear legal mandate to do so and (6) on immediate ban on further sale, production, importation, or recycling ol PCBs. Thomas J. Billy, Chief of the Fishery Products Inspection and Safety Division of the National Marine Fisheries Service, asked for a more conservative approach, saying: . t "We believe responsible regulatory action has been taken already to deal with the public health issue and we fully support the current 5 p.p.m. temporary tolerances for PCBs in fishery products. How ever, our concern is that certain information presented at this conference and other pressures could result in precipitous further regulatory actions that are not based upon the full and complete information necessary to justify actions." Billy said that no change in the present tolerance In fish should be contemplated until full consideration has been given to: (o) New, conclusive toxicological Information; (b) the role of the specific species in the diet; (cl probable fuither decreases in PCB levels over an extended period of time; (d) direct economic impact on the fishing industry as well as the overall economic impact, and (e) alternative government and Industry approaches for assuring consumer protection. MONS 032559 Page 32 December 1, 1975 FOOD CHEMICAL NEWS The Commerce Department official concluded: "There is a lock of recognition by some that an industry depends upon the natural resources we are discussing end we have imposed a serious problem on them that is not of their making. The seafood Industry is concerned about the safety of their products and have been and continue to be willing to take responsible actions to protect public health. "However, NMFS is concerned that the lessons from the past in over-regulating or implementing unnecessary regulatory actions will not be heeded." HEW Scientist Cites PCB Health Dangers; Independent Scientists Disagree Dec i edoi ' The mo:: t I I I HU The most serious charges leveled against PCBs as a danger to human health < uring the meeting came from Center for Disease Control scientist Dr, Renate Kimbrough, who documented studies indicating that long term exposure to PCBs in rodents produces "a tumorigenic response which consists of the development of atypical areas, neo plastic nodules and hepatocellular carcinoma." She said that based on these and other findings in experimental animals, ingestion of PCBs in humans must be curtailed. FDA's Associate Director for Sciences In the Bureau of Foods, Dr. Albert C. Kolbye, Jr., had cited Kimbrough's data on carcinogenicity in animals in testimony presented In New York during hearings on the General Electric Company's alleged violation of the Environmental Conservation Law of the State of New York. ~- Another speaker at the PCB conference, Dr. J. C, Calandra, Industrial Bio-Test Laboratories, noted that in a rat study conducted at his lab no evidence of hepatocellular carcinogenicity of the PCB-containing products tested was found. Calandra said that one of the scientists who evaluated the slides had re-evaluated the Kimbrough slic.es and did not agree with the reported findings. Dr. James R. Allen, ol the University of Wisconsin, reported that female rhesus monkeys exposed to dietary levels of 2.5 to 5.0 p.p.m. of PCB developed irregularities Of the menstrual cycles within 4 months. Allen said that after 6 months exposure, the animals were mated with control males . The University of Wisconsin pathologist summarized the results as follows: lx of the eight females on the 5.0 p.p.m. PCB diet conceived; the remaining two animals antinued to cycle and were mated five times without conceiving. Five of the six animals |dt conceived aborted or experienced early fetal resorption. Eight out of eight females on a 2.5 p.p.m. diet conceived. However, 3 of the 8 females did not carry their fetuses to tm. I i jo six Infants born to the PCB-fed females were small (350 vs 475 g) and disp, I areas ( culuneous hyporpigmentation. Skin biopsies obtained shortly after birth coni .d PCBs. a result of exposure to PCBs througliLi etating mothers, the PCB levels of the , .ants' (sues increased rapidly. Within 2 months the infants developed conjunctivitis, periorbital . ; ; , f" " MONS 032560 December 1, 1975 Page 33 FOOD CHEMICAL NEWS edema, loss of eyelashes and acne. Three infants expired within 4 months following birth. The surviving 3 animals were weaned and showed decreased severity of symptoms after 4 months on a milk supplement diet free of PCBs. Allen noted that in contrast to the severe effects of low PCB exposure experienced by female rhesus monkeys, male monkeys tolerated 5.0 p.p.m. PCBs as a dietary additive for one year without showing signs of severe intoxication. He pointed out that these males showed no reproductive abnormalities. RECALLS: MORE IMPORTED PIMIENTOS The Food and Drug Administration last week disclosed two more Class II "priority" recalls of piinlentos Imported from Spain because, of failure to control acidity in the canning process (See story. Page 22). Osage Brand Whole Plmientos were recalled by Cherokee Products Company, Haddock, Ga., from Alabama, Arkansas, Texas, Florida, Georgia, Pennsylvania, Missouri, Tennessee, Louisiana, New Hampshire, Massachusetts, Michigan, Minnesota, Wisconsin, Kansas, North Carolina, South Carolina, West Virginia, Virginia, California and Nevada. The institutional size cans were packed by Jose Maris Garcia Gomarlz, Murcia, Spain. Cherokee also recalled La Molinera Brand Choice Whole Sweet Red Pimientos from Michigan and North Carolina. The manufacturer was Hernandez Perez Hnos. S.R.C. Molina de Segura, Murcia, Spain. A criminal case was instituted by FDA against Hallam & Son, Inc. , Springfield, Mo., on grounds stored foods were held under Insanitary conditions and were rodent and/or insect contaminated. Meanwhile, Barton's Candy Corp. reassured its stockholders at a meeting alter the firm and Its president, George Klein, pleaded guilty to a one-count charge Involving Insect-contaminated flour. The firm announced that the bag of flour, delivered early last year, was found to be unfit for use, and "it wasn't used in the production of any of Barton's products." FDA recently seized: (1) fiozen salmon, in possession of Traco, Inc., Seattle, Wash., on grounds of decomposition; and (2) frozen pancakes, shipped by Juno Chefs, Inc., Brooklyn, N. Y. , on grounds they were held under insanitary conditions and were Insect and rodent contaminated. Renulatorv Letters Hit Product Labeling An FDA regulatory letter sent Nov. 11 to Edible Soy Products, Inc., Hudson, Iowa, said the product name Pro-Nuts was false and misleading "for a soybean product since it represents and suggests that the product Is a nut product." HONS 032561