Document VJyKaBoxwrqOj0zwZqwvodBLq

ws November 23, 1970 Page S FOOD CHEMICAL NEWS In addition to instituting the new relationships between Washington and 0 Hile's group is working on possible ways to improve FDA's field operatior pilot test in the field, slated to last from 6 to 9 months, will test c nt apaches to inspection, sample collection, and analysis -- with 1 ope that ted jues can be formalized into a national approach. The tests ma rolve giv emphasis to certain critical areas in specific segments of ij^n , or to cei ideographical areas. FDA-ers M > that the pilot test will lead to conclusions ab of plants an ^products, and about the kinds of attention na segments of Si^jistry. random sampling i by specific Hile's staffers will institute an 8 or 9 month fie|ef test of statistical analytical methods to determfl||kwhether FDA is successful in^Pffecting changes in' specific situations. Such an^Haproach was recommended a study of FDA's field opera tions by Booz, Allen <S8Jyiinilton, and a pilot tert has been conducted. FDA STUDYING ECONOMIC IMPAC^N INDUSTRY -The FoocT arid'Drug'Admjtnisfrations /the economic impact of agency reatingLlaXLs on industry^ ^rlU'S^Uptrto^eterurU'i,^ 0 FDA decisions are not base#lipon econom^ponsiderations, FDA-ers say, but they add that industry economics should be understood by the agency. Knowledge of where the regulated industries are going ec^gmically would help FDA to do a more effective job, jpgency spokesmen say. The survey is als*rexpected to cover such subjects a.-.the number and location of plants, and r$&y have a bearing on FDA planning of inspections. Another benefit seen by FDA-ffl's from the economic study of industry woulctjDe in budget justifications The new Industry Economics Unit will be headed by David B. Dfcjrsey, assistant to FDA Deputy Commissioner James Grant. Before joining FDA, Sl&rsey was in Allied^hemical's Office of International Finance. Working with hiafeds William McV#dkers, who was formerly in the Chemical Division of the Comme^|JDepart- t's Bureau of Defense Services Administration. A third economist is ejected be added to the Unit. f^ECTO SURVEY FOR PCB'S IN FOOD rr=r------- -------:------ ------ ------- --------- The Food and Drug Administration has asked its 17 District Offices to survey food commodities that ha/ e the potential for contamination by polychlorinated biphenyls ,j with particular emphasis oh fluid mi qSNN 552s05 STLCOPCB4090922 Page 6 November 23, 1970 FOOD CHEMICAL NEWS FDA-ers have been expressing concern about possible environmental contamination from industrial chemicals, including PCBs (See FOOD CHEMICAL NEWS, Oct. 19, Page 3), and have been planning new programs to gather information on a number of chemicals. The PCB directive, which is identified as an addendum to the agency's pesticide program, is a surveillance operation, which is aimed prinClpally~at~obtaining lnfor^- fnatforf,'buOt^does not'preclude' regulatory followup J - ** - - . ---- ------- -V - - FDA issued special instrugjdcms on the_number of fluid milk samples it wanted covered in the program, pther commodities^ which FDA said are to be included in the Districts1 regular survey coverage of pesticides on a planned basis, that , will be analyzed for PCBsdnclude'manufacturecr'clairy products, fish, animal feed's^ | (norr-medicateciT'partrcularly those with fishmeal components), shell eggs, and.; any others where the Districts feel there is information of potential contamination with PCBs. ; ; ' )A to Use Same Multiresidue Techniques Utilized for Qrqanochlorines FDA noted that the multiresidue methodology now used for organochlorine pesticides also detects PCBs, and ordered analyses conducted aTt*fhe same time for the PCBs. PCBs have been detected in foods (fish, milk, and eggs) as well as fish-eating birds and other wildlife, FDA told the field, noting, however, that thefexacTToutes j pFcontaminatiori are stiH"subjecdt6~sp_ecurationj Earlier this year, FDA issued informal guidelines to the field on PCBs as an aid to States that had encountered problems with contamination of food products (See FOOD CHEMICAL NEWS, July 20, Page 2). Noting that PCBs have been used as plasticizers, modifiers in paints, electrical insulators, lubricants, fire retardants, and in printing inks, textile dyes and transfer fluids, FDA speculated that some theories on the route of contamination poir to industrial wastes from plants using PCBs, leaching of PCB from plastic objects in waste disposal, and accidental uses of PCBs as solvents, for which they are not intended, such as vehicles for spray preparations. In one instance, FDA advised the field, the use of PCB in silo coatings has been correlated with the finding of residues in stored feeds and in the milk of dairy animals. -FDA noted that the PCBs are manufactured by Monsanto under the trade name? Arocror,~with differing physical properties. The agency said that the firm ha^ jeported that they have discontinued sale of-Aroclor for uses other than'those in "closed systems)} (See FOOD CHEMICAL NEWS ,'July 27',~Page 2)', a report? /the agency'said "has"notrbeerrvalidated'byTDAT"J 1 FDA said knowledge of the toxicity of PCBs is somewhat limited, but there is evidence which indicates that the chemical may increase the toxicity of pesticides, adding that investigations of the effects of PCB on growth, mortality, and repro duction are in progress, DSW 552506 STLCOPCB4090923 FDA LAWYER TAKES TOUGH STANCE ON FOOD VIOLATIONS d.n L. Gottlieb, Deputy Assistant General Counsel of the Department of Health, Edlmation and Welfare, recently attacked laxness in the food industry --Rising the j^gctre of criminal prosecutions at all management levels. j SpecifidSJy, Gottlieb attacked conditions in the food industry in Puerto Rico, at a Seminarlter Puerto Rican Food Industries held at San Juan (See FQ0D CHEMICAL NEWS, Novml6, Page 3). However, his remarks apparently werq'intended to apply to the food industry generally. / / The attorney, wh<3&Kandles Food and Drug Administration matters, said that when a food plant violati%i is found, the agency is often toldJ^we will clean-it up" and "But you know how. ha^l it is to get good people these/fays. " Gottlieb said: "How muchthougNL how much interest, hojtf much concern is given by people ik the food industry by the health and well being of'the astraiomical number^of people who rely I on them every day, thraktimes a da^Tfor sustenance, for life itself? In today's c^Hizatioj^ if the food industry doesn't do its job, the Natrai will starve. And if it does its job poorly, the Nation ma^^icken because of malnutri tion, or it will sicken becau#^Hkdisease, as a result of poor sanitation practice^which S^use, generate, and encourage the dissemination of harmr^organisms in the food. "There is no other skiSjle group that I can^ink of that has so frequent and sq^ferribly important contacri^with the whole population evenypfngle day of our lives, and^c a context in which we arj^o vulnerable "... howgifiuch solace will we, as a Nation, derlffe? out of the phrasjff,': 'I told them to keep the place clean' aiio^You ' know hdrhard it 1b to get good help today1 if half the country is doyjwith sickness due to Salmonella or other food bor conUBnination? " Gottlieb Jffged food companies to properly motivate their personnel "to BScome the kiiwof good people whose lack we lament ..." He added: "It musl obvicyfrs that if the workers see and feel that management doesn't really car^ wheeler or not the product is produced under sanitary conditions, certainly thl : care." DSW 552507 STLCOPCB4090924 Page 20 November 23, 1970 FOOD CHEMICAL NEWS J They are merely private scientific experts whose opinions form the factual basis for the agency's decision." j ^^ Meanwhile, BVM's newly created Division of Nutritional Sciences (See FOOD CHEMICAL NEWS, Nov. 9, Page 20) has begun as its first major project an efficacy review of low-level antibiotic combinations used for growth promotion that were not studied by the NAS-NRC panels. ; FDA has been following a policy of requiring that effectiveness of each ingredient in combinations be established before granting new approvals, and has applied the same criteria to fixed combinations evaluated by the NAS-NRC (See FOOD CHEMICAL NEWS, April 6, Page 8). The new review will probably result in requests to manufacturers to supply data for previously approved combinations showing that each of the antibiotics used has an additive effect. FDA has already asked for this type of information from producers of fixed combinations that have been reviewed by the NAS-NRC panels. ' i j Antibiotics will also be the subject of letters to manufacturers advising them that FDA does not have sufficient information on their use in liquid supplements. FDA has made a wide appeal to diethylstilbestrol producers and distributors to submit data showing that DES will be stable in liquid supplements under adverse conditions along with a request for submission of analytical methods for assaying DES liquid feed supplements and other data on safety and efficacy (See FOOD CHEMICAL NEWS, Nov. 9, Page 20). A second letter has gone to DES producers who haven't responded advising them that if the information isn't received within 60 days, FDA will have "to consider discontinuance of Form 1800's for medicated liquid feed supplements manufactured with your DES premix. " This same approach will be taken with the liquid antibiotics -- first a request for information followed by a warning that the Forms 1800 will be discontinued unless the requested safety and efficacy data iare submitted. ^GRDERE PC B ` S" OUT OF;PESTTCIDES~IFT 6~MONTHS~$ The~Department of Agriculture's PesticideXRegulatioh DivisibrThas ordered poly /chlorinated biphenyls and polychlorinated terphenyls out of-pesticide formulations^I 'either as active or inactive ingredients within six months. " The Food and Drug Administration recently ordered a study by its field offices to determine the extent of PCB contamination of food products (See story, Page 5). The PRD notice Oct. 29' pointed to the accumulating data on the chronid.toxicity of the chemicals to fish and birds and the potential contamination of the environ ment as the reason for the phasing out of their use in economic poisons, chief of which has been as extenders to prolong the persistence of pesticides. . DSW 552508 STLCOPCB4090925 Dvember 23, 1970- Page 21 FOOD CHEMICAL NEWS "Although the use of these chemicals in economic poisons is not considered an acute hazard to man or his environment," PRD said, "they do contribute to environ mental pollution," adding: "Any benefits derived from their use are outweighed by the resulting environmental contamination and the possible long range adverse effects on fish and wildlife, Therefore, the presence of these chemicals in economic poisons must be phased out." PRD said it believed that six months is a reasonable period of time within which formula changes could be made, and requested copies of the revised statement of composition of new formulas plus new labeling for'the affected products. PRD also corrected an earlier notice in which it said it "erroneously listed" piperor butoxide in a group of compounds requiring teratogenic studies (See FOOD CHEMIC1 NEWS, April 27, Page 6). This compound is one that requires further carcinogenic data, PRD said, "in order to properly evaluate its safety in view of current infor mation. " In the earlier announcement, PRD listed a number of pesticides requiring teratogenic or carcinogenic testing to continue current registrations. Meanwhile, Chairman Randolph (D-W. Va.) of the Senate Public Works Committee announced last week that his Committee would begin hearings Dec. 1 on the nomine tion of William D. Ruckelshaus, former Assistant Attorney General, as Administrate of the Environmental Protection Agency (See FOOD CHEMICAL NEWS, Nov. 9, Page 37). Randolph disclosed that his Committee had jurisdiction after conferences with Chairman Magnuson (D-Wash.) of the Commerce Committee and Chairman Jackson^ (D-Wash.) of the Interior Committee. Randolph invited the chairmen and the ranking minority members of those two committees plus the leaders from the Agri-i; culture and Labor and Public Welfare Committees to sit in on the Ruckelshaus nomination,! hearings. SENATE UNIT MOVES CPA TOWARD ENACTMENT The Democratic leadership in Congress is hoping to move legislation to establish a new Independent Consumer Protection Agency through both chambers by the first week of December. o> The Senate Commerce Committee Nov. 19 ordered Sen. Ribicoff's (D-Conn.) bill (S 4459) to the floor with minor modifications, which appear acceptable to the Government Operations Committee where the proposal originated (See FOOD CHEMICAL NEWS, Oct. 5, Page 16). DSW 552509 STLCOPCB4090926