Document dQeneLN8GOv66v3dX69e422N9

November 23, 1970 Page 5 FOOD CHEMICAL NEWS In addition to instituting the new relationships between Washington and thi eld. Hlle's group is working on possible ways to improve FDA's field operatloi Lpilot test in the field, slated to last from 6 to 9 months, will test difMInt saches to inspection, sample collection, and analysis -- with thOmope that tedBklques can be formalized into a national approach. The tests maylnvolve givlqkemphasis to certain critical areas in specific segments of ig^ustry, or to certa^beographlcal areas. FDA-ers that the pilot test will lead to conclusions abaft random sampling of plants anwroducts, and about the kinds of attention n^raed by specific segments of Skistry. Hile's staffers al^wlll institute an 8 or 9 month fleetest of statistical analytical methods to determ^kwhether FDA is successful inueffecting changes in'specific situations. Such an^^proach was recommended in a study of FDA's field opera- tions by Booz, Allen amilton, and a pilot tstdt has been conducted. FDA STUDYING ECONOMIC IMPACl */ JSTRY 'The FodtTShd 'Drug Artmt ntstratintrj||greatinn 'iW:IKaUItlV1BUtlilUlHiUSrUwitrtOrdetmiUliW /the economic .impact of agency difclsfltas on industry^ FDA decisions are not basedftipon econondl^ionslderatlons, FDA-ers say, but they add that Industry economise should be undentood by the agency. Knowledge of where the regulated Mnustrles are going ectn^gmically would help FDA to do a more effective job,jlgency spokesmen say. The survey is alsW'expected to cover such subjects alfc^he number and location of plants, and ibdy have a bearing on FDA planning of ireactions. Another benefit seen by FDA-Ws from the economic study of Industry woul&jpe in budget Justifications The new Iiyoustry Economics Unit will be headed by David B. D^fsey, assistant to FDA Deputy Commissioner James Grant. Before Joining FDA, ufcrsey was in AlHsAJmemical's Office of International Finance. Working with hiatus William McySflcers, who was formerly in the Chemical Division of the Commea^Depart- t's Bureau of Defense Services Administration. A third economist is eh&ected Tbe added to the Unit, .. ... I^PR~TO survey FOR PCB'S in food products! The Food and Drug Administration has asked its 17 District Offices to survey food commodities that hat e the potential for contamination by polychlorinated biphenyls, with particular emphasjs on fluld_mllkj| MONS 033705 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 eimed~prlriClpallyat-obtainlng lrtfoijffiatioh,'but it does n6t*prSCHiae~feguratofy followup j' ' FDA Issued special instructions on the number of fluid milk samples it wanted covered in the program. Qther~commodities[, which FDA said are to be included in the Districts' regular survey coverage of pesticides on a planned basis, that will be analyzed for PCBsdnclude'manufacturetFdairy products, fish, animal feedsj (nonwmedlc'ated7'partlCUlarly those with fishmeal components), shell eggs, and any others where the Districts feel there is information of potentlarcontamination with PCBs. . to Use Same Multiresidue Techniques Utilized for Oroanochlorlnes FDA noted that the multiresidue methodology now used for organochlorine pesticides also detects PCBs, and ordered analyses conducted at the 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 thefexact routes J pf"contamination are still~subJect't6_specul'atioig ' 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 (Sea 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 poln ! 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' Aroclor,'with differing physical properties. The agency said that the firm ha^ /sported that they have discontinued sale of Aroclor for uses other than those 'in "closed systems! (See FOOD CHEMICAL NEWS, July 27',`Page 2)`, a reportl ,/the agency said 11 ho S'not been-validated byTDA. "J -J 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. MONS 033706 FDA LAWYER TAKES TOUGH STANCE ON FOOD VIOLATIONS vin L. Gottlieb, Deputy Assistant General Counsel of the Department of Health, Edmatlon and Welfare, recently attacked laxness In the food Industry - -jdiainq the^bgctre of criminal prosecutions at all management levels. SpeclflcUy, Gottlieb attacked conditions In the food Industry In Puerto Rico, at a SemlnaMbr Puerto Rican Food Industries held at San Juan (See FQ0D CHEMICAL NEWS, Nov\l6, Page 3). However, his remarks apparently werr'lntended to apply to the food lnt^stry generally. / The attorney, whS^iandles Food and Drug Administration iters, said that when a food plant violates is found, the agency Is often told i will clean it up" and "But you know how had It Is to get good people these /ays " Gottlieb said: ' "How much thoug^k how much Interest, hqtf much concern Is given by people^k the food Industry yrthe health and well being of the astmomlcal numbeiVof people who rely on them every day, thraktlmes a da^f for sustenance, for life itself? In today's c^Uizatlcra7if the food industry doesn't do its Job, the Nat^nwrttl starve. And if it does its Job poorly, the Nation mawSlcken because of malnutri tion, or it will sicken because o^isease, as a result of poor sanitation practlce^vhlch o^uise, generate, and encourage the dissemlngpon of harm^Lorganisms in fhe food. "There is no other sMftle group that I can\ilnk of that has so frequent and s^irrlbly important contactwith the whole population evervJfmgle day of our lives, and\g a context in which we arwso vulnerable howsftuch solace will we, as a Nation, der^u out of the phrase^. 'I. told them to kee'p the place clean' aiS^You know hap hard It li to got good help today' if half tha Aumtry is doeflrwlth sickness due to Salmonella or other food bofl contamination? " GottliebaFged food companies to properly motivate their personnel "to Become the Urmol good people whose lack we lament ..." He added: "It musT obvi^p that if the workers see and feel that management doesn't really cari whether or not the product is produced under sanitary conditions, certainly thl w^'t care." HONS 033707 Page 20 November 23, 1970 FOOD CHEMICAL NEWS They are merely private scientific experts whose opinions form the factual basis for the agency's decision." 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. 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 diethylstllbestrol producers and distributors to submit data showing that DES will be stable in liquid supplements underadverse 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." til 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 'are submitted. rORDERS PCB'S OUT of; praTi<^ES7_iropNras-T[ The Department of Agriculture's Pesticldes'Regulation Division has ordered poly chlorinated biphenyls and polychlorinated terphenyls out of-pesticide formulations/ `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 produots (See story, Page 5). The PRD notice Oct. 29' pointed to the accumulating data on the chronic.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. . MONS 033708 ltovember 23, 1970 - Page 21 FOOD CHEMICAL NEWS "Although the use of these chemicals In economic poisons Is not considered an acute haeard 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 effeots 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" piperoni butoxide In a group of compounds requiring teratogenic studies (See FOOD CHEMICA , 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 teratogenii or carcinogenic testing to continue current registrations. 9 Meanwhile, Chairman Randolph (D-W, Va.) of the Senate Public Works Committee a announced last week that his Committee would begin hearings Dec. 1 on the nomiiw 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 Agrl- - ,, culture and Labor and Public Welfare Committees to sit in on the Ruckelshaus 1 nomination., hearings. SENATE UNIT MOVES CPA TOWARD ENACTMENT The Democratic leadership in Congress is hoping to move legislation to establish a naw Independent Consumer Protection Agency through both chambers by the first week of December. The Senate Commerce Committee Nov. 19 ordered Sen. Rlbicoffs (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). MONS 033 709