Document x1xgE27NB0agEkEEgw8bE8zn6

V* Nt .'3, 1970 A r-. gt FOOD CHI ..tlo.i to institu ng the new relationships between Washington a.d .1 ( .ie s group is working on possible ways to improve FDA's field operation. A pilot test in the field, slated to last from 6 to 9 months, will test differen. approaches to inspection, sample collection, and analysis - - with the hope that techniques can be formalized into a national approach. The tests may Involve giving emphasis to certain critical areas in specific segments of industry, or to certain geographical areas. FDA-ers hope that the pilot test will lead to conclusions about random sampling of plants and products, and about the kinds of attention needed by specific ! segments of industry. Hile's staffers also will institute an 8 or 9 month field test of statistical analytical methods to determine whether FDA is successful in effecting changes in specific situations. Such an approach was recommended in a study of FDA's field opera tions by Booz, Allen & Hamilton, and a pilot test has been conducted. O FDA STUDYING ECONOMIC IMPACT ON INDUSTRY T' Food d Drug Administration is creating r.n Industry Economics Unit detenr 1! i}. >no :c impact of agency decisions in industry. FDA decisions are not based upon economic considerations, FDA-ers say, but they add that industry economics should be understood by the agency. Knowledge of where the regulated industries are going economically would help FDA to do a more effective Job, agency spokesmen say. The survey is also expected to cover such subjects as the number and location oi plants, and may have a bearing on FDA planning of inspections. Another benefit seen by FDA-ers from the economic study of industry would be in budget Justifications. The new Industry Economics Unit will be headed by David B. Dorsey, assistant to FDA Deputy Commissioner James Grant. Before joining FDA, Dorsey was in Allied Chemical's Office of International Finance. Working with him is William McVickers, who was formerly in the Chemical Division of the Commerce Depart ment's Bureau of Defense Services Administration. A third economist is expected to be added to the Unit. 9 0T' : : SURVEY FOR PCB'S IN FOOD PRODUCTS . The Food and Drug Administration has asked its 17 District Offices to survey fr _ o commodities that her e the potential for contamination by polychlorinated bipheny.s, with particular> phosfs~dri~nuiamilk) HONS 033687 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 principally at obtaining info;- mation, but it does not preclude regulatory follov.n:i . ' FDA issued special Instructions on the number of fluid milk samples it wanted covered in the program. Other commodiliesv which FDA said are to be included in the Districts' regular survey coverage oi pesticides on a planned basis, that will be analyzed for PCBs include manufactured dairy products, fish, anlmel feeds (non-medlcated, particularly those with fishmeal components), shell eggs ,,nd any others where the Districts feel there is information of potential contamination with PCBs. EBft. to Use Same Multiresidue Techniques Utilized for Oraanochlorines FDA noted that the multiresidue methodology now used for organochlorine pesticides else 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 the. exact routes of contamination are still subject to speculation? `~ 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 TOOD 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 A. transfer fluids, FDA speculated that some theories on the route of contamination point 1 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. V ' 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 FCBs are manufactured by Monsanto under the trade name Aroclor, with differing physical property's. The agency said that the firm has reported that they have discontinued sale of Aroclor for uses other than those 'in "C. rod systems'! (See FOOD CHEMICAL NEWS, July 27, Page 2), a report" rtht "rncy said "has not hern validated by TDA. - FDA aald knowledge of the toxicity of PCBs is somewhat limited, but there Is evidence which indlcetea 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. HONS 033688 November 23, 1970 Page 7 FOOD CHEMICAL NEWS TDA emphasized that the preliminary results of these studies are such that it f Is Important to know how widespread PCB contamination may be. j ______ t o =----------------------- FDA LAWYER TAKES TOUGH STANCE ON FOOD VIOLATIONS Alvin L. Gottlieb, Deputy Assistant General Counsel of the Department of Health, Education and Welfare, recently attacked laxness In the food Industry - - raising the spectre of criminal prosecutions at all management levels. Specifically, Gottlieb attacked conditions in the food industry in Puerto Rico, at a Seminar for Puerto Rican Food Industries held at San Juan (See FOOD CHEMICAL NEWS, Nov. 16, Page 3). However, his remarks apparently were intended to apply to the food Industry generally. The attorney, who handles Food and Drug Administration matters, said that when a food plant violation is found, the agency is often told "we will clean it up" and "But you know how hard it is to get good people these days." Gottlieb said: "How much thought, how much Interest, how much concern is given by people in the food industry to the health and well being of the astronomical numbers of people who rely on them every day, three times a day, for sustenance, for life itself? In today's civilization, if the food industry doesn't do its job, the Nation will starve. And if it does its job poorly, the Nation may sicken because of malnutri tion, or it will sicken because of disease, as a result of poor sanitation practices which cause, generate, and encourage the dissemination of harmful organisms in the food. "There is no other single group that I can think of that has so frequent and so terribly important contact with the whole population every single day of our lives, and in a context in which we are so vulnerable . . . "... how much solace will we, as a Nation, derive out of the phrases, 'I told them to keep the place clean' aiid 'You ' know how hard it is to get good help today' if half the country is down with sickness due to Salmonella or other food borne contamination? " , Gottlieb urged food companies to properly motivate their personnel "to become the kind of good people whose lack we lament ..." He added: "It must be obvious that if the workers see and feel that management doesn't really care whether or not the product is produced under sanitary conditions, certainly they won't care." HONS 033689