Document k63wYNJ2X9QNVn2r08xze5Xnb

JL ' November 23, 1970 o Utyv-rrcCrj-'i/a ) Page S FOOD CHEMICAL NEWS In addition to instituting the new relationships between Washington aftd the field, Hile's group is Working on possible ways to Improve FDA's field operations. A pilot test in the\fleld, slated to last from 6 to 9 months, will te^l different approaches to inspection, sample collection, and analysis -- with the hope that techniques can be formalized into a national approach. The tedts may Involve giving emphasis to certain critical areas in specific segments of industry, or to certain geographical\areas. / FDA-ers hope that thewilot test will lead to conclusioiyTabout 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/lleld test of statistical analytical methods to determine whether FDA is successfurln 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. FDA STUDYING ECONOMIC IMPACT ON INDUSTRY The Food and Drug Administration Wcreatlng an Industry Economics Unit to determine the economic impact of agency decisions on Industry. FDA decisions are not based uoon economic considerations, FDA-ers say, but they add that industry economics snould beVinderstood by the agency. Knowledge ' of where the regulated industries are going economically would help FDA to do a more effective job, agency spokesmenXsay. The survey is also expected to cover suchNsubJects as the number and location of plants, and may have a bearing on FDA planning of inspections. Another benefit seen by FDA-ers Irony :he 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 ChemicaTs Office of International Flnance\ Working with him is William McVlokers, wno was formerly in the Chemical Division of the Commerce Depart ment's Bureau of Defense Services Administration. \ A third economist is expected to be addea to the Unit. The Food and Drug Administration has aBked its 17 District Offices to survey food commodities that hor e the potential for contamination by polychlorinated biphenyls, MONS 03iiig Page 6 November 23, 1970 (J ) rOOD CHEMICAL NEWS TDA-ers have been expressing concern about possible environmental contamination from Industrial chemicals, including PCBs (See FOOD CHEMICAL NEWS, Oct. 19, Page 3), and have boon planning new programs to gather information on a number of chemicals. Vhe PCB directive, which is identified as an addendum to the agency's pesticide ^program, is a surveillance operation, which is aimed principally at obtaining Infor mation, but it (foes not preclude regulatory followup. . ........... j :. ^DA issued special Instructions on the number of fluid milk samples it wanted^ fevered in the programjj Other 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 PCBs include manufactured dairy product tl$h, `bnimal feedi (non-medlcated, particularly those with fishmeai'components), Ihell eggs', and ` ny otherfc Where the Districts feel there is information of potential contaminations -ith PCBsl FDA to Use Same Multiresidue Techniques Utilized for Organochlorines TDA noted that the multiresidue methodology now used for organochlorlne pesticides also detectsffcetffc, and ordered analyses conducted at the same time for the pcbV K<fes 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, TDA issued informal guidelines to the field on PCBs as an aid to States that had encountered problems with contamination of food products (See rOOD 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 point 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, TDA 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 has Pbjibrttod ItiH'they have dlaoonUnued^alelSf Aroelor lor uses Other thenthoaa Xlh "closed system!" (See rOOD CHEMICAL NEWS, July 27, Page 2), WretxSft HONS 032220 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. t November 23, 1970 Page 7 FOOD CHEMICAL NEWS TDA emphasized that the preliminary results of these studies are such that It Is Important to know how widespread PCB contamination may be. TDA LAWYER TAKES TOUGH STANCE ON FOOD VIOLATIONS Alvin L. Gottlleb^T'Beputy Assistant General Counsel oj'the Department of Health, Education and Welfare,, recently attacked laxness in the food Industry -- raising the spectre of crlmlnarprosecutlons at all management levels. Specifically, Gottlieb attacked conditions in the food industry In Puerto Rico, at a Seminar for Puerto Rican Pood Industries held at San Juan (See FOOD CHEMICAL NEWS, Nov. 16, Page 3). However, his remaps 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, theregenc/ 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 J^terest, 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 Naiion 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 Agenerate, and encourage the dissen/hation of harmful onjanlsms In (he 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 /ingle day of our lives, anpin a context In which we are /o vulnerable "... how mufch solace will we, as a Nation,\derive out of the phrases, 11 told them to keep the place clean' arid 'You ' know how ha/d it is to get good help today' if half the country is down with sickness due to Salmonella or otherfood borne contamlnat/on? " Gottlieb urged fo^d companies to properly motivate their personnel "to become the kind of good/people whose lack we lament ..." He added: "It must be obvious that lfAhe workers see and feel that management doesn't really care whether or noj the product is produced under sanitary conditions, certainly they won't care. HONS 032221