Document ppooqZy3LpgG8ognZMzb6JEwd

Page fl October 17, 1977 FOOD CHEMICAL NEWS T^Commissioner added; "Unlll we can generate a basic research^sl^lnfshment that prCJViti^sjiseful shortcuts to what Is now a hopelessly unimaginative and time consuming process-,-until we can rebuild and Improve ihe private-sector testing establishment, and untlf-we^can develop similar capabilities In the public sector to monitor and extend it, we wTiUopntlnue In the uncomfortable position of con stantly having to pick up the jsiece's"rath.erjhan preventing breakage," The Commissioner saicfmuch of the current regulator reXpm talk "amounts to a mindless request'to 'Make 'em go away,"' commenting; "BuTTo-go away would be to pretenc^tfat in the food supply there simply aren't any public costiPtjf jwiu^te actl^ltfT and that's not true. What we need is an TDA so well equipped, so wetK pfefc to offer advice, that unpleasant surprises don't ---------- ------------------T" RECONSIDERATION OF PCB TOLERANCES URGED .BECAUSE OF IBT QUESTIONS The Massachusetts Audubon Society has asked that the Food and Drug Administration "reconsider" Its proposed revised temporary tolerances for polychlorinated biphenyls because of questions raised about studies conducted by Industrial Bio-Test Labora tories (See FOOD CHEMICAL NEWS, March 28, Page 2). The Society, In letters to FDA and to the Environmental Protection Agency, urged ' that the temporarytolerance proposal be reconsidered and, "If Judged necessary," that TDA "propose new tolerances or ... re-open the matter for public comment." | The group said: "Although the discrepancies in the reports can be resolved only by a thorough re-examination of the pathological material, the data are already sufficient to show that the assumption of no-effect levels at 10 p.p.m., on which FDA's proposed temporary tolerances were based In 1973 and 1977, Is no longer tenable." The Society said "the IBT reports on toxicological studies with PCBs in rats and dogs contain discrepancies and inconsistencies which appear similar to those reported to have been Identified by FDA and EPA In IBT reports on tests with other chemicals," adding that "the data In the IBT reports give prlma facie evidence of toxic effects of PCBs In both rats and dogs at dietary levels as low as 1 p.p.m." Audubon's lan C. T, Nisbet said the 1973 temporary tolerances for PCBs were based "primarily on data from tests carried out at IBT," noting that the same data weie cited In FDA's 1977 proposal to reduce the toieiances, "and appear to be the primary toxi cological basis for the proposed tolerances." Nisbet said he has "reviewed the IRT experiments with PCBs, on behalf of EPA, and found discrepancies Similar to those reported to have been found in other IBT rcnoits." Saying that his "findings have been reviewed and accepted by the Administrator ot EPA," he wroLe that, "The raw data In the IBT reports show serious toxicological ef fects at dose levels at and below ihosc leportbd as 'no-effect* levels and uiih.-cd as such by EDA In establishing temporary tolerances. o HONS 000237