Document 15eDMQKyLkvRQqdpV1NdzMYjo

(Zp S. P. Wheeler December 23, 1968 Bran Oil Poisoning by Kaneclor Your memo December 9, 1968 D. A. Olson W. R. Richards P. C. Benignus D. Roush I think the following consents are pertinent with regard to the recent Incident in Japan: 1. In the U. 3. the only "hygienic regulations" referring to chlorinated biphenyls are the Threshold Limit Values (TLV) for Aroclore 1242 and 125&. The values are 1.0 mg/ cubic meter of air and 0.5 og/M-*, respectively. These limits have been set by the American Conference of Governmental Industrial Hygienists, a quasi-official group with no legal authority for establishing federal standards. These levels are time weighted averages deemed to be safe for 8-hour daily exposures In industry for a lifetime of work. Although they are intended as guidelines, a number of Individual states have considered the TLVs as appropriate for adoption in state codes and regulations. Furthar, by reference, the TLYs can be enforced by the 0. S. Department of Labor in industrial plants subject to the Walsh-Healey contract act. 2. There are no regulations concerning the Aroclors in applications where there might be oral ingestion of these materials. For example, there are no direct food additive or indirect food additive uses approved by the Food and Drug Administration. To our knowledge none of Monsanto1s customers have applied for a petition for regulations permitting such use although currently a petition .'for the use of Aroclor 5^60 in adhesives for food packages is in development. Similarly there have been no applications In the pesticides field where the U. S. Department of Agriculture would have to be consulted. In the absence of prospective uses which would require such governmental clearances, there has been no incentive to undertake the extensive animal toxicity studies which would provlds data necessary for establishing a human diet tolerance. Dsw 312321 STLCOPCB4072307 D. A. Olson -2- Deeembar 23# 1968 i 3. If there were extensive animal toxicity data available, I do not believe the Pood and Drus Administration would set o tolerance level in foods whore the presence of the chlorinated biphenyl re salted in-om leakage from a heat transfer system. Such presence, v/ould result from leakage or other accidental contamination and would not be accepted as Icing "necessary"- or adding anything beneficial to a food grade substance. . . I don't know of any U. S. regulations which give either the Pood and Drug Administration or the Department of Agriculture approval authority for heat transfer materials. Obviously, the food end drug agencies have the general, authority to conch .an and seise food products that are ''adulterated'' or "contaminated''. It is on this basis that the Medical Department ha3 stated that any cooking oil or other food product containing more than '.'0 pom" should be destroyed . . if the manufacturer or processor of the food product is to avoid government action. 4. The data or literature concerning effects of chlorinated biphenyls cn humans relate only to excessive vapor inhalation or excessive skin, exposures. It is not possible - at this point to extrapolate from any of the animal t cod city data or human accidental exposures to a "safe" ingestion level for humans. 5. The chlorinated biphenyls are not "poisons" or"drugs". There are a number of definitions in the U. S. relating to the classification of industrial chemicals and household products. Included are definitions of the Interstate Commerce Commission, the Federal Hazardous Substances Labeling Act, the National Safety Council recommendations, etc*. Each of these establishes levels of toxicity and poison categories by the results of specific animal tests. The chlorinated biphenyls v/ould not be classed as '-poisons" by any of these definitions. They v/ould be considered "toxic" but no more co than many common industrial chemicals and, as a matter of fact, many formulated products used around the home. OS'N STLCOPCB4072308 '0. A. Olson -3- December 23, 1968 I don't know how much of the above will help In the situation in Japan but I leave it to your judgetsent as to what should be forwarded. Elmer P. Wheeler cs I DSW 312323 STLCOPCB4072309