Document jgOrX6RN5Z6NVyxgELwkMpQwp

JAMES, R. PHELPS PAUL M. HYMAN ROBERT A. DORMER ROBERT T. ANGAROLA STEPHEN H. MCNAMARA ROGER C. THIES THOMAS SCARLETT JEFFREY N. GIBBS BRIAN J. DONATO FRANK J. SASINOWSKI DIANE B. McCOLL A. WES SIEGNER. JR. SAMIA N. RODRIGUEZ MARY BETH NERAAS BRIAN L. PENOLETON SUZAN ONEL ALAN G. MINSK GAL P. MIDDLEKAUFF KENNETH A. OLSEN LAW OFFICES Hyman, Phelps 8 McNamara, P. C. 700 THIRTEENTH STREET, N. W. SUITE 1200 WASHINGTON, D. C. 20005 RECEIVED OCT 2 0 1993 CJOSEPHSTfltflHINDERER C, JOSEPH STI OF COUNSEL HYMAN. PHELPS & MCNAMARA TELEPHONE 12021 737-5600 FACSIMILE 12021 737-9329 IRVINE. CALIFORNIA 92 714 TELEPHONE 17141 553-7400 FACSIMILE 1714) 553- 7433 October 15, 1993 DIRECT DIAL 12021 737 4289 Mary E. Schulz, Esq. Senior Environmental Counsel The BFGoodrich Company Law Department GEON Division 6100 Oak Tree Boulevard Independence, Ohio 44131 Dear Mary: On October 12, 1993, FDA finally published its proposed "threshold of regulation" policy for food packaging materials. 58 Fed. Reg. 52719. A copy of the Federal Register notice is enclosed for your review. The proposal closely follows the existing system for obtaining "no object" letters from FDA. Because of the Delaney Clause, the agency proposes to apply the threshold of regulation only to noncarcinogens. Materials with trace amounts of carcinogenic impurities would be eligible for the threshold of regulation only if two criteria are met: (1) the TD50 (the feeding dose that causes cancer in 50 percent of test animals) for the impurity is less than 6.25 mg per kg body weight per day, and (2) the chemical structure of the substance containing the impurity does not suggest potential carcinogenicity. This is similar to the "constituents" rationale used by FDA to approve color additives that are not themselves carcinogens, but that contain trace amounts of known carcinogenic impurities. See 58 Fed. Reg. at 52723; Scott v. FDA. 728 F.2d 322 (6th Cir. 1984) . FDA proposes a threshold limit of "dietary concentrations at or below 0.5 ppb, corresponding to dietary exposure levels at or below 1.5 micrograms/person/day." 58 Fed. Reg. at 52722. For currently-approved direct food additives, the agency would apply a dietary exposure limit of "less than 1 percent of the acceptable daily intake as determined by the safety data in the Food and Drug Administration files." 58 Fed. Reg. at 52723. KtCci * BFG52092 OCT 19 1993 1 21739001 Mary E. Schulz, Esq. October 15, 1993 Page 2 Hyman, Phelps 8 McNamara, P.C. In addition to formalizing the data for requesting exemption from regulation as a food additive, the proposed rule provides that FDA may on its own initiative reconsider its decision and withdraw an existing exemption. 58 Fed. Reg. at 52725. Perhaps most importantly, FDA proposes to make available to the public a list of the substances exempted from regulation as food additives. The list will disclose the name of the company that requested the exemption, the chemical name of substance (no reference to the trade name), and the specific use for which an exemption has been granted, including any limits on such use. The environmental assessment submitted with the exemption request will also be placed on public display. 58 Fed. Reg. at 52724. I recommend that BFGoodrich review the proposal to determine if any of the provisions are likely to present difficulties for any of the company's products. If so, BFGoodrich should consider submitting comments to the agency. The deadline for public comment is December 13, 1993. Best regards. Sincerely AWS/ljg Enclosure 0927.001.01 2173900Z l