McIlwain v. Hayes, 81-2204

• Decision Date: 19 October 1982
• Docket Number: No. 81-2204,81-2204
• Citation: 690 F.2d 1041,223 U.S.App.D.C. 304
• Parties: Wende McILWAIN, et al., Appellants, v. Arthur Hull HAYES, Jr., Commissioner, Food and Drug Administration, et al.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 1041

690 F.2d 1041

223 U.S.App.D.C. 304

Wende McILWAIN, et al., Appellants, v. Arthur Hull HAYES, Jr., Commissioner, Food and Drug

Administration, et al.

No. 81-2204.

United States Court of Appeals, District of Columbia Circuit.

Argued May 25, 1982.

Decided Oct. 19, 1982.

Katherine A. Meyer with whom William B. Schultz, Washington, D.C., was on the brief for appellants.

Stephen F. Ross, Atty., Dept. of Justice, Washington, D.C., for appellee, Hayes, Com'r, Food and Drug Admin., John J. Powers, III and Mark C. Del Bianco, Attys., Dept. of Justice, Washington, D.C. and Donald O. Beers, Associate Chief Counsel, Food and Drug Admin., Rockville, Md., were on the brief, for appellee, Hayes, Com'r, Food and Drug Admin. Robert B. Nicholson, Atty., Dept. of Justice, Washington, D.C., also entered an appearance for appellee, Hayes, Com'r, Food and Drug Admin.

Robert M. Sussman, with whom Ellen J. Flannery, Washington, D.C., was on the brief, for appellee, Cosmetic, Toiletry and Fragrance Ass'n.

Thomas A. Guidoboni with whom Daniel R. Thompson and Mark W. Smith, Washington, D.C., were on the brief, for appellee, Certified Color Manufacturers' Ass'n.

Before MIKVA and BORK, Circuit Judges and JAMESON, ^* United States Senior District Judge for the District of Montana.

Opinion for the Court filed by Circuit Judge BORK.

Dissenting opinion filed by Circuit Judge MIKVA.

BORK, Circuit Judge:

Prior to 1960, color additives used in foods, drugs, and cosmetics could be marketed lawfully unless the Food and Drug Administration ("FDA") tested them and found them unsafe. Because of the FDA's limited resources, Congress believed this testing process likely to be unduly prolonged. In 1960, therefore, the Color Additive Amendments to the Food, Drug, and Cosmetic Act shifted the burden of testing and proof of safety to industry. A color additive is to be deemed unsafe unless industry proves its safety. Recognizing that this would take time with many commercially established additives, Congress provided a grace period of two and one-half years. Additives undergoing testing were to be provisionally listed as available for use. If proven safe, they were to be permanently listed. If not proven safe, the additives were, of course, to be removed from the market.

The present case involves a dispute over the extent and exercise of the power Congress gave the Commissioner of the FDA to postpone the time (the "closing date") by which proof of safety was to be required or the additive delisted and removed from the market. While some additives have been proven safe and permanently listed for use and others have not been proven safe and have been removed from the market, the twenty-three additives in question here have been on the market under provisional listings for over twenty years. The Commissioner of the FDA has repeatedly postponed the closing dates for proof of their safety. On November 4, 1980, the FDA published a proposed rule announcing an intention once more to postpone the closing dates from January 31, 1981, for periods ranging from one to three and one-half years for the various additives. Appellants challenge this latest round of postponements, contending that the Commissioner lacks the authority to keep drugs not yet proven safe on the market for so many years or that, if he has such authority, he has abused his discretion.

We hold that the Commissioner's latest extensions for proving the safety of these color additives are within his lawful authority and discretion. Undoubtedly, in 1960 many members of Congress anticipated that color additive testing would be completed more rapidly than has been the case with respect to some additives. Just as certainly, however, Congress foresaw that unavoidable delays were possible and provided a statutory mechanism for the Commissioner to cope with such problems. Most significantly, for the issues in this case, Congress provided no limit upon the number of times postponements could be made. The primary reason for the repeated postponements here is that testing technology has evolved and improved so rapidly that, by the time a color additive has been shown to be safe under one series of tests or is still undergoing testing, more sophisticated testing procedures have been devised and the Commissioner orders that the time-consuming testing process begin anew.

It is important to realize what "proving" safety necessarily means. A color additive is subjected to the best tests available and safety is assumed to be shown if no evidence of harm to health is found. We are informed by the Commissioner that no test data supplied so far indicate any problem with the safety of the twenty-three color additives involved here, and it is only the fact that new, more rigorous tests have since become available that makes it possible to say that these products have not yet been conclusively demonstrated to be safe. Under these circumstances, we think it both reasonable and within the express powers conferred upon him by Congress for the Commissioner to postpone the closing dates for the color additives in question. We therefore affirm the judgment of the district court.

Background

The Statutory and Administrative Framework

Under the 1960 Color Additive Amendments to the Food, Drug, and Cosmetic Act, a color additive is deemed unsafe unless and until the Commissioner permanently lists such additive by regulation upon a finding that it is safe for its intended use. 21 U.S.C. § 376(a) (1976). ¹ The burden rests with industry to test the color additive and establish its safety to the satisfaction of the Commissioner. 21 U.S.C. § 376(b). ²

Congress recognized that the necessary testing could not be done instantaneously and so provided a statutory mechanism for a transitional period. Commercially established color additives were permitted to remain on the market for two and one-half years while the industry completed safety testing. Should this period prove inadequate, section 203(a)(2) of the transitional provisions gave the Commissioner discretion to postpone, "from time to time," the closing date

with respect to a provisional listing ... for such period or periods as he finds necessary to carry out the purpose of this section, if in the (Commissioner's) judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive .... ³

In both 1971 and 1977 the Commissioner determined that scientific standards had changed sufficiently to require new tests although the tests already administered had produced no evidence of unsafety. These tests were the best available at the time they were mandated. In 1971, the Commissioner extended the provisional listings so that all ingested colors could be tested for teratology and reproduction effects. 36 Fed.Reg. 3806 (1971). Five years later the Commissioner found that chronic toxicity studies of thirty-one color additives performed in the 1960's were deficient when judged by the scientific standards of 1976. 41 Fed.Reg. 41,860, 41,863 (1976). He directed industry to conduct a second generation of chronic toxicity studies. 42 Fed.Reg. 6992 (1977).

The Commissioner stated that "(t)he available studies do not show any adverse effects associated with use of any of the 31 color additives under their intended conditions of use." 41 Fed.Reg. at 41,863. The inadequacies of the studies available in 1977, the Commissioner pointed out in the preamble to the proposed rule, were not "the result of inherent defects in the studies or failures to conduct them competently(,)" but rather were "attributable to the dynamic and ever-improving scientific techniques for testing" these color additives. Id. ⁴ He therefore postponed the closing dates for all of the twenty-three additives for nearly four years to January 31, 1981.

The regulations imposed upon industry and FDA alike the duties of conducting the necessary testing and data evaluation within strict time limits. ⁵ Acknowledging that these time limits would require both agency and industry to give the project the highest priority, the Commissioner declared:

In the unlikely event that unforeseen and unavoidable circumstances arise to make compliance with the requirements of the final regulation virtually impossible, the Commissioner will consider requests for brief extensions of the closing dates. The Commissioner cautions, however, that such requests will be considered only if "extraordinary circumstances" exist and maximum effort has been given to meeting the deadlines.

42 Fed.Reg. at 6998.

Some of the appellants in the present case brought a suit to challenge the Commissioner's 1977 decision to extend the closing dates, arguing that the transitional provisions authorized extensions only where necessary to complete on-going studies. The district court held the Commissioner's action to be well within his authority. Health Research Group v. Califano, Civ. Action No. 77-293 (D.D.C. Sept. 23, 1977). Plaintiffs withdrew their appeal after the FDA entered into a stipulation agreeing, among other things, to make available to the public progress reports, evaluations of such reports, and applications for extensions of closing dates.

The FDA now concedes that the studies the agency required industry to make could not be completed within the time period provided in 1977. Brief for Defendant-Appellee Hayes at 10. In early 1980, three industry sponsors, including the Certified Color Manufacturers Association ("CCMA") and the Cosmetics, Toiletry and Fragrance Association ("CTFA"), who are also appellees here, petitioned for further postponements. On November 14, 1980, the Commissioner proposed to postpone the closing dates of twenty-three color additives, citing four factors causing "unforeseen and unavoidable delays": (1) the additional time required for the approval of the...