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MCILWAIN v. HAYES

November 4, 1981

Wende McILWAIN, et al., Plaintiffs,
v.
Arthur Hull HAYES, Jr., Commissioner, Food and Drug Administration, Defendant



The opinion of the court was delivered by: FLANNERY

MEMORANDUM

This matter is before the court on cross-motions for summary judgment. Approximately four years ago, a similar group of plaintiffs *fn1" brought before this court a similar challenge to actions taken by the Commissioner of the Food and Drug Administration (hereinafter "FDA"). See Health Research Group v. Califano, No. 77-293 (Sept. 23, 1977) (memorandum opinion). At that time this court decided on the basis of both the administrative record before it and the broad discretion granted to the FDA by the statute that the Commissioner's actions were lawful and that the defendants were entitled to summary judgment. For the reasons discussed below, the result is the same in this case.

 FACTS

 Plaintiffs in this action seek declaratory and injunctive relief from certain actions taken by the FDA pursuant to the Color Additive Amendments. 21 U.S.C. § 376. In these Amendments Congress established two systems under which the FDA could list color additives for general use. First, and most important, Congress established the general rule that no color additive could be permanently listed for use unless it had been established, to the FDA's satisfaction, that the particular additive was safe. 21 U.S.C. §§ 376(a)&(b). This decision shifted the burden to industry to establish the safety of any additives proposed for use in the public at large. *fn2" 21 U.S.C. § 376(b). Second, recognizing the great amounts of time and effort required to establish safety and not wanting to deprive the public of the useful benefits of these additives *fn3" while waiting for industry to meet this burden, Congress provided a scheme for provisional listing which applied to all additives then in use that did not pose health risks. 21 U.S.C. § 376 (note-section 203(a)(1) (B)). Any such provisional listing was to last for two and one-half years, unless the Commissioner decided that an extension of the provisional listing was justified. Id. at section 203(a)(2). The Amendments gave the Commissioner broad discretion to grant extensions. Once the provisional listing for any given additive ends, then the FDA must decide whether the additive should be permanently listed. If industry cannot satisfy the burden of establishing the additive's safety at this point, then the additive will not be permanently listed and it will no longer be available for use.

 In the case at bar, plaintiffs specifically challenge the FDA's decision to extend, for varying amounts of time, *fn4" the provisional listings of twenty-three color additives. As a result of a number of previous FDA extensions of provisional listing status, the last of which was the extension challenged before this court four years ago, the provisional listings for all twenty-three of these additives was scheduled to end on January 31, 1981. After determining that a further extension of provisional listing was necessary to allow for both the completion of ongoing scientific testing and the evaluation of the data resulting therefrom, *fn5" the Commissioner on November 4, 1980, published a proposed rule in the Federal Register notifying the public that he intended to extend the provisional listings of these twenty-three additives beyond the January 31 closing date. 45 Fed. Reg. 75226 (1980).

 Comments on this proposal were received and evaluated by the FDA. After evaluating all the relevant evidence, a final notice of extension was to be promulgated and published by the FDA before the January 31 closing date; this never occurred, however, because on January 29, 1981, President Reagan issued a memorandum postponing the publication of all final rules for sixty days. See 46 Fed. Reg. 11227 (1981). Believing its final notice of extension to be prohibited by this memorandum, the FDA did not publish the final notice of extension until it received special clearance to do so from the Office of Management and Budget. As a result, the final rule extending the provisional listings for these twenty-three additives was not published until March 27, 1981, approximately two months after the closing date for the provisional listings. 46 Fed. Reg. 18954 (1981).

 DISCUSSION

 I. Effect of the Delay in Publishing the Final Notice of Extension

 
1) a provisional listing lasts until its closing date, unless the FDA postpones the closing date,
 
2) the closing date for the twenty-three provisional listings in this case was January 31, 1981,
 
3) no final notice of extension or postponement was published by the FDA prior to the closing date, hence the provisional listings for these twenty-three additives expired,
 
4) since the provisional listings expired, the color additives at issue could only be relisted for use on the basis of a permanent listing decision.

 As noted above, requiring the FDA to relist the additives according to "permanent listing" criteria would have a tremendous impact upon the ...


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