Court Opinion

ID: 9469804
Source: CourtListenerOpinion
Date Created: 2023-08-05 02:49:47.280176+00
Date Added: 2024-06-11T17:41:34.871569
License: Public Domain

MIKVA, Circuit Judge,
dissenting:
By 1960, Congress clearly was dissatisfied with the manner in which the Food and Drug Administration (FDA) was carrying out its mandate to regulate the use of color additives in foods, drugs, and cosmetics. The assignment of the burden of proof, requiring the FDA to show that an additive was unsafe before it could be removed from the market, had caused the law to become largely a dead letter. And so, in the Color Additive Amendments of 1960 (Amendments),1 Congress shifted the burden of testing color additives from the FDA to industry, forcing industry to prove each additive safe before the additive could be permanently listed and marketed. To manage the problem arising from those additives already on the market, Congress established a provisional listing program that was to end after the additive was proven safe or unsafe, or after a two and one-half year period, whichever came first. Only under exceptional circumstances was it anticipated that any additives already on the market would take more than two and one-half years to be proven safe or removed from the market. Indeed, the major factor that motivated Congress to enact the Amendments was the possibility that if the burden were not shifted, the FDA might take “as much as 20 years” to determine the safety of the existing additives. See infra text at 1050.
Some twenty-two years later, the majority is willing to let the FDA and industry go some more tortured miles to keep color additives that have not been proven safe on the market. The majority has ignored the fact that Congress has spoken on the subject and allows industry to capture in court a victory that it was denied in the legislative arena. The 1960 Color Additive Amendments have been made inoperative by judicial fiat. I dissent.
I. Statutory Framework
The discussion and holding in the majority opinion reveal a determined refusal to acknowledge the major change the Amendments wrought in the regulation of color additives. Prior to 1960, every additive was allowed to enter the market unless the FDA could establish that the additive was not harmless. As a means of consumer protection, this allocation of the burden of proof proved to be inadequate. S.Rep.No. 795, 86th Cong., 1st Sess. 3 (1959) (hereinafter “S.Rep.”); H.R.Rep.No. 1761, 86th Cong., 2d Sess. 8 (1960), U.S.Code Cong. & Admin. News, p. 2887 (hereinafter “H.R.Rep.”). Spot testing during the late 1950’s demonstrated that a number of additives on the market were not harmless and made clear the need for retesting. Limited in its resources, the FDA estimated that such a process, if it were to conduct the safety determinations itself, could take “as much as 20 years.” Color Additive Hearings on H.R. 7624 and S. 2197 Before the House Committee on Interstate and Foreign Commerce, 86th Cong., 2d Sess. 25 (1960) (hereinafter “Hearings"); S.Rep. at 4; H.R.Rep. at 8. Fearing that additional additives would eventually be found unsafe and that the public could be exposed to these additives for an extended period of time, Secretary Flemming of the Department of Health, Education and Welfare (HEW) agreed that Congress should change the law:
*1051The crux of the matter with respect to the deficiency in consumer protection under the law as it now stands is simply this: While the [color additives] now permitted were originally listed on the premise that they were “harmless,” our own retesting program — using newer scientific knowledge — has shown this premise to be false with respect to most of the colors retested so far. This makes it probable that the premise will also prove to be false on many of the remaining colors. Yet, under the present law, we must continue our tests and assume the burden of proving as to each listed color that it is not harmless before we can take that color off the permitted list. It would take many years for the Food and Drug Administration to complete this testing of the [color additives] now in use. This burden, it seems to us, properly belongs on those who manufacture the colors ....
Hearings at 39-40. See also S.Rep. at 3-4.
In the face of delayed identification and removal of the harmful additives, Congress chose not to wait “as much as 20 years” for the FDA to complete its testing. As Congressman Delaney, a principal sponsor of the Amendments, explained:
It is vitally important for the protection of the consumer that the producer of a dye be required to test it for safety before permitting its introduction into our foods, drugs, or cosmetics. The Food and Drug Administration simply does not have the facilities or the staff to test all the colors proposed for use. The Agency is now engaged in retesting coaltar dyes it cleared for use many years ago, and as a result of new and more sensitive testing procedures, a number of these dyes have been found to be harmful and have been removed from the approved list. FDA figures that it would take 20 years to complete the retesting program. During that time the public would have to run the risk of daily exposure to dyes which have not been clearly proven to be safe. This cannot be justified on any grounds.
106 Cong.Rec. 14350 (June 25,1960) (emphasis added).
As a consequence, Congress legislated to shift to industry the burden of proving each new additive to be safe. The question remained, however, how the additives already on the markets were to be treated. Although Congress wanted an “orderly transition” from the previous regulatory scheme to the new one, H.R.Rep. at 10, the desire for orderliness hardly constituted carte blanche approval of those additives that were already being marketed.
In fact, Congress expressly rejected industry’s request that existing additives be “grandfathered” into the law, see Hearings at 233, 546-47. Congress did so in spite of the fact that it had used such an approach in comparable licensing schemes for food additives and drugs. See generally 21 U.S.C. §§ 321(p)(l), (s)(4). The reason for this rejection is clear. There is a sharp distinction between food additives and drugs, which add either medicinal or nutritional value to a product, and color additives, which merely enhance the product’s appearance.2 As Congressman Delaney observed:
I can say that in the matter of color additives there is every reason why we should have a strong bill. Some food additives serve a useful purpose. They have helped develop and improve our food supply in many ways. However, color additives provide no nutrient value. They have no value at all, except so-called eye appeal. We should be particularly careful with them, therefore. They add nothing in any other way.
Hearings at 108.
Congress chose instead a two and one-half year transitional period — a choice that was deliberate and knowing as far as Congress was concerned. As the majority cor*1052rectly points out, Congress received much testimony on the appropriate length of time for these tests. Majority at 1047-1048. What the majority ignores, however, is the statement by Secretary Flemming summarizing the position of HEW in support of the bill and time frame chosen:
There was indication during the hearings that some believe the [Amendment] requires every additive to be tested for 7 years before a decision can be reached as to its safety. This is not correct.
Safety of a food additive is ordinarily determined by feeding the chemical to test animals for 2 years. This feeding period permits observations to be made on any changes in the test animal that would indicate any type of hazard, of which cancer is but one.
If the chemical passes the 2-year test, it may then be allowed in food. If it fails to pass because the 2-year test raises some question that still needs to be explored, then the decision as to whether further testing should be undertaken is an economic one to be reached by the promoter of the additive.

In the vast majority of cases the 2-year test permits a final decision on the chemical. But if it does not, public health considerations certainly would require that the chemical not be used until its safety is fully established.

Hearings at 503-04 (emphasis added).
Extensions of the two and one-half year statutory time period were expected to be infrequent and difficult to come by. Secretary Flemming made clear that any extensions were to be limited in nature:
There is no justification, from the point of view of the public interest, in driving either color manufacturers of food, drug, or cosmetic producers, dependent upon the use of color, out of business where the particular use of color involved is one which can safely, be admitted under proper conditions of use (including tolerance limitations and certification requirements) established by this Department. Hence, while, as a consumer protection agency, we are concerned first and foremost with the protection of consumer interests, equity to the commercial interests concerned is also a factor in the submission of this proposal. It should, however, be stressed in this connection that we could not agree to a dilution or relaxation of the limitations of the carefully designed transitional provisions of this bill with respect to color additives which have heretofore been in commercial use.
Hearings at 26 (emphasis added).
Accordingly, while Congress did not explicitly limit the number of extensions the Commissioner could grant, it agreed with the Secretary’s assessment and provided that an extension could be granted only if consistent with the public health, only pending completion of the necessary scientific investigations, and only if consistent with the good faith completion of such investigations as soon as reasonably practicable. Nowhere did Congress suggest that an extension should last for twenty years — the very time period used as the extremity requiring Congress to shift the testing burden to industry.
Although Congress did allow industry a grace period of two and one-half years, it explicitly stated that the transitional provisions were designed to provide for the use of existing additives only “on an interim basis for a reasonable period,” § 203(a)(1). While the majority insists that this case can be resolved on the basis of the plain meaning of the statute, it reads this phrase out of existence. What is “reasonable” must be determined in light of the entire statutory scheme. In this case Congress made the decision that a “reasonable period” was not, in general, any longer than two and one-half years. Moreover, in enacting the Amendments, Congress explicitly rejected a retesting program that could last “as much as 20 years” because it was “[unwilling] to allow widespread use of [color additives] in the absence of scientific information on the effect of these products on the human body.” Certified Color Manufacturers Ass’n v. Mathews, 543 F.2d 284, 287 (D.C. Cir.1976).
*1053II. Regulatory History
For twenty-two years, the twenty-three color additives at issue in this case have been used commercially notwithstanding the clear directive of Congress to the contrary. The majority admits this is a long time, but they hold that “[perfection is not a requirement of the statute.” Majority at 1049. Such a perception of “perfection” suggests that the court may not think this dispute as important as appellants or the Congress seem to believe. Indeed the majority suggests that appellants’ challenge is “little more than nitpicking.” One may marvel at the tolerance and patience that the majority exhibit toward the administrative process, but one equally must be dismayed at the short shrift given a clear legislative mandate.
At the time the Amendments were enacted in 1960, some eighty-four additives were currently being used in foods, drugs, and cosmetics and therefore were deemed provisionally listed. The safety of these eighty-four additives was still undetermined two and one-half years later, however, and, consequently, the closing dates were extended on January 11, 1963. From this first extension until February 4, 1977, the closing dates for each of the twenty-three additives at issue in this case were extended an additional twelve to sixteen times. The justification for these extensions was that additional time was needed to complete the scientific testing necessary to determine the additives’ safety. By 1977, only thirty-two additives had been removed from the provisional list — twenty having been permanently listed and the other twelve having been found unsafe.
In granting the 1977 extensions, the FDA Commissioner squarely confronted the question of whether the number of extensions to date was consistent with the congressional mandate. After conceding that “Congress probably did not anticipate in 1960 that color additives would be provisionally listed in 1976,” 42 Fed.Reg. 6992, 6993 (Feb. 4, 1977), the Commissioner stated that the 1977 extension should “close the books” on the matter. Id. at 6992. He stressed the fact that only in “extraordinary circumstances” would the time requirements be altered and that failure to comply with the prescribed time schedule would “result in termination of the provisional listing of the affected color additive.” Id. at 6995-96. The Commissioner asserted that the FDA’s review of the data and final determinations would be given the “highest priority” by the agency and stated that he expected industry to give the project the “same high priority.” Id. at 6998. He added:
[I]n 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.
Id. (emphasis added).
Notwithstanding those strong words uttered in 1977, the FDA has continued to kick the statutory scheme into perdition. In 1977, industry was able to push the deadline into 1981, and on March 27, 1981, in the decision under review here, the FDA Commissioner extended the extensions to 1984— an appropriate year indeed.
Conclusion
This charade of the regulation of color additives is a pungent example of the administrative process at its worst. Twenty-two years ago, Congress passed a statute saying that industry would have the burden of proving that color additives were safe. Over this twenty-two year period, the FDA has time after time extended the deadlines for industry to make its ease for existing color additives. By affirming the 1981 decision of the FDA Commissioner granting this latest extension, the majority of this court puts its imprimatur on this disgraceful track record.
It is quite likely that some of these additives cannot be shown to be safe. In fact, a preliminary study by the National Cancer *1054Institute concludes that Red Dye No. 9, still provisionally listed, is a carcinogen.3 Nevertheless, the majority’s decision today allows these additives to stay on the market long after Congress would have required industry to fish or cut bait. The majority tells the appellants not to seek a “perfect” result from the statute. The Court’s decision may well be the pluperfect result of contempt for the legislative process — a situation in which Congress speaks but the court spikes.

. Pub.L.No. 86-618, 74 Stat. 399. Title II, which deals with the transitional provisions at issue here, has not been codified. It is contained in the note following 21 U.S.C. § 376 (1976). Its principal section is section 203.

. The extremely limited value of color additives has also been recognized by the Supreme Court in Flemming v. Florida Citrus Exchange, 358 U.S. 153, 162, 79 S.Ct. 160, 166, 3 L.Ed.2d 188 (1958), and by this court in Certified Color Manufacturers Ass’n v. Mathews, 543 F.2d 284, 296 (D.C.Cir.1976).

. More recently, an industry-sponsored study of Blue Dye No. 2 has indicated that rats fed Blue Dye No. 2 have a “significant difference in incidence of brain neoplasms.” Washington Post, Sept. 24, 1982, at A16, col. 1. Although this study has not been confirmed, it demonstrates that the risks to consumers while these untested dyes remain on the market may be more than potential.