Letters We welcome letters from readers, particularly commentaries that reflect upon or take issue with material we have published. The writer's name, affiliation, address, and tele phone number should be included. Because of space limitations, letters are subject to abridgment. It's Delaney, It's De Minimis... TO THE EDITOR: I read with interest former FDA Chief Counsel Richard Cooper's article "Stretching Delaney Till It Breaks" (Regulation, November/ December 1985) describing the evolution of the agency's interpretation of the Delaney clause and other food safety laws as they relate to the regulation of possible carcinogens in the food supply. The bulk of the article represents a reasoned analysis of agency decisions and judicial interpretations spanning four administrations, acknowledging the relevance of increasing scientific sophistication in analytic methodology and the emergence of quantitative risk assessment techniques in what the author describes as "the rational elaboration of a major and sound approach to regulation," driven by scientific facts and progress. The logic of Mr. Cooper's analysis breaks down, however, in the conclusion that in considering a de minimis interpretation of the Delaney clause we may have crossed the line defining the limits of administrative discretion in interpreting a statute. First and foremost, the mission of the FDA, and the purpose of the food safety laws, is the protection of the public health, in this instance protecting the public from potential risks posed by the use of food and color additives. In carrying out this mission, our primary tools are scientific ones. After carefully reviewing all the data presented we must come to a conclusion as to the general safety and likely carcinogenic risk posed by an additive. Only if we can conclude as a matter of public health that the risk is so small as to be effectively no risk, and that the benefit to the public of prohibiting an additive's use is essentially nil, may we then conclude as a legal matter that the risk is de minimis with respect to the Delaney clause. To date, the FDA has tentatively invoked a de minimis interpretation Regulation in a single instance, the use of methylene chloride to decaffeinate coffee, a process that may result in minute amounts of residual methylene chloride in the finished product. The detailed rationale for that conclusion is set out in a Federal Register proposed rule open to public comment (50 FR 243, 5155151559), and is grounded on our best scientific assessment of exposure and potential risk. Even though all available human data and animal feeding studies showed no carcinogenic effects, agency scientists took an extremely conservative approach in assessing risk based on the most sensitive rodent inhalation study, and then evalu 2 SEPTEMBER OCTOBER 1986, REGULATION ated likely exposures to small but detectable residues of methylene chloride now permitted in coffee. We concluded that the risk, if any, is essentially nonexistent. In short, a de minimis interpretation is not in any meaningful sense different from a "no risk" standard. An extremely conservative lifetime risk estimate, for example on the order of one-in-a-million-a theoretical maximum risk, not an actuarial risk-is not zero, but is so small as to be indistinguishable from no risk for any prac tical, public health purpose. If that were not so, I would agree with Mr. Cooper's assertion that the de minimis interpretation should not be adopted without legislative authorization. Mr. Cooper criticizes the FDA primarily for exceeding his view of the limits of its institutional authority as part of the executive branch. Yet the de minimis concept is a well-accepted principle of statutory interpretation applied over the years to many statutes, including those designed to protect the public health, and it always has the effect of introducing some limited degree of flexibility when a law appears absolute on its face, but no statutory purpose or gain to the public would be achieved by interpreting it liter ally. In this respect, the de minimis principle is no different from the other interpretations described in Mr. Cooper's article, which he be lieves were justified. According to the article, there is a "settled understanding" that the Delaney clause was intended to permit no risk of human cancer from food additives. It is certainly debatable that everyone knowl edgeable about the Delaney clause and its history believes that the provision is literally absolute. It is not the rule in any event that a law widely understood to have particu lar meaning can never be further interpreted administratively, and the courts have held that changing circumstances (e.g., the development of new knowledge) since enactment may be taken into account. The article gives several examples of interpretations that represented departures from what had been the "settled understanding," but Mr. Cooper apparently views them as part of the "rational elaboration" of policy. Should we have awaited express authorization from Congress? Although it may be most clear cut and inarguable to insist on specific legislative action to codify an agen cy's interpretation of any statute, the potential of getting the law amended should not be a justification for inaction in the face of problems that must be addressed. I am persuaded that the de minimis interpretation is a rational approach to applying the Delaney clause in modern circumstances consistent with the latest scientific knowledge. Adopting a de minimis interpretation will permit FDA to reach sensible results that take into account the paramount concern for protecting the public against the risk of cancer. Certainly it will not expose the public to greater risk than did the other decisions described in Mr. Cooper's article. There are no losers when a federal agency acts sensibly, based on the relevant science and in light of established judicial precedent. Frank E. Young, M.D., Ph.D. Commissioner Food and Drug Administration Washington, D.C. DELANEY CLAUSE Mr. ROBINSON. What is your present view of problems involving the present language of the Delaney Clause? Has it been possible to refine the administrative interpretations of the statutory language to any useful extent, or are your problems dependent on relief from legislative actions? Dr. HAYES. It is clear that the Delaney Clause has become increasingly controversial in recent years. It is also clear that the ability of scientists to detect low levels of carcinogens is much greater today that it was when the Delaney Clause was enacted. In addition, it is claimed that science now has a greater ability to de termine the significance to humans of data showing that some substances cause cancer in animals. Ideas for modifying the agency's traditional administrative interpretations of the Delaney Clause are presently under consideration, but as of this moment, no final decision has been made concerning any of the options under consideration. An Advance Notice concerning a new risk assessment approach to trace carcinogenic constituents of food and color additives, including food packaging, has been developed and will be published in the near future. It should be pointed out that changes in administrative interpretation, while they may affect the nature and extent of the way in which the Delaney Clause is applied, cannot render the Delaney Clause null and void. In other words, FDA cannot change the fact that the statute prohibits the FDA from approving as a food or color additive a substance that causes cancer in man or animal upon ingestion. Therefore, if basic changes in policy are thought to be necssary, legislation will be needed. We are in the process of considering options for possible legislative proposals. DEPARTMENT OF HEALTH & HUMAN SERVICES February 10, 1987 Office of the Secretary Office of the General Counsel NOTE TO TOM SCARLETT - - So far as I can tell my search this morning was not exhaustive FDA has treated the phrase "induces cancer" as meaning "produces" or "causes" the disease, with credible evidence of a statistically significant increase in tumors in treated animals versus controls generally being sufficient to show that a compound "induces cancer. See, for example, the various SOM FR notices. That treatment doesn't appear to have been the result of extended consideration, perhaps because the agency never had occasion to focus on the phrase "induces cancer, perhaps because the phrase does not seem to leave much room to maneuver. Nothing in the Commissioner's DES Decision (44 FR 54852; Sept. 21, 1979), in the final rule permanently listing lead acetate (45 FR 72112; Oct. 31, 1980), or in the final rules, terminating the provisional listings of Orange 17 (48 FR 13976; Apr. 1, 1983) and Red 19 for ingested uses (48 FR 5264; Feb. 4, 1983), suggests a different view of the meaning of "induces cancer, for example, that a compound that poses a de minimis risk of cancer doesn't "induce" cancer at all. That interpretation is hinted at in CTFA's comments in the methylene chloride proceeding. A copy of the relevant pages from CTFA's comments is attached. Mik 2. Michael M. Landa CC: Geyer, Der fler 226 Federal Register / Vol. 48. No. 64 / Friday, April 1, 1983 / Notices [Docket Nos. 761-0386 and 83C-4102) Color Additives; Denial of Petition for AGENCY: Food and Drug Administration. SUMMARY: The Food and Drug Administration (FDA) is denying that portion of a color additive petition (CAP 9C0000) that requests the "permanent” listing of D&C Orange No. 17 as a color additive for use in ingested drugs and cosmetics. FDA is taking this action because of evidence indicating that this color additive is an animal carcinogen. Published elsewhere in this issue of the Federal Register is a document announcing the expiration of the provisional listing of D&C Orange No. 17 for use in ingested drugs and cosmetics. FDA also is announcing the withdrawal of that portion of the petition that requested the listing of this color additive for use in cosmetics intended for use in the area of the eye. The portion of the petition requesting the permanent listing of D&C Orange No. 17 for coloring external drugs and cosmetics is still under consideration. and the color additive will remain provisionally listed for external drug and cosmetic uses until the agency completes its evaluation of the data on the external uses. Published elsewhere in this issue of the Federal Register is a regulation extending the provisional listing of D&C Orange No. 17 for use in externally applied drugs and cosmetics until May 31, 1983. DATE: Objections by May 2, 1983. ADDRESS: Written objections may be sent to the Dockets Management Branch (HFA-308), Food and Drug Administration, Rm. 4-62, 5800 Fishers FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATIONE L. Introduction D&C Orange No. 17 is the subject of a color additive petition (CAP 9C0000) 14045 that was submitted on April 14, 1988, by the Toilet Goods Association, Inc. (now the Cosmetic. Toiletry and Fragrance Association, Inc. (CTFA), 1110 Vermont Ave. NW., Washington, DC 20005). FDA published a notice of filing of the petition in the Federal Register of August & 1973 (38 FR 21199). The petition, filed under the provisions of section 708 of the Federal Food, Drug. and Cosmetic Act (the act) (21 U.S.C. 378), requested the permanent listing of D&C Orange No. 17 for coloring lipsticks, ingested drugs, and externally applied drugs and cosmetics. In a letter dated May 14, 1974, the peditioner requested that the petition be amended to include listing D&C Orange No. 17 for eye-area usa. FDA published an amended filing notice for the petition in the Federal Register of March 5, 1978 (41 FR 9584), to include the listing of D&C Orange No. 17 for eye/area use. FDA notified the petitioner by letters dated May 14, 1978, August 15, 1977, and August 4, 1978, of the need for data to support the use of D&C Orange No. 17 in cosmetics intended for use in the area of the eye. In the latest letter, dated October 24, 1978, FDA advised the petitioner to consider withdrawing that portion of the petition that sought approval of the use of D&C Orange No. 17 in cosmetics intended for use in the area of the eye because it appeared that the required data from eye-area studies would not be readily available. The petitioner has not submitted the required data on syc-150a use. Therefore, FDA considers that portion of the petition that relates to the listing of D&C No. 17 for eye-area use to be withdrawn without prejudice in accordance with the provisions of § 71.4 (21 CFR 71.4). Use of D&C Orange No. 17 in the area of the eye has never been covered by the provisional listing of this color additive. Future consideration by FDA of the permanent listing of D&C Orange No. 17 for eye-area use will require the submission of a new color additive petition for that use. II. Regulatory History The color additive D&C Orange No. 17 has been in use for many years. Because D&C Orange No. 17 was in use at the time the Color Additive Amendments of 1980 were enacted, it was provisionally listed for drug and cosmetic use in the Federal Register of October 12, 1980 (25 FR 9759). In the Federal Register of February 4. 1977 (42 FR 8991), FDA published revised provisional regulations which required new chronic toxicity studies on 31 color additives, including D&C Orange No. 17, as a condition for |