consumed. A low level of concern for these radiolytic products is also indicated by the fact that they are present even before packaging, storage or preparation only in the ppb range. It is important that the semi-synthetic diet be palatable to the species being tested and thus, short-term, pilot feeding studies of the diet should be conducted to determine its acceptance. The caloric density (digestible energy) of the diet must be within the proper range. caloric density of the diet of rapidly growing rats is below 2.9 kcal per cubic centimeter of food, the weanling rat cannot meet its energy requirement and its growth rate is impaired'. The daily dietary intake of Sprague-Dawley female cats varies dramatically with functional state; If the i.e., non-pregnant 10 to 15 %, pregnant 20 g and lactating 30 to 35 g. Thus, the dietary demands of the test species will depend upon the type of testing. The mutritional demands of a reproductive or teratogenic study will obviously be different than those of a chronic coxicity study and these differences in mutritional requirements must be considered in the dietary regimen being developed. provided with a diet which is very high in proteia ( 30 to 50% for 600 days), significant glomerulosclerosis was coserved. It is recommended that the following treatment groups be included in reproduction studies with irradiated food product3 1) control group ca normal laboratory diet, 2) control group on semi-synthetic diet, 3) control group on unirradiated food component supplemented to nutritional requirements by seni-synthetic diet, and 4) test group on irradiated food couponent supplemenced to nutritional requirments by semi-syathetic diet. In other types of toxicity testing; e.g., chronic studies, a normal laboratory diet group nay not be required?. References 'l. Report of the American Institute of Nutrition Ad Hoc Committee on Standards for Nutritional Studies. J. Nutrit. 107: 1340-8, 1977. 2. Memo of telephone conversatioa wich Dr. J.G. Bieri, May 28, 1980. 3. Nu trient Requirements of Laboratory Animals, National Academy of 4. Bras, G. and Ross, M.!. Kidney Disease and Nutrition in the Rac. Tox. Appl. Pharmacoi. 6:247-262, 1964, Dr. MILLER. In a similar manner, the international community has also attempted to evaluate the safety of irradiated foods. In the 1960's several organizations of the United Nations established a joint committee of experts knowledgeable in many disciplines to review the data and to make recommendations regarding this new processing method. Their recommendations have been published in a series of reports on various aspects of food irradiation. To a significant extent these deliberations—the deliberations of this expert committee-have tracked our own and have proceeded on a parallel course to our own activity. We, of course, are considering these recommendations and the supporting data, but it is important to point out that our decisions have been based on our own review, which is what is required under the law. As you know, FDA's special involvement in food irradiation is mandated by the Food Additives Amendment of 1958 which specifically includes sources of radiation in the definition of a food additive. Let me emphasize, Madam Chairperson, this is not a policy decision of FDA. This is in the act, and we are compelled to act in this direction. This legislation requires premarket approval before a source of radiation may be used to process food, and states that a food is adulterated if it has been intentionally subjected to radiation unless there is a food additive regulation. The proposal that the Agency published in February 1984 was preceded by several earlier actions concerning irradiation of food. A historical list is attached to my full statement for your review. As it will show, we permitted the use of irradiation for the control of insect infestation of wheat and wheat products since 1963, and the use of irradiation for sprout inhibition since 1964. And I might point out to you that these were among the first regulations in the world permitting the use of food irradiation. Prior to the publication of our most recent proposal in February 1984, the Agency published an advanced notice of proposed rulemaking in 1981. That notice, as is the current proposal, was based on the current criteria for safety evaluation recommended by our irradiated foods committee, and was the first step in the administrative process which was intended to establish new operating criteria for evaluating safety data. As you know, Madam Chairperson, this proposal permits the use of irradiation for sprout inhibition and shelf life extension of fresh fruits and vegetables, and for insect infestation of foods at doses not to exceed 100 kilorads. It also proposed the sterilization of spices at doses not to exceed 3 megarads, and I'd like to submit that proposal for the record. Mrs. LLOYD. Without objection it will be included. 18992 Federal Register / Vol. 46, No. 59 / Friday, March 27. 1981 / Proposed Rules DEPARTMENT OF HEALTH AND In 1958. the Congress amended the Federal Food, Drug. and Cosmetic Act (the act) prohibiting the use of a new food additive until the sponsor by methods that can easily detect the establishes its safety and FDA issues a presence of radioisotopes that occur regulation specifying conditions of safe naturally in foods. The question of the use. This amendment was the result of safety of radiolytic products is an extensive examination of the safety addressed in the Bureau of Foods of the American food supply and the Irradiated Food Committee report. (A recognition that substances added to National Bureau of Standards paper, food may have a potential harmful ""Radioactivity Criteria for Radiation effect. Processing of Foods" by H. W. Koch and Congress also showed concern over a E. H. Eisenhower, is on file with the new method of food preservation with FDA Dockets Management Branch ionizing radiation and specifically (HFA-305). Food and Drug included sources of radiation in the Administration, Rm. 4–62. 5600 Fishers definitions of food additive (section Lane, Rockville, MD 20857 and may be 201(s]) and adulterated food (section seen from 9 a.m. to 4 p.m. Monday 402(a)(7)) of the act. Section 201(s) through Friday. The Bureau of Foods' states: "The term 'food additive' means Irradiated Food Committee report is also any substance the intended use of which on file and copies are available on results or may reasonably be expected request from the Dockets Management to result, directly or indirectly, in its Branch. (address above)). becoming a component or otherwise Applications for food irradiation affecting the characteristics of any food extend from low doses for limited shelf (including any substance intended for life extension to high doses for complete use in producing, manufacturing. sterilization of foods. Existing packing, processing, preparing, treating. alternative methods for achieving these packaging. transporting, or holding food: effects in foods require the use of a and including any source of radiation variety of chemical and physical means. intended for any such use), For example, irradiation might be used (emphasis added). The adulteration as a substitute for food additives (nitrite). fumigants (ethylene dibromide, • (7) if it has been ethylene oxide), and plant regulators intentionally subjected to radiation. (maleic hydrazide). and as a food unless the use of the radiation was in processing technique for food conformity with a regulation or preservation (canning. pasteurization). In the 1960's FDA received several exemption in effect pursuant to section 409." The specific inclusion of irradiated petitions for regulation of irradiation food in the amendment shows clearly processing for various types of foods. At that the FDA is responsible for present only irradiation for sprout regulating the use of irradiated foods by inhibition of potatoes and insect disinfestation of wheat and wheat flour requiring a rigorous review of the potential hazards associated with this are approved, and there has been no food treatment. commercial application of these approved uses. Background There have been many difficulties • Food irradiation may involve the encountered in the process of following sources of ionizing radiation: determining whether irradiated foods gamma radiation from radionuclides, are safe. In the past, toxicological high energy electrons derived from indices and protocols were applied tu electron beam accelerators, and X-rays. irradiated foods as if the whole A variety of technical effects such as irradiated food were a discrete chemical sprout inhibition, insect control. entity similar to a "conventional" food pasteurization, and food sterilization additive. This approach was based on have been demonstrated. section 409(c)(3)(A) of the act, which These technical effects are a function states: "In determining *** whether a of the absolute amount of energy proposed use of a food additive is safe. absorbed by food (expressed as the Secretary shall consider among radiation dose in rads). In considering other relevant factors-(a) the probable the safety of irradiated foods, the consumption of the additive and of any agency has considered both the substance formed in or on food because induction of new radioactive species of the use of the additive; *** "A major and production of toxic radiolytic problem with the safety evaluation of products. The question of induction of irradiated foods was the lack of new radioactive species was resolved in knowledge of the identity, amount, and the early 1960's: the accumulated toxicity of the radiolytic products evidence shows that the use of ionizing formed in food by irradiation. Thus, radiation of appropriate source energy irradiated food, a food containing levels does not induce any detectable unknown amounts of radiolytic products radioactivity in foods when measured formed by the irradiation process, was Federal Register / Vol. 46. No. 59 / Friday. March 27, 1981 / Proposed Rules 18993 tested for safety using chronic animal feeding studies. Evaluating the safety of irradiated foods by such testing methods was impractical for several reasons. The most significant problem was the limited ability to obtain a "safety factor from a classical dose response curve obtained from animal feeding studies. Because irradiated food itself was considered the "chemical" to be tested in these studies. it was very difficult to feed the exaggerated amounts of food that are necessary for the purpose of traditional toxicity testing. For example, it is not possible to obtain a 100-fold safety factor if the food fed to animals is greater than 1 percent of the total buman diet. It was further recognized in early studies that increasing the radiation dose (10x, 100x, etc.) as a means of exaggerating the amount of radiolytic products is not a viable alternative for practical as well as theoretical reasons. The renewed interest in irradiation as a possible safe alternatve to chemicals in food led the agency to review the complex issue of irradiated foods. An internal FDA task force, the Bureau of Foods's Irradiated Food Committee, was formed to evaluate the agency's policy on irradiated foods according to the current state-of-the-art knowledge in toxicology and radiation chemistry and to recommend criteria for safety evaluation. The Committee submitted its final report to the Director, Bureau of Foods, FDA, in August 1980. The Committee has submitted the following recommendations: a. Food irradiated at doses of 100 kilorads (krad) or less will be considered wholesome and safe for human consumption b. Food irradiated at doses exceeding 100 krad will be subject to toxicological testing consisting of a battery of four short-term mutagenicity tests and two 90-day feeding studies (one rodent, one nonrodent mammalian species). G A food class comprising no more than 0.01 percent of the daily diet and irradiated at doses of 3 megarads (Mrad) or less will be considered safe for human consumption without toxicological testing. The work of the Committee did not include a complete evaluation of existing toxicologic data. The Committee focused on how the safety of irradiated foods can be scientifically evaluated, applying scientific principles. and not on wbether any irradiated food has been demonstrated to be safe. Hence, these recommendations were based on: (1) projected levels of human exposure. (2) qualitative and quantitative estimates of radiolytic products and how these compare with common food constituents in the human necessary safeguards for the irradiation diet. and (3) state-of-the-art sensitivity processing of food. These comments will of toxicological tests. aid FDA in considering its irradiated The agency has accepted the foods policy. The agency is also aware Committee's report on the safety of the following issues which may have evaluation of irradiated foods and will a bearing on its deliberation: supplement this report with recent 1. Whether there is need for specific experimental data relevant to the safety good manufacturing practice regulations. of irradiated foods. including any necessary safeguards. for The agency is considering the the irradiation processing of food. following actions: 2. Whether there is need for labeling 1. Proposal of a regulation on the of irradiated foods. The present Commissioner's initiative under section regulations require the following 409 and other provisions of the act labeling declaracions: "Treated with permitting isradiation of any food at a ionizing radiation" or "Treated with dose not exceeding 100 krad. FDA is electron radiation on retail packages. initially considering monitoring food and Treated with ionizing radiationirradiation at such a dose by a do not irradiate again" or Treated with registration process. Alternatively, FDA electron radiation-do not irradiate is also considering requiring a limited again" on wholesale packages and on petition that demonstrates the intended technical effect of the process but invoices or bills of lading of bulk shipments. without the additional safety data that would ordinarily be required to support 3. The environmental impact of foods a food additive petition. processed by irradiation or of the 2. Publication of guidelines for the process itself. 4. The economic impact of the preparation of petitions seeking FDA approval for food irradiation at a dose proposed agency actions, including any exceeding 100 krad. specific good manufacturing practice 3. Adoption of a policy that a food regulations and any labeling class comprising only a minor portion of requirements that may be adapted. The the daily diet and irradiated at a dose of proposed changes in criteria for 5 Mrad or less may be considered safe evaluating the safety of processing of for human consumption based upon. food ay impose a less costly burden on minimal biological testing. food processors while still assuring FDA also will consider the report of safety. the Joint FAO/LAEA/WHO Expert Any proposed regulation based on Committee on Wholesomeness of this advance notice would have Lradiated Food in its evaluation. This beneficial economic impact on international committee, sponsored by manufacturers, due to reduced testing the Food and Agriculture Organization. requirements. FDA requests information International Atomic Energy Agency, and views on whether any such and the World Health Organization first proposed regulation will be a "major met in 1978 to review and assess all rule" under the criteria in section 1(b) of data on the wholesomeness of irradiated Executive Order 12291, as well as foods and to identify specific uses of information to enable the agency to food irradiation where data were determine whether to prepare an initial sufficient to conclude that the process regulatory flexibility analysis as could be used safely. The most recent required by the Regulatory Flexibility meeting of this Committee in Geneva Act (Pub. L 98–354. 5 U.S.C. 603 and from October 27 to November 3, 1980. 504). FDA specifically requests was held to review data accumulated information on the total number of worldwide since 1978 to establish the businesses affected by the proposal. the wholesomeness of irradiated foods. The number of small businesses affected by Committee's proceedings will have a the proposal, and the effect (in direct bearing on any Codex quantitative terms, where feasible) on Alimentarius standards that are each firm, including any small business. developed for irradiated foods and sent Interested persons may, on or before to member States for approval June 25. 1981, submit to the Dockets Request for Comments Management Branch (HFA-305), Food and Drug Administration. Rm 4-42. 5800 FDA invites public comment on all Fishers Lane, Rockville, MD 20857, aspects of the agency's proposed food written comments regarding this irradiation policy. The agency is advance notice of proposal. Four copies particularly interested in receiving of any comments are to be submitted. substantive comments on the Bureau of except that individuals may submit one Foods' Lrradiated Food Committee copy. Comments are to be identified report. pertinent data on the safety of with the docket number found in irradiated foods, and suggestions for any brackets in the heading of this document. Received comments may be Dated: March 23, 1981. BILLING COO1 4110-04 Dr. MILLER. On April 16 FDA extended the comment period for an additional 30 days, to May 16, 1984, and the comment period is now closed. At this time the Agency has received well over 3,700 comments in response to this proposal. The only proposal we have ever made which received a greater number of comments was our proposal to deregulate saccharine. After review and considering all of these comments we will, of course, develop a final rule for the irradiation of foods. you will bear with me for just another moment or two, Madam Chairperson, I was asked if I would comment among other things on the future of food irradiation. I do so in this regard, taking off my official hat and putting on my personal hat. It is difficult to be both advocate and evaluator at the same time. It is important to understand at the outset that FDA's responsibility in the evaluational process is limited to the determination of the safety of the process at the proposed effective doses. As I have indicated, FDA believes that the process is safe at the levels we have proposed. The question of its commercial feasibility is, of course, beyond the scope of our official evaluation. Nonetheless, after some 20 years of research in the field of food irradiation, Í clearly have some personal views on the subject. I believe that the extent to which food irradiation will become a commercially practical process is difficult to predict at this time because of the complexity of the issues and the fact that there are many, many other factors, in addition to technical feasibility and safety issues, involved. Let me restrict myself to just one in particular. Probably the most difficult question to deal with is the kind of technical neophobia, if you will, in which the public is inherently suspicious of new processes, particularly those based upon technologies in which they cannot differentiate between the technology when used for different purposes. Thus the public continues to confuse the problems and potential hazards associated with the use of radiation for weaponry or power generation with those that may be associated with its use for food irradiation. They simply do not understand at this point that the irradiation process does not and cannot produce a radioactive product, and that the use of isotopic sources of ionizing radiation for food irradiation does not generate nuclear waste. Moreover, they forget that radiation has been used for the sterilization of hospital supplies for certain kinds of patients for many years without any ill effects. Thus it seems to me that the industry has a major education effort ahead to convince the public that food irradiation is a safe and potentially useful technique to expand and improve our food supply. If this is not done, then I do not believe that this technology will be fully exploited. It is difficult sometimes, Madam Chairman, to be sheriff in a frontier town when enthusiasm runs high. FDA's role in this process has been to evaluate its safety and its effectiveness to the purposes to which it is set. We are the sheriff, and this is the job that is given to us by law. We have concluded that, at the levels which we have established in our proposals, the process is safe and effective. It is now, I believe, the turn of the industry and the private sector particularly to begin to exploit this technology and to pro |