FDA Proposes to Make its Labeling Regulations for Irradiated Foods More Lenient
The Food and Drug Administration has issued a proposed rule that would revise its labeling regulations at 21 CFR 179.26 applicable to foods (including dietary supplements) for which irradiation has been approved by FDA.
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Written or electronic comments are due by July 3, 2007.
FDA is proposing that only those irradiated foods in which the irradiation causes a material change in the food, or a material change in the consequences that may result from the use of the food, bear the radura logo and the term "irradiated," or a derivative thereof, in conjunction with explicit language describing the change in the food or its conditions of use.
FDA is also proposing to allow a firm to petition FDA for use of an alternate term to "irradiation" (other than "pasteurized"), and to permit a firm to use the term "pasteurized" in lieu of "irradiated," provided it notifies FDA that the irradiation process being used meets the criteria specified for use of the term "pasteurized" in the Federal Food, Drug, and Cosmetic Act, and FDA does not object to the notification.
(FDA notes that, for purposes of this rulemaking, it is using the term "material change" to refer to a change in the organoleptic, nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling.)
Highlights of FDA's Proposed Rule
The following are the highlights of the regulatory language of FDA's proposed rule:
Only foods where irradiation causes material change would bear logo, disclosure statement. FDA is proposing to amend 21 CFR 179.26(c)(1) (retail packages) and redesignate (c)(2) (food not in package form) as (c)(3) in order to require that only those foods that have been treated with radiation, and in which the irradiation caused a material change in the characteristics of the food must bear the radura logo and the term "irradiated," or other derivatives in conjunction with explicit language describing the change in the food or its conditions of use (e.g., "irradiated to inhibit sprouting").
FDA notes that it believes that the radura logo is still a necessary part of the label statement because it derives from the symbol that has been used internationally to convey the fact that the food has been irradiated.
(Current regulations state that the logo and statement "treated with irradiation" or "treated by irradiation" are required for irradiated food, not just irradiated food which has undergone a "material change. ")
Alternate terms to "irradiated" may be used, etc. FDA is proposing in 21 CFR 179.26(c)(1) and redesignated (c)(3) to permit the use of alternate terms to "irradiated" or any of its derivatives, on the labels and labeling of irradiated foods.
FDA is also proposing to add 21 CFR 179.26(c)(2) so that an alternate term in lieu of "irradiated" would be able to be used on the labels and labeling of foods that have been treated by irradiation, if it meets the following provisions:
(i) A term that is not false or misleading in any material respect may be used in lieu of "irradiated," or any of its derivatives, if its use is approved in response to a petition that has been submitted to FDA using the procedures under 21 CFR 10.30 for approval of the alternate term, or, if use of the term "pasteurized" is permissible under the requirements in 21 CFR 179.26(c)(2)(ii).
(ii) The term "pasteurized" may be used in lieu of "irradiated" or any of its derivatives if the irradiation process is:
Reasonably certain to achieve destruction or elimination in the food of the most resistant microorganism of public health significance that is likely to occur in the food;
At least as protective of the public health as a process or treatment that is defined as pasteurization in 21 CFR Chapter I;
Effective for a period that is least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and
The subject of a notification to the Secretary of Health and Human Services that includes effectiveness data regarding the process or treatment and the Secretary has not made a determination in 120 days after the receipt of the notification that the process or treatment involved has not been shown to meet the requirements provided in 21 CFR 179.26(c)(2)(ii)(A), (B), and (C).
(The current regulations do not provide for the use of alternate terms for "irradiated.")
- written or electronic comments due by July 3, 2007
- comments on the information collection on the use of an alternative to "irradiation" are due by May 4, 2007
FDA contact - Loretta Carey (301) 436-2371
FDA proposed rule (D/N 2005N-0272, FR Pub 04/04/07), available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-1636.pdf