E6-7178. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by June 12, 2006.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Irradiation in the Production, Processing, and Handling of Food—(OMB Control Number 0910-0186)—Extension

Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, § 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2)(i) requires that the label or accompanying labeling bear adequate directions for installation and use. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.) The records required by § 179.25(e) are used by FDA inspectors to assess compliance with the regulation that establishes limits within which radiation may be safely used to treat food. The agency cannot ensure safe use without a method to assess compliance with the dose limits, and there are no practicable methods for analyzing most foods to determine whether they have been treated with ionizing radiation and are within the limitations set forth in part 179. Records inspection is the only way to determine whether firms are complying with the regulations for treatment of foods with ionizing radiation.

In the Federal Register of February 6, 2006 (71 FR 6075), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received one letter in response which contained several comments and suggestions. These suggestions and FDA's responses follow.

The comment expresses concern that records maintained under the regulation must only be retained for a maximum of 3 years. The comment asserts that irradiation of food is a new process, the long-term effects of which are unknown. The comment recommends that the required records be retained for 7 years.

FDA disagrees. The records required by § 179.25(e) must be retained for a period of time that exceeds the shelf life of the irradiated food product by 1 year, up to a maximum of 3 years, whichever period is shorter. There is no need to retain the information longer than 1 year after the end of the shelf life of the irradiated food because by that time the food has either been consumed or discarded. Thus, it is unnecessary for FDA to require firms to retain the records for a longer period of time.

The comment also suggested that FDA permit comments to the docket to be filed by e-mail and suggested that food treated under part 179 of the regulations should be labeled with the word, “Irradiated.”

FDA agrees that irradiated food should be labeled and notes that labeling requirements for irradiated foods are found at § 179.26(c). These comments are outside the scope of the four collection of information topics on which the notice solicits comments and, thus, will not be addressed further.

Table 1—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Record	Total Hours
179.25(e)	6	120	720	1	720
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 4, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.