[Federal Register Volume 71, Number 91 (Thursday, May 11, 2006)]
[Notices]
[Pages 27503-27504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0038]


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.

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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: 202-395-6974.

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



[[Page 27504]]

    Dated: May 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7178 Filed 5-10-06; 8:45 am]
BILLING CODE 4160-01-S