[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Notices]
[Pages 73054-73055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-5325]


Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the recordkeeping and labeling 
requirements for food irradiation processors.

DATES: Submit written comments on the collection of information by 
February 28, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520) Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of a collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Irradiation in the Production, Processing, and Handling of Food--21 
CFR Part 179 (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 as a food additive. 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 assure safe use of 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 73055]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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179.21(b)(1) and 179.21(b)(2)(i)        4               1               4               5              20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency of    Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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179.25(e)                               3             120             360               1             360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of firms who process food using irradiation is extremely 
limited. FDA estimates that there is a single irradiation plant whose 
business is devoted primarily (i.e., approximately 100 percent) to 
irradiation of food and other agricultural products. Two other firms 
also irradiate small quantities of food (mainly spices). FDA estimates 
that this irradiation accounts for no more than 10 percent of the 
business for each of these firms. Although recent FDA rulemaking has 
authorized the irradiation of red meat, United States Department of 
Agriculture/Food Safety and Inspection Service (USDA/FSIS) has yet to 
issue a rule regarding meat irradiation. Actual implementation of meat 
irradiation cannot take place until USDA/FSIS final regulations are in 
place, which may not take place until later this fiscal year. At this 
time, FDA has no basis for estimating the extent of changes in the food 
irradiation business as a result of future USDA/FSIS actions. 
Therefore, the average estimated burden is based on: (1) Facility 
devoting 100 percent of its business (or 300 hours for recordkeeping 
annually) to food irradiation; (2) facilities devoting 10 percent of 
their business or 60 hours (2 x 30 hours) for recordkeeping annually, 
to food irradiation or (300 + 60)/3 = 120 x 3 firms x 1 hour = 360 
hours annually.
    No burden has been estimated for the labeling requirements in 
Secs. 179.21(b)(2)(i) and (b)(2)(ii) and 179.26(c) because the 
information to be disclosed is information that has been supplied by 
FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public is not a collection of information.

    Dated: December 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-33761 Filed 12-28-99; 8:45 am]
BILLING CODE 4160-01-F