[Federal Register Volume 66, Number 205 (Tuesday, October 23, 2001)]
[Notices]
[Pages 53614-53615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26651]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0276]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Suggested Documentation for Demonstrating 
Compliance With the Channels of Trade Provision for Foods With 
Vinclozolin Residues

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments on the collection of information by 
November 23, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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

Suggested Documentation for Demonstrating Compliance With the 
Channels of Trade Provision for Foods With Vinclozolin Residues 
Description

    Under the pesticide tolerance reassessment process that the 
Environmental Protection Agency (EPA) was mandated to carry out under 
the Food Quality Protection Act of 1996 (FQPA), EPA has proposed to 
revoke the

[[Page 53615]]

tolerances for the pesticide chemical vinclozolin on several food 
commodities. The FQPA includes a provision in section 408(l)(5) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a(l)(5)), referred to 
as the ``channels of trade provision,'' that addresses the 
circumstances under which a food is not unsafe solely due to the 
presence of a residue from a pesticide chemical whose tolerance has 
been revoked, suspended, or modified by EPA.
    In general, FDA anticipates that the party responsible for food 
found to contain vinclozolin residues (within the former tolerance) 
after the tolerance for the pesticide chemical has been revoked, will 
be able to demonstrate that such food was packed or processed during 
the acceptable timeframes cited in the draft guidance, by providing 
appropriate documentation to the agency as discussed in the draft 
guidance. FDA is not suggesting that firms maintain a certain set list 
of documents where anything less or different would likely be 
considered unacceptable. Rather, the agency is leaving it to each 
firm's discretion to maintain appropriate documentation to demonstrate 
that the food was so packed or processed.
    Examples of documentation which FDA anticipates will serve this 
purpose consists of documentation associated with packing codes, batch 
records, and inventory records. These are types of documents that many 
food processors routinely generate as part of their basic food-
production operations.
    The likely respondents to this collection of information are firms 
in the produce and food-processing industries that handle food products 
that may contain residues of vinclozolin after the tolerances for this 
pesticide chemical have been revoked.
    In the Federal Register of July 10, 2001 (66 FR 35990), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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     No. of        Annual Frequency per
   Respondents           Response         Total Annual Responses    Hours per Response          Total Hours
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307                         1                     307                       3                     921
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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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     No. of        Annual Frequency per
  Recordkeepers        Recordkeeping       Total Annual Records   Hours per Recordkeeper        Total Hours
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31                          1                      31                      16                     496
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Estimates for the annual reporting burden were determined by using 
the maximum number of samples collected throughout a year that FDA 
believes might be found to contain vinclozolin residues. The estimated 
annual reporting burden was determined using the total number of 
samples historically tested for vinclozolin and the number of samples 
that historically contained vinclozolin residues. These numbers 
established a rate of samples expected to contain vinclozolin residues. 
This rate, when applied to the number of potentially affected 
establishments, was used to calculate the number of expected 
respondents.
    When determining the estimated annual recordkeeping burden, FDA 
estimated that most firms (at least 90 percent) maintain (or maintain 
access to) documentation such as packing codes, batch records, and 
inventory records as part of their basic food production and/or import 
operations. Therefore, the recordkeeping burden was calculated as the 
time required for the 10 percent of firms which may not currently be 
maintaining this documentation to develop and maintain (or maintain 
access to) documentation such as batch records, inventory records, 
sales records, and distribution records.

    Dated: October 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26651 Filed 10-22-01; 8:45 am]
BILLING CODE 4160-01-S