[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Notices]
[Pages 59853-59855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1309]


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

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 6, 2000.

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

    Description: Under the pesticide tolerance reassessment process 
that the Environmental Protection Agency (EPA) was mandated to carry 
out under the Food Quality Protection Act (FQPA), EPA has proposed to 
revoke the tolerances for the pesticide chemical methyl parathion on 
several food commodities. The FQPA includes a provision in section 
408(l)(5) of the Federal Food, Drug, and Cosmetic Act (the 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tolerance has been revoked, suspended, or modified by EPA. These 
circumstances are met if the party responsible for the food can 
demonstrate to FDA that the residue in the food resulted from 
application of the pesticide chemical to the food commodity at a time 
and in a manner that was lawful under the Federal Insecticide Fungicide 
and Rodenticide Act (FIFRA).
    In general, FDA anticipates that the party responsible for food 
found to contain methyl parathion residues (within the former 
tolerance) after the

[[Page 59854]]

tolerance for the pesticide chemical has been revoked, will be able to 
demonstrate that the residue resulted from a lawful application under 
FIFRA by providing appropriate documentation to the agency showing that 
such food was packed or processed on or prior to December 31, 2000, as 
discussed in the draft guidance that was announced in a notice that FDA 
published in the Federal Register of June 2, 2000 (65 FR 35376) (the 
June notice). 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 that FDA anticipates will serve this 
purpose include but are not limited to packing codes, batch records, 
and inventory records; it is anticipated that most food processors 
routinely generate this documentation as part of their basic food-
production operations.
    Description of Respondents: The likely respondents to this 
collection of information are firms in the produce and food-processing 
industries who handle food products that may contain residues of methyl 
parathion after the tolerances for this pesticide chemical in those 
foods have been revoked.
    In the June notice, 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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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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67                                                      1              67               3            201
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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
      No. of Recordkeepers         Frequency per   Total Annual      Hours per      Total Hours    Total Capital
                                   Recordkeeping      Records      Recordkeeper                        Costs
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83                                      1              83              16           1,328           $500
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\1\There are no 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 may be found to contain methyl parathion residues. Because all 
residues are expected to have dissipated from nonfrozen foods by the 
time FDA intends to question firms about when a food product was packed 
or processed (i.e., after December 31, 2000), FDA included only frozen 
food in its estimate (i.e., processors of foods stored under 
refrigerated and ambient conditions were excluded). Although residues 
within the former tolerance resulting from legal application of methyl 
parathion are not expected to be found in nonfrozen foods after 
December 31, 2000, under the channels of trade provision, firms will 
have an opportunity to make a showing that any such food was packed or 
processed on or before this date.
    Considering the variation in and effects of food handling, 
particularly with regard to the time between pesticide application and 
freezing, FDA estimated that potentially half of all frozen food 
products sampled may contain methyl parathion residues, and therefore, 
the responsible party, under the approach set forth in this guidance, 
would be subject to the reporting requirement since it would be the 
burden of the responsible party to demonstrate that food found to 
contain methyl parathion residues within the former tolerance was 
packed or processed on or before December 31, 2000.
    When determining the annual recordkeeping burden, importers and 
domestic processors of frozen food commodities affected by the 
revocation of the pesticide chemical methyl parathion were considered. 
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 and 
inventory records. It was estimated that with $500 or less, the 
necessary software and/or hard copy filing systems could be obtained to 
implement a system.
    Because all residues are expected to have dissipated from nonfrozen 
foods by the time FDA intends to ask for a showing under section 
408(l)(5) of the act (i.e., after December 31, 2000), FDA used the 
number of frozen food processors when determining the annual 
recordkeeping burden. In the June notice, this burden was originally 
determined to be 6,600 hours. However, due to revisions that FDA will 
include in the final guidance document, the proposed information 
collection was refined, and the annual recordkeeping burden decreased 
to 1,328 hours. The ``Category II Documentation,'' which consisted of 
documentation relating to the institution of auditing programs and 
supplier verification, will be removed from the final guidance as 
suggested documentation to be provided to demonstrate compliance with 
the channels of trade provision.
    As with the annual reporting burden estimate, although nonfrozen 
food processors are entitled to make a showing under the channels of 
trade provision, they were excluded from this estimate because based 
upon residue dissipation estimates provided by EPA, methyl parathion 
residues within the former tolerance resulting from legal application 
are not expected to be found in nonfrozen commodities after December 
31, 2000.


[[Page 59855]]


    Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25700 Filed 10-5-00; 8:45 am]
BILLING CODE 4160-01-F