[Federal Register: October 6, 2000 (Volume 65, Number 195)]
[Notices]
[Page 59853-59855]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc00-95]
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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tolerance has been revoked, suspended, or modified by EPA.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