[Federal Register Volume 66, Number 132 (Tuesday, July 10, 2001)]
[Notices]
[Pages 35990-35992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0276]


Draft Guidance for Industry: Channels of Trade Policy for 
Commodities With Vinclozolin Residues; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Guidance for 
Industry: Channels of Trade Policy for Commodities With Vinclozolin 
Residues'' (the draft guidance). The draft guidance presents FDA's 
policy for implementing the channels of trade provision for the 
pesticide chemical vinclozolin in the Federal Food, Drug, and Cosmetic 
Act (FFDCA) as amended by the Food Quality Protection Act (FQPA) of 
1996. The draft guidance is intended to assist firms in understanding 
FDA's planned approach to the enforcement of this provision of the FQPA 
with regard to residues of vinclozolin in food.

DATES: Submit written comments concerning on the draft guidance by 
September 10, 2001, to ensure their adequate consideration of the 
comments in the preparation of a revised guidance, if warranted. 
However, you may submit comments at any time.

ADDRESSES: Submit written comments concerning the draft guidance and 
the collection of information provisions to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit written requests for single copies of 
the draft guidance entitled ``Guidance for Industry: Channels of Trade 
Policy for Commodities With Vinclozolin Residues'' to Michael E. 
Kashtock, Center for Food Safety and Applied Nutrition (HFS-305), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
5321. Send one self-adhesive address label to assist that office in 
processing your request, or include a fax number to which the draft 
guidance may be sent. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4681, FAX 202-205-4422, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On August 3, 1996, the FQPA was signed into law. This law, which 
amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and the FFDCA, established a new safety standard for pesticide residues 
in food, with an emphasis on protecting the health of infants and 
children. In accordance with the FQPA, the Environmental Protection 
Agency (EPA), is responsible for regulating the use of pesticides 
(under the FIFRA) and establishing tolerances or exemptions from the 
requirement for tolerances for residues of pesticide chemicals in food 
commodities (under the FFDCA). EPA, in accordance with the FQPA, is in 
the process of reassessing the pesticide tolerances and exemptions that 
were in effect when the FQPA was signed into law. When EPA determines 
that a pesticide's tolerance level does not meet the safety standard 
under section 408 of the act (21 U.S.C. 346a), the registration for the 
pesticide may be canceled under the FIFRA for all or certain uses. In 
addition, the tolerances for that pesticide may be lowered or revoked 
for the corresponding food commodities. Under section 408(l)(2) of the 
FFDCA (21 U.S.C. 346a(l)(2)), when the registration for a pesticide is 
canceled or

[[Page 35991]]

modified due in whole or in part to dietary risks to humans posed by 
residues of that pesticide chemical on food, the effective date for the 
revocation of such tolerance (or exemption in some cases) must be no 
later than 180 days after the date such cancellation becomes effective 
or 180 days after the date on which the use of the canceled pesticide 
becomes unlawful under the terms of the cancellation, whichever is 
later.
    When EPA takes such actions, food derived from a commodity that was 
lawfully treated with the pesticide may not have cleared the channels 
of trade by the time the revocation or new tolerance level takes 
effect. The food could be found by FDA, the agency that is responsible 
for monitoring pesticide residue levels and enforcing the pesticide 
tolerances in most foods (the U.S. Department of Agriculture (USDA) has 
responsibility for monitoring residue levels and enforcing pesticide 
tolerances in egg products and most meat and poultry products), to 
contain a residue of that pesticide that does not comply with the 
revoked or lowered tolerance. FDA would normally deem such food to be 
in violation of the law by virtue of it bearing an illegal pesticide 
residue. The food would be subject to FDA enforcement action as an 
``adulterated'' food. However, the channels of trade provision of the 
FQPA address the circumstances under which a food is not unsafe solely 
due to the presence of a residue from a pesticide chemical for which 
the tolerance has been revoked, suspended, or modified by EPA. The 
channels of trade provision (section 408(l)(5) of the FFDCA) states the 
following:
    PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF 
PESTICIDE.--Notwithstanding any other provision of this Act, if a 
tolerance or exemption for a pesticide chemical residue in or on a 
food has been revoked, suspended, or modified under this section, an 
article of that food shall not be deemed unsafe solely because of 
the presence of such pesticide chemical residue in or on such food 
if it is shown to the satisfaction of the Secretary that-
    (A) the residue is present as the result of an application or 
use of a pesticide at a time and in a manner that was lawful under 
the Federal Insecticide, Fungicide, and Rodenticide Act; and
    (B) the residue does not exceed a level that was authorized at 
the time of that application or use to be present on the food under 
the tolerance, exemption, food additive regulation, or other 
sanction then in effect under this Act; unless, in the case of any 
tolerance or exemption revoked, suspended, or modified under this 
subsection or subsection (d) or (e), the Administrator has issued a 
determination that consumption of the legally treated food during 
the period of its likely availability in commerce will pose an 
unreasonable dietary risk.
    For reasons explained by EPA in its proposed rule on pesticide 
tolerance revocations published elsewhere in this issue of the Federal 
Register, EPA is proposing to revoke the pesticide tolerances for 
vinclozolin on bell peppers andcucumbers\1\, and also is proposing to 
revoke the pesticide tolerances for vinclozolin on strawberries and 
stonefruit as quickly as possible after consideration of comments.
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    \1\Vinclozolin is not registered for use on bell peppers and 
cucumbers in the United States. The tolerances for vinclozolin on 
bell peppers and cucumbers provide the importation of these 
commodities with vinclozolin residues.
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    FDA anticipates that some processed strawberries and stonefruit 
bearing vinclozolin residues resulting from lawful domestic application 
of this pesticide will remain in the channels of trade after the 
revocation of the applicable tolerance. In addition, FDA anticipates 
that some bell peppers and cucumbers, both fresh and processed, that 
were legally imported bearing residues of vinclozolin will be in the 
channels of trade after the revocation of the applicable tolerance. If 
FDA encounters processed strawberries, processed stonefruit, fresh or 
processed bell peppers, or fresh or processed cucumbers bearing a 
residue of vinclozolin, it intends to address the situation in 
accordance with this draft guidance. FDA has developed this draft 
guidance to set forth its policy for how FDA plans to approach its 
enforcement of the channels of trade provision with respect to the 
pesticide chemical vinclozolin.
    With this document, FDA is announcing the availability of the draft 
guidance. The draft guidance represents FDA's current thinking on its 
planned enforcement approach to the channels of trade provision and how 
such provision relates to FDA-regulated products with vinclozolin 
residues. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. The draft guidance is 
being distributed for comment purposes, in accordance with the FDA's 
final rule on administrative practices and procedures for good guidance 
practices (21 CFR 10.115; 65 FR 56468, September 19, 2000).

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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.
    Title: Suggested Documentation for Demonstrating Compliance With 
the Channels of Trade Provision for Foods With Vinclozolin Residues
    Description: Under the pesticide tolerance reassessment process 
that EPA wasmandated to carry out under the FQPA, EPA has proposed to 
revoke the tolerances for the pesticide chemical vinclozolin on several 
food commodities. The FQPA includes a provision in section 408(l)(5) of 
the FFDCA, 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

[[Page 35992]]

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.
    Description of Respondents: 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
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     No. of Respondents           Annual Frequency per 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 Recordkeepers       Annual Frequency per Response          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.

III. Comments

    Interested persons should submit to the Dockets Management Branch 
(address above) written comments regarding the draft guidance by 
September 10, 2001, to ensure adequate consideration of the comments of 
the comments in the preparation of a revised guidance, if warranted. 
However, interested persons may submit written comments at any time. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Submit to the 
Dockets Management Branch written comments concerning this collection 
of information by September 10, 2001. The draft guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    An electronic version of the draft guidance is available on the 
Internet at http://www.fda.gov.

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17047 Filed 7-9-01; 8:45 am]
BILLING CODE 4160-01-S