[Federal Register Volume 68, Number 141 (Wednesday, July 23, 2003)]
[Notices]
[Pages 43535-43538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0263]


Draft Guidance for Industry: Channels of Trade Policy for 
Commodities With Residues of Pesticide Chemicals, for Which Tolerances 
Have Been Revoked, Suspended, or Modified by the Environmental 
Protection Agency; 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availability of a level 1 draft guidance entitled ``Guidance for 
Industry: Channels of Trade Policy for Commodities With Residues of 
Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, 
or Modified by the Environmental Protection Agency'' (the draft 
guidance). This draft guidance presents FDA's general policy for 
implementing the channels of trade provision in the Federal Food, Drug, 
and Cosmetic Act (the act), as amended by the Food Quality Protection 
Act (FQPA) of 1996.

DATES: Submit written or electronic comments by September 22, 2003 to 
ensure adequate consideration in the preparation of the guidance 
document. Comments on this draft guidance may be submitted at any time. 
Submit comments on the collection of information by September 22, 2003.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Channels of Trade Policy for 
Commodities With Residues of Pesticide Chemicals, for Which Tolerances 
Have

[[Page 43536]]

Been Revoked, Suspended, or Modified by the Environmental Protection 
Agency'' to Michael E. Kashtock, Center for Food Safety and Applied 
Nutrition (CFSAN) (see FOR FURTHER INFORMATION CONTACT). Include a 
self-addressed adhesive label to assist that office in processing your 
request.
    Submit written comments concerning the draft guidance and the 
information collection provisions to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. 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electronic access to the draft guidance.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 (CFSAN) (HFS-305), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 
301-436-2022, FAX: 301-436-2651, 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 act, established a new safety standard for pesticide residues 
in food, with an emphasis on protecting the health of infants and 
children. The Environmental Protection Agency (EPA) is responsible for 
regulating the use of pesticides (under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA)) and for establishing tolerances 
or exemptions from the requirement for tolerances for residues of 
pesticide chemicals in food commodities (under the act). EPA, in 
accordance with the FQPA, is in the process of reassessing the 
pesticide tolerances and exemptions which 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 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 act, when the registration 
for a pesticide is canceled or 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 
act addresses 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 act) states the 
following:
    PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF A 
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 
a 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.
    FDA anticipates that food bearing lawfully applied residues of 
pesticide chemicals that are the subject of future EPA action the act 
to revoke, suspend, or modify their tolerances, will remain in the 
channels of trade after the applicable tolerance is revoked, suspended, 
or modified. If FDA encounters food bearing a residue of a pesticide 
chemical for which the tolerance has been revoked, suspended, or 
modified, 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 the agency plans to approach its enforcement of the 
channels of trade provision in the act with respect to pesticide 
chemicals that are subject to future EPA action to revoke, suspend, or 
modify their tolerances.
    FDA is announcing the availability of this level 1 draft guidance. 
The draft guidance when finalized, will represent FDA's current 
thinking on its planned enforcement approach to the channels of trade 
provision of the act and how such provision relates to FDA regulated 
products with residues of pesticide chemicals for which tolerances have 
been revoked, suspended, or modified. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. You can use an alternative approach if the approach satisfies 
the requirements of the applicable statutes and regulations. If you 
want to discuss an alternative approach, contact the FDA staff 
responsible for implementing the guidance. If you cannot identify the 
appropriate FDA staff, call the telephone number listed on the title 
page of the guidance. The draft guidance is being distributed for 
comment purposes, in accordance with the FDA's good guidance practices 
regulation in 21 CFR 10.115(g).

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 in this document.

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    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: Channels of Trade Policy for Commodities With Residues of 
Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, 
or Modified by the Environmental Protection Agency

    Description: Under the pesticide tolerance reassessment process 
that EPA was mandated to carry out under the FQPA, EPA is expected to 
revoke, suspend, or modify tolerances for the pesticide chemicals on 
various food commodities. Section 408(l)(5) of the act includes a 
provision, referred to as the ``channels of trade provision,'' that 
addresses the circumstances under which a food will not be deemed 
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 the previously mentioned pesticide chemical residues 
(within the former tolerance) after the tolerance for the pesticide 
chemical has been revoked, suspended, or modified will be able to 
demonstrate that such food was handled, e.g., 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 document. FDA is not suggesting that firms maintain an 
inflexible set 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 handled during the acceptable 
timeframes.
    Examples of documentation which FDA anticipates will serve this 
purpose consist 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 
pesticide chemicals after the tolerances for the pesticide chemicals 
have been revoked, suspended, or modified.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                  No. of Responses per
              No. of Respondents                       Respondent          Total Annual Responses      Hours per Response            Total Hours
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652                                                                   1                       652                         3                     1,956
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA does not know which pesticide chemicals will have their 
tolerances revoked, suspended, or modified in the future. Instead of 
calculating the paperwork burden for any one pesticide, FDA calculated 
the cost for an ``average'' pesticide by looking at test results for 
417 pesticide chemicals on domestic products and 450 pesticide 
chemicals on imported products. FDA then used the average percent of 
samples found with residues as a substitute for the rate of residues 
found from a specific pesticide chemical.
    The estimated annual reporting burden was determined using the 
average percent of samples found with residues for all pesticides for 
domestic and imported products. Using 1999 pesticide monitoring data, 
domestic products were tested for residues of 417 pesticide chemicals. 
On average, 1.02 percent of samples tested positive for a given 
pesticide chemical. For 450 pesticides tested for residues on imported 
products, on average 2.40 percent of samples contained a given 
pesticide chemical residue. This rate of positive findings for product 
samples was applied to the number of potentially affected 
establishments, 3,730 importers and 23,201 domestic businesses, giving 
an expected number of 326 potentially-affected businesses per 
revocation, suspension, or modification of a tolerance. FDA expects 
this number to be an overestimate of the number of affected businesses 
for two reasons. One, the positive residue test may be below the new 
tolerance. Second, tolerances may not be altered for all products. If 
the tolerance was altered for only vegetables but not fruit, then the 
number of affected establishments would be smaller. We assume two 
pesticide tolerances are altered per year, resulting in 652 businesses 
reporting per year. To date, tolerances have been revoked for two 
pesticide chemicals. However, FDA expects the total number of pesticide 
tolerances that are revoked, suspended, or modified by EPA to increase.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                       Annual Frequency      Total Annual          Hours per
                No. of Recordkeepers                   per Recordkeeping        Records          Recordkeeper         Total Hours        Capital Costs
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65                                                                    1                  65                  16               1,040             $32,571
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In determining the estimated annual recordkeeping burden, FDA 
estimated that at least 90 percent of firms maintain documentation, 
such as packing codes, batch records, and inventory records, as part of 
their basic food production or

[[Page 43538]]

import operations. Therefore, the recordkeeping burden was calculated 
as the time required for the 10 percent of firms that may not currently 
be maintaining this documentation to develop and maintain 
documentation, such as batch records and inventory records. For firms 
that do not maintain documentation, such as batch records and inventory 
records, as part of their normal manufacturing operations, it was 
estimated that with $500 or less, the necessary software and hardcopy 
filing systems could be obtained to implement a system.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this draft 
guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The draft guidance and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

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

    Dated: July 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18634 Filed 7-22-03; 8:45 am]
BILLING CODE 4160-01-S