[Federal Register: July 23, 2003 (Volume 68, Number 141)]
[Notices]
[Page 43535-43538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy03-65]
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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Draft Guidance for Industry: Channels of Trade Policy for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Have Been Revoked, Suspended, or Modified by the Environmental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availability of a level 1 draft guidance entitled ``Guidance for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Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended,
or Modified by the Environmental Protection Agency'' (the draft
guidance). This draft guidance presents FDA's general policy for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 Comments on this draft guidance may be submitted at any time.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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Channels of Trade Policy for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Been Revoked, Suspended, or Modified by the Environmental Protection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Submit written comments concerning the draft guidance and the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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electronic access to the draft guidance.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: mkashtoc@cfsan.fda.gov.
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.
[[Page 43537]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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