Notice2023-26564
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 231 (Monday, December 4, 2023)</title>
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[Federal Register Volume 88, Number 231 (Monday, December 4, 2023)]
[Notices]
[Pages 84146-84148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2564]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 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Tolerances Have Been Revoked, Suspended, or Modified by the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 Pursuant to Dietary Risk Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information 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 (including recommendations) on the
collection of information by January 3, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0562. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#e0b0b2a1b394818686a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="2a7a786b795e4b4c4c6a4c4e4b04424259044d455c">[email protected]</span></a>.
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.
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 Pursuant to Dietary
Risk Considerations
OMB Control Number 0910-0562--Extension
This information collection supports FDA guidance. The Food Quality
Protection Act of 1996 (Pub. L. 104-170), which amended the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (Pub. L. 80-104)
and the Federal Food, Drug, and Cosmetic Act (FD&C 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 FIFRA) and for establishing tolerances or exemptions
from the requirement for tolerances for residues of pesticide chemicals
in food commodities (under the FD&C Act). EPA may, for various reasons,
e.g., as part of a systematic review or in response to new information
concerning the safety of a specific pesticide, reassess whether a
tolerance for a pesticide residue continues to meet the safety standard
in section 408 of the FD&C Act (21 U.S.C. 346a). When EPA determines
that a pesticide's tolerance level does not meet that safety standard,
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 FD&C Act, when the registration for
a pesticide is canceled or modified due to, in whole or in part,
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 has
responsibility for monitoring residue levels and enforcing pesticide
tolerances in meat, poultry, catfish, and certain egg products), to
contain a residue of that pesticide that does not comply with the
revoked or lowered tolerance. We 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
FD&C 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 FD&C Act)
states that food containing a residue of such a pesticide shall not be
deemed ``adulterated'' by virtue of the residue, if the residue is
within the former tolerance, and the responsible party can demonstrate
to FDA's satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner that were lawful
under FIFRA.
To assist respondents with the information collection, we have
developed the guidance document entitled ``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 Pursuant to Dietary Risk Considerations'' (May 2005).
The guidance represents FDA's current thinking on its planned
enforcement approach to the channels of trade provision of the FD&C Act
and how that provision relates to FDA-regulated products with residues
of pesticide chemicals for which tolerances have been revoked,
suspended, or modified by EPA under dietary risk considerations. The
guidance can be
[[Page 84147]]
found at the following link: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals-which-tolerances">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals-which-tolerances</a>.
We anticipate that food bearing lawfully applied residues of
pesticide chemicals that are the subject of future EPA action to
revoke, suspend, or modify their tolerances, will remain in the
channels of trade after the applicable tolerance is revoked, suspended,
or modified. If we encounter food bearing a residue of a pesticide
chemical for which the tolerance has been revoked, suspended, or
modified, we intend to address the situation in accordance with
provisions of the guidance. In general, we anticipate that the party
responsible for food found to contain 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 guidance by providing
appropriate documentation to FDA as discussed in the guidance document.
We are not suggesting that firms maintain an inflexible set of
documents where anything less or different would likely be considered
unacceptable. Rather, we are 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
that we anticipate 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.
In the Federal Register of August 2, 2023 (88 FR 50880), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received 2 comments, one of which was not
PRA related and will not be addressed in this document. The other
comment questioned the utility of pesticide application records used to
demonstrate a pesticide was applied at an acceptable time and in a
lawful manner for crops commingled with other commodities. The channels
of trade provision (section 408(l)(5) of the FD&C Act) states that food
containing a residue of such a pesticide shall not be deemed
``adulterated'' by virtue of the residue, if the residue is within the
former tolerance, and the responsible party can demonstrate to FDA's
satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner which were
lawful under FIFRA. We leave it to each firm's discretion to maintain
appropriate documentation to demonstrate that the food was so handled
during the acceptable timeframes. Pesticide spray records may be used
as a documentation to demonstrate the residues in food are from an
application of the pesticide at a time and in a manner which were
lawful under FIFRA.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Submission of documentation........................................ 1 1 1 3 3
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA under dietary risk
considerations in the next 3 years to remain at a low level, as there
have been no changes to the safety standard for pesticide residues in
food since 1996. Thus, we expect the number of submissions we receive
under the guidance document to also remain at a low level. However, to
avoid counting this burden as zero, we have estimated the burden at one
respondent making one submission a year for a total of one annual
submission.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per record
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Develop documentation process...................................... 1 1 1 16 16
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 84148]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26564 Filed 12-1-23; 8:45 am]
BILLING CODE 4164-01-P
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