Notice2023-16422
Agency Information Collection Activities; Proposed Collection; 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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
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Published
August 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's guidance for industry entitled "Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations."
Full Text
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<title>Federal Register, Volume 88 Issue 147 (Wednesday, August 2, 2023)</title>
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[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50880-50882]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16422]
[[Page 50880]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2564]
Agency Information Collection Activities; Proposed Collection;
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of Pesticide Chemicals, for Which Tolerances Have Been Revoked,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, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's guidance for industry 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.''
DATES: Either electronic or written comments on the collection of
information must be submitted by October 2, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 2, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-2564 for ``Agency Information Collection Activities;
Proposed Collection; 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.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#bfefedfeeccbded9d9ffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="49191b081a3d282f2f092f2d286721213a672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice
[[Page 50881]]
of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
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 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.
We estimate the burden of this collection of information as
follows:
[[Page 50882]]
Table 1--Estimated Annual Reporting Burden \1\
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No. of
No. of responses Total annual Average
Activity respondents per responses burden per Total hours
respondent 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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No. of Average
Activity No. of records per Total annual burden per Total hours
recordkeepers recordkeeper records 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.
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: July 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16422 Filed 8-1-23; 8:45 am]
BILLING CODE 4164-01-P
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