[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50880-50882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16422]



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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of Pesticide Chemicals, for Which Tolerances Have Been Revoked, 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Tolerances Have Been Revoked, Suspended, or Modified by the 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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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

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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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals-which-tolerances.
    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:

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                                 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