[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Pages 28639-28642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2021]


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of Pesticide Chemicals, for Which Tolerances Have Been Revoked, 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 or Agency) 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Have Been Revoked, Suspended, or Modified by the Environmental 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: Submit either electronic or written comments on the collection 
of information by July 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 13, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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'').

[[Page 28640]]

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-2017-N-2021 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.
     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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 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

    The Food Quality Protection Act of 1996, which amended the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) 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

[[Page 28641]]

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.
    In the Federal Register of May 18, 2005 (70 FR 28544), we announced 
the availability of a final 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.'' 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.
    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. Accordingly, under the PRA, we are requesting 
the extension of OMB approval for the information collection provisions 
in the guidance.
    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:

                                                     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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.
    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.
    We based our estimate of the hours per response on the assumption 
that the information requested in the guidance is readily available to 
the submitter. We expect that the submitter will need to gather 
information from appropriate persons in the submitter's company and to 
prepare this information for submission to FDA. The submitter will 
almost always merely need to copy existing documentation. We believe 
that this effort should take no longer than 3 hours per submission.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                      Number of                        Average burden
                           Activity                                 Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
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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 28642]]

    In determining the estimated annual recordkeeping burden, we 
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 import operations. Therefore, the 
recordkeeping burden was calculated as the time required for the 10 
percent of firms that may not be currently maintaining this 
documentation to develop and maintain documentation, such as batch 
records and inventory records. In previous information collection 
requests, this recordkeeping burden was estimated to be 16 hours per 
record. We have retained our prior estimate of 16 hours per record for 
the recordkeeping burden. As shown in table 1 of this document, we 
estimate that one respondent will make one submission per year. 
Although we estimate that only 1 of 10 firms will not be currently 
maintaining the necessary documentation, to avoid counting the 
recordkeeping burden for the 1 submission per year as 1/10th of a 
recordkeeper, we estimate that 1 recordkeeper will take 16 hours to 
develop and maintain documentation recommended by the guidance.

    Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10272 Filed 5-12-20; 8:45 am]
 BILLING CODE 4164-01-P


