82_FR_24233 82 FR 24133 - 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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations

82 FR 24133 - 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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 100 (May 25, 2017)

Page Range24133-24136
FR Document2017-10710

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/reinstatement 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entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''

Federal Register, Volume 82 Issue 100 (Thursday, May 25, 2017)
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24133-24136]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0094]


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of Pesticide Chemicals, for Which Tolerances Have Been Revoked, 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.

-----------------------------------------------------------------------

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/reinstatement 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 24, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2008-N-0094 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 will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at

[[Page 24134]]

https://www.regulations.gov or at the Division of Dockets Management 
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 Division of Dockets Management. 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.thefederalregister.org/fdsys/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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under 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, 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 (the 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 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. 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 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

[[Page 24135]]

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: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetalsNaturalToxinsPesticides/ucm077918.htm. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of documentation........................................               1                1                1                3                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 will 
receive under the guidance document will 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop documentation process......................................               1                1                1               16               16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 out of 10 firms will not be currently 
maintaining the necessary documentation, to avoid counting the 
recordkeeping burden for the 1 submission per year as 1/10 of a 
recordkeeper, we estimate that 1 recordkeeper will take 16 hours to 
develop and maintain documentation recommended by the guidance.


[[Page 24136]]


    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10710 Filed 5-24-17; 8:45 am]
BILLING CODE 4164-01-P



                                   Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices                                           24133

        FDA received 10,450,824 prior notices                request for review. Thus, the Agency                  DATES:  Submit either electronic or
     through ABI/ACS during 2014;                            has estimated a total reporting burden of             written comments on the collection of
     11,282,015 during 2015; and 12,153,880                  8 hours.                                              information by July 24, 2017.
     during 2016. Based on this experience,                     FDA received 235 post-hold                         ADDRESSES: You may submit comments
     the Agency estimates that                               submissions under § 1.285(i) during                   as follows:
     approximately 1,700 users of ABI/ACS                    2014; 218 during 2015; and 337 during
     will submit an average of 7,647 prior                   2016. Based on this experience, the                   Electronic Submissions
     notices annually, for a total of                        Agency estimates that 263 post-hold                     Submit electronic comments in the
     12,999,900 prior notices received                       submissions under § 1.285(i) will be                  following way:
     annually through ABI/ACS. FDA                           submitted annually. FDA estimates that                  • Federal eRulemaking Portal:
     estimates the reporting burden for a                    it will take about 1 hour to prepare the              https://www.regulations.gov. Follow the
     prior notice submitted through ABI/ACS                  written notification described in                     instructions for submitting comments.
     to be 10 minutes, or 0.167 hour, per                    § 1.285(i)(2)(i). Thus, the Agency                    Comments submitted electronically,
     notice, for a total burden of 2,170,983                 estimates a total reporting burden of 263             including attachments, to https://
     hours. This estimate takes into                         hours.                                                www.regulations.gov will be posted to
     consideration the burden hours already                                                                        the docket unchanged. Because your
                                                               Dated: May 18, 2017.
     counted in the information collection                                                                         comment will be made public, you are
                                                             Anna K. Abram,                                        solely responsible for ensuring that your
     approval for FDA importer’s entry
     notice (OMB control number 0910–                        Deputy Commissioner for Policy, Planning,             comment does not include any
                                                             Legislation, and Analysis.                            confidential information that you or a
     0046), as previously discussed.
        FDA received 1,529,110 prior notices                 [FR Doc. 2017–10712 Filed 5–24–17; 8:45 am]           third party may not wish to be posted,
     through PNSI during 2014; 1,633,567                     BILLING CODE 4164–01–P                                such as medical information, your or
     during 2015; and 1,768,790 during 2016.                                                                       anyone else’s Social Security number, or
     Based on this experience, the Agency                                                                          confidential business information, such
     estimates that approximately 27,000                     DEPARTMENT OF HEALTH AND                              as a manufacturing process. Please note
     registered users of PNSI will submit an                 HUMAN SERVICES                                        that if you include your name, contact
     average of 70 prior notices annually, for                                                                     information, or other information that
     a total of 1,890,000 prior notices                      Food and Drug Administration
                                                                                                                   identifies you in the body of your
     received annually. FDA estimates the                    [Docket No. FDA–2008–N–0094]                          comments, that information will be
     reporting burden for a prior notice                                                                           posted on https://www.regulations.gov.
     submitted through PNSI to be 23                         Agency Information Collection                           • If you want to submit a comment
     minutes, or 0.384 hour, per notice, for                 Activities; Proposed Collection;                      with confidential information that you
     a total burden of 725,760 hours.                        Comment Request; Channels of Trade                    do not wish to be made available to the
        FDA received 7,265 cancellations of                  Policy for Commodities With Residues                  public, submit the comment as a
     prior notices through ABI/ACS during                    of Pesticide Chemicals, for Which                     written/paper submission and in the
     2014; 7,910 during 2015; and 5,948                      Tolerances Have Been Revoked,                         manner detailed (see ‘‘Written/Paper
     during 2016. Based on this experience,                  Suspended, or Modified by the                         Submissions’’ and ‘‘Instructions’’).
     the Agency estimates that                               Environmental Protection Agency
     approximately 7,040 users of ABI/ACS                                                                          Written/Paper Submissions
                                                             Pursuant to Dietary Risk
     will submit an average of 1 cancellation                Considerations                                           Submit written/paper submissions as
     annually, for a total of 7,040                                                                                follows:
     cancellations received annually through                 AGENCY:    Food and Drug Administration,                 • Mail/Hand delivery/Courier (for
     ABI/ACS. FDA estimates the reporting                    HHS.                                                  written/paper submissions): Division of
     burden for a cancellation submitted                     ACTION:   Notice.                                     Dockets Management (HFA–305), Food
     through ABI/ACS to be 15 minutes, or                                                                          and Drug Administration, 5630 Fishers
     0.25 hour, per cancellation, for a total                SUMMARY:   The Food and Drug                          Lane, Rm. 1061, Rockville, MD 20852.
     burden of 1,760 hours.                                  Administration (FDA or Agency) is                        • For written/paper comments
        FDA received 36,324 cancellations of                 announcing an opportunity for public                  submitted to the Division of Dockets
     prior notices through PNSI during 2014;                 comment on the proposed collection of                 Management, FDA will post your
     39,553 during 2015; and 29,743 during                   certain information by the Agency.                    comment, as well as any attachments,
     2016. Based on this experience, the                     Under the Paperwork Reduction Act of                  except for information submitted,
     Agency estimates that approximately                     1995 (PRA), Federal Agencies are                      marked and identified, as confidential,
     35,208 registered users of PNSI will                    required to publish notice in the                     if submitted as detailed in
     submit an average of 1 cancellation                     Federal Register concerning each                      ‘‘Instructions.’’
     annually, for a total of 35,208                         proposed collection of information,                      Instructions: All submissions received
     cancellations received annually. FDA                    including each proposed extension/                    must include the Docket No. FDA–
     estimates the reporting burden for a                    reinstatement of an existing collection               2008–N–0094 for ‘‘Agency Information
     cancellation submitted through PNSI to                  of information, and to allow 60 days for              Collection Activities; Proposed
     be 15 minutes, or 0.25 hour, per                        public comment in response to the                     Collection; Comment Request; Channels
     cancellation, for a total burden of 8,802               notice. This notice solicits comments on              of Trade Policy for Commodities With
     hours.                                                  the information collection provisions of              Residues of Pesticide Chemicals, for
        FDA has not received any requests for                FDA’s guidance for industry entitled                  Which Tolerances Have Been Revoked,
     review under § 1.283(d) or § 1.285(j) in                ‘‘Channels of Trade Policy for                        Suspended, or Modified by the
     the last 3 years; therefore, the Agency                 Commodities With Residues of Pesticide                Environmental Protection Agency
     estimates that one or fewer requests for                Chemicals, for Which Tolerances Have                  Pursuant to Dietary Risk
     review will be submitted annually. FDA                  Been Revoked, Suspended, or Modified                  Considerations.’’ Received comments
     estimates that it will take a requestor                 by the Environmental Protection Agency                will be placed in the docket and, except
     about 8 hours to prepare the factual and                Pursuant to Dietary Risk                              for those submitted as ‘‘Confidential
     legal information necessary to prepare a                Considerations.’’                                     Submissions,’’ publicly viewable at


VerDate Sep<11>2014   18:04 May 24, 2017   Jkt 241001   PO 00000   Frm 00039   Fmt 4703   Sfmt 4703   E:\FR\FM\25MYN1.SGM   25MYN1


     24134                         Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices

     https://www.regulations.gov or at the                   public submit reports, keep records, or               level does not meet that safety standard,
     Division of Dockets Management                          provide information to a third party.                 the registration for the pesticide may be
     between 9 a.m. and 4 p.m., Monday                       Section 3506(c)(2)(A) of the PRA (44                  canceled under FIFRA for all or certain
     through Friday.                                         U.S.C. 3506(c)(2)(A)) requires Federal                uses. In addition, the tolerances for that
        • Confidential Submissions—To                        Agencies to provide a 60-day notice in                pesticide may be lowered or revoked for
     submit a comment with confidential                      the Federal Register concerning each                  the corresponding food commodities.
     information that you do not wish to be                  proposed collection of information,                   Under section 408(l)(2) of the FD&C Act,
     made publicly available, submit your                    including each proposed extension of an               when the registration for a pesticide is
     comments only as a written/paper                        existing collection of information,                   canceled or modified due to, in whole
     submission. You should submit two                       before submitting the collection to OMB               or in part, dietary risks to humans posed
     copies total. One copy will include the                 for approval. To comply with this                     by residues of that pesticide chemical
     information you claim to be confidential                requirement, FDA is publishing notice                 on food, the effective date for the
     with a heading or cover note that states                of the proposed collection of                         revocation of such tolerance (or
     ‘‘THIS DOCUMENT CONTAINS                                information set forth in this document.               exemption in some cases) must be no
     CONFIDENTIAL INFORMATION.’’ The                            With respect to the following                      later than 180 days after the date such
     Agency will review this copy, including                 collection of information, FDA invites                cancellation becomes effective or 180
     the claimed confidential information, in                comments on these topics: (1) Whether                 days after the date on which the use of
     its consideration of comments. The                      the proposed collection of information                the canceled pesticide becomes
     second copy, which will have the                        is necessary for the proper performance               unlawful under the terms of the
     claimed confidential information                        of FDA’s functions, including whether                 cancellation, whichever is later.
     redacted/blacked out, will be available                 the information will have practical                      When EPA takes such actions, food
     for public viewing and posted on                        utility; (2) the accuracy of FDA’s                    derived from a commodity that was
     https://www.regulations.gov. Submit                     estimate of the burden of the proposed                lawfully treated with the pesticide may
     both copies to the Division of Dockets                  collection of information, including the              not have cleared the channels of trade
     Management. If you do not wish your                     validity of the methodology and                       by the time the revocation or new
     name and contact information to be                      assumptions used; (3) ways to enhance                 tolerance level takes effect. The food
     made publicly available, you can                        the quality, utility, and clarity of the              could be found by FDA, the Agency that
     provide this information on the cover                   information to be collected; and (4)                  is responsible for monitoring pesticide
     sheet and not in the body of your                       ways to minimize the burden of the                    residue levels and enforcing the
     comments and you must identify this                     collection of information on                          pesticide tolerances in most foods (the
     information as ‘‘confidential.’’ Any                    respondents, including through the use                U.S. Department of Agriculture has
     information marked as ‘‘confidential’’                  of automated collection techniques,                   responsibility for monitoring residue
     will not be disclosed except in                         when appropriate, and other forms of                  levels and enforcing pesticide tolerances
     accordance with 21 CFR 10.20 and other                  information technology.                               in egg products and most meat and
     applicable disclosure law. For more                                                                           poultry products), to contain a residue
                                                             Channels of Trade Policy for
     information about FDA’s posting of                                                                            of that pesticide that does not comply
                                                             Commodities With Residues of
     comments to public dockets, see 80 FR                                                                         with the revoked or lowered tolerance.
                                                             Pesticide Chemicals, for Which
     56469, September 18, 2015, or access                                                                          We would normally deem such food to
                                                             Tolerances Have Been Revoked,
     the information at: https://www.gpo.gov/                                                                      be in violation of the law by virtue of
                                                             Suspended, or Modified by the
     fdsys/pkg/FR-2015-09-18/pdf/2015-                                                                             it bearing an illegal pesticide residue.
                                                             Environmental Protection Agency
     23389.pdf.                                                                                                    The food would be subject to FDA
                                                             Pursuant to Dietary Risk
        Docket: For access to the docket to                                                                        enforcement action as an ‘‘adulterated’’
                                                             Considerations—OMB Control Number
     read background documents or the                                                                              food. However, the channels of trade
                                                             0910–0562—Extension
     electronic and written/paper comments                                                                         provision of the FD&C Act addresses the
                                                                The Food Quality Protection Act of                 circumstances under which a food is not
     received, go to https://                                1996, which amended the Federal
     www.regulations.gov and insert the                                                                            unsafe solely due to the presence of a
                                                             Insecticide, Fungicide, and Rodenticide               residue from a pesticide chemical for
     docket number, found in brackets in the                 Act (FIFRA) and the Federal Food, Drug,
     heading of this document, into the                                                                            which the tolerance has been revoked,
                                                             and Cosmetic Act (the FD&C Act),                      suspended, or modified by EPA. The
     ‘‘Search’’ box and follow the prompts                   established a new safety standard for                 channels of trade provision (section 408
     and/or go to the Division of Dockets                    pesticide residues in food, with an                   (l)(5) of the FD&C Act) states that food
     Management, 5630 Fishers Lane, Rm.                      emphasis on protecting the health of                  containing a residue of such a pesticide
     1061, Rockville, MD 20852.                              infants and children. The                             shall not be deemed ‘‘adulterated’’ by
     FOR FURTHER INFORMATION CONTACT: Ila                    Environmental Protection Agency (EPA)                 virtue of the residue, if the residue is
     S. Mizrachi, Office of Operations, Food                 is responsible for regulating the use of              within the former tolerance, and the
     and Drug Administration, Three White                    pesticides (under FIFRA) and for                      responsible party can demonstrate to
     Flint North, 10A63, 11601 Landsdown                     establishing tolerances or exemptions                 FDA’s satisfaction that the residue is
     St., North Bethesda, MD 20852, 301–                     from the requirement for tolerances for               present as the result of an application of
     796–7726, PRAStaff@fda.hhs.gov.                         residues of pesticide chemicals in food               the pesticide at a time and in a manner
     SUPPLEMENTARY INFORMATION: Under the                    commodities (under the FD&C Act).                     that were lawful under FIFRA.
     PRA (44 U.S.C. 3501–3520), Federal                      EPA may, for various reasons, e.g., as                   In the Federal Register of May 18,
     Agencies must obtain approval from the                  part of a systematic review or in                     2005 (70 FR 28544), we announced the
     Office of Management and Budget                         response to new information concerning                availability of a guidance document
     (OMB) for each collection of                            the safety of a specific pesticide,                   entitled ‘‘Channels of Trade Policy for
     information they conduct or sponsor.                    reassess whether a tolerance for a                    Commodities With Residues of Pesticide
     ‘‘Collection of information’’ is defined                pesticide residue continues to meet the               Chemicals, for Which Tolerances Have
     in 44 U.S.C. 3502(3) and 5 CFR                          safety standard in section 408 of the                 Been Revoked, Suspended, or Modified
     1320.3(c) and includes Agency requests                  FD&C Act (21 U.S.C. 346a). When EPA                   by the Environmental Protection Agency
     or requirements that members of the                     determines that a pesticide’s tolerance               Pursuant to Dietary Risk


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                                       Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices                                               24135

     Considerations.’’ The guidance                                chemical for which the tolerance has                  handled during the acceptable
     represents FDA’s current thinking on its                      been revoked, suspended, or modified,                 timeframes.
     planned enforcement approach to the                           we intend to address the situation in                    Examples of documentation that we
     channels of trade provision of the FD&C                       accordance with provisions of the                     anticipate will serve this purpose
     Act and how that provision relates to                         guidance. In general, we anticipate that              consist of documentation associated
     FDA-regulated products with residues                          the party responsible for food found to               with packing codes, batch records, and
     of pesticide chemicals for which                              contain pesticide chemical residues                   inventory records. These are types of
     tolerances have been revoked,                                 (within the former tolerance) after the               documents that many food processors
     suspended, or modified by EPA under                           tolerance for the pesticide chemical has              routinely generate as part of their basic
     dietary risk considerations. The                              been revoked, suspended, or modified                  food-production operations.
     guidance can be found at the following                        will be able to demonstrate that such                 Accordingly, under the PRA, we are
     link: http://www.fda.gov/Food/                                food was handled, e.g., packed or                     requesting the extension of OMB
     GuidanceRegulation/Guidance                                                                                         approval for the information collection
                                                                   processed, during the acceptable
     DocumentsRegulatoryInformation/                                                                                     provisions in the guidance.
                                                                   timeframes cited in the guidance by
     ChemicalContaminantsMetals                                                                                             Description of Respondents: The
     NaturalToxinsPesticides/                                      providing appropriate documentation to                likely respondents to this collection of
     ucm077918.htm. We anticipate that                             FDA as discussed in the guidance                      information are firms in the produce
     food bearing lawfully applied residues                        document. We are not suggesting that                  and food processing industries that
     of pesticide chemicals that are the                           firms maintain an inflexible set of                   handle food products that may contain
     subject of future EPA action to revoke,                       documents where anything less or                      residues of pesticide chemicals after the
     suspend, or modify their tolerances, will                     different would likely be considered                  tolerances for the pesticide chemicals
     remain in the channels of trade after the                     unacceptable. Rather, we are leaving it               have been revoked, suspended, or
     applicable tolerance is revoked,                              to each firm’s discretion to maintain                 modified.
     suspended, or modified. If we encounter                       appropriate documentation to                             FDA estimates the burden of this
     food bearing a residue of a pesticide                         demonstrate that the food was so                      collection of information as follows:

                                                        TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                      Number of                              Average
                                                                                   Number of                           Total annual
                                     Activity                                                       responses per                          burden per   Total hours
                                                                                  respondents                           responses
                                                                                                      respondent                            response

     Submission of documentation ..............................................         1                   1                1                 3            3
        1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


       We expect the total number of                               the guidance document will also remain                expect that the submitter will need to
     pesticide tolerances that are revoked,                        at a low level. However, to avoid                     gather information from appropriate
     suspended, or modified by EPA under                           counting this burden as zero, we have                 persons in the submitter’s company and
     dietary risk considerations in the next 3                     estimated the burden at one respondent                to prepare this information for
     years to remain at a low level, as there                      making one submission a year for a total              submission to FDA. The submitter will
     have been no changes to the safety                            of one annual submission.                             almost always merely need to copy
     standard for pesticide residues in food                          We based our estimate of the hours                 existing documentation. We believe that
     since 1996. Thus, we expect the number                        per response on the assumption that the               this effort should take no longer than 3
     of submissions we will receive under                          information requested in the guidance is              hours per submission.
                                                                   readily available to the submitter. We
                                                     TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                       Number of                          Average
                                                                                    Number of                          Total annual
                                     Activity                                                         records per                        burden per     Total hours
                                                                                  recordkeepers                          records
                                                                                                     recordkeeper                      recordkeeping

     Develop documentation process .........................................            1                   1                1                16            16
        1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


        In determining the estimated annual                        such as batch records and inventory                   necessary documentation, to avoid
     recordkeeping burden, we estimated                            records. In previous information                      counting the recordkeeping burden for
     that at least 90 percent of firms maintain                    collection requests, this recordkeeping               the 1 submission per year as 1/10 of a
     documentation, such as packing codes,                         burden was estimated to be 16 hours per               recordkeeper, we estimate that 1
     batch records, and inventory records, as                      record. We have retained our prior                    recordkeeper will take 16 hours to
     part of their basic food production or                        estimate of 16 hours per record for the               develop and maintain documentation
     import operations. Therefore, the                             recordkeeping burden. As shown in                     recommended by the guidance.
     recordkeeping burden was calculated as                        table 1 of this document, we estimate
     the time required for the 10 percent of                       that one respondent will make one
     firms that may not be currently                               submission per year. Although we
     maintaining this documentation to                             estimate that only 1 out of 10 firms will
     develop and maintain documentation,                           not be currently maintaining the



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     24136                                    Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices

       Dated: May 18, 2017.                                                      ACTION:       Notice.                                                       statements for the information
     Anna K. Abram,                                                                                                                                          collections are available on the Internet
     Deputy Commissioner for Policy, Planning,
                                                                                 SUMMARY:    The Food and Drug                                               at http://www.reginfo.gov/public/do/
     Legislation, and Analysis.                                                  Administration (FDA) is publishing a
                                                                                                                                                             PRAMain. An Agency may not conduct
                                                                                 list of information collections that have
     [FR Doc. 2017–10710 Filed 5–24–17; 8:45 am]                                                                                                             or sponsor, and a person is not required
                                                                                 been approved by the Office of
     BILLING CODE 4164–01–P
                                                                                 Management and Budget (OMB) under                                           to respond to, a collection of
                                                                                 the Paperwork Reduction Act of 1995.                                        information unless it displays a
                                                                                 FOR FURTHER INFORMATION CONTACT: Ila
                                                                                                                                                             currently valid OMB control number.
     DEPARTMENT OF HEALTH AND
     HUMAN SERVICES                                                              S. Mizrachi, FDA PRA Staff, Office of
                                                                                 Operations, Food and Drug
     Food and Drug Administration                                                Administration, Three White Flint
     [Docket Nos. FDA–2013–N–1423; FDA–
                                                                                 North, 11601 Landsdown St., North
     2013–N–0730; FDA–2012–N–0977; FDA–                                          Bethesda, MD 20852, 301–796–7726,
     2013–N–0557; FDA–2009–N–0380; FDA–                                          PRAStaff@fda.hhs.gov.
     2013–N–0514; FDA–2013–N–0190; FDA–                                          SUPPLEMENTARY INFORMATION: The
     2010–D–0350; FDA–2016–N–0538; FDA–                                          following is a list of FDA information
     2013–N–1428]                                                                collections recently approved by OMB
                                                                                 under section 3507 of the Paperwork
     Agency Information Collection
                                                                                 Reduction Act of 1995 (44 U.S.C. 3507).
     Activities; Announcement of Office of
                                                                                 The OMB control number and
     Management and Budget Approvals
                                                                                 expiration date of OMB approval for
     AGENCY:        Food and Drug Administration,                                each information collection are shown
     HHS.                                                                        in table 1. Copies of the supporting

                                                       TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
                                                                                                                                                                                   OMB control   Date approval
                                                                             Title of collection                                                                                      No.           expires

     Importer’s Entry Notice ............................................................................................................................................            0910–0046      12/31/2019
     Threshold of Regulation for Substances Used in Food-Contact Articles ...............................................................                                            0910–0298      12/31/2019
     Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children
       and Adolescents ...................................................................................................................................................           0910–0312      12/31/2019
     Postmarket Surveillance of Medical Devices ..........................................................................................................                           0910–0449      12/31/2019
     Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications ..........................                                                            0910–0523      12/31/2019
     Administrative Procedures for Clinical laboratory Improvement Amendments of 1988 Categorization (42 CFR
       493.17) .................................................................................................................................................................     0910–0607      12/31/2019
     Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986; as amended by
       the Family Smoking Prevention and Tobacco Control Act ..................................................................................                                      0910–0671      12/31/2019
     Guidance for Industry on Tobacco Retailer Training Programs .............................................................................                                       0910–0745      12/31/2019
     Animation in Direct-to-Consumer Advertising .........................................................................................................                           0910–0826      12/31/2019
     Guidance for Industry: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities
       Under Section 503B of the Federal Food, Drug, and Cosmetic Act ...................................................................                                            0910–0827      12/31/2019



       Dated: May 18, 2017.                                                      29, 2017. The BSC will provide input to                                     Information about the meeting and
     Anna K. Abram,                                                              the NTP on programmatic activities and                                      registration is available at http://
     Deputy Commissioner for Policy, Planning,                                   issues. The preliminary agenda has been                                     ntp.niehs.nih.gov/go/165.
     Legislation, and Analysis.                                                  updated and topics include reports from
                                                                                 the NIEHS/NTP Director and NTP                                              DATES:  Meeting: June 29, 2017; it begins
     [FR Doc. 2017–10711 Filed 5–24–17; 8:45 am]
                                                                                 Associate Director, and presentations on                                    at 8:30 a.m. Eastern Standard Time
     BILLING CODE 4164–01–P
                                                                                 programmatic activities including NTP                                       (EST) until adjournment.
                                                                                 efforts and challenges toward studying                                        Dated: May 11, 2017.
     DEPARTMENT OF HEALTH AND                                                    real world exposures and a state of the                                     John R. Bucher,
     HUMAN SERVICES                                                              science evaluation of transgenerational                                     Associate Director, National Toxicology
                                                                                 inheritance of health effects. This                                         Program.
     National Institutes of Health                                               meeting will also provide opportunity                                       [FR Doc. 2017–10695 Filed 5–24–17; 8:45 am]
                                                                                 for input on an effort being coordinated
     National Toxicology Program Board of                                                                                                                    BILLING CODE 4140–01–P
                                                                                 by the Interagency Coordinating
     Scientific Counselors; Announcement
                                                                                 Committee on the Validation of
     of Meeting; Request for Comments;
                                                                                 Alternative Methods (ICCVAM) to
     Amended Notice
                                                                                 explore new approaches for evaluating
     SUMMARY:   This notice amends Federal                                       the safety of chemicals and medical
     Register notice 82 FR 20484, published                                      products in the United States. All other
     May 2, 2017, announcing the National                                        information in the original notice has
     Toxicology Program (NTP) Board of                                           not changed. Interested individuals
     Scientific Counselors (BSC) meeting and                                     should visit the meeting Web page to
     requesting comments. The deadline for                                       stay abreast of agenda topics and other
     registration has been changed to June                                       arrangements for the meeting.


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Document Created: 2018-11-08 08:52:34
Document Modified: 2018-11-08 08:52:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by July 24, 2017.
ContactIla S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation82 FR 24133 

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