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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 24133-24136 [2017-10710]
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
FDA received 10,450,824 prior notices
through ABI/ACS during 2014;
11,282,015 during 2015; and 12,153,880
during 2016. Based on this experience,
the Agency estimates that
approximately 1,700 users of ABI/ACS
will submit an average of 7,647 prior
notices annually, for a total of
12,999,900 prior notices received
annually through ABI/ACS. FDA
estimates the reporting burden for a
prior notice submitted through ABI/ACS
to be 10 minutes, or 0.167 hour, per
notice, for a total burden of 2,170,983
hours. This estimate takes into
consideration the burden hours already
counted in the information collection
approval for FDA importer’s entry
notice (OMB control number 0910–
0046), as previously discussed.
FDA received 1,529,110 prior notices
through PNSI during 2014; 1,633,567
during 2015; and 1,768,790 during 2016.
Based on this experience, the Agency
estimates that approximately 27,000
registered users of PNSI will submit an
average of 70 prior notices annually, for
a total of 1,890,000 prior notices
received annually. FDA estimates the
reporting burden for a prior notice
submitted through PNSI to be 23
minutes, or 0.384 hour, per notice, for
a total burden of 725,760 hours.
FDA received 7,265 cancellations of
prior notices through ABI/ACS during
2014; 7,910 during 2015; and 5,948
during 2016. Based on this experience,
the Agency estimates that
approximately 7,040 users of ABI/ACS
will submit an average of 1 cancellation
annually, for a total of 7,040
cancellations received annually through
ABI/ACS. FDA estimates the reporting
burden for a cancellation submitted
through ABI/ACS to be 15 minutes, or
0.25 hour, per cancellation, for a total
burden of 1,760 hours.
FDA received 36,324 cancellations of
prior notices through PNSI during 2014;
39,553 during 2015; and 29,743 during
2016. Based on this experience, the
Agency estimates that approximately
35,208 registered users of PNSI will
submit an average of 1 cancellation
annually, for a total of 35,208
cancellations received annually. FDA
estimates the reporting burden for a
cancellation submitted through PNSI to
be 15 minutes, or 0.25 hour, per
cancellation, for a total burden of 8,802
hours.
FDA has not received any requests for
review under § 1.283(d) or § 1.285(j) in
the last 3 years; therefore, the Agency
estimates that one or fewer requests for
review will be submitted annually. FDA
estimates that it will take a requestor
about 8 hours to prepare the factual and
legal information necessary to prepare a
VerDate Sep<11>2014
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request for review. Thus, the Agency
has estimated a total reporting burden of
8 hours.
FDA received 235 post-hold
submissions under § 1.285(i) during
2014; 218 during 2015; and 337 during
2016. Based on this experience, the
Agency estimates that 263 post-hold
submissions under § 1.285(i) will be
submitted annually. FDA estimates that
it will take about 1 hour to prepare the
written notification described in
§ 1.285(i)(2)(i). Thus, the Agency
estimates a total reporting burden of 263
hours.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10712 Filed 5–24–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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.’’
SUMMARY:
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24133
Submit either electronic or
written comments on the collection of
information by July 24, 2017.
ADDRESSES: You may submit comments
as follows:
DATES:
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
E:\FR\FM\25MYN1.SGM
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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, PRAStaff@fda.hhs.gov.
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
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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
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Sfmt 4703
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
E:\FR\FM\25MYN1.SGM
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
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/Food/
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/
ChemicalContaminantsMetals
NaturalToxinsPesticides/
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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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,
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18:04 May 24, 2017
Jkt 241001
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
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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.
E:\FR\FM\25MYN1.SGM
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, FDA PRA Staff, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 11601 Landsdown St., North
Bethesda, MD 20852, 301–796–7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
SUMMARY:
[FR Doc. 2017–10710 Filed 5–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–1423; FDA–
2013–N–0730; FDA–2012–N–0977; FDA–
2013–N–0557; FDA–2009–N–0380; FDA–
2013–N–0514; FDA–2013–N–0190; FDA–
2010–D–0350; FDA–2016–N–0538; FDA–
2013–N–1428]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Importer’s Entry Notice ............................................................................................................................................
Threshold of Regulation for Substances Used in Food-Contact Articles ...............................................................
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children
and Adolescents ...................................................................................................................................................
Postmarket Surveillance of Medical Devices ..........................................................................................................
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications ..........................
Administrative Procedures for Clinical laboratory Improvement Amendments of 1988 Categorization (42 CFR
493.17) .................................................................................................................................................................
Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986; as amended by
the Family Smoking Prevention and Tobacco Control Act ..................................................................................
Guidance for Industry on Tobacco Retailer Training Programs .............................................................................
Animation in Direct-to-Consumer Advertising .........................................................................................................
Guidance for Industry: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act ...................................................................
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10711 Filed 5–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments;
Amended Notice
This notice amends Federal
Register notice 82 FR 20484, published
May 2, 2017, announcing the National
Toxicology Program (NTP) Board of
Scientific Counselors (BSC) meeting and
requesting comments. The deadline for
registration has been changed to June
SUMMARY:
VerDate Sep<11>2014
18:04 May 24, 2017
Jkt 241001
29, 2017. The BSC will provide input to
the NTP on programmatic activities and
issues. The preliminary agenda has been
updated and topics include reports from
the NIEHS/NTP Director and NTP
Associate Director, and presentations on
programmatic activities including NTP
efforts and challenges toward studying
real world exposures and a state of the
science evaluation of transgenerational
inheritance of health effects. This
meeting will also provide opportunity
for input on an effort being coordinated
by the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) to
explore new approaches for evaluating
the safety of chemicals and medical
products in the United States. All other
information in the original notice has
not changed. Interested individuals
should visit the meeting Web page to
stay abreast of agenda topics and other
arrangements for the meeting.
PO 00000
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Fmt 4703
Sfmt 9990
Date approval
expires
0910–0046
0910–0298
12/31/2019
12/31/2019
0910–0312
0910–0449
0910–0523
12/31/2019
12/31/2019
12/31/2019
0910–0607
12/31/2019
0910–0671
0910–0745
0910–0826
12/31/2019
12/31/2019
12/31/2019
0910–0827
12/31/2019
Information about the meeting and
registration is available at https://
ntp.niehs.nih.gov/go/165.
Meeting: June 29, 2017; it begins
at 8:30 a.m. Eastern Standard Time
(EST) until adjournment.
DATES:
Dated: May 11, 2017.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2017–10695 Filed 5–24–17; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\25MYN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24133-24136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10710]
-----------------------------------------------------------------------
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.gpo.gov/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,
PRAStaff@fda.hhs.gov.
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: https://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
