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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 28639-28642 [2020-10272]
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Federal Register / Vol. 85, No. 93 / Wednesday, May 13, 2020 / Notices
households. Specific data elements OCS
is seeking to collect are detailed below.
In 2015, state LIHEAP grantees
provided household-level data to
identify LIHEAP recipients that
participated in the 2015 RECS. ACF is
requesting no changes in the type of
data or the form of data collection for
the 2020 reinstatement of the project.
State LIHEAP grantees will be asked to
furnish data for LIHEAP recipient
households that reside in areas included
in the RECS sample.
For each household, report the
following:
• Name
• Address (including ZIP code)
• Gross Income
• Household Size
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Household or Client ID
Heating assistance awarded
Amount of heating assistance
Date of heating assistance
Cooling assistance awarded
Amount of cooling assistance
Date of cooling assistance
Crisis assistance awarded
Amount of crisis assistance
Date of crisis assistance
Other assistance awarded
Amount of other assistance
Date of other assistance
Presence of children 5 or younger
Presence of adult 60 or older
Presence of disabled
The following are additional optional
data items that grantees can provide if
the data are available in your database:
• Tenancy (i.e., own or rent)
• Type(s) of fuel used
• Heat included in rent
This data will help ACF to analyze
specific information for the LIHEAP
recipient population in accordance with
42 U.S.C. 8629(b)(2), including
information related to benefits targeting,
energy usage, and energy insecurity, and
it will support analysis of LIHEAP data
for the annual Report to Congress and
the annual LIHEAP Home Energy
Notebook. The collection of this data is
authorized in 42 U.S.C. 8629(a).
Respondents: State Governments and
the District of Columbia
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
Action Transmittal Reinstatement without Change of the
FY 2020 RECS LIHEAP Administrative Data Matching ..
51
1
24
1,224
408
Estimated Total Annual Burden
Hours: 408.
As LIHEAP is a block grant, there is
varying capacity to collect and report
data among grantees. The estimated
burden hours displayed above are for
the average LIHEAP grantee. All
LIHEAP grantees have existing data
systems to collect, maintain, and
analyze this data to complete annual
reporting requirements.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s guidance
for industry entitled ‘‘Channels of Trade
Policy for Commodities With Residues
of Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations.’’
SUMMARY:
Authority: 42 U.S.C. 8629(a).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–10230 Filed 5–12–20; 8:45 am]
BILLING CODE 4184–80–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2017–N–2021]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Channels of Trade
Policy for Commodities With Residues
of Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations
AGENCY:
Food and Drug Administration,
HHS.
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Notice.
Submit either electronic or
written comments on the collection of
information by July 13, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 13, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 13, 2020. Comments
DATES:
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received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–2021 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Channels
of Trade Policy for Commodities With
Residues of Pesticide Chemicals, for
Which Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
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19:53 May 12, 2020
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the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
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Channels of Trade Policy for
Commodities With Residues of
Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations
OMB Control Number 0910–0562—
Extension
The Food Quality Protection Act of
1996, which amended the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug,
and Cosmetic Act (FD&C Act),
established a new safety standard for
pesticide residues in food, with an
emphasis on protecting the health of
infants and children. The
Environmental Protection Agency (EPA)
is responsible for regulating the use of
pesticides (under FIFRA) and for
establishing tolerances or exemptions
from the requirement for tolerances for
residues of pesticide chemicals in food
commodities (under the FD&C Act).
EPA may, for various reasons, e.g., as
part of a systematic review or in
response to new information concerning
the safety of a specific pesticide,
reassess whether a tolerance for a
pesticide residue continues to meet the
safety standard in section 408 of the
FD&C Act (21 U.S.C. 346a). When EPA
determines that a pesticide’s tolerance
level does not meet that safety standard,
the registration for the pesticide may be
canceled under FIFRA for all or certain
uses. In addition, the tolerances for that
pesticide may be lowered or revoked for
the corresponding food commodities.
Under section 408(l)(2) of the FD&C
Act, when the registration for a
pesticide is canceled or modified due to,
in whole or in part, dietary risks to
humans posed by residues of that
pesticide chemical on food, the effective
date for the revocation of such tolerance
(or exemption in some cases) must be no
later than 180 days after the date such
cancellation becomes effective or 180
days after the date on which the use of
the canceled pesticide becomes
unlawful under the terms of the
cancellation, whichever is later.
When EPA takes such actions, food
derived from a commodity that was
lawfully treated with the pesticide may
not have cleared the channels of trade
by the time the revocation or new
tolerance level takes effect. The food
could be found by FDA, the Agency that
is responsible for monitoring pesticide
residue levels and enforcing the
pesticide tolerances in most foods (the
U.S. Department of Agriculture has
responsibility for monitoring residue
levels and enforcing pesticide tolerances
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Federal Register / Vol. 85, No. 93 / Wednesday, May 13, 2020 / Notices
in meat, poultry, catfish, and certain egg
products), to contain a residue of that
pesticide that does not comply with the
revoked or lowered tolerance. We would
normally deem such food to be in
violation of the law by virtue of it
bearing an illegal pesticide residue. The
food would be subject to FDA
enforcement action as an ‘‘adulterated’’
food. However, the channels of trade
provision of the FD&C Act addresses the
circumstances under which a food is not
unsafe solely due to the presence of a
residue from a pesticide chemical for
which the tolerance has been revoked,
suspended, or modified by EPA. The
channels of trade provision (section
408(l)(5) of the FD&C Act) states that
food containing a residue of such a
pesticide shall not be deemed
‘‘adulterated’’ by virtue of the residue, if
the residue is within the former
tolerance, and the responsible party can
demonstrate to FDA’s satisfaction that
the residue is present as the result of an
application of the pesticide at a time
and in a manner that were lawful under
FIFRA.
In the Federal Register of May 18,
2005 (70 FR 28544), we announced the
availability of a final guidance
document entitled ‘‘Channels of Trade
Policy for Commodities With Residues
of Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations.’’ The guidance
represents FDA’s current thinking on its
planned enforcement approach to the
channels of trade provision of the FD&C
Act and how that provision relates to
FDA-regulated products with residues
of pesticide chemicals for which
tolerances have been revoked,
suspended, or modified by EPA under
dietary risk considerations. The
guidance can be found at the following
link: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-channelstrade-policy-commodities-residuespesticide-chemicals.
We anticipate that food bearing
lawfully applied residues of pesticide
chemicals that are the subject of future
EPA action to revoke, suspend, or
modify their tolerances, will remain in
the channels of trade after the
applicable tolerance is revoked,
suspended, or modified. If we encounter
food bearing a residue of a pesticide
chemical for which the tolerance has
been revoked, suspended, or modified,
we intend to address the situation in
accordance with provisions of the
guidance. In general, we anticipate that
the party responsible for food found to
contain pesticide chemical residues
(within the former tolerance) after the
tolerance for the pesticide chemical has
been revoked, suspended, or modified
will be able to demonstrate that such
food was handled, e.g., packed or
processed, during the acceptable
28641
timeframes cited in the guidance by
providing appropriate documentation to
FDA as discussed in the guidance
document. We are not suggesting that
firms maintain an inflexible set of
documents where anything less or
different would likely be considered
unacceptable. Rather, we are leaving it
to each firm’s discretion to maintain
appropriate documentation to
demonstrate that the food was so
handled during the acceptable
timeframes.
Examples of documentation that we
anticipate will serve this purpose
consist of documentation associated
with packing codes, batch records, and
inventory records. These are types of
documents that many food processors
routinely generate as part of their basic
food-production operations.
Accordingly, under the PRA, we are
requesting the extension of OMB
approval for the information collection
provisions in the guidance.
Description of Respondents: The
likely respondents to this collection of
information are firms in the produce
and food processing industries that
handle food products that may contain
residues of pesticide chemicals after the
tolerances for the pesticide chemicals
have been revoked, suspended, or
modified.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
We expect the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA under
dietary risk considerations in the next 3
years to remain at a low level, as there
have been no changes to the safety
standard for pesticide residues in food
since 1996. Thus, we expect the number
of submissions we receive under the
guidance document to also remain at a
low level. However, to avoid counting
this burden as zero, we have estimated
the burden at one respondent making
one submission a year for a total of one
annual submission.
We based our estimate of the hours
per response on the assumption that the
information requested in the guidance is
readily available to the submitter. We
expect that the submitter will need to
gather information from appropriate
persons in the submitter’s company and
to prepare this information for
submission to FDA. The submitter will
almost always merely need to copy
existing documentation. We believe that
this effort should take no longer than 3
hours per submission.
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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.
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Federal Register / Vol. 85, No. 93 / Wednesday, May 13, 2020 / Notices
In determining the estimated annual
recordkeeping burden, we estimated
that at least 90 percent of firms maintain
documentation, such as packing codes,
batch records, and inventory records, as
part of their basic food production or
import operations. Therefore, the
recordkeeping burden was calculated as
the time required for the 10 percent of
firms that may not be currently
maintaining this documentation to
develop and maintain documentation,
such as batch records and inventory
records. In previous information
collection requests, this recordkeeping
burden was estimated to be 16 hours per
record. We have retained our prior
estimate of 16 hours per record for the
recordkeeping burden. As shown in
table 1 of this document, we estimate
that one respondent will make one
submission per year. Although we
estimate that only 1 of 10 firms will not
be currently maintaining the necessary
documentation, to avoid counting the
recordkeeping burden for the 1
submission per year as 1/10th of a
recordkeeper, we estimate that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10272 Filed 5–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Questionnaire and Data
Collection Testing, Evaluation, and
Research for the Health Resources and
Services Administration, OMB No.
0915–0379—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
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SUMMARY:
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approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than June 12, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Questionnaire and Data Collection
Testing, Evaluation, and Research for
HRSA, OMB No. 0915–0379—
Extension.
Abstract: The purpose of collections
under this generic clearance is to obtain
formative information from respondents
to develop new questions,
questionnaires and tools and to identify
problems in instruments currently in
use. This clearance request is limited to
formative research activities
emphasizing data collection, toolkit
development, and estimation
procedures and reports for internal
decision-making and development
purposes. This clearance request does
not extend to the collection of data for
public release or policy formation. It is
anticipated that these studies will rely
heavily on qualitative techniques to
meet their objectives. In general, these
activities are not designed to yield
results that meet generally accepted
standards of statistical rigor but are
designed to obtain valuable formative
information to develop more effective
and efficient data collection tools that
will yield more accurate results and
decrease non-response.
A 60-day notice published in the
Federal Register on March 2, 2020, vol.
85, No. 41, pp. 12307–09. There were no
public comments.
Need and Proposed Use of the
Information: HRSA conducts cognitive
interviews, focus groups, usability tests,
field tests/pilot interviews, and
experimental research in laboratory and
field settings, both for applied
questionnaire development and
evaluation as well as more basic
research on response errors in surveys.
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HRSA staff use various techniques to
evaluate interviewer administered, selfadministered, telephone, Computer
Assisted Personal Interviewing (CAPI),
Computer Assisted Self-Interviewing,
Audio Computer-Assisted SelfInterviewing, and web-based
questionnaires. Professionally
recognized procedures are followed in
each information collection activity to
ensure high quality data. Examples of
these procedures could include the
following:
• Monitoring by supervisory staff of a
certain percent of telephone interviews;
• Conducting cognitive interviewing
techniques, including think-aloud
techniques and debriefings;
• Data-entry from mail or paper-andpencil surveys will be computerized
through scannable forms or checked
through double-key entry;
• Observers will monitor focus
groups, and focus group proceedings
will be recorded; and
• Data submitted through on-line
surveys will be subjected to statistical
validation techniques to ensure
accuracy (such as disallowing out-ofrange values).
Each request under this generic
clearance will specify the procedures to
be used. Participation will be fully
voluntary, and non-participation will
have not affect eligibility for, or receipt
of, future HRSA health services research
activities or grant awards, recruitment
or participation. Specific testing and
evaluation procedures will be described
when we notify OMB about each new
request. Appropriate consent
procedures will be customized and used
for each information collection activity
and any collection of personal, privacyprotected information will be handled
in accordance with all applicable
requirements. If the encounter is to be
recorded, the respondent’s permission
to record will be obtained before
beginning the interview.
Screening—When screening is
required (e.g., quota sampling), the
screening will be as brief as possible
and the screening questionnaire will be
provided as part of the submission to
OMB. Collection methods—The
particular information collection
methods used will vary, but may
include the following
• Individual in-depth interviews—Indepth interviews will commonly be
used to ensure that the meaning of a
questionnaire or strategy is understood
by the respondent. When in-depth
interviewing is used, the interview
guide will be provided to OMB for
review.
• Focus groups—Focus groups will be
used to obtain insights into beliefs and
E:\FR\FM\13MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Pages 28639-28642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2021]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Channels of Trade Policy for Commodities With Residues
of Pesticide Chemicals, for Which Tolerances Have Been Revoked,
Suspended, or Modified by the Environmental Protection Agency Pursuant
to Dietary Risk Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's guidance for industry entitled ``Channels of Trade Policy for
Commodities With Residues of Pesticide Chemicals, for Which Tolerances
Have Been Revoked, Suspended, or Modified by the Environmental
Protection Agency Pursuant to Dietary Risk Considerations.''
DATES: Submit either electronic or written comments on the collection
of information by July 13, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 13, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
[[Page 28640]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-2021 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Channels of Trade Policy for
Commodities With Residues of Pesticide Chemicals, for Which Tolerances
Have Been Revoked, Suspended, or Modified by the Environmental
Protection Agency Pursuant to Dietary Risk Considerations.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Channels of Trade Policy for Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have Been Revoked, Suspended, or
Modified by the Environmental Protection Agency Pursuant to Dietary
Risk Considerations
OMB Control Number 0910-0562--Extension
The Food Quality Protection Act of 1996, which amended the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FD&C Act), established a new safety
standard for pesticide residues in food, with an emphasis on protecting
the health of infants and children. The Environmental Protection Agency
(EPA) is responsible for regulating the use of pesticides (under FIFRA)
and for establishing tolerances or exemptions from the requirement for
tolerances for residues of pesticide chemicals in food commodities
(under the FD&C Act). EPA may, for various reasons, e.g., as part of a
systematic review or in response to new information concerning the
safety of a specific pesticide, reassess whether a tolerance for a
pesticide residue continues to meet the safety standard in section 408
of the FD&C Act (21 U.S.C. 346a). When EPA determines that a
pesticide's tolerance level does not meet that safety standard, the
registration for the pesticide may be canceled under FIFRA for all or
certain uses. In addition, the tolerances for that pesticide may be
lowered or revoked for the corresponding food commodities.
Under section 408(l)(2) of the FD&C Act, when the registration for
a pesticide is canceled or modified due to, in whole or in part,
dietary risks to humans posed by residues of that pesticide chemical on
food, the effective date for the revocation of such tolerance (or
exemption in some cases) must be no later than 180 days after the date
such cancellation becomes effective or 180 days after the date on which
the use of the canceled pesticide becomes unlawful under the terms of
the cancellation, whichever is later.
When EPA takes such actions, food derived from a commodity that was
lawfully treated with the pesticide may not have cleared the channels
of trade by the time the revocation or new tolerance level takes
effect. The food could be found by FDA, the Agency that is responsible
for monitoring pesticide residue levels and enforcing the pesticide
tolerances in most foods (the U.S. Department of Agriculture has
responsibility for monitoring residue levels and enforcing pesticide
tolerances
[[Page 28641]]
in meat, poultry, catfish, and certain egg products), to contain a
residue of that pesticide that does not comply with the revoked or
lowered tolerance. We would normally deem such food to be in violation
of the law by virtue of it bearing an illegal pesticide residue. The
food would be subject to FDA enforcement action as an ``adulterated''
food. However, the channels of trade provision of the FD&C Act
addresses the circumstances under which a food is not unsafe solely due
to the presence of a residue from a pesticide chemical for which the
tolerance has been revoked, suspended, or modified by EPA. The channels
of trade provision (section 408(l)(5) of the FD&C Act) states that food
containing a residue of such a pesticide shall not be deemed
``adulterated'' by virtue of the residue, if the residue is within the
former tolerance, and the responsible party can demonstrate to FDA's
satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner that were lawful
under FIFRA.
In the Federal Register of May 18, 2005 (70 FR 28544), we announced
the availability of a final guidance document entitled ``Channels of
Trade Policy for Commodities With Residues of Pesticide Chemicals, for
Which Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk
Considerations.'' The guidance represents FDA's current thinking on its
planned enforcement approach to the channels of trade provision of the
FD&C Act and how that provision relates to FDA-regulated products with
residues of pesticide chemicals for which tolerances have been revoked,
suspended, or modified by EPA under dietary risk considerations. The
guidance can be found at the following link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals.
We anticipate that food bearing lawfully applied residues of
pesticide chemicals that are the subject of future EPA action to
revoke, suspend, or modify their tolerances, will remain in the
channels of trade after the applicable tolerance is revoked, suspended,
or modified. If we encounter food bearing a residue of a pesticide
chemical for which the tolerance has been revoked, suspended, or
modified, we intend to address the situation in accordance with
provisions of the guidance. In general, we anticipate that the party
responsible for food found to contain pesticide chemical residues
(within the former tolerance) after the tolerance for the pesticide
chemical has been revoked, suspended, or modified will be able to
demonstrate that such food was handled, e.g., packed or processed,
during the acceptable timeframes cited in the guidance by providing
appropriate documentation to FDA as discussed in the guidance document.
We are not suggesting that firms maintain an inflexible set of
documents where anything less or different would likely be considered
unacceptable. Rather, we are leaving it to each firm's discretion to
maintain appropriate documentation to demonstrate that the food was so
handled during the acceptable timeframes.
Examples of documentation that we anticipate will serve this
purpose consist of documentation associated with packing codes, batch
records, and inventory records. These are types of documents that many
food processors routinely generate as part of their basic food-
production operations. Accordingly, under the PRA, we are requesting
the extension of OMB approval for the information collection provisions
in the guidance.
Description of Respondents: The likely respondents to this
collection of information are firms in the produce and food processing
industries that handle food products that may contain residues of
pesticide chemicals after the tolerances for the pesticide chemicals
have been revoked, suspended, or modified.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA under dietary risk
considerations in the next 3 years to remain at a low level, as there
have been no changes to the safety standard for pesticide residues in
food since 1996. Thus, we expect the number of submissions we receive
under the guidance document to also remain at a low level. However, to
avoid counting this burden as zero, we have estimated the burden at one
respondent making one submission a year for a total of one annual
submission.
We based our estimate of the hours per response on the assumption
that the information requested in the guidance is readily available to
the submitter. We expect that the submitter will need to gather
information from appropriate persons in the submitter's company and to
prepare this information for submission to FDA. The submitter will
almost always merely need to copy existing documentation. We believe
that this effort should take no longer than 3 hours per submission.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[[Page 28642]]
In determining the estimated annual recordkeeping burden, we
estimated that at least 90 percent of firms maintain documentation,
such as packing codes, batch records, and inventory records, as part of
their basic food production or import operations. Therefore, the
recordkeeping burden was calculated as the time required for the 10
percent of firms that may not be currently maintaining this
documentation to develop and maintain documentation, such as batch
records and inventory records. In previous information collection
requests, this recordkeeping burden was estimated to be 16 hours per
record. We have retained our prior estimate of 16 hours per record for
the recordkeeping burden. As shown in table 1 of this document, we
estimate that one respondent will make one submission per year.
Although we estimate that only 1 of 10 firms will not be currently
maintaining the necessary documentation, to avoid counting the
recordkeeping burden for the 1 submission per year as 1/10th of a
recordkeeper, we estimate that 1 recordkeeper will take 16 hours to
develop and maintain documentation recommended by the guidance.
Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10272 Filed 5-12-20; 8:45 am]
BILLING CODE 4164-01-P
