Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 84146-84148 [2023-26564]
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<![CDATA[
84146
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522(a)(3).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–26552 Filed 12–1–23; 8:45 am]
BILLING CODE 4184–45–P
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Tolerances Have Been Revoked,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
OMB Control Number 0910–0562—
Extension
Food and Drug Administration
This information collection supports
FDA guidance. The Food Quality
Protection Act of 1996 (Pub. L. 104–
170), which amended the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (Pub. L. 80–104) and the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), established a new safety
standard for pesticide residues in food,
with an emphasis on protecting the
health of infants and children. The
Environmental Protection Agency (EPA)
is responsible for regulating the use of
pesticides (under FIFRA) and for
establishing tolerances or exemptions
from the requirement for tolerances for
residues of pesticide chemicals in food
commodities (under the FD&C Act).
EPA may, for various reasons, e.g., as
part of a systematic review or in
response to new information concerning
the safety of a specific pesticide,
reassess whether a tolerance for a
pesticide residue continues to meet the
safety standard in section 408 of the
FD&C Act (21 U.S.C. 346a). When EPA
determines that a pesticide’s tolerance
level does not meet that safety standard,
the registration for the pesticide may be
canceled under FIFRA for all or certain
uses. In addition, the tolerances for that
pesticide may be lowered or revoked for
the corresponding food commodities.
Under section 408(l)(2) of the FD&C
Act, when the registration for a
pesticide is canceled or modified due to,
in whole or in part, dietary risks to
humans posed by residues of that
pesticide chemical on food, the effective
[Docket No. FDA–2023–N–2564]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 3,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
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. The OMB
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
control number for this information
collection is 0910–0562. Also include
the FDA docket number found in
brackets in the heading of this
document.
VerDate Sep<11>2014
19:20 Dec 01, 2023
Jkt 262001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
date for the revocation of such tolerance
(or exemption in some cases) must be no
later than 180 days after the date such
cancellation becomes effective or 180
days after the date on which the use of
the canceled pesticide becomes
unlawful under the terms of the
cancellation, whichever is later.
When EPA takes such actions, food
derived from a commodity that was
lawfully treated with the pesticide may
not have cleared the channels of trade
by the time the revocation or new
tolerance level takes effect. The food
could be found by FDA, the Agency that
is responsible for monitoring pesticide
residue levels and enforcing the
pesticide tolerances in most foods (the
U.S. Department of Agriculture has
responsibility for monitoring residue
levels and enforcing pesticide tolerances
in meat, poultry, catfish, and certain egg
products), to contain a residue of that
pesticide that does not comply with the
revoked or lowered tolerance. We would
normally deem such food to be in
violation of the law by virtue of it
bearing an illegal pesticide residue. The
food would be subject to FDA
enforcement action as an ‘‘adulterated’’
food. However, the channels of trade
provision of the FD&C Act addresses the
circumstances under which a food is not
unsafe solely due to the presence of a
residue from a pesticide chemical for
which the tolerance has been revoked,
suspended, or modified by EPA. The
channels of trade provision (section
408(l)(5) of the FD&C Act) states that
food containing a residue of such a
pesticide shall not be deemed
‘‘adulterated’’ by virtue of the residue, if
the residue is within the former
tolerance, and the responsible party can
demonstrate to FDA’s satisfaction that
the residue is present as the result of an
application of the pesticide at a time
and in a manner that were lawful under
FIFRA.
To assist respondents with the
information collection, we have
developed the guidance document
entitled ‘‘Channels of Trade Policy for
Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have
Been Revoked, Suspended, or Modified
by the Environmental Protection Agency
Pursuant to Dietary Risk
Considerations’’ (May 2005). The
guidance represents FDA’s current
thinking on its planned enforcement
approach to the channels of trade
provision of the FD&C Act and how that
provision relates to FDA-regulated
products with residues of pesticide
chemicals for which tolerances have
been revoked, suspended, or modified
by EPA under dietary risk
considerations. The guidance can be
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices
found at the following link: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-channels-tradepolicy-commodities-residues-pesticidechemicals-which-tolerances.
We anticipate that food bearing
lawfully applied residues of pesticide
chemicals that are the subject of future
EPA action to revoke, suspend, or
modify their tolerances, will remain in
the channels of trade after the
applicable tolerance is revoked,
suspended, or modified. If we encounter
food bearing a residue of a pesticide
chemical for which the tolerance has
been revoked, suspended, or modified,
we intend to address the situation in
accordance with provisions of the
guidance. In general, we anticipate that
the party responsible for food found to
contain pesticide chemical residues
(within the former tolerance) after the
tolerance for the pesticide chemical has
been revoked, suspended, or modified
will be able to demonstrate that such
food was handled, e.g., packed or
processed, during the acceptable
timeframes cited in the guidance by
providing appropriate documentation to
FDA as discussed in the guidance
document. We are not suggesting that
firms maintain an inflexible set of
documents where anything less or
different would likely be considered
unacceptable. Rather, we are leaving it
to each firm’s discretion to maintain
appropriate documentation to
demonstrate that the food was so
handled during the acceptable
timeframes. Examples of documentation
that we anticipate will serve this
purpose consist of documentation
associated with packing codes, batch
records, and inventory records. These
are types of documents that many food
processors routinely generate as part of
their basic food-production operations.
Description of Respondents: The
likely respondents to this collection of
information are firms in the produce
and food processing industries that
handle food products that may contain
residues of pesticide chemicals after the
tolerances for the pesticide chemicals
have been revoked, suspended, or
modified.
In the Federal Register of August 2,
2023 (88 FR 50880), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received 2 comments,
84147
one of which was not PRA related and
will not be addressed in this document.
The other comment questioned the
utility of pesticide application records
used to demonstrate a pesticide was
applied at an acceptable time and in a
lawful manner for crops commingled
with other commodities. 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
which were lawful under FIFRA. We
leave it to each firm’s discretion to
maintain appropriate documentation to
demonstrate that the food was so
handled during the acceptable
timeframes. Pesticide spray records may
be used as a documentation to
demonstrate the residues in food are
from an application of the pesticide at
a time and in a manner which were
lawful under FIFRA.
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.
We expect the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA under
dietary risk considerations in the next 3
years to remain at a low level, as there
have been no changes to the safety
standard for pesticide residues in food
since 1996. Thus, we expect the number
of submissions we receive under the
guidance document to also remain at a
low level. However, to avoid counting
this burden as zero, we have estimated
the burden at one respondent making
one submission a year for a total of one
annual submission.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
record
Total hours
Develop documentation process .........................................
1
1
1
16
16
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
19:20 Dec 01, 2023
Jkt 262001
PO 00000
Frm 00029
Fmt 4703
Sfmt 9990
E:\FR\FM\04DEN1.SGM
04DEN1
84148
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26564 Filed 12–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1929]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by January 3,
2024.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
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. The OMB
control number for this information
collection is 0910–0167. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:20 Dec 01, 2023
Jkt 262001
Orphan Drugs—21 CFR Part 316
OMB Control Number 0910–0167—
Extension
This information collection helps
support implementation of sections 525,
526, 527, and 528 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360aa, 360bb, 360cc, and 360dd),
as well as related guidance and Agency
forms. Sections 525, 526, 527, and 528
of the FD&C Act pertain to the
development of drugs for rare diseases
or conditions, including biological
products and antibiotics, otherwise
known or referred to as ‘‘orphan drugs.’’
Specifically, section 525 of the FD&C
Act requires written recommendations
on studies required for approval of a
marketing application for a drug for a
rare disease or condition. Section 526 of
the FD&C Act provides for designation
of drugs as orphan drugs when certain
conditions are met; section 527 provides
conditions under which a sponsor of an
approved orphan drug enjoys exclusive
FDA marketing approval for that drug
for the orphan indication for a period of
7 years; and, finally, section 528 is
intended to encourage sponsors to make
investigational orphan drugs available
for treatment of persons in need on an
open protocol basis before the drug has
been approved for general marketing.
Open protocols may permit patients
who are not part of the formal clinical
investigation to obtain treatment where
adequate supplies exist and no
alternative effective therapy is available.
Agency regulations in part 316,
subpart A (21 CFR part 316, subpart A)
(§§ 316.1 through 316.4) identify the
scope of coverage, applicable
definitions, and statutory provisions
applicable to orphan drugs. The
regulations in part 316, subpart B
(§§ 316.10 through 316.14) set forth
content and format elements for written
recommendation requests and discuss
FDA providing or refusing to provide
the requested written recommendations.
Similarly, regulations in part 316,
subpart C (§§ 316.20 through 316.30)
prescribe content and format elements
for requesting orphan drug designation;
identify submission schedules for
requisite information including
amendments, updates, and reports; and
provide for publication and revocation
of orphan drug designation. Regulations
in part 316, subparts D and E (§§ 316.31
through 316.40) address orphan drug
exclusive approval and open protocols
for investigations, respectively. Finally,
regulations in part 316, subpart F
(§§ 316.50 through 316.52) provide for
the issuance of guidance documents that
apply to the orphan drug provisions of
the FD&C Act and regulations in part
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
316. The list is maintained on the
internet and guidance documents are
issued in accordance with our good
guidance practices regulation in 21 CFR
10.115, which provide for public
comment at any time.
The information collection includes
the Agency guidance document entitled
‘‘Meetings with the Office of Orphan
Products Development: Guidance for
Industry, Researchers, Patient Groups,
and Food and Drug Administration
Staff’’ (July 2015), available for
download at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/meetings-officeorphan-products-development. It
provides recommendations to industry,
researchers, patient groups, and other
stakeholders interested in requesting a
meeting, including a teleconference,
with the Office of Orphan Products
Development (OOPD) on issues related
to orphan drug designation requests,
humanitarian use device designation
requests, rare pediatric disease
designation requests, funding
opportunities through the Orphan
Products Grants Program and the
Pediatric Device Consortia Grants
Program, and orphan product patientrelated topics of concern. It is also
intended to assist OOPD staff in
addressing such meeting requests. The
guidance describes procedures for
requesting, preparing, scheduling,
conducting, and documenting such
meetings and discusses background
information we recommend be included
in such requests.
The information collection includes
Form FDA 3671, Common EMEA/FDA
Application for Orphan Medicinal
Product, and Form FDA 4035, FDA
Orphan Drug Designation Request Form,
intended to benefit sponsors who desire
to seek orphan designation of drugs
intended for rare diseases or conditions
from FDA. The form is a simplified
method for sponsors to provide only the
information required by § 316.20 for
FDA decision making. Orphan drug
designation requests and related
submissions (amendments, annual
reports, etc.), humanitarian use device
designation, and rare pediatric disease
designation requests and submissions
may be submitted electronically by
email to the OOPD.
As communicated on our website at
https://www.fda.gov/industry/medicalproducts-rare-diseases-and-conditions/
designating-orphan-product-drugs-andbiological-products, respondents may
submit orphan drug designation
requests electronically through the
Center for Drug Evaluation and Research
(CDER) NextGen portal, or by emailing
the required information to
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 88, Number 231 (Monday, December 4, 2023)]
[Notices]
[Pages 84146-84148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26564]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2564]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 3, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://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. The OMB control number for
this information collection is 0910-0562. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Channels of Trade Policy for Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have Been Revoked, Suspended, or
Modified by the Environmental Protection Agency Pursuant to Dietary
Risk Considerations
OMB Control Number 0910-0562--Extension
This information collection supports FDA guidance. The Food Quality
Protection Act of 1996 (Pub. L. 104-170), which amended the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (Pub. L. 80-104)
and the Federal Food, Drug, and Cosmetic Act (FD&C Act), established a
new safety standard for pesticide residues in food, with an emphasis on
protecting the health of infants and children. The Environmental
Protection Agency (EPA) is responsible for regulating the use of
pesticides (under FIFRA) and for establishing tolerances or exemptions
from the requirement for tolerances for residues of pesticide chemicals
in food commodities (under the FD&C Act). EPA may, for various reasons,
e.g., as part of a systematic review or in response to new information
concerning the safety of a specific pesticide, reassess whether a
tolerance for a pesticide residue continues to meet the safety standard
in section 408 of the FD&C Act (21 U.S.C. 346a). When EPA determines
that a pesticide's tolerance level does not meet that safety standard,
the registration for the pesticide may be canceled under FIFRA for all
or certain uses. In addition, the tolerances for that pesticide may be
lowered or revoked for the corresponding food commodities.
Under section 408(l)(2) of the FD&C Act, when the registration for
a pesticide is canceled or modified due to, in whole or in part,
dietary risks to humans posed by residues of that pesticide chemical on
food, the effective date for the revocation of such tolerance (or
exemption in some cases) must be no later than 180 days after the date
such cancellation becomes effective or 180 days after the date on which
the use of the canceled pesticide becomes unlawful under the terms of
the cancellation, whichever is later.
When EPA takes such actions, food derived from a commodity that was
lawfully treated with the pesticide may not have cleared the channels
of trade by the time the revocation or new tolerance level takes
effect. The food could be found by FDA, the Agency that is responsible
for monitoring pesticide residue levels and enforcing the pesticide
tolerances in most foods (the U.S. Department of Agriculture has
responsibility for monitoring residue levels and enforcing pesticide
tolerances in meat, poultry, catfish, and certain egg products), to
contain a residue of that pesticide that does not comply with the
revoked or lowered tolerance. We would normally deem such food to be in
violation of the law by virtue of it bearing an illegal pesticide
residue. The food would be subject to FDA enforcement action as an
``adulterated'' food. However, the channels of trade provision of the
FD&C Act addresses the circumstances under which a food is not unsafe
solely due to the presence of a residue from a pesticide chemical for
which the tolerance has been revoked, suspended, or modified by EPA.
The channels of trade provision (section 408(l)(5) of the FD&C Act)
states that food containing a residue of such a pesticide shall not be
deemed ``adulterated'' by virtue of the residue, if the residue is
within the former tolerance, and the responsible party can demonstrate
to FDA's satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner that were lawful
under FIFRA.
To assist respondents with the information collection, we have
developed the guidance document entitled ``Channels of Trade Policy for
Commodities With Residues of Pesticide Chemicals, for Which Tolerances
Have Been Revoked, Suspended, or Modified by the Environmental
Protection Agency Pursuant to Dietary Risk Considerations'' (May 2005).
The guidance represents FDA's current thinking on its planned
enforcement approach to the channels of trade provision of the FD&C Act
and how that provision relates to FDA-regulated products with residues
of pesticide chemicals for which tolerances have been revoked,
suspended, or modified by EPA under dietary risk considerations. The
guidance can be
[[Page 84147]]
found at the following link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals-which-tolerances.
We anticipate that food bearing lawfully applied residues of
pesticide chemicals that are the subject of future EPA action to
revoke, suspend, or modify their tolerances, will remain in the
channels of trade after the applicable tolerance is revoked, suspended,
or modified. If we encounter food bearing a residue of a pesticide
chemical for which the tolerance has been revoked, suspended, or
modified, we intend to address the situation in accordance with
provisions of the guidance. In general, we anticipate that the party
responsible for food found to contain pesticide chemical residues
(within the former tolerance) after the tolerance for the pesticide
chemical has been revoked, suspended, or modified will be able to
demonstrate that such food was handled, e.g., packed or processed,
during the acceptable timeframes cited in the guidance by providing
appropriate documentation to FDA as discussed in the guidance document.
We are not suggesting that firms maintain an inflexible set of
documents where anything less or different would likely be considered
unacceptable. Rather, we are leaving it to each firm's discretion to
maintain appropriate documentation to demonstrate that the food was so
handled during the acceptable timeframes. Examples of documentation
that we anticipate will serve this purpose consist of documentation
associated with packing codes, batch records, and inventory records.
These are types of documents that many food processors routinely
generate as part of their basic food-production operations.
Description of Respondents: The likely respondents to this
collection of information are firms in the produce and food processing
industries that handle food products that may contain residues of
pesticide chemicals after the tolerances for the pesticide chemicals
have been revoked, suspended, or modified.
In the Federal Register of August 2, 2023 (88 FR 50880), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received 2 comments, one of which was not
PRA related and will not be addressed in this document. The other
comment questioned the utility of pesticide application records used to
demonstrate a pesticide was applied at an acceptable time and in a
lawful manner for crops commingled with other commodities. 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 which were
lawful under FIFRA. We leave it to each firm's discretion to maintain
appropriate documentation to demonstrate that the food was so handled
during the acceptable timeframes. Pesticide spray records may be used
as a documentation to demonstrate the residues in food are from an
application of the pesticide at a time and in a manner which were
lawful under FIFRA.
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.
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA under dietary risk
considerations in the next 3 years to remain at a low level, as there
have been no changes to the safety standard for pesticide residues in
food since 1996. Thus, we expect the number of submissions we receive
under the guidance document to also remain at a low level. However, to
avoid counting this burden as zero, we have estimated the burden at one
respondent making one submission a year for a total of one annual
submission.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per record
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 84148]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26564 Filed 12-1-23; 8:45 am]
BILLING CODE 4164-01-P
