Pesticide Registration Review; Proposed Decisions for Several Pesticides; Notice of Availability and Request for Comment, 99253-99257 [2024-28976]
Download as PDF
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
forms/white-house-environmentaljustice-advisory-council-whejac-publiccomment; or by emailing comments to
whejac@epa.gov. The WHEJAC will
accept written comments through
Tuesday, December 31, 2024.
B. Information About Services for
Individuals With Disabilities or
Requiring English Language Translation
Assistance: For information about
access or services for individuals
requiring assistance, contact Audrie
Washington at whejac@epa.gov.
mailto:To request special
accommodations for a disability or other
assistance, please submit your request at
least seven (7) working days prior to the
meeting to give EPA sufficient time to
process your request.
Deeohn Ferris,
Director, Office of Policy, Partnerships and
Program Development (OPPPD), Office of
Environmental Justice and External Civil
Rights.
[FR Doc. 2024–28953 Filed 12–9–24; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2024–0520; FRL–12406–01–
OCSPP]
Pesticide Registration Review;
Proposed Decisions for Several
Pesticides; Notice of Availability and
Request for Comment
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Notice.
This notice announces the
availability of and solicits comments on
EPA’s proposed decisions for the
following pesticides: alpha methyl
mannoside; Duddingtonia flagrans
strain IAH 1297; Pepino mosaic virus,
strain CH2, isolate 1906; and sheep fat.
EPA is proposing that no further review
is necessary for these pesticides at this
time based on its previous
determinations that these pesticides
meet the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) standard
for registration.
DATES: Comments must be received on
or before February 10, 2025.
ADDRESSES: Submit your comments,
identified by the registration review
case name and number for the specific
pesticide of interest provided in Table 1
of Unit II., through the Federal
eRulemaking Portal at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Additional
instructions on commenting and visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
pesticide-specific information, contact:
The Chemical Review Manager for the
pesticide of interest identified in Table
1 of Unit II.
SUMMARY:
99253
For general information on the
registration review program, contact:
Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511M),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave, NW, Washington, DC
20460–0001; telephone number: (202)
566–1533; email address:
kausch.jeannine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public
in general and may be of interest to a
wide range of stakeholders including
environmental, human health, farm
worker, and agricultural advocates; the
chemical industry; pesticide users; and
members of the public interested in the
sale, distribution, or use of pesticides.
Since others also may be interested,
EPA has not attempted to describe all
the specific entities that may be affected
by this action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
Chemical Review Manager identified in
Table 1 of Unit II.
II. What action is the Agency taking?
Consistent with 40 CFR 155.46, this
notice announces the availability of
EPA’s proposed registration review
decisions for the pesticides shown in
Table 1 and opens a 60-day public
comment period on these proposed
decisions. The proposed decisions for
the pesticides and their associated
rationale follow in Unit IV.
TABLE 1—PROPOSED REGISTRATION REVIEW DECISIONS BEING ISSUED
Registration review case name and No.
Chemical review manager and contact information
Alpha Methyl Mannoside; Case Number 6332 ........................................
Duddingtonia flagrans strain IAH 1297; Case Number 6534 ..................
Pepino mosaic virus, strain CH2, isolate 1906; Case Number 6528 ......
Sheep Fat; Case Number 6339 ...............................................................
khammond on DSK9W7S144PROD with NOTICES
III. Registration Review Background
Section 3(g) of the FIFRA requires
EPA to periodically review registered
pesticides to ensure that each pesticide
continues to satisfy the statutory
standard for registration; that is, the
pesticide can perform its intended
function without unreasonable adverse
effects on human health or the
environment. See 7 U.S.C. 136a(g); 40
CFR 155.40(a). Through its registration
review program, EPA reevaluates each
pesticide’s registration based on current
scientific and other knowledge about
the pesticide, including its effects on
human health and the environment,
taking into consideration any changes in
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
James Parker, parker.james@epa.gov, (202) 566–1594.
Joseph Mabon, mabon.joseph@epa.gov, (202) 566–1535.
Joseph Mabon, mabon.joseph@epa.gov, (202) 566–1535.
James Parker, parker.james@epa.gov, (202) 566–1594.
law, regulations, or policy since the last
review. EPA has promulgated
regulations governing the registration
review process in 40 CFR part 155,
subpart C.
Pursuant to 40 CFR 155.46, EPA may
decide that registration review is
complete and additional review is not
needed for certain pesticides. That
regulation provides the following: ‘‘The
Agency may determine that there is no
need to reconsider a previous decision
that a pesticide satisfies the standard of
registration in FIFRA. In such cases,
instead of establishing a pesticide
registration review case docket as
described in § 155.50, the Agency may
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
propose that, based on its determination
that a pesticide meets the FIFRA
standard for registration, no further
review will be necessary. In such
circumstances, the Agency will publish
a notice in the Federal Register
announcing the availability of the
proposed decision and provide a
comment period of at least 60 calendar
days. The Agency will publish a notice
in the Federal Register announcing the
availability of a final version of the
decision, an explanation of any changes
to the proposed decision and its
response to any comments. The date of
the final notice of availability would be
used as the date of the latest registration
E:\FR\FM\10DEN1.SGM
10DEN1
99254
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
khammond on DSK9W7S144PROD with NOTICES
review for the purpose of scheduling
subsequent registration reviews.’’
When EPA promulgated the
procedural regulations for registration
review in 2006 (published in the
Federal Register on August 9, 2006 (71
FR 45720) (FRL–8080–4)), the Agency
explained that ‘‘[t]he purpose of this
provision [section 155.46] is to give the
Agency flexibility to not schedule a
pesticide for registration review if the
pesticide has such low toxicity,
exposure, or risk that another review
would not change the Agency’s position
and would not be an effective use of
resources. The Agency may also use this
provision for a pesticide that has
recently undergone a comprehensive
review. In proposed decisions issued
under § 155.46, the Agency generally
would explain why it believes that no
additional review is necessary and
reference, as appropriate, publicly
available documentation to support the
Agency’s position.’’
As stated in section 155.46, the final
notice serves as the date for the
registration review cycle for the
specified pesticide(s) and is used for
purposes of scheduling the next
registration review under FIFRA section
3(g). The next round of registration
review for any chemical that goes
through the 40 CFR 155.46 process
would need to be completed within 15
years after the final determination.
IV. EPA’s Proposed Decisions
EPA has determined that the
pesticides identified in Table 1 of Unit
II. (alpha methyl mannoside;
Duddingtonia flagrans strain IAH 1297;
Pepino mosaic virus, strain CH2, isolate
1906; and sheep fat) present very low
toxicity, exposure, and risks to human
health and the environment. No human
health or environmental incidents have
been reported since the registration of
the first products containing these
pesticides. Additionally, each of the
listed pesticides underwent a
comprehensive review during the
registration of products containing those
pesticides, in which EPA concluded
that the products met the FIFRA
standard for registration. No changes in
use pattern, exposure, or toxicity have
occurred, no new data have become
available, and no other data have been
identified since the first products
containing these pesticides were
registered that would result in changes
in the risk profile of the pesticides.
Accordingly, the Agency has
determined that there is no need to
reconsider those previous decisions.
Since another review would not change
the Agency’s position and would not be
an effective use of resources, EPA is
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
proposing that further review is
unnecessary at this time and that the
registration review for alpha methyl
mannoside; Duddingtonia flagrans
strain IAH 1297; Pepino mosaic virus,
strain CH2, isolate 1906; and sheep fat
be completed. The specific proposed
decision for each pesticide is described
below.
A. Alpha Methyl Mannoside (Case
Number 6332)
Alpha methyl mannoside is a
naturally occurring mannoside
carbohydrate present in a variety of
plant-based foods in the form of
mannose polymers. As a pesticide, it is
used as a plant regulator to increase
growth in a variety of plants such as
vegetable, fruit, peanut, and bulb and
root crops; ornamentals, potted plants,
bedding plants, and cut flowers in
greenhouses; and turfgrass.
EPA has determined its previous
decision for two products containing
alpha methyl mannoside does not need
to be reconsidered. That decision
document and supporting documents
are posted to docket identification (ID)
number EPA–HQ–OPP–2017–0419 on
https://www.regulations.gov. As stated
in that document, EPA determined that
use of the pesticide would not cause
unreasonable adverse effects to human
health or the environment, based
primarily on the low toxicity and
exposure expected from the pesticide as
described below:
1. FIFRA—Human Health Risk. The
database of studies required to support
the assessment of risk to human health
of alpha methyl mannoside is complete.
EPA does not expect dietary (food and
drinking water) or other nonoccupational risks from use of alpha
methyl mannoside as an active
ingredient in pesticide products. Data
demonstrated that alpha methyl
mannoside is of low toxicity through all
routes of exposure, and no toxicological
endpoints have been identified. No risks
of concern are expected from
occupational exposures when used
according to label directions. Residues
of alpha methyl mannoside are exempt
from the requirement of a tolerance in
or on all raw agricultural commodities
under 40 CFR 180.1352. The pesticide is
of low risk to humans (including
pesticide handlers and people exposed
post-application) due to both low
toxicity and exposure. No additional
risk assessments are needed.
2. FIFRA—Ecological Risk. No risks of
concern were identified in the previous
ecological assessment. Risks of concern
are not anticipated to birds, mammals,
freshwater fish, aquatic invertebrates,
nontarget plants, or nontarget insects
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
(including honey bees) from the
pesticidal use of alpha methyl
mannoside as a plant regulator to
increase growth. Since the products
were registered, there has been no
change in use patterns that would
prompt reevaluation of risk. The
pesticide is of low risk to nontarget
species due to both low toxicity and
exposure. No additional risk
assessments are needed.
3. 155.46 Proposal. EPA has
determined that the products containing
alpha methyl mannoside satisfy the
FIFRA standard for registration. The
pesticide is of such low toxicity,
exposure, and risk that additional
review would not be an effective use of
Agency resources. All applicable data
requirements have been satisfied. There
have been no changes in use pattern,
exposure, or toxicity since the first
products containing this pesticide were
registered, nor have any new data been
identified that would result in changes
in the risk profile of the pesticide. In
addition, no human health or
environmental incidents have been
reported since the registration of the
first products containing this pesticide.
Finally, EPA is not aware of any
changes in law, regulation, or policy in
relation to this pesticide that need to be
considered at this time. Therefore, EPA
is proposing that no further review of
alpha methyl mannoside is necessary
and registration review can be
completed at this time because the
pesticide continues to meet the FIFRA
registration standard.
4. Other Actions.
i. Endangered Species Act (ESA). EPA
is making a ‘‘May Affect, Not Likely to
Adversely Affect’’ determination for
listed plants for products containing
alpha methyl mannoside because (1)
there is potential for beneficial effects to
listed plants within the spray drift zone
due to alpha methyl mannoside’s effect
as a plant regulator, and (2) EPA does
not expect any contemporaneous
adverse effects to listed species based on
low toxicity and limited environmental
exposure. This potential for beneficial
effects is based on alpha methyl
mannoside’s mode of action, and EPA
has determined that any such effects are
likely to be negligible. EPA is
developing an assessment to support
informal consultation under ESA
section 7(a)(2) for the products that
contain active ingredients with the
potential for beneficial effects, including
alpha methyl mannoside. EPA will
complete this informal consultation
before or concurrent with issuing a final
registration review decision for alpha
methyl mannoside.
E:\FR\FM\10DEN1.SGM
10DEN1
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
ii. The Endocrine Disruptor Screening
Program (EDSP). Because the available
data indicate that the substance is not
anticipated to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen, EPA
intends to seek consensus from its
internal peer review process to
determine whether an exemption from
the requirements of the EDSP under
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(p)(4) is
appropriate. If so, EPA will issue that
exemption before or concurrent with
issuing a final registration review
decision for alpha methyl mannoside.
khammond on DSK9W7S144PROD with NOTICES
B. Duddingtonia Flagrans Strain IAH
1297 (Case Number 6534)
Duddingtonia flagrans strain IAH
1297 is an animal feed-through fungal
pesticide that forms filamentous
structures that trap/kill nematodes in
manure. This limits the presence of
parasitic nematodes in pastureland,
thereby reducing the cycle of nematode
infection in grazing animals.
EPA has determined that its previous
registration decision for two products
containing Duddingtonia flagrans strain
IAH 1297 does not need to be
reconsidered. That decision document
and supporting documents are posted to
docket ID number EPA–HQ–OPP–2017–
0276 on https://www.regulations.gov. As
stated in that document, EPA
determined that use of the pesticide
would not cause unreasonable adverse
effects to human health or the
environment, based primarily on the
low toxicity/pathogenicity and exposure
expected from the pesticide as described
below:
1. FIFRA—Human Health Risk. The
toxicology database required to support
the assessment of risk to human health
is complete and demonstrates that
Duddingtonia flagrans strain IAH 1297
is not associated with significant
toxicity, irritation, pathogenicity, or
other adverse effects. EPA does not
expect dietary (food or drinking water)
or other non-occupational risks from use
of Duddingtonia flagrans strain IAH
1297 due to low toxicity/pathogenicity
and exposure potential. No risks of
concern are expected from occupational
exposures when used according to label
directions. Duddingtonia flagrans strain
IAH 1297 is also exempt from the
requirement of a tolerance in or on all
food commodities under 40 CFR
180.1355. The pesticide is of low risk to
humans (including pesticide handlers
and people exposed post-application)
due to both low toxicity/pathogenicity
and exposure. No additional risk
assessments are needed.
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
2. FIFRA—Ecological Risk. The
Duddingtonia flagrans strain IAH 1297
database of studies and information
required to support the ecological risk
assessment is complete and deemed
adequate for making a risk
determination. Duddingtonia flagrans is
a ubiquitous organism that will not be
present above background levels, except
during application, at which point it is
then expected to rapidly degrade and
return to background levels.
Duddingtonia flagrans also has a high
host specificity for certain nematodes,
proliferates poorly in soil, and does not
spread well beyond treated locations.
Based on low exposure from feedthrough applications, as well as
specificity to nematodes and lack of
effects to other taxa, risks of concern to
nontarget organisms are not anticipated
from the use of the pesticide products
containing Duddingtonia flagrans strain
IAH 1297. The pesticide is of low risk
to nontarget species due to both low
toxicity/pathogenicity and exposure. No
additional risk assessments are needed.
3. 155.46 Proposal. EPA has
determined that products containing
Duddingtonia flagrans strain IAH 1297
satisfy the FIFRA standard for
registration. The pesticide is of such low
toxicity/pathogenicity, exposure, and
risk that additional review would not be
an effective use of Agency resources. All
applicable data requirements have been
satisfied. There have been no changes in
use pattern, exposure, or toxicity/
pathogenicity since the first products
containing this pesticide were
registered, nor have any new data been
identified that would result in changes
in the risk profile of the pesticide. In
addition, no human health or
environmental incidents have been
reported since the registration of the
first products containing the pesticide.
Finally, EPA is not aware of any
changes in law, regulation, or policy in
relation to this pesticide that need to be
considered at this time. Therefore, EPA
is proposing that no further review of
Duddingtonia flagrans strain IAH 1297
is necessary and registration review can
be completed at this time because the
pesticide continues to meet the FIFRA
registration standard.
4. Other Actions.
i. ESA. EPA is making a ‘‘No Effect’’
determination under the ESA for the
labeled uses of Duddingtonia flagrans
strain IAH 1297 based on the low
toxicity/pathogenicity of and limited
environmental exposure to the
pesticide. The reasons for this
determination are the same grounds as
those described in review of the first
products containing Duddingtonia
flagrans strain IAH 1297 registered by
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
99255
EPA (see the decision document and
supporting ecological risk assessment
posted to docket ID number EPA–HQ–
OPP–2017–0276 on https://
www.regulations.gov).
ii. EDSP. Because the available data
indicate that the substance is not
anticipated to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen, EPA
intends to seek consensus from its
internal peer review process to
determine whether an exemption from
the requirements of the EDSP under
FFDCA section 408(p)(4) is appropriate.
If so, EPA will issue that exemption
before or concurrent with issuing a final
registration review decision for
Duddingtonia flagrans strain IAH 1297.
C. Pepino Mosaic Virus, Strain CH2,
Isolate 1906 (Case Number 6528)
Pepino mosaic virus, strain CH2,
isolate 1906 is an attenuated strain of
the plant pathogen Pepino mosaic virus
that causes a heightened defense
response in treated plants, resulting in
resistance when those treated plants
encounter more pathogenic strains of
Pepino mosaic virus. Applications of
Pepino mosaic virus, strain CH2, isolate
1906 are made only to tomato plants in
greenhouses.
EPA has determined that its previous
registration decision for one product
containing Pepino mosaic virus, strain
CH2, isolate 1906 does not need to be
reconsidered. That decision document
and supporting documents are posted to
docket ID number EPA–HQ–OPP–2017–
0527 on https://www.regulations.gov. As
stated in that document, EPA
determined that use of the pesticide
would not cause unreasonable adverse
effects to human health or the
environment, based primarily on the
low toxicity/pathogenicity and exposure
expected from the pesticide as described
below:
1. FIFRA—Human Health Risk. The
database required to support the
assessment of risk to human health is
complete, and the data demonstrate that
Pepino mosaic virus, strain CH2, isolate
1906 is not associated with significant
toxicity, irritation, pathogenicity, or
other adverse effects. EPA does not
expect dietary (food and drinking water)
or other non-occupational risks from use
of Pepino mosaic virus, strain CH2,
isolate 1906 as an active ingredient in
the pesticide product. No risks of
concern are expected from occupational
exposures when used according to label
directions. Pepino mosaic virus, strain
CH2, isolate 1906 is also exempt from
the requirement of a tolerance in or on
tomato under 40 CFR 180.1361. The
pesticide is of low risk to humans
E:\FR\FM\10DEN1.SGM
10DEN1
khammond on DSK9W7S144PROD with NOTICES
99256
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
(including pesticide handlers and
people exposed post-application) due to
both low toxicity/pathogenicity and
exposure. No additional risk
assessments are needed.
2. FIFRA—Ecological Risk. The
Pepino mosaic virus, strain CH2, isolate
1906 database of studies and
information required to support the
ecological risk assessment is complete.
Further, environmental exposure is
anticipated to be very low since Pepino
mosaic virus, strain CH2, isolate 1906 is
for use in greenhouses only with a label
requirement to disinfect greenhouse
drainage water. Based on the low
exposure potential, supporting data, and
acceptable scientific rationale, risks of
concern are not anticipated for
nontarget organisms as a result of the
labeled uses of the product containing
Pepino mosaic virus, strain CH2, isolate
1906. The pesticide is of low risk to
nontarget species due to both low
toxicity and exposure. No additional
risk assessments are needed.
3. 155.46 Proposal. EPA has
determined that the product containing
Pepino mosaic virus, strain CH2, isolate
1906 satisfies the FIFRA standard for
registration. The pesticide is of such low
toxicity/pathogenicity, exposure, and
risk that additional review would not be
an effective use of Agency resources. All
applicable data requirements have been
satisfied. There have been no changes in
use pattern, exposure, or toxicity/
pathogenicity since the first product
containing this pesticide was registered,
nor have any new data been identified
that would result in changes in the risk
profile of the pesticide. In addition, no
human health or environmental
incidents have been reported since the
registration of the first product
containing the pesticide. Finally, EPA is
not aware of any changes in law,
regulation, or policy in relation to this
pesticide that need to be considered at
this time. Therefore, EPA is proposing
that no further review of Pepino mosaic
virus, strain CH2, isolate 1906 is
necessary and registration review can be
completed at this time because the
pesticide continues to meet the FIFRA
registration standard.
4. Other Actions.
i. ESA. EPA is making a ‘‘No Effect’’
determination under the ESA for the
labeled uses of Pepino mosaic virus,
strain CH2, isolate 1906 based on the
low toxicity/pathogenicity of and
limited environmental exposure to the
pesticide. The reasons for this
determination are the same grounds as
those described in review of the first
product containing Pepino mosaic virus,
strain CH2, isolate 1906 registered by
EPA (see the decision document and
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
supporting ecological risk assessment
posted to docket ID number EPA–HQ–
OPP–2017–0527 on https://
www.regulations.gov).
ii. EDSP. Because the available data
indicate that the substance is not
anticipated to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen, EPA
intends to seek consensus from its
internal peer review process to
determine whether an exemption from
the requirements of the EDSP under
FFDCA section 408(p)(4) is appropriate.
If so, EPA will issue that exemption
before or concurrent with issuing a final
registration review decision for Pepino
mosaic virus, strain CH2, isolate 1906.
D. Sheep Fat (Case Number 6339)
Sheep fat is derived from the body fat
of slaughtered sheep. Due to its rancid
odor and taste, this active ingredient is
used to repel deer, rabbits, elk, and
moose. It is applied as a spray in a
variety of use sites, e.g., agricultural
areas, nurseries, forests, and commercial
and residential landscapes.
EPA has determined that its previous
registration decision for two products
containing sheep fat does not need to be
reconsidered. That decision document
and supporting documents are posted to
docket ID number EPA–HQ–OPP–2019–
0410 on https://www.regulations.gov. As
stated in that document, EPA
determined that use of the pesticide
would not cause unreasonable adverse
effects to human health or the
environment, based primarily on the
low toxicity and exposure expected
from the pesticide as described below:
1. FIFRA—Human Health Risk. The
database of information required to
support the assessment of risk to human
health of sheep fat is complete. EPA
does not expect dietary (food and
drinking water) or other nonoccupational risks from use of sheep fat
as an active ingredient in pesticide
products. Data demonstrated that sheep
fat is of low acute toxicity through all
routes of exposure, and no toxicological
end points have been identified. No
risks of concern are expected from
occupational exposures when used
according to label directions. Residues
of sheep fat are exempt from the
requirement of a tolerance in or on all
food commodities under 40 CFR
180.950(c). The pesticide is of low risk
to humans (including pesticide handlers
and people exposed post-application)
due to both low toxicity and exposure.
No additional risk assessments are
needed.
2. FIFRA—Ecological Risk. No risk
concerns were identified in previous
ecological assessments based primarily
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
on the low toxicity and natural
occurrence of components in sheep fat.
The application methods include handheld, knapsack, or garden sprayers with
a flat fan or cone nozzle to directly treat
impacted plants and therefore greatly
limit the exposure of nontarget taxa to
sheep fat. EPA further noted that the
active ingredient has a nontoxic mode of
action, its components (fatty acids) are
ubiquitous in the environment, and its
components have a history of exposure
with no adverse effects to nontarget
organisms. Risks of concern are not
anticipated for nontarget organisms as a
result of the labeled uses of the
pesticide products containing sheep fat.
The pesticide is of low risk to nontarget
species due to both low toxicity and
exposure. No additional risk
assessments are needed.
3. 155.46 Proposal. EPA has
determined that the products containing
sheep fat satisfy the FIFRA standard for
registration. The pesticide is of such low
toxicity, exposure, and risk that
additional review would not be an
effective use of Agency resources. All
applicable data requirements have been
satisfied. There have been no changes in
use pattern, exposure, or toxicity since
the first products containing this
pesticide were registered, nor have any
new data been identified that would
result in changes in the risk profile of
the pesticide. In addition, no human
health or environmental incidents have
been reported since the registration of
the first products containing the
pesticide. Finally, EPA is not aware of
any changes in law, regulation, or policy
in relation to this pesticide that need to
be considered at this time. Therefore,
EPA is proposing that no further review
of sheep fat is necessary and registration
review can be completed at this time
because the pesticide continues to meet
the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a ‘‘No Effect’’
determination under the ESA for the
labeled uses of sheep fat based on the
low toxicity of and limited
environmental exposure to the
pesticide. The reasons for this
determination are the same grounds as
those described in review of the first
products containing sheep fat registered
by EPA (see the decision document and
supporting ecological risk assessment
posted to docket ID number EPA–HQ–
OPP–2019–0410 on https://
www.regulations.gov).
ii. EDSP. Because the available data
indicate that the substance is not
anticipated to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen, EPA
intends to seek consensus from its
E:\FR\FM\10DEN1.SGM
10DEN1
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
internal peer review process to
determine whether an exemption from
the requirements of the EDSP under
FFDCA section 408(p)(4) is appropriate.
If so, EPA will issue that exemption
before or concurrent with issuing a final
registration review decision for sheep
fat.
khammond on DSK9W7S144PROD with NOTICES
V. What is EPA’s authority for taking
this action?
EPA is issuing these proposals
pursuant to 40 CFR 155.46 to comply
with its statutory mandate to
periodically review all registered
pesticides under section 3(g) of FIFRA.
7 U.S.C. 136a(g).
VI. What should I consider as I prepare
comment for EPA?
1. Submitting CBI. Do not submit CBI
to EPA through email or https://
www.regulations.gov. If you wish to
include CBI in your comment, please
follow the applicable instructions at
https://www.epa.gov/dockets/
commenting-epa-dockets#rules and
clearly mark the information that you
claim to be CBI. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for Preparing Your Comments.
When preparing and submitting your
comments, see the commenting tips at:
https://www.epa.gov/dockets/
commenting-epa-dockets.
3. Environmental Justice. EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. To help
address potential environmental justice
issues, EPA seeks information on any
groups or segments of the population
who, as a result of their location,
cultural practices, or other factors, may
have atypical or disproportionately high
and adverse human health impacts or
environmental effects from exposure to
the pesticides discussed in this
document, compared to the general
population.
All comments should be submitted
using the method in ADDRESSES and
must be received by EPA on or before
the closing date. These comments will
become part of the docket for the
pesticides included in Table 1 in Unit
II. EPA will consider all comments
received by the closing date and may
respond to comments in a ‘‘Response to
Comments Memorandum’’ in the docket
and/or in any subsequent final
registration review decision, as
appropriate.
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
Authority: 7 U.S.C. 136 et seq.
Dated: December 4, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2024–28976 Filed 12–9–24; 8:45 am]
BILLING CODE 6560–50–P
EXPORT-IMPORT BANK
[Public Notice: 2024–6125]
Agency Information Collection
Activities: Submission to the Office of
Management and Budget for Review
and Approval; Comment Request; EIB
18–05, Itemized Statement of Payments
Long-Term Guarantee and Direct
Loan—Local Costs
Export-Import Bank of the
United States.
ACTION: Submission for OMB review and
comments request.
AGENCY:
The Export-Import Bank of
the United States (EXIM), as a part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
Agencies to comment on the proposed
information collection, as required by
the Paperwork Reduction Act of 1995.
DATES: Comments should be received on
or before February 10, 2025 to be
assured of consideration.
ADDRESSES: Comments may be
submitted electronically on
www.regulations.gov (EIB 18–02), by
email to donna.schneider@exim.gov, or
by mail to Donna Schneider, ExportImport Bank of the United States, 811
Vermont Ave. NW, Washington, DC
20571. The form can be viewed at:
https://img.exim.gov/s3fs-public/pub/
pending/EIB+18-05_itemized_
statement_of_payments-local_cost_
form_2025.xlsx.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Donna Schneider, 202–565–
3612.
SUMMARY:
This form
is to be completed by EXIM borrowers
as required under certain EXIM longterm guarantee and direct loan
transactions in conjunction with a
borrower’s request for disbursement for
local cost goods and services. It is used
to summarize disbursement documents
submitted with a borrower’s request and
to calculate the requested financing
amount. It will enable EXIM to identify
the specific details of the amount of
disbursement requested for approval to
ensure that the financing request is
complete and in compliance with
EXIM’s disbursement requirements.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
99257
This form will be uploaded into an
electronic disbursement portal.
Titles and Form Number: EIB 18–05,
Itemized Statement of Payments Longterm Guarantee and Direct Loan—Local
Costs.
OMB Number: 3048–0057.
Type of Review: Regular.
Need and Use: The information
collected will assist in determining
compliance of disbursement requests for
local cost goods and services submitted
to EXIM through an electronic
disbursement portal under certain longterm guarantee and direct loan
transactions.
Affected Public: This form affects
EXIM borrowers involved in financing
local cost goods and services under
certain long-term guarantee and direct
loan transactions.
Annual Number of Respondents: 30.
Estimated Time per Respondent: 30
minutes.
Annual Burden Hours: 15 hours.
Frequency of Reporting or Use: As
needed.
Dated: December 4, 2024.
Andrew Smith,
Records Officer.
[FR Doc. 2024–28904 Filed 12–9–24; 8:45 am]
BILLING CODE 6690–01–P
EXPORT-IMPORT BANK
[Public Notice: 2024–6121]
Agency Information Collection
Activities: Submission to the Office of
Management and Budget for Review
and Approval; Comment Request; EIB
11–05, Exporter’s Certificate for Loan
Guarantee & MT Insurance Programs
Export-Import Bank of the
United States.
ACTION: Submission for OMB review and
comments request.
AGENCY:
The Export-Import Bank of
the United States (EXIM), as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
Agencies to comment on the proposed
information collection, as required by
the Paperwork Reduction Act of 1995.
DATES: Comments must be received on
or before February 10, 2025 to be
assured of consideration.
ADDRESSES: Comments may be
submitted electronically on
www.regulations.gov (EIB 11–05), by
email to Donna Schneider,
donna.schneider@exim.gov, or by mail
to Donna Schneider, Export-Import
Bank, 811 Vermont Ave. NW,
Washington, DC 20571. The information
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
Agencies
[Federal Register Volume 89, Number 237 (Tuesday, December 10, 2024)]
[Notices]
[Pages 99253-99257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28976]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2024-0520; FRL-12406-01-OCSPP]
Pesticide Registration Review; Proposed Decisions for Several
Pesticides; Notice of Availability and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of and solicits
comments on EPA's proposed decisions for the following pesticides:
alpha methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino
mosaic virus, strain CH2, isolate 1906; and sheep fat. EPA is proposing
that no further review is necessary for these pesticides at this time
based on its previous determinations that these pesticides meet the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard
for registration.
DATES: Comments must be received on or before February 10, 2025.
ADDRESSES: Submit your comments, identified by the registration review
case name and number for the specific pesticide of interest provided in
Table 1 of Unit II., through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting and visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For pesticide-specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in Table 1 of Unit II.
For general information on the registration review program,
contact: Jeannine Kausch, Biopesticides and Pollution Prevention
Division (7511M), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW, Washington, DC 20460-
0001; telephone number: (202) 566-1533; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, EPA has not attempted to describe all the specific entities
that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in Table 1 of Unit II.
II. What action is the Agency taking?
Consistent with 40 CFR 155.46, this notice announces the
availability of EPA's proposed registration review decisions for the
pesticides shown in Table 1 and opens a 60-day public comment period on
these proposed decisions. The proposed decisions for the pesticides and
their associated rationale follow in Unit IV.
Table 1--Proposed Registration Review Decisions Being Issued
------------------------------------------------------------------------
Chemical review manager and
Registration review case name and No. contact information
------------------------------------------------------------------------
Alpha Methyl Mannoside; Case Number James Parker,
6332. [email protected], (202)
566-1594.
Duddingtonia flagrans strain IAH 1297; Joseph Mabon,
Case Number 6534. [email protected], (202)
566-1535.
Pepino mosaic virus, strain CH2, Joseph Mabon,
isolate 1906; Case Number 6528. [email protected], (202)
566-1535.
Sheep Fat; Case Number 6339............ James Parker,
[email protected], (202)
566-1594.
------------------------------------------------------------------------
III. Registration Review Background
Section 3(g) of the FIFRA requires EPA to periodically review
registered pesticides to ensure that each pesticide continues to
satisfy the statutory standard for registration; that is, the pesticide
can perform its intended function without unreasonable adverse effects
on human health or the environment. See 7 U.S.C. 136a(g); 40 CFR
155.40(a). Through its registration review program, EPA reevaluates
each pesticide's registration based on current scientific and other
knowledge about the pesticide, including its effects on human health
and the environment, taking into consideration any changes in law,
regulations, or policy since the last review. EPA has promulgated
regulations governing the registration review process in 40 CFR part
155, subpart C.
Pursuant to 40 CFR 155.46, EPA may decide that registration review
is complete and additional review is not needed for certain pesticides.
That regulation provides the following: ``The Agency may determine that
there is no need to reconsider a previous decision that a pesticide
satisfies the standard of registration in FIFRA. In such cases, instead
of establishing a pesticide registration review case docket as
described in Sec. 155.50, the Agency may propose that, based on its
determination that a pesticide meets the FIFRA standard for
registration, no further review will be necessary. In such
circumstances, the Agency will publish a notice in the Federal Register
announcing the availability of the proposed decision and provide a
comment period of at least 60 calendar days. The Agency will publish a
notice in the Federal Register announcing the availability of a final
version of the decision, an explanation of any changes to the proposed
decision and its response to any comments. The date of the final notice
of availability would be used as the date of the latest registration
[[Page 99254]]
review for the purpose of scheduling subsequent registration reviews.''
When EPA promulgated the procedural regulations for registration
review in 2006 (published in the Federal Register on August 9, 2006 (71
FR 45720) (FRL-8080-4)), the Agency explained that ``[t]he purpose of
this provision [section 155.46] is to give the Agency flexibility to
not schedule a pesticide for registration review if the pesticide has
such low toxicity, exposure, or risk that another review would not
change the Agency's position and would not be an effective use of
resources. The Agency may also use this provision for a pesticide that
has recently undergone a comprehensive review. In proposed decisions
issued under Sec. 155.46, the Agency generally would explain why it
believes that no additional review is necessary and reference, as
appropriate, publicly available documentation to support the Agency's
position.''
As stated in section 155.46, the final notice serves as the date
for the registration review cycle for the specified pesticide(s) and is
used for purposes of scheduling the next registration review under
FIFRA section 3(g). The next round of registration review for any
chemical that goes through the 40 CFR 155.46 process would need to be
completed within 15 years after the final determination.
IV. EPA's Proposed Decisions
EPA has determined that the pesticides identified in Table 1 of
Unit II. (alpha methyl mannoside; Duddingtonia flagrans strain IAH
1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat)
present very low toxicity, exposure, and risks to human health and the
environment. No human health or environmental incidents have been
reported since the registration of the first products containing these
pesticides. Additionally, each of the listed pesticides underwent a
comprehensive review during the registration of products containing
those pesticides, in which EPA concluded that the products met the
FIFRA standard for registration. No changes in use pattern, exposure,
or toxicity have occurred, no new data have become available, and no
other data have been identified since the first products containing
these pesticides were registered that would result in changes in the
risk profile of the pesticides. Accordingly, the Agency has determined
that there is no need to reconsider those previous decisions. Since
another review would not change the Agency's position and would not be
an effective use of resources, EPA is proposing that further review is
unnecessary at this time and that the registration review for alpha
methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino mosaic
virus, strain CH2, isolate 1906; and sheep fat be completed. The
specific proposed decision for each pesticide is described below.
A. Alpha Methyl Mannoside (Case Number 6332)
Alpha methyl mannoside is a naturally occurring mannoside
carbohydrate present in a variety of plant-based foods in the form of
mannose polymers. As a pesticide, it is used as a plant regulator to
increase growth in a variety of plants such as vegetable, fruit,
peanut, and bulb and root crops; ornamentals, potted plants, bedding
plants, and cut flowers in greenhouses; and turfgrass.
EPA has determined its previous decision for two products
containing alpha methyl mannoside does not need to be reconsidered.
That decision document and supporting documents are posted to docket
identification (ID) number EPA-HQ-OPP-2017-0419 on https://www.regulations.gov. As stated in that document, EPA determined that
use of the pesticide would not cause unreasonable adverse effects to
human health or the environment, based primarily on the low toxicity
and exposure expected from the pesticide as described below:
1. FIFRA--Human Health Risk. The database of studies required to
support the assessment of risk to human health of alpha methyl
mannoside is complete. EPA does not expect dietary (food and drinking
water) or other non-occupational risks from use of alpha methyl
mannoside as an active ingredient in pesticide products. Data
demonstrated that alpha methyl mannoside is of low toxicity through all
routes of exposure, and no toxicological endpoints have been
identified. No risks of concern are expected from occupational
exposures when used according to label directions. Residues of alpha
methyl mannoside are exempt from the requirement of a tolerance in or
on all raw agricultural commodities under 40 CFR 180.1352. The
pesticide is of low risk to humans (including pesticide handlers and
people exposed post-application) due to both low toxicity and exposure.
No additional risk assessments are needed.
2. FIFRA--Ecological Risk. No risks of concern were identified in
the previous ecological assessment. Risks of concern are not
anticipated to birds, mammals, freshwater fish, aquatic invertebrates,
nontarget plants, or nontarget insects (including honey bees) from the
pesticidal use of alpha methyl mannoside as a plant regulator to
increase growth. Since the products were registered, there has been no
change in use patterns that would prompt reevaluation of risk. The
pesticide is of low risk to nontarget species due to both low toxicity
and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the products containing
alpha methyl mannoside satisfy the FIFRA standard for registration. The
pesticide is of such low toxicity, exposure, and risk that additional
review would not be an effective use of Agency resources. All
applicable data requirements have been satisfied. There have been no
changes in use pattern, exposure, or toxicity since the first products
containing this pesticide were registered, nor have any new data been
identified that would result in changes in the risk profile of the
pesticide. In addition, no human health or environmental incidents have
been reported since the registration of the first products containing
this pesticide. Finally, EPA is not aware of any changes in law,
regulation, or policy in relation to this pesticide that need to be
considered at this time. Therefore, EPA is proposing that no further
review of alpha methyl mannoside is necessary and registration review
can be completed at this time because the pesticide continues to meet
the FIFRA registration standard.
4. Other Actions.
i. Endangered Species Act (ESA). EPA is making a ``May Affect, Not
Likely to Adversely Affect'' determination for listed plants for
products containing alpha methyl mannoside because (1) there is
potential for beneficial effects to listed plants within the spray
drift zone due to alpha methyl mannoside's effect as a plant regulator,
and (2) EPA does not expect any contemporaneous adverse effects to
listed species based on low toxicity and limited environmental
exposure. This potential for beneficial effects is based on alpha
methyl mannoside's mode of action, and EPA has determined that any such
effects are likely to be negligible. EPA is developing an assessment to
support informal consultation under ESA section 7(a)(2) for the
products that contain active ingredients with the potential for
beneficial effects, including alpha methyl mannoside. EPA will complete
this informal consultation before or concurrent with issuing a final
registration review decision for alpha methyl mannoside.
[[Page 99255]]
ii. The Endocrine Disruptor Screening Program (EDSP). Because the
available data indicate that the substance is not anticipated to
produce any effect in humans similar to an effect produced by a
naturally occurring estrogen, EPA intends to seek consensus from its
internal peer review process to determine whether an exemption from the
requirements of the EDSP under Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(p)(4) is appropriate. If so, EPA will issue that
exemption before or concurrent with issuing a final registration review
decision for alpha methyl mannoside.
B. Duddingtonia Flagrans Strain IAH 1297 (Case Number 6534)
Duddingtonia flagrans strain IAH 1297 is an animal feed-through
fungal pesticide that forms filamentous structures that trap/kill
nematodes in manure. This limits the presence of parasitic nematodes in
pastureland, thereby reducing the cycle of nematode infection in
grazing animals.
EPA has determined that its previous registration decision for two
products containing Duddingtonia flagrans strain IAH 1297 does not need
to be reconsidered. That decision document and supporting documents are
posted to docket ID number EPA-HQ-OPP-2017-0276 on https://www.regulations.gov. As stated in that document, EPA determined that
use of the pesticide would not cause unreasonable adverse effects to
human health or the environment, based primarily on the low toxicity/
pathogenicity and exposure expected from the pesticide as described
below:
1. FIFRA--Human Health Risk. The toxicology database required to
support the assessment of risk to human health is complete and
demonstrates that Duddingtonia flagrans strain IAH 1297 is not
associated with significant toxicity, irritation, pathogenicity, or
other adverse effects. EPA does not expect dietary (food or drinking
water) or other non-occupational risks from use of Duddingtonia
flagrans strain IAH 1297 due to low toxicity/pathogenicity and exposure
potential. No risks of concern are expected from occupational exposures
when used according to label directions. Duddingtonia flagrans strain
IAH 1297 is also exempt from the requirement of a tolerance in or on
all food commodities under 40 CFR 180.1355. The pesticide is of low
risk to humans (including pesticide handlers and people exposed post-
application) due to both low toxicity/pathogenicity and exposure. No
additional risk assessments are needed.
2. FIFRA--Ecological Risk. The Duddingtonia flagrans strain IAH
1297 database of studies and information required to support the
ecological risk assessment is complete and deemed adequate for making a
risk determination. Duddingtonia flagrans is a ubiquitous organism that
will not be present above background levels, except during application,
at which point it is then expected to rapidly degrade and return to
background levels. Duddingtonia flagrans also has a high host
specificity for certain nematodes, proliferates poorly in soil, and
does not spread well beyond treated locations. Based on low exposure
from feed-through applications, as well as specificity to nematodes and
lack of effects to other taxa, risks of concern to nontarget organisms
are not anticipated from the use of the pesticide products containing
Duddingtonia flagrans strain IAH 1297. The pesticide is of low risk to
nontarget species due to both low toxicity/pathogenicity and exposure.
No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that products containing
Duddingtonia flagrans strain IAH 1297 satisfy the FIFRA standard for
registration. The pesticide is of such low toxicity/pathogenicity,
exposure, and risk that additional review would not be an effective use
of Agency resources. All applicable data requirements have been
satisfied. There have been no changes in use pattern, exposure, or
toxicity/pathogenicity since the first products containing this
pesticide were registered, nor have any new data been identified that
would result in changes in the risk profile of the pesticide. In
addition, no human health or environmental incidents have been reported
since the registration of the first products containing the pesticide.
Finally, EPA is not aware of any changes in law, regulation, or policy
in relation to this pesticide that need to be considered at this time.
Therefore, EPA is proposing that no further review of Duddingtonia
flagrans strain IAH 1297 is necessary and registration review can be
completed at this time because the pesticide continues to meet the
FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a ``No Effect'' determination under the ESA
for the labeled uses of Duddingtonia flagrans strain IAH 1297 based on
the low toxicity/pathogenicity of and limited environmental exposure to
the pesticide. The reasons for this determination are the same grounds
as those described in review of the first products containing
Duddingtonia flagrans strain IAH 1297 registered by EPA (see the
decision document and supporting ecological risk assessment posted to
docket ID number EPA-HQ-OPP-2017-0276 on https://www.regulations.gov).
ii. EDSP. Because the available data indicate that the substance is
not anticipated to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen, EPA intends to seek
consensus from its internal peer review process to determine whether an
exemption from the requirements of the EDSP under FFDCA section
408(p)(4) is appropriate. If so, EPA will issue that exemption before
or concurrent with issuing a final registration review decision for
Duddingtonia flagrans strain IAH 1297.
C. Pepino Mosaic Virus, Strain CH2, Isolate 1906 (Case Number 6528)
Pepino mosaic virus, strain CH2, isolate 1906 is an attenuated
strain of the plant pathogen Pepino mosaic virus that causes a
heightened defense response in treated plants, resulting in resistance
when those treated plants encounter more pathogenic strains of Pepino
mosaic virus. Applications of Pepino mosaic virus, strain CH2, isolate
1906 are made only to tomato plants in greenhouses.
EPA has determined that its previous registration decision for one
product containing Pepino mosaic virus, strain CH2, isolate 1906 does
not need to be reconsidered. That decision document and supporting
documents are posted to docket ID number EPA-HQ-OPP-2017-0527 on
https://www.regulations.gov. As stated in that document, EPA determined
that use of the pesticide would not cause unreasonable adverse effects
to human health or the environment, based primarily on the low
toxicity/pathogenicity and exposure expected from the pesticide as
described below:
1. FIFRA--Human Health Risk. The database required to support the
assessment of risk to human health is complete, and the data
demonstrate that Pepino mosaic virus, strain CH2, isolate 1906 is not
associated with significant toxicity, irritation, pathogenicity, or
other adverse effects. EPA does not expect dietary (food and drinking
water) or other non-occupational risks from use of Pepino mosaic virus,
strain CH2, isolate 1906 as an active ingredient in the pesticide
product. No risks of concern are expected from occupational exposures
when used according to label directions. Pepino mosaic virus, strain
CH2, isolate 1906 is also exempt from the requirement of a tolerance in
or on tomato under 40 CFR 180.1361. The pesticide is of low risk to
humans
[[Page 99256]]
(including pesticide handlers and people exposed post-application) due
to both low toxicity/pathogenicity and exposure. No additional risk
assessments are needed.
2. FIFRA--Ecological Risk. The Pepino mosaic virus, strain CH2,
isolate 1906 database of studies and information required to support
the ecological risk assessment is complete. Further, environmental
exposure is anticipated to be very low since Pepino mosaic virus,
strain CH2, isolate 1906 is for use in greenhouses only with a label
requirement to disinfect greenhouse drainage water. Based on the low
exposure potential, supporting data, and acceptable scientific
rationale, risks of concern are not anticipated for nontarget organisms
as a result of the labeled uses of the product containing Pepino mosaic
virus, strain CH2, isolate 1906. The pesticide is of low risk to
nontarget species due to both low toxicity and exposure. No additional
risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the product containing
Pepino mosaic virus, strain CH2, isolate 1906 satisfies the FIFRA
standard for registration. The pesticide is of such low toxicity/
pathogenicity, exposure, and risk that additional review would not be
an effective use of Agency resources. All applicable data requirements
have been satisfied. There have been no changes in use pattern,
exposure, or toxicity/pathogenicity since the first product containing
this pesticide was registered, nor have any new data been identified
that would result in changes in the risk profile of the pesticide. In
addition, no human health or environmental incidents have been reported
since the registration of the first product containing the pesticide.
Finally, EPA is not aware of any changes in law, regulation, or policy
in relation to this pesticide that need to be considered at this time.
Therefore, EPA is proposing that no further review of Pepino mosaic
virus, strain CH2, isolate 1906 is necessary and registration review
can be completed at this time because the pesticide continues to meet
the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a ``No Effect'' determination under the ESA
for the labeled uses of Pepino mosaic virus, strain CH2, isolate 1906
based on the low toxicity/pathogenicity of and limited environmental
exposure to the pesticide. The reasons for this determination are the
same grounds as those described in review of the first product
containing Pepino mosaic virus, strain CH2, isolate 1906 registered by
EPA (see the decision document and supporting ecological risk
assessment posted to docket ID number EPA-HQ-OPP-2017-0527 on https://www.regulations.gov).
ii. EDSP. Because the available data indicate that the substance is
not anticipated to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen, EPA intends to seek
consensus from its internal peer review process to determine whether an
exemption from the requirements of the EDSP under FFDCA section
408(p)(4) is appropriate. If so, EPA will issue that exemption before
or concurrent with issuing a final registration review decision for
Pepino mosaic virus, strain CH2, isolate 1906.
D. Sheep Fat (Case Number 6339)
Sheep fat is derived from the body fat of slaughtered sheep. Due to
its rancid odor and taste, this active ingredient is used to repel
deer, rabbits, elk, and moose. It is applied as a spray in a variety of
use sites, e.g., agricultural areas, nurseries, forests, and commercial
and residential landscapes.
EPA has determined that its previous registration decision for two
products containing sheep fat does not need to be reconsidered. That
decision document and supporting documents are posted to docket ID
number EPA-HQ-OPP-2019-0410 on https://www.regulations.gov. As stated
in that document, EPA determined that use of the pesticide would not
cause unreasonable adverse effects to human health or the environment,
based primarily on the low toxicity and exposure expected from the
pesticide as described below:
1. FIFRA--Human Health Risk. The database of information required
to support the assessment of risk to human health of sheep fat is
complete. EPA does not expect dietary (food and drinking water) or
other non-occupational risks from use of sheep fat as an active
ingredient in pesticide products. Data demonstrated that sheep fat is
of low acute toxicity through all routes of exposure, and no
toxicological end points have been identified. No risks of concern are
expected from occupational exposures when used according to label
directions. Residues of sheep fat are exempt from the requirement of a
tolerance in or on all food commodities under 40 CFR 180.950(c). The
pesticide is of low risk to humans (including pesticide handlers and
people exposed post-application) due to both low toxicity and exposure.
No additional risk assessments are needed.
2. FIFRA--Ecological Risk. No risk concerns were identified in
previous ecological assessments based primarily on the low toxicity and
natural occurrence of components in sheep fat. The application methods
include hand-held, knapsack, or garden sprayers with a flat fan or cone
nozzle to directly treat impacted plants and therefore greatly limit
the exposure of nontarget taxa to sheep fat. EPA further noted that the
active ingredient has a nontoxic mode of action, its components (fatty
acids) are ubiquitous in the environment, and its components have a
history of exposure with no adverse effects to nontarget organisms.
Risks of concern are not anticipated for nontarget organisms as a
result of the labeled uses of the pesticide products containing sheep
fat. The pesticide is of low risk to nontarget species due to both low
toxicity and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the products containing
sheep fat satisfy the FIFRA standard for registration. The pesticide is
of such low toxicity, exposure, and risk that additional review would
not be an effective use of Agency resources. All applicable data
requirements have been satisfied. There have been no changes in use
pattern, exposure, or toxicity since the first products containing this
pesticide were registered, nor have any new data been identified that
would result in changes in the risk profile of the pesticide. In
addition, no human health or environmental incidents have been reported
since the registration of the first products containing the pesticide.
Finally, EPA is not aware of any changes in law, regulation, or policy
in relation to this pesticide that need to be considered at this time.
Therefore, EPA is proposing that no further review of sheep fat is
necessary and registration review can be completed at this time because
the pesticide continues to meet the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a ``No Effect'' determination under the ESA
for the labeled uses of sheep fat based on the low toxicity of and
limited environmental exposure to the pesticide. The reasons for this
determination are the same grounds as those described in review of the
first products containing sheep fat registered by EPA (see the decision
document and supporting ecological risk assessment posted to docket ID
number EPA-HQ-OPP-2019-0410 on https://www.regulations.gov).
ii. EDSP. Because the available data indicate that the substance is
not anticipated to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen, EPA intends to seek
consensus from its
[[Page 99257]]
internal peer review process to determine whether an exemption from the
requirements of the EDSP under FFDCA section 408(p)(4) is appropriate.
If so, EPA will issue that exemption before or concurrent with issuing
a final registration review decision for sheep fat.
V. What is EPA's authority for taking this action?
EPA is issuing these proposals pursuant to 40 CFR 155.46 to comply
with its statutory mandate to periodically review all registered
pesticides under section 3(g) of FIFRA. 7 U.S.C. 136a(g).
VI. What should I consider as I prepare comment for EPA?
1. Submitting CBI. Do not submit CBI to EPA through email or
https://www.regulations.gov. If you wish to include CBI in your
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the
information that you claim to be CBI. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for Preparing Your Comments. When preparing and submitting
your comments, see the commenting tips at: https://www.epa.gov/dockets/commenting-epa-dockets.
3. Environmental Justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, EPA
seeks information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical or disproportionately high and adverse human health
impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.
All comments should be submitted using the method in ADDRESSES and
must be received by EPA on or before the closing date. These comments
will become part of the docket for the pesticides included in Table 1
in Unit II. EPA will consider all comments received by the closing date
and may respond to comments in a ``Response to Comments Memorandum'' in
the docket and/or in any subsequent final registration review decision,
as appropriate.
Authority: 7 U.S.C. 136 et seq.
Dated: December 4, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2024-28976 Filed 12-9-24; 8:45 am]
BILLING CODE 6560-50-P