Acetophenone; Exemption From the Requirement of a Tolerance, 21103-21107 [2023-07459]
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2023–0271]
Safety Zone; Menominee River,
Marinette, WI
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Notification of enforcement of
regulation.
AGENCY:
The Coast Guard will enforce
the safety zone on the Menominee River
in Marinette, WI, on April 15, 2023,
from 7:30 a.m. to 2:00 p.m. This action
is necessary and intended to protect the
safety of life and property on navigable
waterways before, during and after the
launch of a naval vessel from Marinette
Marine on the Menominee River in
Marinette, WI. During the enforcement
period, the Coast Guard will enforce
restrictions upon, and control
movement of, vessels in the safety zone.
No person or vessel may enter, transit,
or anchor within the safety zone while
it is being enforced unless authorized by
the Captain of the Port Lake Michigan
or a designated representative.
DATES: The regulations in row (3) of
Table 4 to 33 CFR 165.929 will be
enforced from 7:30 a.m. through 2:00
p.m. on April 15, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this document,
call or email Chief Petty Officer Jeromy
Sherrill, Sector Lake Michigan
Waterways Management Division, U.S.
Coast Guard; telephone 414–747–7148,
email Jeromy.N.Sherrill@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Safety Zone;
Annual Events Requiring Safety Zones
in the Captain of the Port Lake Michigan
Zone listed in 33 CFR 165.929, Table 4,
row (3) for the operations at Marinette
Marine on April 15, 2023, from 7:30
a.m. to 2:00 p.m. This action is being
taken to protect the safety of life and
property on navigable waterways of the
Menominee River, WI, for the launching
of a naval vessel. The safety zone will
encompass all waters of the Menominee
River in the vicinity of Marinette Marine
Corporation, from the U.S. HWY 41
Bridge to the Ogden Street Bridge.
Pursuant to 33 CFR 165.23 and
165.929, entry into, transiting, or
anchoring within the safety zone during
an enforcement period is prohibited
unless authorized by the Captain of the
Port Lake Michigan or a designated
representative. Those seeking
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SUMMARY:
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permission to enter the safety zone may
request permission from the Captain of
Port Lake Michigan via channel 16,
VHF–FM. Vessels and persons granted
permission to enter the safety zone shall
obey the directions of the Captain of the
Port Lake Michigan or a designated
representative.
This notification of enforcement is
issued under authority of 33 CFR
165.929 and 5 U.S.C. 552(a). In addition
to this notification of enforcement in the
Federal Register, the Coast Guard will
provide the maritime community with
advance notification of this enforcement
period via Broadcast Notice to Mariners
or Local Notice to Mariners. If the
Captain of the Port Lake Michigan
determines that the safety zone need not
be enforced for the full duration stated
in this notification, permission to enter
the safety zone may be granted using a
Broadcast Notice to Mariners.
The Captain of the Port Lake
Michigan or a designated representative
will inform the public through a
Broadcast Notice to Mariners of any
changes in the planned schedule. The
Captain of the Port Lake Michigan or a
representative may be contacted via
Channel 16, VHF–FM or at (414) 747–
7182.
Dated: March 31, 2023.
Doreen Mccarthy,
Commander, U.S. Coast Guard, Acting
Captain of the Port Lake Michigan.
[FR Doc. 2023–07444 Filed 4–7–23; 8:45 am]
BILLING CODE 9110–04–P
21103
acetophenone, when used in accordance
with the terms of that exemption.
DATES: This regulation is effective April
10, 2023. Objections and requests for
hearings must be received on or before
June 9, 2023, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0274, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–2875; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0274; FRL–10822–01–
OCSPP]
Acetophenone; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of acetophenone
when used as an inert ingredient
(solvent or co-solvent) in pesticide
formulations applied to growing crops.
ADAMA Makhteshim Ltd. submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting the establishment of this
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
SUMMARY:
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A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2021–0274 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before June
9, 2023. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2021–0274, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets#express.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
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II. Petition for Exemption
In the Federal Register of June 1, 2021
(86 FR 29229) (FRL–10023–95), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP IN–
11493) by ADAMA Makhteshim Ltd.,
3120 Highwoods Blvd., Suite 100,
Raleigh, NC 27604. The petition
requested that the existing exemption in
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40 CFR 180.920 for residues of
acetophenone (CAS Reg. No. 98–86–2)
be amended to include additional uses
for acetophenone as a solvent or cosolvent inert ingredient in pesticide
formulations applied to growing crops.
That document referenced a summary of
the petition prepared by ADAMA
Makhteshim Ltd., the petitioner, which
is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. When making a
safety determination for an exemption
for the requirement of a tolerance
FFDCA section 408(c)(2)(B) directs EPA
to consider the considerations in section
408(b)(2)(C) and (D). Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
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result to infants and children from
aggregate exposure to the pesticide
chemical residue . . . .’’ Section
408(b)(2)(D) lists other factors for EPA
consideration making safety
determinations, e.g., the validity,
completeness, and reliability of
available data, nature of toxic effects,
available information concerning the
cumulative effects of the pesticide
chemical and other substances with a
common mechanism of toxicity, and
available information concerning
aggregate exposure levels to the
pesticide chemical and other related
substances, among others.
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
harm to human health. In order to
determine the risks from aggregate
exposure to pesticide inert ingredients,
the Agency considers the toxicity of the
inert in conjunction with possible
exposure to residues of the inert
ingredient through food, drinking water,
and through other exposures that occur
as a result of pesticide use in residential
settings. If EPA is able to determine that
a finite tolerance is not necessary to
ensure that there is a reasonable
certainty that no harm will result from
aggregate exposure to the inert
ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for acetophenone
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with acetophenone follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by acetophenone as well as the noobserved-adverse-effect-level (NOAEL)
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and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
Available acute studies on
acetophenone show moderate oral and
low dermal toxicity. An inhalation
toxicity study showed moderate
inhalation toxicity. Acetophenone was
shown to be a mild irritant to the skin
and a severe eye irritant but was not
reported to be a dermal sensitizer.
Several repeat dose oral studies (i.e.,
a 17-week dietary toxicity study in rats,
a 90-day gavage study in rats, two
developmental toxicity studies in rats
and rabbits and a repeat dose toxicity
test combined with a reproductive/
developmental screening test in rats)
have been conducted with
acetophenone. The most sensitive effect
in the acetophenone database is
decreased body weight, which was
observed starting at 300 mg/kg/day in a
developmental gavage study in rats and
at 500 mg/kg/day in the 90-day gavage
study in rats.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program.
No effects attributed to a single
exposure were seen in the studies
provided and therefore, a point of
departure (POD) for acute dietary risk
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was not determined. The most sensitive
effect in the acetophenone database is
decreased body weight, which was
observed starting at 300 mg/kg/day in a
developmental gavage study in rats and
at 500 mg/kg/day in the 90-day gavage
study in rats. Therefore, both studies are
considered co-critical. The chronic
dietary, incidental oral, dermal and
inhalation endpoints are selected from
the NOAEL of 250 mg/kg/day based on
body weight changes observed starting
at 300 mg/kg/day in rats.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to acetophenone, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
acetophenone in food as follows:
Because no acute endpoint of concern
was identified, a quantitative acute
dietary exposure assessment is
unnecessary. In conducting the chronic
dietary exposure assessment using the
Dietary Exposure Evaluation Model
DEEM–FCIDTM, Version 4.02, EPA used
food consumption information from the
U.S. Department of Agriculture’s
National Health and Nutrition
Examination Survey, What we eat in
America, (NHANES/WWEIA). This
dietary survey was conducted from 2005
to 2010. The Inert Dietary Exposure
Evaluation Model (I–DEEM) is a highly
conservative model with the assumption
that the residue level of the inert
ingredient would be no higher than the
highest tolerance for a given
commodity. Implicit in this assumption
is that there would be similar rates of
degradation between the active and
inert ingredient (if any) and that the
concentration of inert ingredient in the
scenarios leading to these highest of
tolerances would be no higher than the
concentration of the active ingredient.
The model assumes 100 percent crop
treated (PCT) for all crops and that every
food eaten by a person each day has
tolerance-level residues. A complete
description of the general approach
taken to assess inert ingredient risks in
the absence of residue data is contained
in the memorandum entitled ‘‘Update to
D361707: Dietary Exposure and Risk
Assessments for the Inerts.’’ (12/21/
2021) and can be found at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2018–0090–
0002.
2. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for
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acetophenone, a conservative drinking
water concentration value of 100 ppb
based on screening level modeling was
used to assess the contribution to
drinking water for the chronic dietary
risk assessments for parent compound.
These values were directly entered into
the dietary exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables). Based on the pesticide product
labels reviewed, in a conservative effort
to assess exposure, the EPA has
conducted a screening level assessment
using high-end exposure scenarios for
pesticidal use on lawns/turf and
antimicrobial cleaning products.
Risks were calculated using the
Margin of Exposure (MOE) approach.
This is a ratio of the body burden to the
toxicological Point of Departure (POD).
A MOE greater than 100 indicates that
the exposure scenario does not
demonstrate a risk of concern for
acetophenone. For all residential
handler and post-application scenarios,
for both adults and children, for
application of pesticides containing this
inert ingredient to lawns and turf and
use in cleaning produces, the MOEs
were greater than 100 and therefore,
there is no risk of concern.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found acetophenone to
share a common mechanism of toxicity
with any other substances, and
acetophenone does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that acetophenone does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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D. Safety Factor for Infants and
Children
E. Aggregate Risks and Determination of
Safety
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act (FQPA)
Safety Factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
No evidence of offspring susceptibility
was observed in the available
developmental studies in rats and
rabbits or the reproductive/
developmental toxicity study in rats.
The offspring effects observed in all
three studies occurred only in the
presence of maternal toxicity.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced from 10X to 1X. That
decision is based on the following
findings:
i. The toxicity database for
acetophenone is complete.
ii. Acetophenone is a known
hypnotic. Clinical signs of neurotoxicity
were observed in the available studies.
However, these effects were seen at the
same or higher doses than the body
weight changes. Therefore, the POD is
protective of any potential neurotoxicity
effects.
iii. There is no evidence that
acetophenone results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to acetophenone
in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by acetophenone.
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, acetophenone is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to acetophenone
from food and water will utilize 41.2%
of the cPAD for children 1 to 2 years
old, the population group receiving the
greatest exposure. Based on the
explanation in this unit, regarding
residential use patterns, chronic
residential exposure to residues of
acetophenone is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Acetophenone is
currently used as an inert ingredient in
pesticide products that are registered for
uses that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to acetophenone.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 120 for adults and 110 for
children 1 to 2 years old. These MOEs
are not of concern because EPA’s level
of concern for acetophenone is a MOE
of 100 or below.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
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identified; however, acetophenone is
not currently used as an inert ingredient
in pesticide products that are registered
for any use patterns that would result in
intermediate-term residential exposure.
Intermediate-term risk is assessed based
on intermediate-term residential
exposure plus chronic dietary exposure.
Because there is no intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for acetophenone.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
structural alerts for carcinogenicity
coupled with the result from the studies
indicating low concern for
mutagenicity, there is low concern for
carcinogenicity with acetophenone.
Therefore, acetophenone is not expected
to pose a cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
acetophenone residues.
V. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance established
under 40 CFR 180.920 for acetophenone
(CAS Reg. No. 98–86–2) can be
amended to include the use as an inert
ingredient (solvent or co-solvent) in
pesticide formulations applied preharvest to growing crops only.
VII. Statutory and Executive Order
Reviews
This action establishes an exemption
from the tolerance requirement under
FFDCA section 408(d) in response to a
petition submitted to the Agency. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
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21107
Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001), or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999), and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000), do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 31, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend table 1 to
180.920, by revising the entry for
‘‘Acetophenone’’ to read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
*
Acetophenone (CAS Reg. No. 98–86–2) .......................................................
........................
*
*
*
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2021–0130 and EPA–HQ–
OPP–2021–0555; FRL–10449–01–OCSPP]
Ethalfluralin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
ddrumheller on DSK120RN23PROD with RULES1
AGENCY:
Jkt 259001
*
This regulation is effective April
10, 2023. Objections and requests for
hearings must be received on or before
June 9, 2023, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2021–0130 and
EPA–HQ–OPP–2021–0555, are available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
ADDRESSES:
This regulation establishes
tolerances for residues of ethalfluralin
in or on multiple crops that are
referenced later in this document. The
Interregional Research Project Number 4
16:14 Apr 07, 2023
*
*
Attractant, solvent, co-solvent.
DATES:
40 CFR Part 180
VerDate Sep<11>2014
*
(IR–4) and Gowan Company LLC.,
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
[FR Doc. 2023–07459 Filed 4–7–23; 8:45 am]
SUMMARY:
Uses
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
*
*
*
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, Acting Director,
Registration Division (7505T), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (202) 566–
1030; email address: RDFRNotices@
epa.gov.
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Agencies
[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Rules and Regulations]
[Pages 21103-21107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07459]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0274; FRL-10822-01-OCSPP]
Acetophenone; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acetophenone when used as an inert
ingredient (solvent or co-solvent) in pesticide formulations applied to
growing crops. ADAMA Makhteshim Ltd. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the
establishment of this exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of acetophenone, when used in accordance with the
terms of that exemption.
DATES: This regulation is effective April 10, 2023. Objections and
requests for hearings must be received on or before June 9, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0274, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-2875; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.
[[Page 21104]]
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0274 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
June 9, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0274, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11493) by
ADAMA Makhteshim Ltd., 3120 Highwoods Blvd., Suite 100, Raleigh, NC
27604. The petition requested that the existing exemption in 40 CFR
180.920 for residues of acetophenone (CAS Reg. No. 98-86-2) be amended
to include additional uses for acetophenone as a solvent or co-solvent
inert ingredient in pesticide formulations applied to growing crops.
That document referenced a summary of the petition prepared by ADAMA
Makhteshim Ltd., the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .'' Section 408(b)(2)(D) lists other factors for EPA consideration
making safety determinations, e.g., the validity, completeness, and
reliability of available data, nature of toxic effects, available
information concerning the cumulative effects of the pesticide chemical
and other substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances, among others.
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for acetophenone including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with acetophenone follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by acetophenone as well as the no-
observed-adverse-effect-level (NOAEL)
[[Page 21105]]
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in this unit.
Available acute studies on acetophenone show moderate oral and low
dermal toxicity. An inhalation toxicity study showed moderate
inhalation toxicity. Acetophenone was shown to be a mild irritant to
the skin and a severe eye irritant but was not reported to be a dermal
sensitizer.
Several repeat dose oral studies (i.e., a 17-week dietary toxicity
study in rats, a 90-day gavage study in rats, two developmental
toxicity studies in rats and rabbits and a repeat dose toxicity test
combined with a reproductive/developmental screening test in rats) have
been conducted with acetophenone. The most sensitive effect in the
acetophenone database is decreased body weight, which was observed
starting at 300 mg/kg/day in a developmental gavage study in rats and
at 500 mg/kg/day in the 90-day gavage study in rats.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
No effects attributed to a single exposure were seen in the studies
provided and therefore, a point of departure (POD) for acute dietary
risk was not determined. The most sensitive effect in the acetophenone
database is decreased body weight, which was observed starting at 300
mg/kg/day in a developmental gavage study in rats and at 500 mg/kg/day
in the 90-day gavage study in rats. Therefore, both studies are
considered co-critical. The chronic dietary, incidental oral, dermal
and inhalation endpoints are selected from the NOAEL of 250 mg/kg/day
based on body weight changes observed starting at 300 mg/kg/day in
rats.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetophenone, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from acetophenone in food as follows:
Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary. In conducting the
chronic dietary exposure assessment using the Dietary Exposure
Evaluation Model DEEM-FCID\TM\, Version 4.02, EPA used food consumption
information from the U.S. Department of Agriculture's National Health
and Nutrition Examination Survey, What we eat in America, (NHANES/
WWEIA). This dietary survey was conducted from 2005 to 2010. The Inert
Dietary Exposure Evaluation Model (I-DEEM) is a highly conservative
model with the assumption that the residue level of the inert
ingredient would be no higher than the highest tolerance for a given
commodity. Implicit in this assumption is that there would be similar
rates of degradation between the active and inert ingredient (if any)
and that the concentration of inert ingredient in the scenarios leading
to these highest of tolerances would be no higher than the
concentration of the active ingredient. The model assumes 100 percent
crop treated (PCT) for all crops and that every food eaten by a person
each day has tolerance-level residues. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Update to
D361707: Dietary Exposure and Risk Assessments for the Inerts.'' (12/
21/2021) and can be found at https://www.regulations.gov in docket ID
number EPA-HQ-OPP-2018-0090-0002.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for acetophenone, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Based
on the pesticide product labels reviewed, in a conservative effort to
assess exposure, the EPA has conducted a screening level assessment
using high-end exposure scenarios for pesticidal use on lawns/turf and
antimicrobial cleaning products.
Risks were calculated using the Margin of Exposure (MOE) approach.
This is a ratio of the body burden to the toxicological Point of
Departure (POD). A MOE greater than 100 indicates that the exposure
scenario does not demonstrate a risk of concern for acetophenone. For
all residential handler and post-application scenarios, for both adults
and children, for application of pesticides containing this inert
ingredient to lawns and turf and use in cleaning produces, the MOEs
were greater than 100 and therefore, there is no risk of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found acetophenone to share a common mechanism of
toxicity with any other substances, and acetophenone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetophenone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
[[Page 21106]]
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. No evidence of offspring
susceptibility was observed in the available developmental studies in
rats and rabbits or the reproductive/developmental toxicity study in
rats. The offspring effects observed in all three studies occurred only
in the presence of maternal toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X. That decision is based on the
following findings:
i. The toxicity database for acetophenone is complete.
ii. Acetophenone is a known hypnotic. Clinical signs of
neurotoxicity were observed in the available studies. However, these
effects were seen at the same or higher doses than the body weight
changes. Therefore, the POD is protective of any potential
neurotoxicity effects.
iii. There is no evidence that acetophenone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to acetophenone in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
acetophenone.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
acetophenone is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
acetophenone from food and water will utilize 41.2% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in this unit, regarding residential
use patterns, chronic residential exposure to residues of acetophenone
is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Acetophenone
is currently used as an inert ingredient in pesticide products that are
registered for uses that could result in short-term residential
exposure, and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to acetophenone.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 120 for adults
and 110 for children 1 to 2 years old. These MOEs are not of concern
because EPA's level of concern for acetophenone is a MOE of 100 or
below.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
acetophenone is not currently used as an inert ingredient in pesticide
products that are registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
acetophenone.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity coupled with the result from the
studies indicating low concern for mutagenicity, there is low concern
for carcinogenicity with acetophenone. Therefore, acetophenone is not
expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to acetophenone residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance
established under 40 CFR 180.920 for acetophenone (CAS Reg. No. 98-86-
2) can be amended to include the use as an inert ingredient (solvent or
co-solvent) in pesticide formulations applied pre-harvest to growing
crops only.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the tolerance requirement
under FFDCA section 408(d) in response to a petition submitted to the
Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning
[[Page 21107]]
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 31, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, amend table 1 to 180.920, by revising the entry
for ``Acetophenone'' to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to 180.920
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Acetophenone (CAS Reg. No. 98-86- .............. Attractant, solvent,
2). co-solvent.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-07459 Filed 4-7-23; 8:45 am]
BILLING CODE 6560-50-P