Fatty acids, C16-18 and C18-unsatd., esters With polyethylene glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption, 95131-95136 [2024-28080]
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Feb. 16, 1994) directs Federal agencies
to identify and address
‘‘disproportionately high and adverse
human health or environmental effects’’
of their actions on communities with
environmental justice (EJ) concerns to
the greatest extent practicable and
permitted by law. Executive Order
14096 (Revitalizing Our Nation’s
Commitment to Environmental Justice
for All, 88 FR 25251, April 26, 2023)
builds on and supplements E.O. 12898
and defines EJ as, among other things,
the just treatment and meaningful
involvement of all people, regardless of
income, race, color, national origin, or
Tribal affiliation, or disability in agency
decision-making and other Federal
activities that affect human health and
the environment.
The State did not evaluate EJ
considerations as part of its SIP
submittal; the CAA and applicable
implementing regulations neither
prohibit nor require such an evaluation.
EPA performed an EJ analysis, as is
described in the proposed action 89 FR
56693 (July 10, 2024) in the section
titled, ‘‘Environmental Justice.’’ The
analysis was done for the purpose of
providing additional context and
information about this rulemaking to the
public, not as a basis of the action. In
Rule No.
*
addition, there is no information in the
record upon which this decision is
based inconsistent with the stated goal
of E.O. 12898/14096 of achieving EJ for
communities with EJ concerns.
This action is subject to the
Congressional Review Act, and EPA will
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. This action
is not a ‘‘major rule’’ as defined by 5
U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by January 31, 2025. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements (see section
307(b)(2)).
List of Subjects in 40 CFR Part 52
State
effective
date
*
*
EPA
effective
date
*
Dated: November 22, 2024.
KC Becker,
Regional Administrator, Region 8.
For the reasons stated in the
preamble, the Environmental Protection
Agency is amending 40 CFR part 52 as
follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart JJ—North Dakota
2. In § 52.1820, the table in paragraph
(e) is amended by adding an entry for
‘‘North Dakota State Implementation
Plan for Regional Haze (Second
Implementation Period)’’ at the end of
the table to read as follows:
■
§ 52.1820
Environmental protection, Air
pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by
Rule title
reference, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and
recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.
*
Identification of plan.
*
*
(e) * * *
*
Final rule
citation/date
*
Comments
*
*
*
North Dakota State Implementation Plan For Regional Haze
*
North Dakota State Implementation Plan for
Regional Haze (Second
Implementation Period).
*
*
North Dakota State Implementation Plan for
Regional Haze
[FR Doc. 2024–27940 Filed 11–29–24; 8:45 am]
BILLING CODE 6560–50–P
*
8/10/2022
1/2/2025
*
[insert Federal Register citation], 12/2/
2024
ENVIRONMENTAL PROTECTION
AGENCY
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[EPA–HQ–OPP–2023–0368; FRL–12393–01–
OCSPP]
Fatty acids, C16–18 and C18-unsatd.,
esters With polyethylene glycol monoMe ether in Pesticide Formulations;
Tolerance Exemption
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Final rule.
This regulation establishes an
exemption from the requirement of a
tolerance for residues of fatty acids,
C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether
(CAS Reg. No. 518299–31–5) when used
as an inert ingredient (surfactant and
related adjuvant of surfactant) on
growing crops and raw agricultural
commodities pre- and post-harvest
limited to 25% by weight in pesticide
formulations. Spring Regulatory
SUMMARY:
40 CFR Part 180
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*
*
Excluding the sections disapproved in
this action. EPA disapproved the
portions of North Dakota’s 2022 SIP
submission relating to CAA section
169A and 40 CFR 51.308(f)(2):
long-term
strategy;
40
CFR
51.308(f)(3): reasonable progress
goals; and 40 CFR 51.308(i): FLM
consultation.
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Sciences on behalf of Sasol Chemicals
(USA) LLC submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA) requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of fatty acids, C16–18 and
C18-unsatd., esters with polyethylene
glycol mono-Me ether, when used in
accordance with the terms of this
exemption.
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This regulation is effective
December 2, 2024. Objections and
requests for hearings must be received
on or before January 31, 2025 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–2023–0368, 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. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, 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.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), 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–2023–0368 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 January 31, 2025. 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–
2023–0368, 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
DATES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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).
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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 Federal Register Office’s eCFR site at https://www.ecfr.gov/
current/title-40/chapter-I/subchapter-E/
part-180?toc=1.
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dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of September
19, 2023 (88 FR 64398, FRL–10579–08),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11755) by Spring
Regulatory Sciences (6620 Cypresswood
Dr., Suite 250, Spring, TX 77379) on
behalf of Sasol Chemicals (USA) LLC
(12120 Wickchester Lane, Houston, TX
77224). The petition requested that 40
CFR 180.910 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe ether (CAS Reg. No. 518299–31–5)
when used as an inert ingredient
(surfactant and related adjuvant of
surfactant) in pesticide formulations
applied to growing crops or raw
agricultural commodities pre- and postharvest limited to 25% by weight in
pesticide formulations. That document
referenced a summary of the petition
prepared by Spring Regulatory Sciences
on behalf of Sasol Chemicals (USA)
LLC, the petitioner, which is available
in the docket at 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
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
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. FFDCA section
408(c)(2)(B) directs EPA to take into
account the considerations in section
408(b)(2)(C) and (D) when making a
safety determination for an exemption
from the requirement of a tolerance.
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 when making
safety determinations, including 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.
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
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sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for fatty acids, C16–18
and C18-unsatd., esters with
polyethylene glycol mono-Me ether,
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with fatty acids, C16–18 and
C18-unsatd., esters with polyethylene
glycol mono-Me ether follows.
reference dose (cRfD, 1.6 mg/kg/day)
will be protective of offspring effects
observed at 250 mg/kg/day. No effects
on reproductive parameters,
neurotoxicity or immunotoxicity were
observed in the available studies.
Concern for carcinogenicity is low,
based on no evidence of tumors or
cancer in chronic/carcinogenicity
studies and negative results in
mutagenicity studies.
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 fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe ether as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in this unit.
The toxicological database of fatty
acids, C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether is
supported by data regarding methyl
laurate and alcohol ethoxylates (C12AE7,
C13AE3, C14AE3, C14AE7, C14AE12,
C15AE3 and C15AE7). EPA has
determined that it is appropriate to
bridge methyl laurate and the
aforementioned alcohol ethoxylates data
to assess fatty acids, C16–18 and C18unsatd., esters with polyethylene glycol
mono-Me ether based on similarities in
the functional groups/structure,
composition, and physical/chemical
properties.
Fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe exhibits low levels of acute toxicity
via the oral, dermal, and inhalation
routes of exposure. It is not a skin
irritant or a skin sensitizer, but it is
minimally irritating to the eyes.
Reduced body weight starting at 250
mg/kg/day was observed in the
combined reproduction and
developmental toxicity test, 2generation reproduction toxicity, and
chronic/carcinogenicity studies.
Increased offspring susceptibility was
observed in the two-generation
reproduction toxicity study in rats.
Reduced body weight in pups was
observed at 250 mg/kg/day in the
absence of maternal toxicity. However,
the concern for offspring susceptibility
is low because the established chronic
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.
An acute dietary endpoint was not
selected because no effect attributable to
a single dose was identified in the
database. Co-critical chronic/
carcinogenicity studies in rats were
selected for the chronic dietary
exposure scenario as well as short- and
intermediate-term incidental oral,
dermal and inhalation exposure
scenarios. The NOAEL of 160 mg/kg/
day and LOAEL of 250 mg/kg/day,
based on decreased body weight, are
selected for risk assessment. The studies
are appropriate for the duration of
exposure, protective of all subchronic
effects, protective of the general
population, and are protective of the
most sensitive lifestage (children). The
standard inter- and intra-species
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uncertainty factors of 10x are applied
(total uncertainty factor = 100x). A
dermal absorption factor of 20% is
applied. The default factor of 100% is
applied for the inhalation absorption
rate.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fatty acids, C16–18 and C18unsatd., esters with polyethylene glycol
mono-Me ether, EPA considered
exposure under the proposed exemption
from the requirement of a tolerance.
There are no known non-pesticidal
dietary exposures for fatty acids, C16–18
and C18-unsatd., esters with
polyethylene glycol mono-Me ether.
EPA assessed dietary exposures from
fatty acids, C16–18 and C18-unsatd., esters
with polyethylene glycol mono-Me
ether in food as follows:
In conducting the 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 (USDA’s)
2005–2010 National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). As
to residue levels in food, no residue data
were submitted for fatty acids, C16–18
and C18-unsatd., esters with
polyethylene glycol mono-Me ether. In
the absence of specific residue data,
EPA has developed an approach which
uses surrogate information to derive
upper bound exposure estimates for the
subject inert ingredient. Upper bound
exposure estimates are based on the
highest tolerance for a given commodity
from a list of high use insecticides,
herbicides, and fungicides. A complete
description of the general approach
taken to assess inert ingredient risks in
the absence of residue data is contained
in the memorandum titled ‘‘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.
In the dietary exposure assessments,
the Agency assumed 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 (if any)
between the active and inert ingredient
and that the concentration of inert
ingredient in the scenarios leading to
these highest levels of tolerances would
be no higher than the concentration of
the active ingredient.
The Agency believes the assumptions
used to estimate dietary exposures lead
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to an extremely conservative assessment
of dietary risk due to a series of
compounded conservatisms. First,
assuming that the level of residue for an
inert ingredient is equal to the level of
residue for the active ingredient will
overstate exposure. The concentrations
of active ingredient in agricultural
products are generally at least 50
percent of the product and often can be
much higher. Further, pesticide
products rarely have a single inert
ingredient; rather there is generally a
combination of different inert
ingredients used which additionally
reduces the concentration of any single
inert ingredient in the pesticide product
in relation to that of the active
ingredient. In the case of fatty acids,
C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether,
EPA made a specific adjustment to the
dietary exposure assessment to account
for the use limitations of the amount of
fatty acids, C16–18 and C18-unsatd., esters
with polyethylene glycol mono-Me
ether that may be in pesticide
formulations (limited to no more than
25%) present at the maximum
limitation rather than at equal quantities
with the active ingredient.
For the purpose of the screening level
dietary risk assessment, a conservative
drinking water concentration value of
100 parts per billion (ppb) based on
screening level modeling was used to
assess the contribution to drinking
water for the chronic dietary risk
assessments for fatty acids, C16–18 and
C18-unsatd., esters with polyethylene
glycol mono-Me ether.
2. 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).
Fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe ether may be used as an inert
ingredient in pesticide products that are
registered for specific uses that may
result in residential exposure, such as
pesticides used in and around the home.
Therefore, screening level residential
handler and post-application risk
assessments have been performed for
common residential exposure scenarios,
using assumptions detailed in the 2012
Residential SOPs (available at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide).
3. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
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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 fatty acids, C16–18
and C18-unsatd., esters with
polyethylene glycol mono-Me ether to
share a common mechanism of toxicity
with any other substances, and fatty
acids, C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance exemption, therefore, EPA has
assumed that fatty acids, C16–18 and C18unsatd., esters with polyethylene glycol
mono-Me ether 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.
D. Additional Safety Factor for the
Protection of Infants and Children
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. 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.
Based on the evaluation of available
toxicity studies, there is low concern for
pre- and postnatal susceptibility from
exposure to fatty acids, C16–18 and C18unsatd., esters with polyethylene glycol
mono-Me ether. The FQPA safety factor
has been reduced to 1X because: (1) the
toxicity database is adequate to
characterize potential pre- and postnatal
risk; (2) the established PoD (160 mg/kg/
day) will be protective of the body
weight decrease in offspring seen at 250
mg/kg/day in the 2-generation
reproduction toxicity study in rats; (3)
no evidence of neurotoxicity was
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observed in the database; and (4) the
assumptions for the exposure
assessment are conservative and
unlikely to underestimate risk.
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, fatty acids, C16–18
and C18-unsatd., esters with
polyethylene glycol mono-Me ether 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 fatty acids,
C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether
from food and water will utilize
approximately 8.9% and 32.3% of the
cPAD for the U.S. population and
children 1–2 years old (the most highly
exposed populations).
3. Short- and intermediate term risks.
Short- and intermediate term aggregate
exposures take into account short- and
intermediate-term residential exposures
plus chronic exposures to food and
water (considered to be a background
exposure level).
Fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe ether may be 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 fatty
acids, C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether.
Using the exposure assumptions
described in this unit for short- and
intermediate-term exposures, EPA has
concluded the combined short- and
intermediate-term food, water, and
residential exposures result in an
aggregate margin of exposure (MOE) of
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268 for adults. Adult residential
exposure combines high end dermal and
inhalation handler exposure from
aerosol spray/trigger pump with a highend post application dermal exposure
from contact with treated lawns. The
combined short- and intermediate-term
aggregated food, water, and residential
pesticide exposures result in an
aggregate MOE of 127 for children.
Children’s residential exposure includes
total exposures associated with contact
with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level
of concern for fatty acids, C16–18 and C18unsatd., esters with polyethylene glycol
mono-Me ether is an MOE of 100 or
below, these MOEs are not of concern.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of fatty acids,
C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether in
or on any food commodities. EPA is
establishing a limitation on the amount
of fatty acids, C16–18 and C18-unsatd.,
esters with polyethylene glycol monoMe ether that may be used in pesticide
formulations applied pre- and postharvest. This limitation will be enforced
through the pesticide registration
process under the Federal Insecticide,
Fungicide, and Rodenticide Act
(‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA will
not register any pesticide formulation
for food use that exceeds 25% fatty
acids, C16–18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether in
the final pesticide formulations to be
applied pre- and post-harvest.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
for residues of fatty acids, C16–18 and
C18-unsatd., esters with polyethylene
glycol mono-Me ether (CAS Reg. No.
518299–31–5) when used as an inert
ingredient (surfactant and related
adjuvant of surfactant) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest under 40 CFR 180.910, limited
to a maximum concentration of 25% in
a pesticide formulation.
VII. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
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
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95135
of actions from review under Executive
Order 12866, titled ‘‘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,
titled ‘‘Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
titled ‘‘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, titled ‘‘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 exemption 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, titled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, titled
‘‘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
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
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.
Authority: 21 U.S.C. 321(q), 346a and 371.
Dated: November 21, 2024.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
2. In § 180.910, amend Table 1 to
180.910 by adding, in alphabetical
order, the entry ‘‘Fatty acids, C16–18 and
C18-unsatd., esters with polyethylene
glycol mono-Me ether’’ to read as
follows:
Therefore, for the reasons stated in the
preamble, the EPA amends 40 CFR
chapter I as follows:
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
■
*
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
*
*
*
*
1. The authority citation for part 180
continues to read as follows:
■
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
*
Fatty acids, C16–18 and C18-unsatd., esters with polyethylene glycol mono-Me ether (CAS
Reg. No. 518299–31–5).
*
*
*
[FR Doc. 2024–28080 Filed 11–29–24; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 93
45 CFR Parts 46 and 73
Final Scientific Integrity Policy;
Withdrawal
Office of the Assistant
Secretary for Planning and Evaluation,
Office of the Secretary, HHS.
ACTION: Withdrawal.
AGENCY:
The Department of Health and
Human Services (HHS) is withdrawing
the Federal Register document
published at 89 FR 92830. The HHS
Scientific Integrity Policy remains in
effect.
DATES: As of December 2, 2024, the
document published at 89 FR 92830, on
November 25, 2024, is withdrawn.
FOR FURTHER INFORMATION CONTACT:
Karen Wehner, Ph.D., Scientific
Integrity Officer, Office of Science and
Data Policy, Office of the Assistant
Secretary for Planning and Evaluation,
Office of the Secretary, HHS at 240–
453–8435 or scientificintegrity@hhs.gov.
SUPPLEMENTARY INFORMATION: Scientific
integrity plays a vital role in the mission
of HHS. Ensuring integrity in science
throughout the Department allows HHS
ddrumheller on DSK120RN23PROD with RULES1
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to foster and produce high-quality
science, communicate effectively with
the public, and base critical policy
decisions on trustworthy and rigorous
scientific findings. HHS has adopted a
Department-wide scientific integrity
policy to further strengthen scientific
integrity and evidence-based
policymaking throughout the
Department.
The Scientific Integrity Policy of the
U.S. Department of Health and Human
Services (Policy) was approved on
September 16, 2024. The finalized
Policy was announced to the HHS
community and posted on the HHS
scientific integrity website, at https://
www.hhs.gov/programs/research/
scientificintegrity/, on
September 30, 2024.
The document that published on
Monday November 25, 2024, at 89 FR
92830 is being withdrawn. The Policy
itself remains in effect and the public
may continue to access the policy on the
HHS website, at https://www.hhs.gov/
sites/default/files/hhs-scientificintegrity-policy.pdf.
HHS would like to clarify that the
Policy does not modify, implement, or
change the Rules referenced in the CFR
citations section, i.e., 42 CFR part 93
and 45 CFR parts 46 and 73; and is not
intended to be guidance about
implementing those Rules. HHS also
notes that the Policy is an internal HHS
policy and only applies to HHS
employees and other covered
individuals as indicated in the Policy.
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Surfactant and related adjuvant of surfactant.
*
*
The effective date of the Policy
remains October 16, 2024.
Dated: November 25, 2024.
Katherine N. Bent,
Associate Deputy Assistant Secretary, Office
of Science and Data Policy, Office of the
Assistant Secretary for Planning and
Evaluation, Department of Health and
Human Services.
[FR Doc. 2024–28128 Filed 11–27–24; 8:45 am]
BILLING CODE 4150–05–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[GN Docket No. 23–65, IB Docket No. 22–
271, FCC 24–28; FR ID 264974]
Single Network Future: Supplemental
Coverage From Space; Space
Innovation
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years,
information collections associated with
certain rules adopted in the 2024 Single
Network Future: Supplemental
Coverage from Space; Space Innovation
Report and Order and Further Notice of
SUMMARY:
E:\FR\FM\02DER1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Rules and Regulations]
[Pages 95131-95136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28080]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0368; FRL-12393-01-OCSPP]
Fatty acids, C16-18 and C18-unsatd., esters With polyethylene
glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
(CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant
and related adjuvant of surfactant) on growing crops and raw
agricultural commodities pre- and post-harvest limited to 25% by weight
in pesticide formulations. Spring Regulatory
[[Page 95132]]
Sciences on behalf of Sasol Chemicals (USA) LLC submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of fatty acids, C16-18 and C18-
unsatd., esters with polyethylene glycol mono-Me ether, when used in
accordance with the terms of this exemption.
DATES: This regulation is effective December 2, 2024. Objections and
requests for hearings must be received on or before January 31, 2025
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-2023-0368, 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. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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: [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 Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2023-0368 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
January 31, 2025. 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-2023-0368, 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 September 19, 2023 (88 FR 64398, FRL-
10579-08), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11755) by Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250,
Spring, TX 77379) on behalf of Sasol Chemicals (USA) LLC (12120
Wickchester Lane, Houston, TX 77224). The petition requested that 40
CFR 180.910 be amended by establishing an exemption from the
requirement of a tolerance for residues of fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert
ingredient (surfactant and related adjuvant of surfactant) in pesticide
formulations applied to growing crops or raw agricultural commodities
pre- and post-harvest limited to 25% by weight in pesticide
formulations. That document referenced a summary of the petition
prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals
(USA) LLC, the petitioner, which is available in the docket at 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
[[Page 95133]]
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. FFDCA section 408(c)(2)(B)
directs EPA to take into account the considerations in section
408(b)(2)(C) and (D) when making a safety determination for an
exemption from the requirement of a tolerance. 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 when making safety determinations,
including 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.
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 fatty acids, C16-18
and C18-unsatd., esters with polyethylene glycol mono-Me
ether, including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
fatty acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether 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 fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
The toxicological database of fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
is supported by data regarding methyl laurate and alcohol ethoxylates
(C12AE7, C13AE3,
C14AE3, C14AE7,
C14AE12, C15AE3 and
C15AE7). EPA has determined that it is
appropriate to bridge methyl laurate and the aforementioned alcohol
ethoxylates data to assess fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
based on similarities in the functional groups/structure, composition,
and physical/chemical properties.
Fatty acids, C16-18 and C18-unsatd., esters
with polyethylene glycol mono-Me exhibits low levels of acute toxicity
via the oral, dermal, and inhalation routes of exposure. It is not a
skin irritant or a skin sensitizer, but it is minimally irritating to
the eyes. Reduced body weight starting at 250 mg/kg/day was observed in
the combined reproduction and developmental toxicity test, 2-generation
reproduction toxicity, and chronic/carcinogenicity studies. Increased
offspring susceptibility was observed in the two-generation
reproduction toxicity study in rats. Reduced body weight in pups was
observed at 250 mg/kg/day in the absence of maternal toxicity. However,
the concern for offspring susceptibility is low because the established
chronic reference dose (cRfD, 1.6 mg/kg/day) will be protective of
offspring effects observed at 250 mg/kg/day. No effects on reproductive
parameters, neurotoxicity or immunotoxicity were observed in the
available studies. Concern for carcinogenicity is low, based on no
evidence of tumors or cancer in chronic/carcinogenicity studies and
negative results in mutagenicity studies.
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.
An acute dietary endpoint was not selected because no effect
attributable to a single dose was identified in the database. Co-
critical chronic/carcinogenicity studies in rats were selected for the
chronic dietary exposure scenario as well as short- and intermediate-
term incidental oral, dermal and inhalation exposure scenarios. The
NOAEL of 160 mg/kg/day and LOAEL of 250 mg/kg/day, based on decreased
body weight, are selected for risk assessment. The studies are
appropriate for the duration of exposure, protective of all subchronic
effects, protective of the general population, and are protective of
the most sensitive lifestage (children). The standard inter- and intra-
species
[[Page 95134]]
uncertainty factors of 10x are applied (total uncertainty factor =
100x). A dermal absorption factor of 20% is applied. The default factor
of 100% is applied for the inhalation absorption rate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fatty acids, C16-18 and C18-unsatd.,
esters with polyethylene glycol mono-Me ether, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. There
are no known non-pesticidal dietary exposures for fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether. EPA assessed dietary exposures from fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether in food as follows:
In conducting the 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
(USDA's) 2005-2010 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether.
In the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
titled ``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.
In the dietary exposure assessments, the Agency assumed 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 (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of fatty acids, C16-18
and C18-unsatd., esters with polyethylene glycol mono-Me
ether, EPA made a specific adjustment to the dietary exposure
assessment to account for the use limitations of the amount of fatty
acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether that may be in pesticide formulations
(limited to no more than 25%) present at the maximum limitation rather
than at equal quantities with the active ingredient.
For the purpose of the screening level dietary risk assessment, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for fatty acids, C16-18 and C18-unsatd., esters
with polyethylene glycol mono-Me ether.
2. 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).
Fatty acids, C16-18 and C18-unsatd., esters
with polyethylene glycol mono-Me ether may be used as an inert
ingredient in pesticide products that are registered for specific uses
that may result in residential exposure, such as pesticides used in and
around the home. Therefore, screening level residential handler and
post-application risk assessments have been performed for common
residential exposure scenarios, using assumptions detailed in the 2012
Residential SOPs (available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide).
3. 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 fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
to share a common mechanism of toxicity with any other substances, and
fatty acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance exemption, therefore, EPA has assumed that fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether 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.
D. Additional Safety Factor for the Protection of Infants and Children
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. 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.
Based on the evaluation of available toxicity studies, there is low
concern for pre- and postnatal susceptibility from exposure to fatty
acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether. The FQPA safety factor has been
reduced to 1X because: (1) the toxicity database is adequate to
characterize potential pre- and postnatal risk; (2) the established PoD
(160 mg/kg/day) will be protective of the body weight decrease in
offspring seen at 250 mg/kg/day in the 2-generation reproduction
toxicity study in rats; (3) no evidence of neurotoxicity was
[[Page 95135]]
observed in the database; and (4) the assumptions for the exposure
assessment are conservative and unlikely to underestimate risk.
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,
fatty acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether 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
fatty acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether from food and water will utilize
approximately 8.9% and 32.3% of the cPAD for the U.S. population and
children 1-2 years old (the most highly exposed populations).
3. Short- and intermediate term risks. Short- and intermediate term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposures to food and water
(considered to be a background exposure level).
Fatty acids, C16-18 and C18-unsatd., esters
with polyethylene glycol mono-Me ether may be 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 fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether.
Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded the combined short-
and intermediate-term food, water, and residential exposures result in
an aggregate margin of exposure (MOE) of 268 for adults. Adult
residential exposure combines high end dermal and inhalation handler
exposure from aerosol spray/trigger pump with a high-end post
application dermal exposure from contact with treated lawns. The
combined short- and intermediate-term aggregated food, water, and
residential pesticide exposures result in an aggregate MOE of 127 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). Because EPA's level of concern for fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether is an MOE of 100 or below, these MOEs are not of
concern.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
fatty acids, C16-18 and C18-unsatd., esters with
polyethylene glycol mono-Me ether in or on any food commodities. EPA is
establishing a limitation on the amount of fatty acids,
C16-18 and C18-unsatd., esters with polyethylene
glycol mono-Me ether that may be used in pesticide formulations applied
pre- and post-harvest. This limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation for food use that exceeds
25% fatty acids, C16-18 and C18-unsatd., esters
with polyethylene glycol mono-Me ether in the final pesticide
formulations to be applied pre- and post-harvest.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether
(CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant
and related adjuvant of surfactant) in pesticide formulations applied
to growing crops and raw agricultural commodities after harvest under
40 CFR 180.910, limited to a maximum concentration of 25% in a
pesticide formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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, titled ``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, titled ``Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22,
2001) or Executive Order 13045, titled ``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, titled ``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 exemption 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, titled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, titled
``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
[[Page 95136]]
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: November 21, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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. 180.910, amend Table 1 to 180.910 by adding, in
alphabetical order, the entry ``Fatty acids, C16-18 and
C18-unsatd., esters with polyethylene glycol mono-Me ether''
to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Fatty acids, C16-18 and C18- 25% by weight Surfactant and
unsatd., esters with related adjuvant
polyethylene glycol mono-Me of surfactant.
ether (CAS Reg. No. 518299-31-
5).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2024-28080 Filed 11-29-24; 8:45 am]
BILLING CODE 6560-50-P
