[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7473-7477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02815]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0783; FRL-9941-49]
Benzyl acetate; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of benzyl acetate (CAS Reg. No. 140-11-4),
when used as an inert ingredient (solvent) in pesticide formulations
applied to growing crops only under 40 CFR 180.920. Technology Sciences
Group, on behalf of the Huntsman Corporation, 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 benzyl acetate.
DATES: This regulation is effective February 12, 2016. Objections and
requests for hearings must be received on or before April 12, 2016, 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-2014-0783, is available at http://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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; 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 Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2014-0783 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
April 12, 2016. 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-2014-0783, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of Wednesday, March 4, 2015 (80 FR 11611)
(FRL-9922-68), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition ((PP) IN-
10748) by Technology Sciences Group (TSG) 1150 18th Street NW., Suite
1000, Washington, DC 20036, on behalf of the Huntsman Corporation, 8600
Gosling Road, The Woodlands, TX 77381. The petition requested that 40
CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of benzyl acetate (CAS Reg. No.
140-11-4) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops only. That document referenced a
summary of the petition prepared by the Huntsman Corporation, the
petitioner, which is available in the docket, http://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
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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(b)(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. 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. . . .''
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 appreciable risks 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 benzyl acetate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with benzyl acetate
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 benzyl acetate 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.
Benzyl acetate exhibits low levels of toxicity via the dermal route
of exposure in rabbits and inhalation and oral routes of exposure in
rats. It is mildly irritating to the skin and minimally irritating to
the eyes in rabbits. It is not a skin sensitizer in guinea pigs.
In a 13-week feeding study in the rat, atrophic seminiferous
tubules were observed in male rats at dose levels of 12,500 parts per
millions (ppm) (equivalent to 900 milligrams/kilogram/day (mg/kg/day)).
The NOAEL was identified as 6,250 ppm (460 mg/kg/day). In mice,
following 13 weeks of exposure via the diet, decreased body weight and
food consumption were observed at all doses. The LOAEL was 3,130 ppm
(425 mg/kg/day). A NOAEL was not established.
In a developmental toxicity study in the rat, maternal and fetal
toxicity were observed at 1,000 mg/kg/day. Maternal toxicity was
manifested as decreased body weight and fetal toxicity was manifested
as reduced body weights, increased incidence of dilation of the renal
pelvis and skeletal variations. Although qualitative fetal
susceptibility is observed, fetal effects occur in the presence of
maternal toxicity and a clear NOAEL of 500 mg/kg/day was established
for maternal and developmental toxicity.
The potential for benzyl acetate to be genotoxic was evaluated in a
battery of in vivo mammalian genotoxicity studies. It was negative in
the Ames assay (with and without metabolic activation), sister
chromatid exchange assay, Chinese hamster ovary cell assay, mouse
micronucleus assay and in the dominant lethal assay in Drosophila.
However, it gave a positive response in the mouse lymphoma assay. Since
other chromosomal aberrations assays as well as gene mutation assays
and a dominant lethal assay gave a negative response, it is concluded
that benzyl acetate is unlikely to be mutagenic.
Evidence of neurotoxicity and neuronal degeneration was identified
in the 13-week studies in rats and mice. Signs of neurotoxicity
included tremors and ataxia that were associated with the degeneration
of the glial cells in the cerebellum and hippocampus at the doses
>=12,500 ppm (>=2,000 mg/kg/day). Since these effects were induced at
doses above the limit dose (1,000 mg/kg/day) and the established cRfD
of 1.10 mg/kg/day, will be protective of these effects, the concern is
low for these effects.
There is evidence that benzyl acetate suppresses immune function in
mammalian systems in the rat however this effect occurs only at a dose
that is lethal and well above the limit dose. In the 13-week feeding
study in the rat, a decrease in the cellular components of the bone
marrow, thymus and lymphoid follicles was observed at 50,000 ppm (3,900
mg/kg/day for males and 4,500 mg/kg/day for females), the highest dose
tested and well above the limit dose. The NOAEL for this study was
12,500 ppm (900 mg/kg/day). The potential for immunotoxicity is not of
concern because the effects occur well above the limit dose and the
exposure to benzyl acetate through the proposed use is unlikely to
occur at such a high dose.
The carcinogenicity of benzyl acetate in F344/N rats,
and B6C3F1 mice using was evaluated using the gavage method
of administration and corn oil as a vehicle. There were indications
that benzyl acetate increased the incidences of pancreatic acinar cell
adenomas in male rats and the incidences of hepatocellular adenomas and
forestomach neoplasms in male and female mice. Because of the
confounding effects of corn oil on the incidences of pancreatic
neoplasm and because of the controversy over the use of the gavage
route of administration, the National Toxicology Program (NTP) decided
to re-study benzyl acetate using the dosed feed route of
administration. In 1993, the NTP conducted a second set of
carcinogenicity studies in rats and mice using the dose feed route of
administration. Benzyl acetate was administered via the diet to rats
and mice at doses up to 12,000 ppm (510/575 mg/kg/day, male/female).
Toxicity was not observed in rats at any dose. In mice, males and
females exhibited reduced body weight throughout the entire study at
345/375 mg/kg/day. There was no evidence of carcinogenicity in mice and
rats. Since the exposure to benzyl acetate is likely to occur via the
dietary route in humans and there is some uncertainty about the use of
corn oil in the gavage study, it is concluded that benzyl acetate is
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unlikely to be carcinogenic to humans via the dietary route of
exposure.
In metabolism studies approximately 90% of benzyl acetate is
excreted as metabolites primarily in the urine after oral or
percutaneous administration. None was detected in the adipose tissue,
blood, kidney, liver, lung, muscle, skin or stomach. The major
metabolite in the urine was hippuric acid and 95 to 99% of the excreted
dose was in this form. Less than 4% remained in the carcass.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The point of departure for benzyl acetate is 110 mg/kg/day from the
NTP 2-year carcinogenicity study in mice (dietary study) based on
decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/
day. There was no NOAEL observed in a 90-day toxicity study in mice
based on the effects on body weights seen at all doses (lowest dose
tested was 3,130 ppm; equal to 425 mg/kg/day); however, in a
carcinogenicity study in mice no effects on body weight were seen at
110 mg/kg/day, therefore, the NOAEL for the carcinogenicity study would
be protective of decreased body weights seen in a 90-day study in mice.
Therefore, 90-day toxicity study in mice was not selected. This
endpoint was used for all exposure scenarios. The dermal absorption and
inhalation factors were 100%. The Agency applied an interspecies
uncertainty factor (10X) and an intraspecies uncertainty factor (10X);
the FQPA safety factor was reduced to 1X.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzyl acetate, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from benzyl acetate in food as follows:
An acute dietary risk assessment was not conducted because no
endpoint of concern following a single exposure was identified in the
available studies. A chronic dietary exposure assessment was completed
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16, which includes 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 2003 to 2008. In the absence of
actual residue data, the inert ingredient evaluation is based on a
highly conservative model that assumes that the residue level of the
inert ingredient would be no higher than the highest established
tolerance for an active ingredient on 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 ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738. Nonpesticidal dietary exposure
to benzyl acetate (e.g., use as a food additive (flavoring agent) were
also considered as part of aggregate chronic dietary risk assessment.
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 benzyl acetate, 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 upon the requested use of benzyl acetate, the Agency does not
expect non-occupational, non-dietary exposures. However, there is a
potential for residential exposure via non-pesticidal uses such as use
in cosmetics and other, pesticide uses, once it is approved. The
residential exposure could occur via ingestion products containing
benzyl acetate, and via dermal and inhalation routes of exposure
through use of products containing benzyl acetate in residential
settings. These residential pesticide exposures are considered short-
term and intermediate-term in nature. Residential exposures to benzyl
acetate as the result of its use as a cosmetic ingredient may be short-
, intermediate- or long-term in nature. The aggregate-short term
exposure assessment for benzyl acetate considers exposures from the
pesticidal and nonpesticidal uses (i.e., flavoring agent and cosmetic
ingredient) and would be protective of any potential long-term exposure
to benzyl acetate resulting from its use in cosmetics as the same
toxicological point of departure is used for all exposure durations and
the average daily exposure estimates for cosmetic use is conservatively
applied to all exposure durations.
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 benzyl
acetate to share a common mechanism of toxicity with any other
substances, and benzyl acetate does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that benzyl
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acetate 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 Web site at http://www.epa.gov/pesticides/cumulative.
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 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 Qualitative fetal
susceptibility was observed in the developmental study in rats.
Maternal (decrease in body weight) and fetal (reduced body weights,
increased incidence of dilation of the renal pelvis and skeletal
variations) toxicity were observed at 1,000 mg/kg/day, the limit dose.
Since fetal toxicity occurs in the presence of maternal toxicity and a
clear NOAEL of 500 mg/kg/day was established, the established cRfD
(1.10 mg/kg/day) will be protective of these effects. The potential for
reproduction toxicity was observed in the 13-week dietary study in
rats. Atrophy of seminiferous tubules was observed in males at 12,500
ppm (900 mg/kg/day). However, the concern for reproduction toxicity is
low since effects occurred at a high dose and a clear NOAEL of 6,250
ppm (460 mg/kg/day) was established. Therefore, the established cRfD
will be protective of this effect. In addition, no female reproductive
parameters were affected in the developmental toxicity study in rats.
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 to 1X. That decision is based on the following
findings:
i. The toxicity database for benzyl acetate contains the following
studies that are adequate to evaluate the potential toxicity of benzyl
acetate for infants and children: A thirteen week feeding study in the
rat, a 13-week feeding study in the mouse, a developmental toxicity
study in the rat, several in vivo and in vitro mutagenicity studies,
and carcinogenicity studies in mice and rats via gavage and dietary
studies.
ii. Evidence of neurotoxicity and neuronal degeneration seen in a
thirteen-week study was determined not to exceed levels of concern
since the effects occurred at doses that were well above the limit dose
(1,000 mg/kg/day). The established cRfD is 1.10 mg/kg/day therefore is
protective of these effects.
iii. Qualitative fetal susceptibility was observed in the
developmental study in rats. Maternal (decrease in body weight) and
fetal (reduced body weights, increased incidence of dilation of the
renal pelvis and skeletal variations) toxicity were observed at 1,000
mg/kg/day, the limit dose. Since fetal toxicity occurs in the presence
of maternal toxicity and a clear NOAEL of 500 mg/kg/day was
established, the established cRfD (1.10 mg/kg/day) will be protective
of these effects. The potential for reproduction toxicity was observed
in the 13-week dietary study in rats. Atrophy of seminiferous tubules
was observed in males at 12,500 ppm (900 mg/kg/day). However, the
concern for reproductive toxicity is low since effects occurred at a
high dose and a clear NOAEL of 6,250 ppm (460 mg/kg/day) was
established.
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 benzyl acetate 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
benzyl acetate.
E. Aggregate Risks and Determination of Safety Section
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,
benzyl acetate 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
benzyl acetate from food and water will utilize 62.9% of the cPAD for
children ages 1 to 2, the population group receiving the greatest
exposure.
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).
Benzyl acetate is likely to 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 benzyl acetate. Using the
exposure assumptions described in this unit for screening-level short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 150 for children
ages 1 to 2 and 260 for adults. Because EPA's level of concern for
benzyl acetate is a MOE of 100 or below, these MOEs are not of concern.
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). Because no intermediate-term adverse effect was identified,
benzyl acetate is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in the dietary carcinogenicity studies in
mice and rats, benzyl acetate 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 benzyl acetate residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the
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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 is
established under 40 CFR 180.920 for benzyl aceetate (CAS Reg. No. 140-
11-4) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops only.
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, 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 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 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, 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: February 4, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.920 add alphabetically the entry ``Benzyl acetate'' to
the table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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* * * * *
Benzyl acetate (CAS Reg. No. 140-11-4).. ....... Solvent
* * * * *
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[FR Doc. 2016-02815 Filed 2-11-16; 8:45 am]
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