n-Butyl benzoate; Exemptions From the Requirement of a Tolerance, 32029-32034 [2015-13818]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
[Pages 32029-32034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13818]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0265; FRL-9927-65]


n-Butyl benzoate; Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of n-butyl benzoate (CAS Reg. No. 136-60-7) 
when used as an inert ingredient (solvent) in pesticide formulations 
applied to growing crops, raw agricultural commodities after harvest, 
and animals and when used as an inert ingredient in antimicrobial 
formulations in food-contact surface sanitizer products at a maximum 
level in the end-use concentration of 15,000 parts per million (ppm). 
Exponent, Inc., on behalf Huntsman Corp., 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 n-butyl benzoate.

DATES: This regulation is effective June 5, 2015. Objections and 
requests for hearings must be received on or before August 4, 2015, 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-2014-0265, 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 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 https://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: RDFRNotices@epa.gov.

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 Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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-2014-0265 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 
August 4, 2015. 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-2014-0265, 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/contacts.html.
    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 October 24, 2014 (Vol. 79 FR 63594) 
(FRL-9916-03), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10682) by Exponent, Inc., 1150 Connecticut Ave. NW., Suite 1100, 
Washington, DC 20035 on behalf Huntsman Corp., 8600 Gosling Road, The 
Woodlands, TX 77381. The petition requested that 40 CFR 180.910, 
180.930, and 180.940 be amended by establishing an exemption from the 
requirement of a tolerance for residues of n-butyl benzoate (CAS Reg. 
No. 136-60-7) when used as an inert ingredient (solvent) in pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest, and animals and when used as an inert

[[Page 32030]]

ingredient in antimicrobial formulations in food-contact surface 
sanitizer products. That document referenced a summary of the petition 
prepared by Exponent, Inc., on behalf Huntsman Corp., the petitioner, 
which is available in the docket, https://www.regulations.gov. No 
tolerance-related comments were received on the notice of filing.
    Based on a review of the data submitted in support of this 
petition, EPA has modified the exemption requested by limiting the 
amount of n-butyl benzoate allowed in food contact sanitizing solutions 
to a maximum 15,000 ppm (1.5%). This limitation is based on the 
Agency's risk assessment which can be found at https://www.regulations.gov in document ``n-Butyl Benzoate; Human Health Risk 
Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as an Inert 
Ingredient in Pesticide Formulations,'' in docket ID number EPA-HQ-OPP-
2014-0265.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(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 n-butyl benzoate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with n-butyl benzoate 
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 n-butyl benzoate 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.
    In acute oral, dermal, and inhalation toxicity studies in rats, n-
butyl benzoate was found to be slightly toxic to nontoxic. In primary 
eye and dermal irritation studies in rabbits, n-butyl benzoate was 
found to be minimally irritating. In a dermal sensitization study in 
guinea pigs, n-butyl benzoate was not a dermal sensitizer.
    In a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test, n-butyl benzoate was 
administered daily to rats by gavage at doses of 0 (vehicle control), 
250, 500 and 1,000 mg/kg bw/day. The NOAEL for parental toxicity was 
1,000 mg/kg/day; the highest dose tested. The LOAEL for parental 
toxicity was not observed in this study. The NOAEL for embryo-fetal 
toxicity was 500 mg/kg bw/day based on increased pup mortality on post-
natal day zero observed at the LOAEL of 1,000 mg/kg/day.
    No positive mutagenic response was observed for n-butyl benzoate in 
a reverse bacterial mutation assay.
    No chronic toxicity data for n-butyl benzoate are available.
    There are no cancer studies available for n-butyl benzoate. n-Butyl 
benzoate is metabolized by esterase mediated hydrolysis resulting in 
the formation of two major polar metabolites, n-butyl alcohol and 
benzoic acid. Each metabolite enters other degradation pathways to be 
rapidly metabolized and/or excreted. Based on predicted rapid 
metabolism and excretion, the lack of specific target organ toxicity in 
the OCSPP Harmonized Test Guideline 870.3650 study, the results of 
genotoxicity testing being negative, and a Quantitative Structure 
Activity Relationship (QSAR) expert model, DEREK Nexus, that indicates 
no structural alerts for carcinogenicity, n-butyl benzote is not 
expected to be carcinogenic.

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

[[Page 32031]]

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/pesticides/factsheets/riskassess.htm.
    1. Acute dietary (all populations). There were no adverse effects 
observed attributable to a single dose for the general population 
(including infants and children) or females 13-49 years of age.
    2. Chronic dietary (all populations). The chronic population 
adjusted dose (cPAD) of 5 mg/kg/day is established based on the NOAEL 
of 500 mg/kg/day from a combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test in rats. The adverse 
effects seen in this study were increased pup mortality observed at the 
LOAEL of 1,000 mg/kg/day. The Food Quality Protection Act (FQPA) safety 
factor/database uncertainty factor of 1X and 10X intra- and 
interspecies uncertainty factors are utilized for dietary risk 
assessment.
    3. Dermal, short- and intermediate-term. The level of concern (LOC) 
for short- and intermediate-term dermal exposure is a margin of 
exposure (MOE) of 100 and the assessment is based on the NOAEL (500 mg/
kg/day) from the combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test in rats.
    4. Inhalation, short- and intermediate term. The LOC for short- and 
intermediate-term inhalation exposure is a MOE of 100 and the 
assessment is based on the NOAEL (500 mg/kg/day) from the combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening test in rats.
    5. Quantification of cancer risk is not appropriate since there are 
no concerns for cancer based on data that n-butyl benzoate is 
metabolized by esterase mediated hydrolysis resulting in the formation 
of two major polar metabolites, n-butyl alcohol and benzoic acid, 
neither substance being a concern for cancer. In addition, there is a 
lack of specific target organ toxicity in the OCSPP Harmonized Test 
Guideline 870.3650 study, the results of genotoxicity testing for n-
butyl benzoate are negative, and QSAR expert model, DEREK Nexus, 
indicates that there are no structural alerts for carcinogenicity. As 
such, n-butyl benzote is not expected to be carcinogenic.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to n-butyl benzoate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from n-butyl benzoate in food as follows:
    The Agency assessed the dietary exposures to n-butyl benzoate as an 
inert ingredient for use in pesticide formulations applied to growing 
crops, raw agricultural commodities, and livestock as well as an inert 
ingredient for use in food-contact surface sanitizing solutions. In the 
case of dietary exposures to n-butyl benzoate as an inert ingredient 
used in pesticide formulations applied to growing crops, raw 
agricultural commodities, and livestock, a chronic dietary exposure 
assessment was conducted using the Dietary Exposure Evaluation Model/
Food Commodity Intake Database (DEEM-FCID)TM, Version 3.16. EPA used 
food consumption information from the U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 
2008. As to residue levels in food, no residue data were submitted for 
n-butyl benzoate. In the absence of specific residue data, EPA has 
developed an approach that 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 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 https://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of the proposed use of n-butyl benzoate as an inert 
ingredient in food-contact sanitizing pesticide products, EPA has 
utilized a conservative, health-protective method of estimating dietary 
intake that is based upon conservative assumptions related to the 
amount of residues that can be transferred to foods as a result of the 
proposed use. This same methodology has been utilized by FDA in 
estimating dietary exposures to antimicrobial pesticides used in food-
handling settings. A complete description of the approach used to 
assess dietary exposures resulting from food contact sanitizing 
solution uses of n-butyl benzoate can be found at https://www.regulations.gov in document ``n-Butyl Benzoate; Human Health Risk 
Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as an Inert 
Ingredient in Pesticide Formulations,'' pp. 13-15 in docket ID number 
EPA-HQ-OPP-2014-0265.
    The exposures from food and food contact sanitizing are then added 
together for the final dietary exposure 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 n-butyl benzoate, 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).
    There are no current or proposed residential uses for n-butyl 
benzoate, however it is possible that n-butyl benzoate may be used as 
an inert ingredient in pesticide products that may have uses resulting 
in potential residential exposures. A complete description of the 
approach used to assess possible residential exposures from n-butyl 
benzoate can be found at https://www.regulations.gov in document ``n-
Butyl Benzoate; Human Health Risk Assessment and Ecological Effects 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations,'' 
pp. 16 in docket ID number EPA-HQ-OPP-2014-0265.
    4. Cumulative effects from substances with a common mechanism of 
toxicity.

[[Page 32032]]

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 n-butyl benzoate to share a common mechanism of 
toxicity with any other substances, and n-butyl benzoate does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
n-butyl benzoate 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 https://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. There is an evidence of 
increased susceptibility of infants and children in the OECD 422 study 
in rats. In this study, the NOAEL for parental toxicity was 1,000 mg/
kg/day; the highest dose tested while the NOAEL for embryo-fetal 
toxicity was 500 mg/kg/day based on increased pup mortality on post-
natal day zero seen at the LOAEL of 1,000 mg/kg/day. However, the 
concern for this susceptibility is low because there is clear NOAEL 
established in the study protecting the offspring, and regulatory doses 
were selected to be protective of these effects. No other residual 
uncertainties were identified with respect to susceptibility. The 
endpoints and doses selected for the dietary risk assessment of n-butyl 
benzoate are protective of adverse effects in both offspring and 
adults.
    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 n-butyl benzoate contains acute 
toxicity, subchronic toxicity, reproductive toxicity, developmental 
toxicity, and genotoxicity data. No immunotoxicity or neurotoxicity 
study is available; however, there was no evidence of any triggers for 
immunotoxicity or neurotoxicity in the database. Therefore, there is no 
need for immunotoxicity or neurotoxicity study at this time and no need 
for additional uncertainty factor for the lack of those studies.
    ii. Although there is evidence that n-butyl benzoate results in 
increased susceptibility in the combined repeated dose toxicity study 
with the reproduction/developmental toxicity screening test in rats, 
that study identified a clear NOAEL for offspring effects, which the 
Agency is using as the endpoint for its assessment. Therefore, the 
concern for these effects is low and there is no need for an additional 
uncertainty factor.
    iii. 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, as well as conservative 
assumptions for food-contact surface sanitizers. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to n-butyl benzoate in drinking water. These 
assessments will not underestimate the exposure and risks posed by n-
butyl benzoate.

E. Aggregate Risks and Determination of Safety

    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, 
n-butyl benzoate 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 
n-butyl benzoate from food and water will utilize 21.0% of the cPAD for 
the U.S. population and 94.1% of the cPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). While n-butyl benzoate 
is not currently used as an inert ingredient in pesticide products that 
are registered for uses that could result in short- or intermediate-
term residential exposure, it is possible that n-butyl benzoate could 
be used in such products and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
potential short- and intermediate-term residential exposures to n-butyl 
benzoate.
    Using the exposure assumptions described in this unit for short-and 
intermediate-term exposures, EPA has concluded the combined food, 
water, and residential exposures result in aggregate short- and 
intermediate-term MOEs of 320 for adults and 100 for children (1-2 
years old). EPA's level of concern for n-butyl benzoate is a MOE of 100 
or below; however these MOEs are not of concern based on the highly 
conservative assumptions made regarding residential and dietary 
exposures to n-butyl benzoate as described in Unit IV. Section C.
    4. Aggregate cancer risk for U.S. population. Based on data that n-
butyl benzoate is metabolized by esterase mediated hydrolysis resulting 
in the formation of two major polar metabolites, n-butyl alcohol and 
benzoic acid. Each metabolite enters other degradation pathways to be 
rapidly metabolized and/or excreted, n-butyl benzoate is not expected 
to pose a cancer risk to humans.
    5. 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 n-butyl benzoate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required for 
n-butyl benzoate in pesticide formulations that include uses on crops 
for pre- and post-harvest, and on animals, since the Agency is 
establishing an exemption from the requirement of a tolerance without 
any numerical limitation.
    An analytical method is also not required for enforcement purposes 
for n-butyl benzoate on food-contact surfaces in antimicrobial 
applications since the Agency is not establishing a numerical tolerance 
for residues of n-butyl benzoate in or on any food commodities. EPA is 
establishing a

[[Page 32033]]

limitation on the amount of n-butyl benzoate that may be used in food-
contact surface antimicrobial applications. That 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 food-contact surface antimicrobial 
applications for sale or distribution that contains greater than 15,000 
ppm (1.5%) of n-butyl benzoate by weight.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established under 40 CFR 180.910, 180.930, and 180.940(a) for n-butyl 
benzoate (CAS Reg. No. 136-60-7) when used as an inert ingredient 
(solvent) in pesticide formulations applied to growing crops, raw 
agricultural commodities after harvest, and animals, and when used as 
an inert ingredient in antimicrobial formulations in food-contact 
surface sanitizer products at a maximum level in the end-use 
concentration of 15,000 parts per million (ppm).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions 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 exemptions 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: May 29, 2015.
Daniel J. Rosenblatt,
Acting 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.


0
2. In Sec.  180.910, add alphabetically the inert ingredient to the 
table to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
           Inert ingredients             Limits            Uses
------------------------------------------------------------------------
 
                                * * * * *
n-Butyl benzoate (CAS Reg. No.136-60-   ........  Solvent.
 7).
 
                                * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, add alphabetically the inert ingredient to the 
table to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
           Inert ingredients             Limits            Uses
------------------------------------------------------------------------
 
                                * * * * *
n-Butyl benzoate (CAS RN 136-60-7)....  ........  Solvent.
 
                                * * * * *
------------------------------------------------------------------------


0
4. In Sec.  180.940(a) add alphabetically the inert ingredient to the 
table to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

[[Page 32034]]



----------------------------------------------------------------------------------------------------------------
                 Pesticide chemical                      CAS Reg. No.                     Limits
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
n-Butyl benzoate....................................           136-60-7   When ready for use, the end-use
                                                                           concentration is not to exceed 15,000
                                                                           ppm.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-13818 Filed 6-4-15; 8:45 am]
BILLING CODE 6560-50-P