80_FR_32137 80 FR 32029 - n-Butyl benzoate; Exemptions From the Requirement of a Tolerance

80 FR 32029 - n-Butyl benzoate; Exemptions From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 108 (June 5, 2015)

Page Range32029-32034
FR Document2015-13818

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.

Federal Register, Volume 80 Issue 108 (Friday, June 5, 2015)
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
[Pages 32029-32034]
From the Federal Register Online  [www.thefederalregister.org]
[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 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: 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 
http://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 http://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: 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 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, http://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 http://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 http://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 http://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 http://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 http://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 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. 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



                                                                      Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations                                         32029

                                                  (447) * * *                                           in the Environmental Protection Agency                 provided in 40 CFR part 178. To ensure
                                                  (i) * * *                                             Docket Center (EPA/DC), West William                   proper receipt by EPA, you must
                                                  (D) Eastern Kern Air Pollution Control                Jefferson Clinton Bldg., Rm. 3334, 1301                identify docket ID number EPA–HQ–
                                                District.                                               Constitution Ave. NW., Washington, DC                  OPP–2014–0265 in the subject line on
                                                  (1) Rule 432, ‘‘Polyester Resin                       20460–0001. The Public Reading Room                    the first page of your submission. All
                                                Operations,’’ adopted on March 13,                      is open from 8:30 a.m. to 4:30 p.m.,                   objections and requests for a hearing
                                                2014.                                                   Monday through Friday, excluding legal                 must be in writing, and must be
                                                *     *     *     *    *                                holidays. The telephone number for the                 received by the Hearing Clerk on or
                                                  (457) * * *                                           Public Reading Room is (202) 566–1744,                 before August 4, 2015. Addresses for
                                                  (i) * * *                                             and the telephone number for the OPP                   mail and hand delivery of objections
                                                  (B) Mojave Desert Air Quality                         Docket is (703) 305–5805. Please review                and hearing requests are provided in 40
                                                Management District.                                    the visitor instructions and additional                CFR 178.25(b).
                                                  (1) Rule 464, ‘‘Oil-Water Separators,’’               information about the docket available                   In addition to filing an objection or
                                                amended on June 23, 2014.                               at http://www.epa.gov/dockets.                         hearing request with the Hearing Clerk
                                                                                                        FOR FURTHER INFORMATION CONTACT:                       as described in 40 CFR part 178, please
                                                *     *     *     *    *
                                                [FR Doc. 2015–13680 Filed 6–4–15; 8:45 am]              Susan Lewis, Registration Division                     submit a copy of the filing (excluding
                                                                                                        (7505P), Office of Pesticide Programs,                 any Confidential Business Information
                                                BILLING CODE 6560–50–P
                                                                                                        Environmental Protection Agency, 1200                  (CBI)) for inclusion in the public docket.
                                                                                                        Pennsylvania Ave. NW., Washington,                     Information not marked confidential
                                                ENVIRONMENTAL PROTECTION                                DC 20460–0001; main telephone                          pursuant to 40 CFR part 2 may be
                                                AGENCY                                                  number: (703) 305–7090; email address:                 disclosed publicly by EPA without prior
                                                                                                        RDFRNotices@epa.gov.                                   notice. Submit the non-CBI copy of your
                                                40 CFR Part 180                                                                                                objection or hearing request, identified
                                                                                                        SUPPLEMENTARY INFORMATION:
                                                                                                                                                               by docket ID number EPA–HQ–OPP–
                                                [EPA–HQ–OPP–2014–0265; FRL–9927–65]                                                                            2014–0265, by one of the following
                                                                                                        I. General Information
                                                n-Butyl benzoate; Exemptions From                                                                              methods:
                                                                                                        A. Does this action apply to me?                         • Federal eRulemaking Portal: http://
                                                the Requirement of a Tolerance
                                                                                                           You may be potentially affected by                  www.regulations.gov. Follow the online
                                                AGENCY:  Environmental Protection                       this action if you are an agricultural                 instructions for submitting comments.
                                                Agency (EPA).                                           producer, food manufacturer, or                        Do not submit electronically any
                                                ACTION: Final rule.                                     pesticide manufacturer. The following                  information you consider to be CBI or
                                                                                                        list of North American Industrial                      other information whose disclosure is
                                                SUMMARY:   This regulation establishes                  Classification System (NAICS) codes is                 restricted by statute.
                                                exemptions from the requirement of a                    not intended to be exhaustive, but rather                • Mail: OPP Docket, Environmental
                                                tolerance for residues of n-butyl                       provides a guide to help readers                       Protection Agency Docket Center (EPA/
                                                benzoate (CAS Reg. No. 136–60–7)                        determine whether this document                        DC), (28221T), 1200 Pennsylvania Ave.
                                                when used as an inert ingredient                        applies to them. Potentially affected                  NW., Washington, DC 20460–0001.
                                                (solvent) in pesticide formulations                     entities may include:                                    • Hand Delivery: To make special
                                                applied to growing crops, raw                              • Crop production (NAICS code 111).                 arrangements for hand delivery or
                                                agricultural commodities after harvest,                    • Animal production (NAICS code                     delivery of boxed information, please
                                                and animals and when used as an inert                   112).                                                  follow the instructions at http://
                                                ingredient in antimicrobial formulations                   • Food manufacturing (NAICS code                    www.epa.gov/dockets/contacts.html.
                                                in food-contact surface sanitizer                       311).                                                    Additional instructions on
                                                products at a maximum level in the end-                    • Pesticide manufacturing (NAICS                    commenting or visiting the docket,
                                                use concentration of 15,000 parts per                   code 32532).                                           along with more information about
                                                million (ppm). Exponent, Inc., on behalf                                                                       dockets generally, is available at
                                                                                                        B. How can I get electronic access to                  http://www.epa.gov/dockets.
                                                Huntsman Corp., submitted a petition to                 other related information?
                                                EPA under the Federal Food, Drug, and                                                                          II. Petition for Exemption
                                                Cosmetic Act (FFDCA), requesting                          You may access a frequently updated
                                                establishment of an exemption from the                  electronic version of 40 CFR part 180                     In the Federal Register of October 24,
                                                requirement of a tolerance. This                        through the Government Publishing                      2014 (Vol. 79 FR 63594) (FRL–9916–03),
                                                regulation eliminates the need to                       Office’s e-CFR site at http://                         EPA issued a document pursuant to
                                                establish a maximum permissible level                   www.ecfr.gov/cgi-bin/text-                             FFDCA section 408, 21 U.S.C. 346a,
                                                for residues of n-butyl benzoate.                       idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                   announcing the filing of a pesticide
                                                                                                        40tab_02.tpl. To access the OCSPP test                 petition (PP IN–10682) by Exponent,
                                                DATES: This regulation is effective June
                                                                                                        guidelines referenced in this document                 Inc., 1150 Connecticut Ave. NW., Suite
                                                5, 2015. Objections and requests for                                                                           1100, Washington, DC 20035 on behalf
                                                                                                        electronically, please go to http://
                                                hearings must be received on or before                                                                         Huntsman Corp., 8600 Gosling Road,
                                                                                                        www.epa.gov/ocspp and select ‘‘Test
                                                August 4, 2015, and must be filed in                                                                           The Woodlands, TX 77381. The petition
                                                                                                        Methods and Guidelines.’’
                                                accordance with the instructions                                                                               requested that 40 CFR 180.910, 180.930,
                                                provided in 40 CFR part 178 (see also                   C. How can I file an objection or hearing              and 180.940 be amended by establishing
                                                Unit I.C. of the SUPPLEMENTARY                          request?                                               an exemption from the requirement of a
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                                                INFORMATION).
                                                                                                          Under FFDCA section 408(g), 21                       tolerance for residues of n-butyl
                                                ADDRESSES:   The docket for this action,                U.S.C. 346a, any person may file an                    benzoate (CAS Reg. No. 136–60–7)
                                                identified by docket identification (ID)                objection to any aspect of this regulation             when used as an inert ingredient
                                                number EPA–HQ–OPP–2014–0265, is                         and may also request a hearing on those                (solvent) in pesticide formulations
                                                available at http://www.regulations.gov                 objections. You must file your objection               applied to growing crops, raw
                                                or at the Office of Pesticide Programs                  or request a hearing on this regulation                agricultural commodities after harvest,
                                                Regulatory Public Docket (OPP Docket)                   in accordance with the instructions                    and animals and when used as an inert


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                                                32030                 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations

                                                ingredient in antimicrobial formulations                reliable information.’’ This includes                  level (LOAEL) from the toxicity studies
                                                in food-contact surface sanitizer                       exposure through drinking water and in                 are discussed in this unit.
                                                products. That document referenced a                    residential settings, but does not include                In acute oral, dermal, and inhalation
                                                summary of the petition prepared by                     occupational exposure. Section                         toxicity studies in rats, n-butyl benzoate
                                                Exponent, Inc., on behalf Huntsman                      408(b)(2)(C) of FFDCA requires EPA to                  was found to be slightly toxic to
                                                Corp., the petitioner, which is available               give special consideration to exposure                 nontoxic. In primary eye and dermal
                                                in the docket, http://                                  of infants and children to the pesticide               irritation studies in rabbits, n-butyl
                                                www.regulations.gov. No tolerance-                      chemical residue in establishing a                     benzoate was found to be minimally
                                                related comments were received on the                   tolerance and to ‘‘ensure that there is a              irritating. In a dermal sensitization
                                                notice of filing.                                       reasonable certainty that no harm will                 study in guinea pigs, n-butyl benzoate
                                                  Based on a review of the data                         result to infants and children from                    was not a dermal sensitizer.
                                                submitted in support of this petition,                  aggregate exposure to the pesticide                       In a combined repeated dose toxicity
                                                EPA has modified the exemption                          chemical residue. . . .’’                              study with the reproduction/
                                                requested by limiting the amount of n-                    EPA establishes exemptions from the                  developmental toxicity screening test, n-
                                                butyl benzoate allowed in food contact                  requirement of a tolerance only in those               butyl benzoate was administered daily
                                                sanitizing solutions to a maximum                       cases where it can be clearly                          to rats by gavage at doses of 0 (vehicle
                                                15,000 ppm (1.5%). This limitation is                   demonstrated that the risks from                       control), 250, 500 and 1,000 mg/kg bw/
                                                based on the Agency’s risk assessment                   aggregate exposure to pesticide                        day. The NOAEL for parental toxicity
                                                which can be found at http://                           chemical residues under reasonably                     was 1,000 mg/kg/day; the highest dose
                                                www.regulations.gov in document ‘‘n-                    foreseeable circumstances will pose no                 tested. The LOAEL for parental toxicity
                                                Butyl Benzoate; Human Health Risk                       appreciable risks to human health. In                  was not observed in this study. The
                                                Assessment and Ecological Effects                                                                              NOAEL for embryo-fetal toxicity was
                                                                                                        order to determine the risks from
                                                Assessment to Support Proposed                                                                                 500 mg/kg bw/day based on increased
                                                                                                        aggregate exposure to pesticide inert
                                                Exemption from the Requirement of a                                                                            pup mortality on post-natal day zero
                                                                                                        ingredients, the Agency considers the
                                                Tolerance When Used as an Inert                                                                                observed at the LOAEL of 1,000 mg/kg/
                                                                                                        toxicity of the inert in conjunction with
                                                Ingredient in Pesticide Formulations,’’                                                                        day.
                                                                                                        possible exposure to residues of the
                                                in docket ID number EPA–HQ–OPP–                                                                                   No positive mutagenic response was
                                                                                                        inert ingredient through food, drinking
                                                2014–0265.                                                                                                     observed for n-butyl benzoate in a
                                                                                                        water, and through other exposures that
                                                                                                                                                               reverse bacterial mutation assay.
                                                III. Inert Ingredient Definition                        occur as a result of pesticide use in                     No chronic toxicity data for n-butyl
                                                   Inert ingredients are all ingredients                residential settings. If EPA is able to                benzoate are available.
                                                that are not active ingredients as defined              determine that a finite tolerance is not                  There are no cancer studies available
                                                in 40 CFR 153.125 and include, but are                  necessary to ensure that there is a                    for n-butyl benzoate. n-Butyl benzoate is
                                                not limited to, the following types of                  reasonable certainty that no harm will                 metabolized by esterase mediated
                                                ingredients (except when they have a                    result from aggregate exposure to the                  hydrolysis resulting in the formation of
                                                pesticidal efficacy of their own):                      inert ingredient, an exemption from the                two major polar metabolites, n-butyl
                                                Solvents such as alcohols and                           requirement of a tolerance may be                      alcohol and benzoic acid. Each
                                                hydrocarbons; surfactants such as                       established.                                           metabolite enters other degradation
                                                polyoxyethylene polymers and fatty                        Consistent with FFDCA section                        pathways to be rapidly metabolized
                                                acids; carriers such as clay and                        408(c)(2)(A), and the factors specified in             and/or excreted. Based on predicted
                                                diatomaceous earth; thickeners such as                  FFDCA section 408(c)(2)(B), EPA has                    rapid metabolism and excretion, the
                                                carrageenan and modified cellulose;                     reviewed the available scientific data                 lack of specific target organ toxicity in
                                                wetting, spreading, and dispersing                      and other relevant information in                      the OCSPP Harmonized Test Guideline
                                                agents; propellants in aerosol                          support of this action. EPA has                        870.3650 study, the results of
                                                dispensers; microencapsulating agents;                  sufficient data to assess the hazards of               genotoxicity testing being negative, and
                                                and emulsifiers. The term ‘‘inert’’ is not              and to make a determination on                         a Quantitative Structure Activity
                                                intended to imply nontoxicity; the                      aggregate exposure for n-butyl benzoate                Relationship (QSAR) expert model,
                                                ingredient may or may not be                            including exposure resulting from the                  DEREK Nexus, that indicates no
                                                chemically active. Generally, EPA has                   exemption established by this action.                  structural alerts for carcinogenicity, n-
                                                exempted inert ingredients from the                     EPA’s assessment of exposures and risks                butyl benzote is not expected to be
                                                requirement of a tolerance based on the                 associated with n-butyl benzoate                       carcinogenic.
                                                low toxicity of the individual inert                    follows.
                                                                                                                                                               B. Toxicological Points of Departure/
                                                ingredients.                                            A. Toxicological Profile                               Levels of Concern
                                                IV. Aggregate Risk Assessment and                         EPA has evaluated the available                         Once a pesticide’s toxicological
                                                Determination of Safety                                 toxicity data and considered their                     profile is determined, EPA identifies
                                                   Section 408(c)(2)(A)(i) of FFDCA                     validity, completeness, and reliability as             toxicological points of departure (POD)
                                                allows EPA to establish an exemption                    well as the relationship of the results of             and levels of concern to use in
                                                from the requirement for a tolerance (the               the studies to human risk. EPA has also                evaluating the risk posed by human
                                                legal limit for a pesticide chemical                    considered available information                       exposure to the pesticide. For hazards
                                                residue in or on a food) only if EPA                    concerning the variability of the                      that have a threshold below which there
                                                determines that the tolerance is ‘‘safe.’’              sensitivities of major identifiable                    is no appreciable risk, the toxicological
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                                                Section 408(b)(2)(A)(ii) of FFDCA                       subgroups of consumers, including                      POD is used as the basis for derivation
                                                defines ‘‘safe’’ to mean that ‘‘there is a              infants and children. Specific                         of reference values for risk assessment.
                                                reasonable certainty that no harm will                  information on the studies received and                PODs are developed based on a careful
                                                result from aggregate exposure to the                   the nature of the adverse effects caused               analysis of the doses in each
                                                pesticide chemical residue, including                   by n-butyl benzoate as well as the no-                 toxicological study to determine the
                                                all anticipated dietary exposures and all               observed-adverse-effect-level (NOAEL)                  dose at which no adverse effects are
                                                other exposures for which there is                      and the lowest-observed-adverse-effect-                observed (the NOAEL) and the lowest


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                                                                      Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations                                         32031

                                                dose at which adverse effects of concern                OCSPP Harmonized Test Guideline                        conservative, health-protective method
                                                are identified (the LOAEL). Uncertainty/                870.3650 study, the results of                         of estimating dietary intake that is based
                                                safety factors are used in conjunction                  genotoxicity testing for n-butyl benzoate              upon conservative assumptions related
                                                with the POD to calculate a safe                        are negative, and QSAR expert model,                   to the amount of residues that can be
                                                exposure level—generally referred to as                 DEREK Nexus, indicates that there are                  transferred to foods as a result of the
                                                a population-adjusted dose (PAD) or a                   no structural alerts for carcinogenicity.              proposed use. This same methodology
                                                reference dose (RfD)—and a safe margin                  As such, n-butyl benzote is not expected               has been utilized by FDA in estimating
                                                of exposure (MOE). For non-threshold                    to be carcinogenic.                                    dietary exposures to antimicrobial
                                                risks, the Agency assumes that any                                                                             pesticides used in food-handling
                                                                                                        C. Exposure Assessment
                                                amount of exposure will lead to some                                                                           settings. A complete description of the
                                                degree of risk. Thus, the Agency                           1. Dietary exposure from food and                   approach used to assess dietary
                                                estimates risk in terms of the probability              feed uses. In evaluating dietary                       exposures resulting from food contact
                                                of an occurrence of the adverse effect                  exposure to n-butyl benzoate, EPA                      sanitizing solution uses of n-butyl
                                                expected in a lifetime. For more                        considered exposure under the                          benzoate can be found at http://
                                                information on the general principles                   proposed exemption from the                            www.regulations.gov in document ‘‘n-
                                                EPA uses in risk characterization and a                 requirement of a tolerance. EPA                        Butyl Benzoate; Human Health Risk
                                                complete description of the risk                        assessed dietary exposures from n-butyl                Assessment and Ecological Effects
                                                assessment process, see http://                         benzoate in food as follows:                           Assessment to Support Proposed
                                                www.epa.gov/pesticides/factsheets/                         The Agency assessed the dietary                     Exemption from the Requirement of a
                                                riskassess.htm.                                         exposures to n-butyl benzoate as an                    Tolerance When Used as an Inert
                                                   1. Acute dietary (all populations).                  inert ingredient for use in pesticide                  Ingredient in Pesticide Formulations,’’
                                                There were no adverse effects observed                  formulations applied to growing crops,                 pp. 13–15 in docket ID number EPA–
                                                attributable to a single dose for the                   raw agricultural commodities, and                      HQ–OPP–2014–0265.
                                                general population (including infants                   livestock as well as an inert ingredient                  The exposures from food and food
                                                and children) or females 13–49 years of                 for use in food-contact surface sanitizing             contact sanitizing are then added
                                                age.                                                    solutions. In the case of dietary                      together for the final dietary exposure
                                                   2. Chronic dietary (all populations).                exposures to n-butyl benzoate as an                    assessment.
                                                The chronic population adjusted dose                    inert ingredient used in pesticide                        2. Dietary exposure from drinking
                                                (cPAD) of 5 mg/kg/day is established                    formulations applied to growing crops,                 water. For the purpose of the screening
                                                based on the NOAEL of 500 mg/kg/day                     raw agricultural commodities, and                      level dietary risk assessment to support
                                                from a combined repeated dose toxicity                  livestock, a chronic dietary exposure                  this request for an exemption from the
                                                study with the reproduction/                            assessment was conducted using the                     requirement of a tolerance for n-butyl
                                                developmental toxicity screening test in                Dietary Exposure Evaluation Model/                     benzoate, a conservative drinking water
                                                rats. The adverse effects seen in this                  Food Commodity Intake Database                         concentration value of 100 ppb based on
                                                study were increased pup mortality                      (DEEM–FCID)TM, Version 3.16. EPA                       screening level modeling was used to
                                                observed at the LOAEL of 1,000 mg/kg/                   used food consumption information                      assess the contribution to drinking
                                                day. The Food Quality Protection Act                    from the U.S. Department of                            water for the chronic dietary risk
                                                (FQPA) safety factor/database                           Agriculture’s National Health and                      assessments for parent compound.
                                                uncertainty factor of 1X and 10X intra-                 Nutrition Examination Survey, What We                  These values were directly entered into
                                                and interspecies uncertainty factors are                Eat in America, (NHANES/WWEIA).                        the dietary exposure model.
                                                utilized for dietary risk assessment.                   This dietary survey was conducted from                    3. From non-dietary exposure. The
                                                   3. Dermal, short- and intermediate-                  2003 to 2008. As to residue levels in                  term ‘‘residential exposure’’ is used in
                                                term. The level of concern (LOC) for                    food, no residue data were submitted for               this document to refer to non-
                                                short- and intermediate-term dermal                     n-butyl benzoate. In the absence of                    occupational, non-dietary exposure
                                                exposure is a margin of exposure (MOE)                  specific residue data, EPA has                         (e.g., textiles (clothing and diapers),
                                                of 100 and the assessment is based on                   developed an approach that uses                        carpets, swimming pools, and hard
                                                the NOAEL (500 mg/kg/day) from the                      surrogate information to derive upper                  surface disinfection on walls, floors,
                                                combined repeated dose toxicity study                   bound exposure estimates for the                       tables).
                                                with the reproduction/developmental                     subject inert ingredient. Upper bound                     There are no current or proposed
                                                toxicity screening test in rats.                        exposure estimates are based on the                    residential uses for n-butyl benzoate,
                                                   4. Inhalation, short- and intermediate               highest tolerance for a given commodity                however it is possible that n-butyl
                                                term. The LOC for short- and                            from a list of high-use insecticides,                  benzoate may be used as an inert
                                                intermediate-term inhalation exposure                   herbicides, and fungicides. A complete                 ingredient in pesticide products that
                                                is a MOE of 100 and the assessment is                   description of the general approach                    may have uses resulting in potential
                                                based on the NOAEL (500 mg/kg/day)                      taken to assess inert ingredient risks in              residential exposures. A complete
                                                from the combined repeated dose                         the absence of residue data is contained               description of the approach used to
                                                toxicity study with the reproduction/                   in the memorandum entitled ‘‘Alkyl                     assess possible residential exposures
                                                developmental toxicity screening test in                Amines Polyalkoxylates (Cluster 4):                    from n-butyl benzoate can be found at
                                                rats.                                                   Acute and Chronic Aggregate (Food and                  http://www.regulations.gov in document
                                                   5. Quantification of cancer risk is not              Drinking Water) Dietary Exposure and                   ‘‘n-Butyl Benzoate; Human Health Risk
                                                appropriate since there are no concerns                 Risk Assessments for the Inerts.’’                     Assessment and Ecological Effects
                                                for cancer based on data that n-butyl                   (D361707, S. Piper, 2/25/09) and can be                Assessment to Support Proposed
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                                                benzoate is metabolized by esterase                     found at http://www.regulations.gov in                 Exemption from the Requirement of a
                                                mediated hydrolysis resulting in the                    docket ID number EPA–HQ–OPP–2008–                      Tolerance When Used as an Inert
                                                formation of two major polar                            0738.                                                  Ingredient in Pesticide Formulations,’’
                                                metabolites, n-butyl alcohol and benzoic                   In the case of the proposed use of n-               pp. 16 in docket ID number EPA–HQ–
                                                acid, neither substance being a concern                 butyl benzoate as an inert ingredient in               OPP–2014–0265.
                                                for cancer. In addition, there is a lack of             food-contact sanitizing pesticide                         4. Cumulative effects from substances
                                                specific target organ toxicity in the                   products, EPA has utilized a                           with a common mechanism of toxicity.


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                                                32032                 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations

                                                Section 408(b)(2)(D)(v) of FFDCA                           3. Conclusion. EPA has determined                   intermediate-term residential exposure
                                                requires that, when considering whether                 that reliable data show the safety of                  plus chronic exposure to food and water
                                                to establish, modify, or revoke a                       infants and children would be                          (considered to be a background
                                                tolerance, the Agency consider                          adequately protected if the FQPA SF                    exposure level). While n-butyl benzoate
                                                ‘‘available information’’ concerning the                were reduced to 1X. That decision is                   is not currently used as an inert
                                                cumulative effects of a particular                      based on the following findings:                       ingredient in pesticide products that are
                                                pesticide’s residues and ‘‘other                           i. The toxicity database for n-butyl                registered for uses that could result in
                                                substances that have a common                           benzoate contains acute toxicity,                      short- or intermediate-term residential
                                                mechanism of toxicity.’’                                subchronic toxicity, reproductive                      exposure, it is possible that n-butyl
                                                   EPA has not found n-butyl benzoate                   toxicity, developmental toxicity, and                  benzoate could be used in such
                                                to share a common mechanism of                          genotoxicity data. No immunotoxicity or                products and the Agency has
                                                toxicity with any other substances, and                 neurotoxicity study is available;                      determined that it is appropriate to
                                                n-butyl benzoate does not appear to                     however, there was no evidence of any                  aggregate chronic exposure through food
                                                produce a toxic metabolite produced by                  triggers for immunotoxicity or                         and water with potential short- and
                                                other substances. For the purposes of                   neurotoxicity in the database. Therefore,              intermediate-term residential exposures
                                                this tolerance action, therefore, EPA has               there is no need for immunotoxicity or                 to n-butyl benzoate.
                                                assumed that n-butyl benzoate does not                  neurotoxicity study at this time and no                   Using the exposure assumptions
                                                have a common mechanism of toxicity                     need for additional uncertainty factor                 described in this unit for short-and
                                                with other substances. For information                  for the lack of those studies.                         intermediate-term exposures, EPA has
                                                regarding EPA’s efforts to determine                       ii. Although there is evidence that n-              concluded the combined food, water,
                                                which chemicals have a common                           butyl benzoate results in increased                    and residential exposures result in
                                                mechanism of toxicity and to evaluate                   susceptibility in the combined repeated                aggregate short- and intermediate-term
                                                the cumulative effects of such                          dose toxicity study with the                           MOEs of 320 for adults and 100 for
                                                chemicals, see EPA’s Web site at                        reproduction/developmental toxicity                    children (1–2 years old). EPA’s level of
                                                http://www.epa.gov/pesticides/                          screening test in rats, that study                     concern for n-butyl benzoate is a MOE
                                                cumulative.                                             identified a clear NOAEL for offspring                 of 100 or below; however these MOEs
                                                                                                        effects, which the Agency is using as the              are not of concern based on the highly
                                                D. Safety Factor for Infants and
                                                                                                        endpoint for its assessment. Therefore,                conservative assumptions made
                                                Children
                                                                                                        the concern for these effects is low and               regarding residential and dietary
                                                   1. In general. Section 408(b)(2)(C) of               there is no need for an additional                     exposures to n-butyl benzoate as
                                                FFDCA provides that EPA shall apply                     uncertainty factor.                                    described in Unit IV. Section C.
                                                an additional tenfold (10X) margin of                      iii. There are no residual uncertainties               4. Aggregate cancer risk for U.S.
                                                safety for infants and children in the                  identified in the exposure databases.                  population. Based on data that n-butyl
                                                case of threshold effects to account for                The dietary food exposure assessments                  benzoate is metabolized by esterase
                                                prenatal and postnatal toxicity and the                 were performed based on 100% CT and                    mediated hydrolysis resulting in the
                                                completeness of the database on toxicity                tolerance-level residues, as well as                   formation of two major polar
                                                and exposure unless EPA determines                      conservative assumptions for food-                     metabolites, n-butyl alcohol and benzoic
                                                based on reliable data that a different                 contact surface sanitizers. EPA made                   acid. Each metabolite enters other
                                                margin of safety will be safe for infants               conservative (protective) assumptions in               degradation pathways to be rapidly
                                                and children. This additional margin of                 the ground and surface water modeling                  metabolized and/or excreted, n-butyl
                                                safety is commonly referred to as the                   used to assess exposure to n-butyl
                                                FQPA Safety Factor (SF). In applying                                                                           benzoate is not expected to pose a
                                                                                                        benzoate in drinking water. These                      cancer risk to humans.
                                                this provision, EPA either retains the                  assessments will not underestimate the                    5. Determination of safety. Based on
                                                default value of 10X, or uses a different               exposure and risks posed by n-butyl                    these risk assessments, EPA concludes
                                                additional safety factor when reliable                  benzoate.
                                                data available to EPA support the choice                                                                       that there is a reasonable certainty that
                                                of a different factor.                                  E. Aggregate Risks and Determination of                no harm will result to the general
                                                   2. Prenatal and postnatal sensitivity.               Safety                                                 population, or to infants and children
                                                There is an evidence of increased                                                                              from aggregate exposure to n-butyl
                                                                                                           1. Acute risk. An acute aggregate risk
                                                susceptibility of infants and children in                                                                      benzoate residues.
                                                                                                        assessment takes into account acute
                                                the OECD 422 study in rats. In this                     exposure estimates from dietary                        V. Other Considerations
                                                study, the NOAEL for parental toxicity                  consumption of food and drinking
                                                was 1,000 mg/kg/day; the highest dose                                                                          A. Analytical Enforcement Methodology
                                                                                                        water. No adverse effect resulting from
                                                tested while the NOAEL for embryo-                      a single oral exposure was identified                     An analytical method for enforcement
                                                fetal toxicity was 500 mg/kg/day based                  and no acute dietary endpoint was                      purposes is not required for n-butyl
                                                on increased pup mortality on post-                     selected. Therefore, n-butyl benzoate is               benzoate in pesticide formulations that
                                                natal day zero seen at the LOAEL of                     not expected to pose an acute risk.                    include uses on crops for pre- and post-
                                                1,000 mg/kg/day. However, the concern                      2. Chronic risk. Using the exposure                 harvest, and on animals, since the
                                                for this susceptibility is low because                  assumptions described in this unit for                 Agency is establishing an exemption
                                                there is clear NOAEL established in the                 chronic exposure, EPA has concluded                    from the requirement of a tolerance
                                                study protecting the offspring, and                     that chronic exposure to n-butyl                       without any numerical limitation.
                                                regulatory doses were selected to be                    benzoate from food and water will                         An analytical method is also not
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                                                protective of these effects. No other                   utilize 21.0% of the cPAD for the U.S.                 required for enforcement purposes for n-
                                                residual uncertainties were identified                  population and 94.1% of the cPAD for                   butyl benzoate on food-contact surfaces
                                                with respect to susceptibility. The                     children 1–2 years old, the population                 in antimicrobial applications since the
                                                endpoints and doses selected for the                    group receiving the greatest exposure.                 Agency is not establishing a numerical
                                                dietary risk assessment of n-butyl                         3. Short- and intermediate-term risk.               tolerance for residues of n-butyl
                                                benzoate are protective of adverse                      Short- and intermediate-term aggregate                 benzoate in or on any food
                                                effects in both offspring and adults.                   exposure takes into account short- and                 commodities. EPA is establishing a


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                                                                      Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations                                                32033

                                                limitation on the amount of n-butyl                     Populations’’ (59 FR 7629, February 16,                Agricultural commodities, Pesticides
                                                benzoate that may be used in food-                      1994).                                                 and pests, Reporting and recordkeeping
                                                contact surface antimicrobial                              Since tolerances and exemptions that                requirements.
                                                applications. That limitation will be                   are established on the basis of a petition                Dated: May 29, 2015.
                                                enforced through the pesticide                          under FFDCA section 408(d), such as
                                                                                                                                                               Daniel J. Rosenblatt,
                                                registration process under the Federal                  the exemptions in this final rule, do not
                                                                                                        require the issuance of a proposed rule,               Acting Director, Registration Division, Office
                                                Insecticide, Fungicide, and Rodenticide
                                                                                                                                                               of Pesticide Programs.
                                                Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA               the requirements of the Regulatory
                                                will not register any food-contact                      Flexibility Act (RFA) (5 U.S.C. 601 et                   Therefore, 40 CFR chapter I is
                                                surface antimicrobial applications for                  seq.), do not apply.                                   amended as follows:
                                                sale or distribution that contains greater                 This action directly regulates growers,
                                                than 15,000 ppm (1.5%) of n-butyl                       food processors, food handlers, and food               PART 180—[AMENDED]
                                                benzoate by weight.                                     retailers, not States or tribes, nor does
                                                                                                        this action alter the relationships or                 ■ 1. The authority citation for part 180
                                                VI. Conclusions                                         distribution of power and                              continues to read as follows:
                                                  Therefore, exemptions from the                        responsibilities established by Congress                   Authority: 21 U.S.C. 321(q), 346a and 371.
                                                requirement of a tolerance are                          in the preemption provisions of FFDCA
                                                established under 40 CFR 180.910,                       section 408(n)(4). As such, the Agency                 ■ 2. In § 180.910, add alphabetically the
                                                180.930, and 180.940(a) for n-butyl                     has determined that this action will not               inert ingredient to the table to read as
                                                benzoate (CAS Reg. No. 136–60–7)                        have a substantial direct effect on States             follows:
                                                when used as an inert ingredient                        or tribal governments, on the
                                                (solvent) in pesticide formulations                     relationship between the national                      § 180.910 Inert ingredients used pre- and
                                                                                                        government and the States or tribal                    post-harvest; exemptions from the
                                                applied to growing crops, raw                                                                                  requirement of a tolerance.
                                                agricultural commodities after harvest,                 governments, or on the distribution of
                                                and animals, and when used as an inert                  power and responsibilities among the                   *        *    *     *       *
                                                ingredient in antimicrobial formulations                various levels of government or between
                                                                                                        the Federal Government and Indian                          Inert ingredients       Limits       Uses
                                                in food-contact surface sanitizer
                                                products at a maximum level in the end-                 Tribes. Thus, the Agency has
                                                use concentration of 15,000 parts per                   determined that Executive Order 13132,
                                                                                                                                                                  *        *       *              *       *
                                                million (ppm).                                          entitled ‘‘Federalism’’ (64 FR 43255,
                                                                                                                                                               n-Butyl benzoate      .............. Solvent.
                                                                                                        August 10, 1999) and Executive Order                     (CAS Reg. No.136–
                                                VII. Statutory and Executive Order                      13175, entitled ‘‘Consultation and                       60–7).
                                                Reviews                                                 Coordination with Indian Tribal
                                                                                                        Governments’’ (65 FR 67249, November                        *        *         *            *      *
                                                   This action establishes exemptions
                                                                                                        9, 2000) do not apply to this action. In
                                                from the requirement of a tolerance
                                                                                                        addition, this action does not impose
                                                under FFDCA section 408(d) in                                                                                  ■ 3. In § 180.930, add alphabetically the
                                                                                                        any enforceable duty or contain any
                                                response to a petition submitted to the                                                                        inert ingredient to the table to read as
                                                                                                        unfunded mandate as described under
                                                Agency. The Office of Management and                                                                           follows:
                                                                                                        Title II of the Unfunded Mandates
                                                Budget (OMB) has exempted these types                   Reform Act (UMRA) (2 U.S.C. 1501 et
                                                of actions from review under Executive                                                                         § 180.930 Inert ingredients applied to
                                                                                                        seq.).                                                 animals; exemptions from the requirement
                                                Order 12866, entitled ‘‘Regulatory                         This action does not involve any                    of a tolerance.
                                                Planning and Review’’ (58 FR 51735,                     technical standards that would require
                                                October 4, 1993). Because this action                                                                          *        *    *     *       *
                                                                                                        Agency consideration of voluntary
                                                has been exempted from review under                     consensus standards pursuant to section                    Inert ingredients       Limits       Uses
                                                Executive Order 12866, this action is                   12(d) of the National Technology
                                                not subject to Executive Order 13211,                   Transfer and Advancement Act
                                                entitled ‘‘Actions Concerning                           (NTTAA) (15 U.S.C. 272 note).                             *        *     *              *       *
                                                Regulations That Significantly Affect                                                                          n-Butyl benzoate    .............. Solvent.
                                                Energy Supply, Distribution, or Use’’ (66               VIII. Congressional Review Act                           (CAS RN 136–60–
                                                FR 28355, May 22, 2001) or Executive                      Pursuant to the Congressional Review                   7).
                                                Order 13045, entitled ‘‘Protection of                   Act (5 U.S.C. 801 et seq.), EPA will
                                                Children from Environmental Health                                                                                  *        *         *            *      *
                                                                                                        submit a report containing this rule and
                                                Risks and Safety Risks’’ (62 FR 19885,                  other required information to the U.S.
                                                April 23, 1997). This action does not                   Senate, the U.S. House of                              ■ 4. In § 180.940(a) add alphabetically
                                                contain any information collections                     Representatives, and the Comptroller                   the inert ingredient to the table to read
                                                subject to OMB approval under the                       General of the United States prior to                  as follows:
                                                Paperwork Reduction Act (PRA) (44                       publication of the rule in the Federal
                                                U.S.C. 3501 et seq.), nor does it require               Register. This action is not a ‘‘major                 § 180.940 Tolerance exemptions for active
                                                any special considerations under                                                                               and inert ingredients for use in
                                                                                                        rule’’ as defined by 5 U.S.C. 804(2).                  antimicrobial formulations (Food-contact
                                                Executive Order 12898, entitled
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                                                                                                        List of Subjects in 40 CFR Part 180                    surface sanitizing solutions).
                                                ‘‘Federal Actions to Address
                                                Environmental Justice in Minority                        Environmental protection,                             *       *    *      *       *
                                                Populations and Low-Income                              Administrative practice and procedure,                     (a) * * *




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                                                32034                   Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations

                                                     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.

                                                           *                        *                       *                          *                       *                      *               *



                                                *      *       *       *      *                           number: (703) 305–7090; email address:                        In addition to filing an objection or
                                                [FR Doc. 2015–13818 Filed 6–4–15; 8:45 am]                RDFRNotices@epa.gov.                                        hearing request with the Hearing Clerk
                                                BILLING CODE 6560–50–P                                    SUPPLEMENTARY INFORMATION:                                  as described in 40 CFR part 178, please
                                                                                                                                                                      submit a copy of the filing (excluding
                                                                                                          I. General Information                                      any Confidential Business Information
                                                ENVIRONMENTAL PROTECTION                                  A. Does this action apply to me?                            (CBI)) for inclusion in the public docket.
                                                AGENCY                                                       You may be potentially affected by                       Information not marked confidential
                                                                                                          this action if you are an agricultural                      pursuant to 40 CFR part 2 may be
                                                40 CFR Part 180                                                                                                       disclosed publicly by EPA without prior
                                                                                                          producer, food manufacturer, or
                                                [EPA–HQ–OPP–2012–0207; FRL–9927–66]                       pesticide manufacturer. The following                       notice. Submit the non-CBI copy of your
                                                                                                          list of North American Industrial                           objection or hearing request, identified
                                                Aluminum Sulfate; Exemption From                          Classification System (NAICS) codes is                      by docket ID number EPA–HQ–OPP–
                                                the Requirement of a Tolerance                            not intended to be exhaustive, but rather                   2012–0207, by one of the following
                                                                                                          provides a guide to help readers                            methods:
                                                AGENCY:  Environmental Protection
                                                                                                          determine whether this document                               • Federal eRulemaking Portal: http://
                                                Agency (EPA).                                                                                                         www.regulations.gov. Follow the online
                                                                                                          applies to them. Potentially affected
                                                ACTION: Final rule.
                                                                                                          entities may include:                                       instructions for submitting comments.
                                                                                                             • Crop production (NAICS code 111).                      Do not submit electronically any
                                                SUMMARY:   This regulation establishes an                    • Animal production (NAICS code                          information you consider to be CBI or
                                                exemption from the requirement of a                       112).                                                       other information whose disclosure is
                                                tolerance for residues of aluminum                           • Food manufacturing (NAICS code                         restricted by statute.
                                                sulfate (CAS Reg. No. 10043–01–3)                         311).                                                         • Mail: OPP Docket, Environmental
                                                under 40 CFR 180.940(a). This                                • Pesticide manufacturing (NAICS                         Protection Agency Docket Center (EPA/
                                                regulation eliminates the need to                         code 32532).                                                DC), (28221T), 1200 Pennsylvania Ave.
                                                establish a maximum permissible level                                                                                 NW., Washington, DC 20460–0001.
                                                for residues of aluminum sulfate.                         B. How can I get electronic access to                         • Hand Delivery: To make special
                                                                                                          other related information?                                  arrangements for hand delivery or
                                                DATES: This regulation is effective June
                                                5, 2015. Objections and requests for                        You may access a frequently updated                       delivery of boxed information, please
                                                hearings must be received on or before                    electronic version of 40 CFR part 180                       follow the instructions at http://
                                                August 4, 2015, and must be filed in                      through the Government Publishing                           www.epa.gov/dockets/contacts.html.
                                                accordance with the instructions                          Office’s e-CFR site at http://                                Additional instructions on
                                                provided in 40 CFR part 178 (see also                     www.ecfr.gov/cgi-bin/text-                                  commenting or visiting the docket,
                                                Unit I.C. of the SUPPLEMENTARY                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                        along with more information about
                                                INFORMATION).                                             40tab_02.tpl. To access the OCSPP test                      dockets generally, is available at
                                                                                                          guidelines referenced in this document                      http://www.epa.gov/dockets.
                                                ADDRESSES: The docket for this action,
                                                                                                          electronically, please go to http://
                                                identified by docket identification (ID)                                                                              II. Background and Statutory Findings
                                                                                                          www.epa.gov/ocspp and select ‘‘Test
                                                number EPA–HQ–OPP–2012–0207, is                           Methods and Guidelines.’’                                      In the Federal Register of May 2,
                                                available at http://www.regulations.gov                                                                               2012, (77 FR 25954) (FRL–9346–1), EPA
                                                or at the Office of Pesticide Programs                    C. How can I file an objection or hearing                   issued a document pursuant to FFDCA
                                                Regulatory Public Docket (OPP Docket)                     request?                                                    section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                                in the Environmental Protection Agency                      Under the Federal Food, Drug, and                         announcing the filing of a pesticide
                                                Docket Center (EPA/DC), West William                      Cosmetic Act (FFDCA) section 408(g),                        tolerance petition (PP 1E7933) by
                                                Jefferson Clinton Bldg., Rm. 3334, 1301                   21 U.S.C. 346a, any person may file an                      Exponent Inc., 1150 Connecticut Ave.
                                                Constitution Ave. NW., Washington, DC                     objection to any aspect of this regulation                  NW., Suite 1100, Washington, DC
                                                20460–0001. The Public Reading Room                       and may also request a hearing on those                     20036, on behalf of Ecolab, Inc., 370 N.
                                                is open from 8:30 a.m. to 4:30 p.m.,                      objections. You must file your objection                    Wabasha Street, St. Paul, MN 55102.
                                                Monday through Friday, excluding legal                    or request a hearing on this regulation                     The petition requested that 40 CFR part
                                                holidays. The telephone number for the                    in accordance with the instructions                         180.940(a) be amended by establishing
                                                Public Reading Room is (202) 566–1744,                    provided in 40 CFR part 178. To ensure                      an exemption from the requirement of a
                                                and the telephone number for the OPP                      proper receipt by EPA, you must                             tolerance for residues of aluminum
                                                Docket is (703) 305–5805. Please review                   identify docket ID number EPA–HQ–                           sulfate for use as an inert ingredient in
                                                the visitor instructions and additional                   OPP–2012–0207 in the subject line on                        antimicrobial pesticide formulations
                                                information about the docket available                    the first page of your submission. All                      applied to food-contact surfaces in
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                                                at http://www.epa.gov/dockets.                            objections and requests for a hearing                       public eating places, dairy-processing
                                                FOR FURTHER INFORMATION CONTACT:                          must be in writing, and must be                             equipment, and food-processing
                                                Susan Lewis, Registration Division                        received by the Hearing Clerk on or                         equipment and utensils at a maximum
                                                (7505P), Office of Pesticide Programs,                    before August 4, 2015. Addresses for                        end use concentration not to exceed 50
                                                Environmental Protection Agency, 1200                     mail and hand delivery of objections                        parts per million (ppm). That document
                                                Pennsylvania Ave. NW., Washington,                        and hearing requests are provided in 40                     referenced a summary of the petition
                                                DC 20460–0001; main telephone                             CFR 178.25(b).                                              prepared by the petitioner Exponent,


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Document Created: 2015-12-15 15:20:32
Document Modified: 2015-12-15 15:20:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 32029 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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