Di-n-butyl carbonate; Exemption From the Requirement of a Tolerance, 34065-34070 [2015-14647]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Rules and Regulations]
[Pages 34065-34070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14647]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0176; FRL-9928-63]


Di-n-butyl carbonate; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of di-n-butyl carbonate (CAS Reg. No. 542-
52-9) 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 pesticide formulations in food-contact surfaces sanitizer 
products at a maximum level

[[Page 34066]]

in the end-use concentration of 15,000 ppm (1.5%). Exponent Inc., on 
behalf of 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 di-n-butyl carbonate.

DATES: This regulation is effective June 15, 2015. Objections and 
requests for hearings must be received on or before August 14, 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-2014-0176, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Director, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0176 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 14, 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-2014-0176, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-
55), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10683) by 
Exponent Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 
20036, on behalf of Huntsman Corporation, 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 di-n-butyl carbonate (CAS 
Reg. No. 542-52-9) 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. That document referenced a summary of the petition 
prepared by Exponent Inc., on behalf of Huntsman Corp., the petitioner, 
which is available in the docket, https://www.regulations.gov. There 
were no comments received in response to 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 di-n-butyl carbonoate allowed in food contact sanitizing 
solutions to a maximum 15,000 ppm (1.5%). This limitation is based on 
the Agency's risk assessment which can be found at https://www.regulations.gov in document ``Di-n-Butyl Carbonate; 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-
2014-0176.

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;

[[Page 34067]]

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 di-n-butyl carbonate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with di-n-butyl carbonate 
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 di-n-butyl carbonate 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.
    Di-n-butyl carbonate acute toxicity testing indicate that it has 
low acute oral, dermal and inhalation toxicity (acute oral and dermal 
LD50 > 2,000 milligrams/kilogram (mg/kg); acute inhalation 
LC50 >8 mg/Liter (mg/L) and is non-irritating to the eyes 
and negative for dermal sensitization. Di-n-butyl carbonate is 
irritating to the skin. In a combined repeated dose toxicity study with 
the reproductive and developmental toxicity screening test, di-n-butyl 
carbonate was administered daily to rats by gavage. The di-n-butyl 
carbonate test material did not result in any test material related 
mortality or clinical observations in the parental animals. No effects 
were observed in the functional observational battery, hematology and 
clotting parameters, clinical chemistry parameters, or organ weights. 
No macroscopic findings related to the test item were observed. No 
histopathological effects were reported in neurological tissues 
(cerebrum, cerebellum, pons, peripheral nerve, spinal cord) (cervical, 
midthoracic and lumbar sections) or any immunological tissues (bone 
marrow, thymus, spleen, lymph nodes).
    The NOAEL of di-n-butyl carbonate in rats is 500 mg/kg bw/day for 
parental animals (males and females) and 500 mg/kg bw/day for embryo-
fetal toxicity. The LOAEL is 750 mg/kg bw/day based on decreased body 
weight gain in male and female paternal animals and embryo-fetal 
toxicity at 750 mg/kg bw/day as evidenced by increased pre- and post-
implantation losses and decreased total number of pups.
    If ingested di-n-butyl carbonate would be readily hydrolyzed by 
esterases in the gut to generate two molar equivalents of n-butanol and 
one molar equivalent of carbonic acid. EPA has stated for the n-butanol 
tolerance reassessment that once absorbed, n-butanol disappears rapidly 
from the blood. The carbonic acid rapidly dissociates into 
CO2 and water.
    Di-n-butyl carbonate was negative in an OCSPP Harmonized Test 
Guideline Bacterial Reverse Mutation Assay (at concentrations ranging 
from 1.5 to 5,000 ug per plate); no positive mutagenic response was 
observed.
    There are no carcinogenicity studies available for di-n-butyl 
carbonate. 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, di-n-butyl carbonate 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 dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No acute toxicological endpoints have been identified for di-n-
butyl carbonate; therefore no acute exposure assessments are warranted.

[[Page 34068]]

    The overall NOAEL for di-n-butyl carbonate was established at 500 
mg/kg/day. The chronic risk assessment for di-n-butyl carbonate is 
based on this endpoint and the chronic reference dose (cRfD) is 
therefore 5.0 mg/kg/day. The cRfD incorporates a 10X interspecies 
factor and a 10X intraspecies factor. Since the FQPA SF has been 
reduced to 1X, the cPAD is also 5.0 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to di-n-butyl carbonate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from di-n-butyl carbonate in food as follows:
    The Agency assessed the dietary exposures to di-n-butyl carbonate 
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 di-n-butyl carbonate 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 di-n-butyl carbonate. In the absence of specific residue 
data, EPA has developed an approach which uses surrogate information to 
derive upper bound exposure estimates for the subject inert ingredient. 
Upper bound exposure estimates are based on the highest tolerance for a 
given commodity from a list of high-use insecticides, herbicides, and 
fungicides. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S. 
Piper, 2/25/09) and can be found at https://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of the proposed use of di-n-butyl carbonate 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 EPA 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 di-n-butyl carbonate can be found at https://www.regulations.gov in document ``Di-n-Butyl Carbonate; 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. 12-23 in docket ID number 
EPA-HQ-OPP-2014-0176.
    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 di-n-butyl carbonate, 
a conservative drinking water concentration value of 100 parts per 
billions (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 di-n-butyl 
carbonate; however, it is possible that di-n-butyl carbonate may be 
used as an inert ingredient in pesticide products. A highly 
conservative residential exposure assessment was performed in which it 
was assumed that all residential use pesticide products would contain 
di-n-butyl carbonate as an inert ingredient. A complete description of 
the approach used to assess possible residential exposures from di-n-
butyl carbonate can be found in https://www.regulations.gov in document 
``Di-n-Butyl Carbonate; 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-2014-0176.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found di-n-butyl carbonate to share a common mechanism 
of toxicity with any other substances, and di-n-butyl carbonate does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that di-n-butyl carbonate does not have a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is evidence for 
qualitative susceptibility in the OECD 422 study. In this study, 
embryo-fetal toxicity was manifested as evidenced by increased pre- and 
post-implantation losses and decreased total number of pups in the 
presence of maternal toxicity (decreased in body weights). However, 
considering the overall toxicity profile and the toxicity endpoints and 
doses selected for di-n-butyl carbonate, the degree of concern for the 
effects observed in the di-n-butyl carbonate reproductive and 
developmental toxicity screening study

[[Page 34069]]

is low. There is a clear NOAEL for the offspring effects, and endpoints 
and regulatory doses were selected for use in the dietary risk 
assessment to be protective of these effects.
    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 di-n-butyl carbonate summarize the 
studies included in the database. EPA concludes that these data are 
sufficient for assessing the effects of di-n-butyl carbonate on infants 
and children.
    ii. There is no indication that di-n-butyl carbonate is a 
neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence that di-n-butyl carbonate 
results in increased susceptibility in rats, the degree of concern for 
these effects is low for the reasons explained in Unit IV.D.2.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues as well as conservative 
assumptions regarding exposures from food-contact sanitizer uses. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to di-n-butyl carbonate in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by di-n-butyl carbonate.

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, 
di-n-butyl carbonate 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 
di-n-butyl carbonate from food and water will utilize 21% of the cPAD 
for the U.S. population and 94% 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 di-n-butyl 
carbonate 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 di-n-butyl 
carbonate 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.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
IV.A., di-n-butyl carbonate 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 di-n-butyl carbonate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required for 
di-n-butyl carbonate in pesticide formulations which 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 di-n-butyl carbonate on food-contact surfaces in antimicrobial 
applications since the Agency is not establishing a numerical tolerance 
for residues of di-n-butyl carbonate in or on any food commodities. EPA 
is establishing a limitation on the amount of di-n-butyl carbonate 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 di-n-butyl carbonate by 
weight.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance is 
established under 40 CFR 180.910, 180.930, and 180.940(a) for di-n-
butyl carbonate (CAS Reg. No. 542-52-9) 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 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

[[Page 34070]]

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: June 5, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


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
------------------------------------------------------------------------
 
                                * * * * *
Di-n-butyl carbonate (CAS Reg. No.    ...............  Solvent.
 542-52-9).
 
                                * * * * *
------------------------------------------------------------------------


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
------------------------------------------------------------------------
 
                                * * * * *
Di-n-butyl carbonate (CAS Reg. No.    ...............  Solvent.
 542-52-9).
 
                                * * * * *
------------------------------------------------------------------------


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) * * *

------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Di-n-butyl carbonate...........        542-52-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed
                                                  15,000 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-14647 Filed 6-12-15; 8:45 am]
 BILLING CODE 6560-50-P