81 FR 53931 - n-Butyl 3-hydroxybutyrate and Isopropyl 3-hydroxybutyrate; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 157 (August 15, 2016)

Page Range		53931-53935
FR Document		2016-19115

This regulation establishes exemptions from the requirement of a tolerance for residues of n-butyl 3-hydroxybutyrate (CAS Reg. No. 53605-94-0) and isopropyl 3-hydroxybutyrate (CAS Reg. No. 54074-94-1) when used as inert ingredients (solvents) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest; to animals; and to food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. Steptoe and Johnson, on behalf of Eastman Chemical Company, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of these exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of n-butyl 3-hydroxybutyrate and isopropyl 3-hydroxybutyrate when applied or used under these conditions.

Federal Register, Volume 81 Issue 157 (Monday, August 15, 2016)

[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Rules and Regulations]
[Pages 53931-53935]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-19115]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0719; FRL-9949-49]

n-Butyl 3-hydroxybutyrate and Isopropyl 3-hydroxybutyrate;
Exemption 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 3-hydroxybutyrate (CAS Reg. No.
53605-94-0) and isopropyl 3-hydroxybutyrate (CAS Reg. No. 54074-94-1)
when used as inert ingredients (solvents) in pesticide formulations
applied to growing crops or raw agricultural commodities after harvest;
to animals; and to food contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils.
Steptoe and Johnson, on behalf of Eastman Chemical Company, submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of these exemptions from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of n-butyl 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate when applied or used under these
conditions.

DATES: This regulation is effective August 15, 2016. Objections and
requests for hearings must be received on or before October 14, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0719, 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 Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0719 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
October 14, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0719, 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 November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10841) by Steptoe and Johnson LLP (1330 Connecticut Avenue NW.,
Washington, DC 20036-1795) on behalf of the Eastman Chemical Company
(200 South Wilcox Drive, Kingsport, TN 37660-5280). The petition
requested that 40 CFR 180.910, 180.930, and 180.940 be amended to
establish exemptions from the requirement of a tolerance for residues
of n-butyl 3-hydroxybutyrate (CAS Reg. No. 53605-94-0); and isopropyl
3-hydroxybutyrate (CAS Reg. No. 54074-94-1) when used as inert
ingredients (solvents) in pesticide formulations applied to pre- and
post-harvest crops under 40 CFR 180.910; to animals under 40 CFR
180.930; and to food contact surface sanitizing solutions under 40 CFR
180.940(a). That document referenced a summary of the petition prepared
by Steptoe and Johnson on behalf of Eastman Chemical Company, the
petitioner, which is available in the docket, http://www.regulations.gov.

[[Page 53932]]

Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit V.B.

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 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate including exposure resulting from the
exemption established by this action. EPA's assessment of exposures and
risks associated with n-butyl 3-hydroxybutyrate and isopropyl 3-
hydroxybutyrate 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 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate 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.
n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate are
structurally similar chemical entities differing only in one methyl
group (CH3). Therefore the toxicity of these two chemicals
is expected to be similar. Since there are no adequate data available
for each one individually, the Agency utilizes read-across data to fill
data gaps.
n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate both
exhibit very low levels of acute oral, dermal and inhalation toxicity
each with LD50 values >5,000 mg/kg. n-Butyl-3-
hydroxybutyrate is moderately irritating to the rabbit eye and is
slightly irritating to rabbit skin. Isopropyl-3-hydroxybutyrate is not
irritating to rabbit skin. n-Butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate are not dermal sensitizers.
In a 28-day subchronic feeding study in rats which included a
reproduction/developmental screening assessment, exposure to isopropyl-
3-hydroxybutyrate resulted in no adverse test item-related
toxicological effects on clinical observations, no adverse effects seen
in FOB assessments, no adverse effects on motor activity evaluations,
no adverse effects seen in gross necropsy observations, male or female
reproductive performance, or neurobehavioral parameters. The no-
observed-adverse-effect-level (NOAEL) for reproductive toxicity was
1,000 mg/kg/day. The NOAEL for systemic toxicity was 1,000 mg/kg/day.
In the absence of effects on the general physical condition of
F1 pups, the NOAEL for neonatal toxicity was 1,000 mg/kg/
day.
n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate were
negative in reverse gene mutation assays. Isopropyl-3-hydroxybutyrate
was negative in a chromosome aberration assay and a gene mutation
assay.
There were no neurotoxicity or immunotoxicity studies available.
However, there was no evidence of adverse neurotoxic effects noted
during the FOB evaluations and the motor activity evaluations. There
was no evidence of immunotoxicity in the available database.
Based on the negative responses seen in the genotoxicity and lack
of systemic toxicity in the reproductive and developmental screening
study, n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate are
considered unlikely to be carcinogenic.
n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate both have
a low solubility; therefore, it is unlikely that either material will
be absorbed by the body and become systemically bioavailable. Both
compounds are expected to hydrolyze quickly and completely in vivo, and
the resulting hydrolysis products are very close in structure or are
the same, depending on the specific hydrolysis product. The available
in vitro data suggests that isopropyl-3-hydroxybutyrate can undergo
fast hydrolysis by enzymes in the plasma and liver to produce n-butyl-
3-hydroxybutyrate, which is perhaps further metabolized. Isopropyl-3-
hydroxybutyrate concentration decreased from approximately 70 [mu]M to
below the limit of detection (<6.68 [mu]M) in plasma within 2 hours and
in rat liver S9 fraction within 30 minutes. Although stable in
phosphate buffer, isopropyl-3-

[[Page 53933]]

hydroxybutyrate concentration levels decreased from 70 [mu]M to below
the LOD within 30 minutes with ONLY slight increases in beta-
hydroxybutyate levels indicating that either it is formed in small
quantity (minor pathway) and/or rapidly metabolized and removed from
the circulation.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. In the 28-day subchronic oral
toxicity study in rats with neurotoxicity measurements, no toxicity was
observed at doses up to 1,000 mg/kg/day. Therefore, the Agency
concluded that it is not necessary to conduct a quantitative risk
assessment.

C. Exposure Assessment

1. Dietary exposure from food, feed uses and drinking water. In
evaluating dietary exposure to n-butyl-3-hydroxybutyrate and isopropyl-
3-hydroxybutyrate, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. EPA assessed dietary exposures
from n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate in food
and drinking water as follows: Dietary exposure can occur from eating
foods or ingesting drinking water containing residues of n-butyl-3-
hydroxybutyrate and isopropyl-3-hydroxybutyrate. Because no hazard
endpoint of concern was identified for the acute and chronic dietary
assessment (food, feed and drinking water uses, a quantitative dietary
exposure risk assessment was not conducted
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate may be
used in inert ingredients in products that are registered for specific
uses that may result in residential exposure, such as pesticides used
in and round the home. However, since no endpoint of concern identified
in the available database, it is not necessary to conduct a
quantitative residential exposure assessment.
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found n-butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate to share a common mechanism of toxicity with any other
substances, and n-butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate 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-3-hydroxybutyrate and
isopropyl-3-hydroxybutyrate 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.
As part of its qualitative assessment, EPA evaluated the available
toxicity and exposure data on n-butyl-3-hydroxybutyrate and isopropyl-
3-hydroxybutyrate and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. EPA considers the toxicity database to be sufficient to evaluate
risk and has identified no residual uncertainty with regard to prenatal
and postnatal toxicity or exposure. No hazard was identified based on
the available studies; therefore, EPA concludes that there are no
threshold effects of concern to infants, children, or adults from n-
butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate. As a result,
EPA concludes that no additional margin of exposure (safety) is
necessary.

E. Aggregate Risks and Determination of Safety

Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of n-butyl-3-
hydroxybutyrate and isopropyl-3-hydroxybutyrate will not pose a risk to
the U.S. population, including infants and children, and 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-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of n-
butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate in or on any
food commodities. EPA is not establishing a limitation on the amount of
n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate that may be
used in pesticide formulations applied to growing crops.

B. Comments

Two generic comments objecting to the use of chemicals in food were
submitted to the docket for this action.

[[Page 53934]]

Neither of the comments contained any specific information bearing on
the Agency's safety finding for these chemicals. The Agency understands
the commenters' concerns and recognizes that some individuals believe
that pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.

VI. Conclusions

Therefore, exemptions from the requirement of a tolerance are
established under 40 CFR 180.910, 40 CFR 180.930, and 40 CFR 180.940(a)
for n-butyl-3-hydroxybutyrate (CAS Reg. No. 53605-94-0) and isopropyl-
3-hydroxybutyrate (CAS Reg. No. 54074-94-1) when used as inert
ingredients (solvents) in pesticide formulations applied to growing
crops or raw agricultural commodities after harvest (40 CFR 180.910);
to animals (40 CFR 180.930); or to food contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils (40 CFR 180.940(a)).

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: July 25, 2016.
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 ingredients 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-3-hydroxybutyrate (CAS .............. Solvent.
Reg. No. 53605-94-0).

* * * * * * *
Isopropyl-3-hydroxybutyrate (CAS .............. Solvent.
Reg. No. 54074-94-1).

* * * * * * *
------------------------------------------------------------------------

[[Page 53935]]

0
3. In Sec. 180.930, add alphabetically the inert ingredients 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-3-hydroxybutyrate (CAS .............. Solvent.
Reg. No. 53605-94-0).

* * * * * * *
Isopropyl-3-hydroxybutyrate (CAS .............. Solvent.
Reg. No. 54074-94-1).

* * * * * * *
------------------------------------------------------------------------

0
4. In Sec. 180.940(a), add alphabetically the inert ingredients to the
table in paragraph (a) 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
------------------------------------------------------------------------

* * * * * * *
n-Butyl-3-hydroxybutyrate......... 53605-94-0 Solvent.

* * * * * * *
Isopropyl-3-hydroxybutyrate....... 54074-94-1 Solvent.

* * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-19115 Filed 8-12-16; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Rules and Regulations 53931

this section is stayed from August 15, holidays. The telephone number for the and hearing requests are provided in 40
2016 until November 14, 2016. Public Reading Room is (202) 566–1744, CFR 178.25(b).
[FR Doc. 2016–19113 Filed 8–12–16; 8:45 am] and the telephone number for the OPP In addition to filing an objection or
BILLING CODE 6560–50–P
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
the visitor instructions and additional as described in 40 CFR part 178, please
information about the docket available submit a copy of the filing (excluding
ENVIRONMENTAL PROTECTION at http://www.epa.gov/dockets. any Confidential Business Information
AGENCY FOR FURTHER INFORMATION CONTACT:
(CBI)) for inclusion in the public docket.
Susan Lewis, Registration Division Information not marked confidential
40 CFR Part 180 (7505P), Office of Pesticide Programs, pursuant to 40 CFR part 2 may be
Environmental Protection Agency, 1200 disclosed publicly by EPA without prior
[EPA–HQ–OPP–2015–0719; FRL–9949–49] notice. Submit the non-CBI copy of your
Pennsylvania Ave. NW., Washington,
objection or hearing request, identified
n-Butyl 3-hydroxybutyrate and DC 20460–0001; main telephone
by docket ID number EPA–HQ–OPP–
Isopropyl 3-hydroxybutyrate; number: (703) 305–7090; email address:
2015–0719, by one of the following
Exemption From the Requirement of a RDFRNotices@epa.gov.
methods:
Tolerance SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
AGENCY: Environmental Protection I. General Information www.regulations.gov. Follow the online
Agency (EPA). instructions for submitting comments.
A. Does this action apply to me? Do not submit electronically any
ACTION: Final rule.
You may be potentially affected by information you consider to be CBI or
SUMMARY: This regulation establishes this action if you are an agricultural other information whose disclosure is
exemptions from the requirement of a producer, food manufacturer, or restricted by statute.
tolerance for residues of n-butyl 3- • Mail: OPP Docket, Environmental
pesticide manufacturer. The following
hydroxybutyrate (CAS Reg. No. 53605– Protection Agency Docket Center (EPA/
list of North American Industrial
94–0) and isopropyl 3-hydroxybutyrate DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is
(CAS Reg. No. 54074–94–1) when used NW., Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
as inert ingredients (solvents) in provides a guide to help readers
pesticide formulations applied to arrangements for hand delivery or
determine whether this document delivery of boxed information, please
growing crops or raw agricultural applies to them. Potentially affected
commodities after harvest; to animals; follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
and to food contact surfaces in public • Crop production (NAICS code 111).
eating places, dairy-processing Additional instructions on commenting
• Animal production (NAICS code or visiting the docket, along with more
equipment, and food-processing 112).
equipment and utensils. Steptoe and information about dockets generally, is
• Food manufacturing (NAICS code available at http://www.epa.gov/
Johnson, on behalf of Eastman Chemical 311).
Company, submitted a petition to EPA dockets.
• Pesticide manufacturing (NAICS
under the Federal Food, Drug, and II. Petition for Exemption
code 32532).
Cosmetic Act (FFDCA), requesting In the Federal Register of November
establishment of these exemptions from B. How can I get electronic access to 23, 2015 (80 FR 72941) (FRL–9936–73),
the requirement of a tolerance. This other related information? EPA issued a document pursuant to
regulation eliminates the need to You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
establish a maximum permissible level electronic version of 40 CFR part 180 announcing the filing of a pesticide
for residues of n-butyl 3- through the Government Printing petition (PP IN–10841) by Steptoe and
hydroxybutyrate and isopropyl 3- Office’s e-CFR site at http:// Johnson LLP (1330 Connecticut Avenue
hydroxybutyrate when applied or used www.ecfr.gov/cgi-bin/text- NW., Washington, DC 20036–1795) on
under these conditions. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ behalf of the Eastman Chemical
DATES: This regulation is effective 40tab_02.tpl. Company (200 South Wilcox Drive,
August 15, 2016. Objections and Kingsport, TN 37660–5280). The
requests for hearings must be received C. How can I file an objection or hearing
petition requested that 40 CFR 180.910,
on or before October 14, 2016, and must request?
180.930, and 180.940 be amended to
be filed in accordance with the Under FFDCA section 408(g), 21 establish exemptions from the
instructions provided in 40 CFR part U.S.C. 346a, any person may file an requirement of a tolerance for residues
178 (see also Unit I.C. of the objection to any aspect of this regulation of n-butyl 3-hydroxybutyrate (CAS Reg.
SUPPLEMENTARY INFORMATION). and may also request a hearing on those No. 53605–94–0); and isopropyl 3-
ADDRESSES: The docket for this action, objections. You must file your objection hydroxybutyrate (CAS Reg. No. 54074–
identified by docket identification (ID) or request a hearing on this regulation 94–1) when used as inert ingredients
number EPA–HQ–OPP–2015–0719, is in accordance with the instructions (solvents) in pesticide formulations
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure applied to pre- and post-harvest crops
or at the Office of Pesticide Programs proper receipt by EPA, you must under 40 CFR 180.910; to animals under
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– 40 CFR 180.930; and to food contact
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in the Environmental Protection Agency OPP–2015–0719 in the subject line on surface sanitizing solutions under 40
Docket Center (EPA/DC), West William the first page of your submission. All CFR 180.940(a). That document
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing referenced a summary of the petition
Constitution Ave. NW., Washington, DC must be in writing, and must be prepared by Steptoe and Johnson on
20460–0001. The Public Reading Room received by the Hearing Clerk on or behalf of Eastman Chemical Company,
is open from 8:30 a.m. to 4:30 p.m., before October 14, 2016. Addresses for the petitioner, which is available in the
Monday through Friday, excluding legal mail and hand delivery of objections docket, http://www.regulations.gov.

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53934 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Rules and Regulations

Neither of the comments contained any Executive Order 12866, this action is to this action. In addition, this action
specific information bearing on the not subject to Executive Order 13211, does not impose any enforceable duty or
Agency’s safety finding for these entitled ‘‘Actions Concerning contain any unfunded mandate as
chemicals. The Agency understands the Regulations That Significantly Affect described under Title II of the Unfunded
commenters’ concerns and recognizes Energy Supply, Distribution, or Use’’ (66 Mandates Reform Act (UMRA) (2 U.S.C.
that some individuals believe that FR 28355, May 22, 2001) or Executive 1501 et seq.).
pesticides should be banned on Order 13045, entitled ‘‘Protection of This action does not involve any
agricultural crops. However, the existing Children from Environmental Health technical standards that would require
legal framework provided by section Risks and Safety Risks’’ (62 FR 19885, Agency consideration of voluntary
408 of the Federal Food, Drug and April 23, 1997). This action does not consensus standards pursuant to section
Cosmetic Act (FFDCA) states that contain any information collections 12(d) of the National Technology
tolerances may be set when persons subject to OMB approval under the Transfer and Advancement Act
seeking such tolerances or exemptions Paperwork Reduction Act (PRA) (44 (NTTAA) (15 U.S.C. 272 note).
have demonstrated that the pesticide U.S.C. 3501 et seq.), nor does it require
meets the safety standard imposed by any special considerations under VIII. Congressional Review Act
that statute. The comment appears to be Executive Order 12898, entitled Pursuant to the Congressional Review
directed at the underlying statute and ‘‘Federal Actions to Address Act (5 U.S.C. 801 et seq.), EPA will
not EPA’s implementation of it; the Environmental Justice in Minority submit a report containing this rule and
citizen has made no contention that Populations and Low-Income other required information to the U.S.
EPA has acted in violation of the Populations’’ (59 FR 7629, February 16, Senate, the U.S. House of
statutory framework. 1994). Representatives, and the Comptroller
VI. Conclusions Since tolerances and exemptions that General of the United States prior to
are established on the basis of a petition publication of the rule in the Federal
Therefore, exemptions from the
under FFDCA section 408(d), such as Register. This action is not a ‘‘major
requirement of a tolerance are
the exemptions in this final rule, do not rule’’ as defined by 5 U.S.C. 804(2).
established under 40 CFR 180.910, 40
require the issuance of a proposed rule,
CFR 180.930, and 40 CFR 180.940(a) for List of Subjects in 40 CFR Part 180
the requirements of the Regulatory
n-butyl-3-hydroxybutyrate (CAS Reg.
Flexibility Act (RFA) (5 U.S.C. 601 et Environmental protection,
No. 53605–94–0) and isopropyl-3-
seq.), do not apply. Administrative practice and procedure,
hydroxybutyrate (CAS Reg. No. 54074–
94–1) when used as inert ingredients This action directly regulates growers, Agricultural commodities, Pesticides
(solvents) in pesticide formulations food processors, food handlers, and food and pests, Reporting and recordkeeping
applied to growing crops or raw retailers, not States or tribes, nor does requirements.
agricultural commodities after harvest this action alter the relationships or Dated: July 25, 2016.
(40 CFR 180.910); to animals (40 CFR distribution of power and Daniel J. Rosenblatt,
180.930); or to food contact surfaces in responsibilities established by Congress
Acting Director, Registration Division, Office
public eating places, dairy-processing in the preemption provisions of FFDCA of Pesticide Programs.
equipment, and food-processing section 408(n)(4). As such, the Agency
has determined that this action will not Therefore, 40 CFR chapter I is
equipment and utensils (40 CFR amended as follows:
180.940(a)). have a substantial direct effect on States
or tribal governments, on the
VII. Statutory and Executive Order PART 180—[AMENDED]
relationship between the national
Reviews government and the States or tribal ■ 1. The authority citation for part 180
This action establishes exemptions governments, or on the distribution of continues to read as follows:
from the requirement of a tolerance power and responsibilities among the
under FFDCA section 408(d) in various levels of government or between Authority: 21 U.S.C. 321(q), 346a and 371.
response to a petition submitted to the the Federal Government and Indian ■ 2. In § 180.910, add alphabetically the
Agency. The Office of Management and tribes. Thus, the Agency has determined inert ingredients to the table to read as
Budget (OMB) has exempted these types that Executive Order 13132, entitled follows:
of actions from review under Executive ‘‘Federalism’’ (64 FR 43255, August 10,
Order 12866, entitled ‘‘Regulatory 1999) and Executive Order 13175, § 180.910 Inert ingredients used pre- and
Planning and Review’’ (58 FR 51735, entitled ‘‘Consultation and Coordination post-harvest; exemptions from the
October 4, 1993). Because this action with Indian Tribal Governments’’ (65 FR requirement of a tolerance.
has been exempted from review under 67249, November 9, 2000) do not apply * * * * *

Inert ingredients Limits Uses

* * * * * * *
n-Butyl-3-hydroxybutyrate (CAS Reg. No. 53605–94–0) ............................................. ........................ Solvent.

* * * * * * *
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Isopropyl-3-hydroxybutyrate (CAS Reg. No. 54074–94–1) ......................................... ........................ Solvent.

* * * * * * *

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Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Rules and Regulations 53935

■ 3. In § 180.930, add alphabetically the § 180.930 Inert ingredients applied to
inert ingredients to the table to read as animals; exemptions from the requirement
of a tolerance.
follows:
* * * * *

Inert ingredients Limits Uses

* * * * * * *
n-Butyl-3-hydroxybutyrate (CAS Reg. No. 53605–94–0) ............................................. ........................ Solvent.

* * * * * * *
Isopropyl-3-hydroxybutyrate (CAS Reg. No. 54074–94–1) ......................................... ........................ Solvent.

* * * * * * *

■ 4. In § 180.940(a), add alphabetically § 180.940 Tolerance exemptions for active (a) * * *
the inert ingredients to the table in and inert ingredients for use in
paragraph (a) to read as follows: antimicrobial formulations (Food-contact
surface sanitizing solutions).
* * * * *

Pesticide chemical CAS Reg. No. Limits

* * * * * * *
n-Butyl-3-hydroxybutyrate ............................................................................................. 53605–94–0 Solvent.

* * * * * * *
Isopropyl-3-hydroxybutyrate ......................................................................................... 54074–94–1 Solvent.

* * * * * * *

* * * * * requires that each tank car built to meet enactment (December 4, 2015). Because
[FR Doc. 2016–19115 Filed 8–12–16; 8:45 am] the DOT Specification 117 and each the actions taken in this final rule
BILLING CODE 6560–50–P non-jacketed tank car retrofitted to meet simply codify these non-discretionary
the DOT Specification 117R be statutory mandates, PHMSA finds that
equipped with a thermal protection timely execution of agency functions
DEPARTMENT OF TRANSPORTATION blanket that is at least 1⁄2-inch thick and would be impeded by the procedures of
meets existing thermal protection public notice that are normally required
Pipeline and Hazardous Materials standards. Further, the FAST Act by the Administrative Procedure Act.
Safety Administration mandates minimum top fittings Further, PHMSA sees no reason to delay
protection requirements for tank cars regulatory action, as we are simply
49 CFR Parts 173 and 179 retrofitted to meet the DOT implementing the non-discretionary
[Docket No. PHMSA–2016–0011 (HM–251C)] Specification 117R. provisions contained in Sections 7304,
DATES: Effective: August 15, 2016. 7305, and 7306 of the FAST Act.
RIN 2137–AF17 PHMSA finds that public notice is
ADDRESSES: Docket: You may view the
public docket online at http:// impracticable and is implementing
Hazardous Materials: FAST Act these changes under the ‘‘good cause’’
Requirements for Flammable Liquids www.regulations.gov or in person at
Dockets Operations, M–30, Ground exemption of the Administrative
and Rail Tank Cars Procedure Act, 5 U.S.C. 553(b)(3)(B),
Floor, Room W12–140, 1200 New Jersey
AGENCY: Pipeline and Hazardous Avenue SE., Washington, DC 20590– thus amending the regulations without
Materials Safety Administration 0001 between 9 a.m. and 5 p.m. Monday advance notice and opportunity for
(PHMSA), DOT. through Friday, except Federal holidays. public comment.
ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: Abbreviations and Terms
SUMMARY: The Pipeline and Hazardous Michael Ciccarone, (202) 366–8553, AAR Association of American Railroads
Materials Safety Administration is Standards and Rulemaking Division, APA Administrative Procedure Act
issuing this final rule to codify in the Pipeline and Hazardous Materials Safety CFR Code of Federal Regulations
Hazardous Materials Regulations certain Administration, U.S. Department of CPC Casualty Prevention Circular
mandates and minimum requirements Transportation, 1200 New Jersey DOT Department of Transportation
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of the FAST Act. Specifically, the FAST Avenue SE., Washington, DC 20590– EA Environmental Assessment
0001. FAST Act Fixing America’s Surface
Act mandates a revised phase-out Transportation Act of 2015
schedule for all DOT Specification 111 SUPPLEMENTARY INFORMATION: The FAST FR Federal Register
tank cars used to transport unrefined Act instructs the Secretary of FRA Federal Railroad Administration
petroleum products (e.g., petroleum Transportation to issue conforming HHFT High-Hazard Flammable Train
crude oil), ethanol, and other Class 3 regulatory amendments immediately or HMR Hazardous Materials Regulations
flammable liquids. The FAST Act also soon after the FAST Act’s date of HMT Hazardous Materials Table

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Document Created: 2016-08-13 02:21:53
Document Modified: 2016-08-13 02:21:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective August 15, 2016. Objections and requests for hearings must be received on or before October 14, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		81 FR 53931
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements