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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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
sradovich on DSK3GMQ082PROD with RULES

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.

VerDate Sep<11>2014 17:35 Aug 12, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\15AUR1.SGM 15AUR1
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.

* * * * * * *
sradovich on DSK3GMQ082PROD with RULES

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

* * * * * * *

VerDate Sep<11>2014 17:35 Aug 12, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\15AUR1.SGM 15AUR1
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
sradovich on DSK3GMQ082PROD with RULES

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

VerDate Sep<11>2014 17:35 Aug 12, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\15AUR1.SGM 15AUR1
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