[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39887-39888]
[FR Doc No: 2017-17740]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4324-DR; Docket ID FEMA-2017-0001]

Oklahoma; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oklahoma (FEMA-4324-DR), dated July 25, 2017,
and related determinations.

DATES: The declaration was issued July 25, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 25, 2017, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Oklahoma resulting from severe storms, tornadoes, straight-line
winds, and flooding during the period of May 16-20, 2017, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Oklahoma.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.

    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Charles Maskell, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Oklahoma have been designated
as adversely affected by this major disaster:

    Alfalfa, Beckham, Cherokee, Coal, Cotton, Delaware, Johnston,
LeFlore, Murray, Muskogee, Okfuskee, Okmulgee, Pittsburg, Pontotoc,
Roger Mills, and Washita Counties for Public Assistance.
    All areas within the State of Oklahoma are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-17740 Filed 8-21-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: January 18, 2007 (Volume 72, Number 11)]
[Notices]
[Page 2275]
[DOCID:fr18ja07-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-394-002]

Northwest Pipeline Corporation; Notice of Compliance Filing

January 10, 2007.
    Take notice that on January 5, 2007, Northwest Pipeline Corporation
(Northwest) tendered for filing as part of its FERC Gas Tariff, Third
Revised Volume No. 1, the following tariff sheets, to be effective
December 26, 2006.

Tenth Revised Sheet No. 19-A
Fourth Revised Sheet No. 302-C

    Northwest states that the purpose of this filing is to comply with
the Commission's December 26, 2006 order in Docket No. RP06-394 to
bring Northwest's tariff into conformance with Commission policy.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-572 Filed 1-17-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Rules and Regulations]
[Pages 33-37]
[FR Doc No: 2017-28317]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0717; FRL-9970-03]

Phenylethyl acetate; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of phenylethyl acetate (CAS Reg. No. 103-
45-7) when used as an inert ingredient (solvent) at a maximum of 0.015%
in pesticide formulations applied to growing crops and raw agricultural
commodities after harvest. Technology Science Group Inc., on behalf of
Janeil Biosurfactant Company, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance.

DATES: This regulation is effective January 2, 2018. Objections and
requests for hearings must be received on or before March 5, 2018, 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-2015-0717, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; 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. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation

in accordance with the instructions provided in 40 CFR part 178. To
ensure proper receipt by EPA, you must identify docket ID number EPA-
HQ-OPP-2015-0717 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 March
5, 2018. 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-2015-0717, 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-
10888) by Technology Sciences Group Inc., on behalf of Jeneil
Biosurfactant Company, 400 N. Dekora Woods Blvd., Saukville, WI 53080.
The petition requested that 40 CFR 180.910 be amended by establishing
an exemption from the requirement of a tolerance for residues of
phenylethyl acetate (CAS Reg. No. 103-45-7) when used as an inert
ingredient (solvent) in pesticide formulations applied to growing crops
and raw agricultural commodities after harvest at a maximum
concentration not to exceed 0.015% by weight of the pesticide
formulation. That document referenced a summary of the petition
prepared by Technology Sciences Group Inc., the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

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 phenylethyl acetate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with phenylethyl acetate
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 phenylethyl acetate 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.
    Phenylethyl acetate exhibits relatively low acute toxicity via the
oral and dermal routes of exposure. Phenylethyl acetate has been
reported to be moderately to severely irritating to the eyes of
rabbits, but only mildly irritating to their skin and not dermally
sensitizing to guinea pigs.
    The toxicity database for phenylethyl acetate includes only one
repeat dose toxicity study. In that study, a subchronic oral toxicity
study via gavage, male rats received 73 mg/kg/day of phenylethyl
acetate. There were no adverse effects seen at that dose, which was the
only dose tested.
    Studies of metabolism following oral ingestion suggests,
phenylethyl acetate is rapidly absorbed, metabolized and

excreted in the urine. Phenylethyl alcohol, phenylacetic acid and
acetic acid are the primary metabolites. Phenylethyl alcohol is
successively oxidized to phenylacetaldehyde and phenylacetic acid in
vivo. Phenylacetaldehyde is oxidized by inducible aldehyde
dehydrogenases and cytosolic isoenzymes to phenylacetic acid.
Phenylacetic acid undergoes species-specific conjugation with a variety
of amino acids, amines, or glucuronic acid followed by excretion almost
exclusively in the urine. All of these metabolites are all naturally
occurring compounds and are normal constituents of the human body. No
toxicological endpoint of concern has been identified for any of these
phenylethyl acetate metabolites.
    The Research Institute for Fragrance Materials, Inc. (RIFM)
reported results of three Ames assays performed on phenylethyl acetate.
Results of all three showed no significant increase in reverse
mutations in Salmonella typhimurium strains TA98, TA100, TA1535, or
TA1537 in the presence or absence of metabolic activation at
concentrations up to 5000 [micro]g/plate phenylethyl acetate.
    No carcinogenicity studies were available in the database for
phenylethyl acetate; however, a DEREK model showed no structural alerts
for carcinogenicity, and the genotoxicity studies were negative.
    No immunotoxicity studies were available in the database for
phenylethyl acetate. However, phenylethyl acetate is readily
metabolized to phenylethyl alcohol, phenylacetic acid and acetic acid
which are all naturally occurring compounds and are normal constituents
of the human body. No toxicological endpoint of concern has been
identified for any of these phenylethyl acetate metabolites.
    No neurotoxicity studies were available in the database for
phenylethyl acetate. However, cholinesterase activity was not affected
nor was there systemic toxicity in a study in rats treated via gavage
with 73 mg/kg/day phenylethyl acetate for 140 days. Additionally, the
chronic reference dose (cRfD) is based on this study and any potential
neurotoxic effects will be protected.

B. Toxicological Points of Departure/Levels of Concern

    Phenylethyl acetate is readily metabolized to phenylethyl alcohol,
phenylacetic acid and acetic acid which are all naturally occurring
compounds and are normal constituents of the human body. No
toxicological endpoint of concern has been identified for any of these
phenylethyl acetate metabolites. For purposes of conducting a risk
assessment in support of this action, a highly conservative
toxicological point of departure of 73 mg/kg/day for all nonacute
exposure durations and routes of exposure was selected for phenylethyl
acetate based on the NOAEL from the subchronic rat oral toxicity study.
A chronic population adjusted dose (cPAD) of 0.73 mg/kg/day was derived
based on the use of the POD and 10X inter- and intraspecies uncertainty
factors and an FQPA Safety Factor of 1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to phenylethyl acetate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from phenylethyl acetate in food as follows:
    i. Acute Exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide chemical, if a
toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure. No such
effects were identified in the toxicological studies for phenylethyl
acetate; therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. The chronic dietary exposure assessment for
this inert ingredient utilizes the Dietary Exposure Evaluation Model
Food Commodity Intake Database (DEEM-FCID), Version 3.16, EPA, which
includes food consumption information from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, ``What
We Eat In America'', (NHANES/WWEIA). This dietary survey was conducted
from 2003 to 2008. In the absence of actual residue data, the inert
ingredient evaluation is based on a highly conservative model which
assumes that the residue level of the inert ingredient would be no
higher than the highest established tolerance for an active ingredient
on a given commodity. Implicit in this assumption is that there would
be similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. A complete description of
the general approach taken to assess inert ingredient risks in the
absence of residue data is contained in the memorandum entitled ``Alkyl
Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments for the
Inerts.'' (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738. In the
case of phenylethyl acetate, an adjustment to the dietary exposure
analysis was made to account for the use at a maximum concentration of
0.015% in pesticide formulations. As part of the aggregate exposure
assessment, dietary exposures to phenylethyl acetate resulting from its
use as a food flavoring agent are also included in the assessment.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for phenylethyl acetate,
a conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Phenylethyl acetate may be used as inert ingredient in pesticide
products that are registered for specific uses that may result in
indoor or outdoor residential exposures. A screening-level residential
exposure and risk assessment was completed utilizing conservative
residential exposure assumptions. The Agency assessed short- and
intermediate-term dermal and inhalation exposures for residential
handlers that would result from low pressure handwand, hose end sprayer
and trigger sprayer for outdoor scenarios of each pesticide type
(herbicide, insecticide and fungicide) and mopping, wiping and aerosol
sprays for indoor scenarios. The Agency assessed post-application
short-term dermal exposure for children and adults as well as short-
term hand-to-mouth exposure for children from contact with treated
lawns.
    Residential exposures to phenylethyl acetate may also occur as a
result of its use as a fragrance component. Estimates of these
exposures are included in the

aggregate exposure assessment of phenylethyl acetate.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found phenylethyl acetate to share a common mechanism
of toxicity with any other substances, and phenylethyl acetate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
phenylethyl acetate 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    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 assessment, EPA evaluated the available toxicity,
metabolism and exposure data on phenylethyl acetate and considered its
validity, completeness, and reliability, as well as the relationship of
this information to human risk. No hazard was identified based on the
available studies. EPA has identified no residual uncertainty with
regard to prenatal and postnatal toxicity or exposure to phenylethyl
acetate; therefore, EPA concludes that no additional margin of exposure
(safety) is necessary for the protection of infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on phenylethyl
acetate, EPA has determined that there is a reasonable certainty that
no harm to any population subgroup will result from aggregate exposure
to phenylethyl acetate under reasonable foreseeable circumstances.
Therefore, the establishment of an exemption from tolerance under 40
CFR 180. 910 for residues of phenylethyl acetate when used as an inert
ingredient in pesticide formulations applied on growing crops and raw
agricultural commodities after harvest at a maximum of 0.015% in the
pesticide formulation, is safe under FFDCA section 408.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
phenylethyl acetate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
phenylethyl acetate from food and water will utilize <0.01% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure.
    3. Short-, intermediate- and long-term risk. Short-, intermediate-
and long-term aggregate exposure takes into account short-,
intermediate- and long-term residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
    Phenylethyl acetate is currently used as an inert ingredient in
pesticide products that are registered for uses that could result in
short- and intermediate-term residential exposure, and there are other,
non-pesticidal residential uses of phenylethyl acetate that could
result in long-term residential exposures; the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-, intermediate- and long-term term residential
exposures to phenylethyl acetate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined respective short-,
intermediate- and long-term term food, water, and residential exposures
result in aggregate margin of exposures (MOE) of 560 for adults and
19,000 for children. Because EPA's level of concern for phenylethyl
acetate is a MOE of 100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit IV.A., phenylethyl acetate is not expected to pose a
cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to phenylethyl acetate residues.

V. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of
phenylethyl acetate that may be used in pesticide formulations, an
analytical enforcement methodology is not necessary for this exemption.
The limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for
sale or distribution for use on growing crops with concentrations of
phenylethyl acetate exceeding 0.015% by weight of the formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for phenylethyl acetate (CAS Reg. No.
103-45-7) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest at a maximum of 0.015% in the pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption 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 exemption 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: December 12, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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

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

* * * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
Phenylethyl acetate (CAS Reg.   Not to exceed 0.015%   Solvent.
 No. 103-45-7).                  in pesticide
                                 formulation..

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

[FR Doc. 2017-28317 Filed 12-29-17; 8:45 am]
 BILLING CODE 6560-50-P