83 FR 25936 - Ethoxylated Fatty Acid Methyl Esters; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 108 (June 5, 2018)

Page Range		25936-25941
FR Document		2018-12060

This regulation establishes an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(1- oxoalkyl)-[omega]-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3-13 moles, when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation. This related group of compounds are collectively known as the ethoxylated fatty acid methyl esters (EFAMEs). BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethoxylated fatty acid methyl esters when used in accordance with the terms of the exemption.

Federal Register, Volume 83 Issue 108 (Tuesday, June 5, 2018)

[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25936-25941]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-12060]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0666; FRL-9976-39]

Ethoxylated Fatty Acid Methyl Esters; 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 poly(oxy-1,2-ethanediyl), [alpha]-(1-
oxoalkyl)-[omega]-methoxy-, where the alkyl chain contains a minimum of
6 and a maximum of 18 carbons and the oxyethylene content is 3-13
moles, when used as an inert ingredient (stabilizer and solubilizing
agent) in pesticide formulations applied to growing crops or raw
agricultural commodities after harvest at a concentration not to exceed
25% by weight in the formulation. This related group of compounds are
collectively known as the ethoxylated fatty acid methyl esters
(EFAMEs). BASF Corporation submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of ethoxylated fatty acid methyl esters when used in
accordance with the terms of the exemption.

DATES: This regulation is effective June 5, 2018. Objections and
requests for hearings must be received on or before August 6, 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-2017-0666, 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: Michael Goodis, 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).

[[Page 25937]]

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-2017-0666 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 6, 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-2017-0666, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11023) by BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932.
The petition requested that 40 CFR 180.910 be amended by establishing
an exemption from the requirement of a tolerance for residues of
poly(oxy-1,2-ethanediyl), [alpha]-(1-oxoalkyl)-[omega]-methoxy-, where
the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and
the oxyethylene content is 3-13 moles (CAS Reg. Nos. 53100-65-5,
194289-64-0, 34398-00-0, 9006-27-3, 32761-35-6, 53467-81-5, 518299-31-
5, 34397-99-4) when used as an inert ingredient (stabilizer and
solubilizing agent) in pesticide formulations applied to growing crops
or raw agricultural commodities after harvest at a concentration not to
exceed 25% by weight in the formulation. That document referenced a
summary of the petition prepared by BASF Corporation, the petitioner,
which is available in the docket, http://www.regulations.gov. No
comments were received in response to the notice of filing that are
relevant to establishment of this exemption.

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 ethoxylated fatty acid methyl
esters including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
ethoxylated fatty acid methyl esters 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. A series of acute toxicology studies have been conducted with
representative EFAMEs. The acute

[[Page 25938]]

toxicity study test substance was C6-10 ethoxylated fatty acid methyl
ester (degree of ethoxylation is 10.6 EO). The studies show that the
EFAMEs are practically non-toxic when ingested or inhaled via acute
exposure. Skin and eye irritation studies indicate that the EFAMEs are
slight skin and eye irritants. The skin sensitization potential of the
EFAMEs could not be determined based on the ambiguous result in the
Buehler assay.
The genotoxicity studies conducted with representative EFAMEs
including bacterial reverse mutation (Ames) test, mouse micronucleus
assay and an in vitro mouse lymphoma assay were negative.
Repeat dose data are not available for the EFAMEs; however, several
repeat dose studies have been conducted with fatty acid methyl/alkyl
esters and alcohol ethoxylates and these studies can be bridged to the
EFAMEs based upon the structural similarities between EFAMEs and
alcohol ethoxylates which are both nonionic surfactants in which the
surfactant properties of each generally result in similar toxicological
effects, at comparable dose levels) and the structural similarities of
EFAMEs with fatty acid methyl/alkyl esters (both having terminal
methoxy or alkoxy groups bound to a fatty acid or fatty acid
derivative). The NOAEL of 50 mg/kg/day from a chronic rat oral feeding
study is the lowest NOAEL observed and is equal to the lowest NOAEL
seen in the subchronic feeding studies. The lowest LOAEL in the
subchronic studies, as well as the LOAEL in the chronic rat oral
feeding study was established at 250 mg/kg/day based on reduced food
consumption and body weight gain. In a dermal toxicity study no signs
of tumors were observed and the dermal NOAEL was reported to be 300 mg/
kg/day. Most of the 90-day studies reported NOAELs ranging from 50-200
mg/kg/day.
The NOAELs for reproductive performance of males and females, as
well as offspring toxicity are considered to range from >250 mg/kg/day
to 1,000 mg/kg/day. None of the studies reported adverse reproductive,
developmental, neurotoxic, or immunotoxic effects at dose levels below
the range of >250 mg/kg/day to 1,000 mg/kg/day.
Specific information on the studies received and the nature of the
adverse effects caused by ethoxylated fatty acid methyl esters as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at http://www.regulations.gov in the document Ethoxylated Fatty
Acid Methyl Esters (CAS Reg. Nos. 53100-65-5, 194289-64-0, 34398-00-0,
9006-27-3, 32761-35-6, 53467-81-5, 518299-31-5, 34397-99-4); ``Human
Health Risk Assessment and Ecological Effects Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as an
Inert Ingredient'' in docket ID number EPA-HQ-OPP-2017-0666.

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 effect attributed to a single dose was not identified in the
toxicology database. The point of departure for chronic dietary
exposures as well as dermal and inhalation exposures is based on a
NOAEL of 50 mg/kg/day from a chronic oral feeding study in rats with
the EFAMEs surrogate chemical, alcohol ethoxylate. In this study, the
LOAEL was 250 mg/kg/day based upon reduced food consumption and body
weight gain and elevated organ-to-body weight ratios. This represents
the lowest NOAEL in the most sensitive species in the toxicity
database. The standard uncertainty factors were applied to account for
interspecies (10X) and intraspecies (10X) variations. The FQPA safety
factor was reduced to 1X to account for completeness of the toxicity
and exposure database and lack of increased prenatal or postnatal
sensitivity as well as a lack of concern for neurotoxicity. A dermal
absorption factor of 100% was used and a default value of 100%
absorption was used for the inhalation absorption factor. The resultant
chronic population adjusted dose (cPAD) is 0.5 mg/kg/day and acceptable
MOEs for residential exposures are >=100.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ethoxylated fatty acid methyl esters, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from ethoxylated fatty acid
methyl esters in food as follows.
Dietary exposure (food and drinking water) to ethoxylated fatty
acid methyl esters can occur following ingestion of foods with residues
from treated crops. Because no adverse effects attributable to a single
exposure of ethoxylated fatty acid methyl esters are seen in the
toxicity databases, an acute dietary risk assessment is not necessary.
For the chronic dietary risk assessment, EPA used the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID^TM, Version 3.16, and food consumption information
from the U.S. Department of Agriculture's (USDA's) 2003-2008 National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA). As to residue levels in food, no residue data were
submitted for ethoxylated fatty acid methyl esters. In the absence of
specific residue data, EPA has developed an approach which uses
surrogate information to derive upper bound exposure estimates for the
subject inert ingredient. Upper bound exposure estimates are based on
the highest tolerance for a given commodity from a list of high use
insecticides, herbicides, and fungicides. One hundred percent crop
treated was assumed, default processing factors, and tolerance-level
residues for all foods and use limitations of not more than 25% in
pesticide formulations. 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.

[[Page 25939]]

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 ethoxylated fatty
acid methyl esters, 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).
Ethoxylated fatty acid methyl esters may be used as inert ingredients
in products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a conservative assessment of potential residential
exposure by assessing ethoxylated fatty acid methyl esters in pesticide
formulations (outdoor scenarios) and in disinfectant-type uses (indoor
scenarios). The Agency's assessment of adult residential exposure
combines high-end dermal and inhalation handler exposure from liquids/
trigger sprayer/home garden and indoor hard surface, wiping with a
high-end post application dermal exposure from contact with treated
lawns. The Agency's assessment of children's residential exposure
includes total post-application exposures associated with total
exposures associated with contact with treated lawns and surfaces
(dermal and hand-to-mouth exposures).
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 ethoxylated fatty acid methyl esters to share a
common mechanism of toxicity with any other substances, and ethoxylated
fatty acid methyl esters does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that ethoxylated fatty acid methyl
esters 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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The toxicity database for
ethoxylated fatty acid methyl esters contains subchronic and
developmental toxicity studies conducted with surrogate chemicals. The
NOAELs for reproductive performance of males and females, as well as
offspring toxicity are considered to range from >250 mg/kg/day to 1,000
mg/kg/day. None of the studies reported effects on the reproductive
system or effects indicative of neurotoxicity.
The established cRfD will be protective of the observed adverse
effect, decreased body weight gain and food consumption, which was
observed at dose levels much lower than potential adverse effects to
infants or children. In addition, the Agency used conservative exposure
estimates, with 100 percent crop treated, tolerance-level residues,
conservative drinking water modeling numbers, and a conservative
assessment of potential residential exposure for infants and children.
Based on the adequacy of the toxicity database, the conservative nature
of the exposure assessment, and the lack of concern for prenatal and
postnatal sensitivity as well as neurotoxicity, the Agency has
concluded that there is reliable data to determine that infants and
children will be safe if the FQPA SF of 10X is reduced to 1X.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD
by dividing the POD (i.e. toxicological endpoint) by all applicable
UFs. For linear cancer risks, EPA calculates the probability of
additional cancer cases given the estimated aggregate exposure. Short,
intermediate, and long term aggregate risks are evaluated by comparing
the estimated aggregate food, water, and residential exposure to the
POD to ensure that the MOE called for by the product of all applicable
UFs is not exceeded.
Although there are no known current residential uses associated
with EFAMEs, a residential exposure assessment was conducted. The level
of concern for residential uses (i.e. non-occupational, non-dietary
exposure) associated with the EFAMEs is low. The level of MOEs for
combined residential exposure is above 100.
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,
the EFAMEs are 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
EFAMEs from food and water will utilize 70% of the cPAD for children 1-
2 years old, the population group receiving the greatest exposure.
Generally, a dietary risk estimate that is less than 100% of the cPAD
does not exceed the Agency's risk concerns.
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). The
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-, intermediate- and water
with sort-, intermediate- and long-term residential exposures to
EFAMEs. Using the exposure assumptions describe in this unit for short-
term exposures, EPA has concluded the combined respective short-,
intermediate- and long- term food water, and residential exposures
resulted in aggregate margin of exposures (MOE) of 335 for adults and
122 for children. Because EPA's level of

[[Page 25940]]

concern for EFAMEs 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., EFAMEs 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 ethoxylated fatty acid methyl esters residues.

V. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation. EPA is establishing
limitations on the amount of EFAMEs that may be used in pesticide
formulations applied to growing crops. These limitations 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 formulation for use on
growing crops or raw agricultural commodities after harvest for sale or
distribution that exceeds 25% by weight of EFAMEs.

VI. Conclusion

Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for poly(oxy-1,2-ethanediyl), [alpha]-
(1-oxoalkyl)-[omega]-methoxy-, where the alkyl chain contains a minimum
of 6 and a maximum of 18 carbons and the oxyethylene content is 3-13
moles (CAS Reg. No. 53100-65-5, 194289-64-0, 4398-00-0, 9006-27-3,
32761-35-6, 53467-81-5, 518299-31-5, and 34397-99-4) when used as an
inert ingredient (stabilizer and solubilizing agent) in pesticide
formulations applied to growing crops or raw agricultural commodities
after harvest at a concentration not to exceed 25% by weight in the
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); Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: May 11, 2018.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Program.
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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

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

* * * * *

[[Page 25941]]

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

* * * * * * *
------------------------------------------------------------------------
Poly(oxy-1,2-ethanediyl), Not to exceed 25% Stabilizer,
[alpha]-(1-oxoalkyl)-[omega]- by weight in solubilizing
methoxy-, where the alkyl chain pesticide agent.
contains a minimum of 6 and a formulation.
maximum of 18 carbons and the
oxyethylene content is 3-13
moles (CAS Reg. No. 53100-65-5,
194289-64-0, 34398-00-0, 9006-
27-3, 32761-35-6, 53467-81-5,
518299-31-5, and 34397-99-4).
------------------------------------------------------------------------

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

[FR Doc. 2018-12060 Filed 6-4-18; 8:45 am]
BILLING CODE 6560-50-P

25936 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations

[FR Doc. 2018–11597 Filed 6–4–18; 8:45 am] List of Subjects Corporation submitted a petition to EPA
BILLING CODE 6560–50–P under the Federal Food, Drug, and
40 CFR Part 60
Cosmetic Act (FFDCA), requesting
Environmental protection, establishment of an exemption from the
ENVIRONMENTAL PROTECTION Administrative practice and procedure, requirement of a tolerance. This
AGENCY Air pollution control, Intergovernmental regulation eliminates the need to
relations, Reporting and recordkeeping establish a maximum permissible level
40 CFR Parts 60, 61, and 63 requirements. for residues of ethoxylated fatty acid
40 CFR Part 61 methyl esters when used in accordance
[EPA–R06–OAR–2016–0091; FRL–9978–89– with the terms of the exemption.
Region 6] Environmental protection, DATES: This regulation is effective June
Administrative practice and procedure, 5, 2018. Objections and requests for
New Source Performance Standards Air pollution control, Arsenic, Benzene, hearings must be received on or before
and National Emission Standards for Beryllium, Hazardous substances, August 6, 2018, and must be filed in
Hazardous Air Pollutants; Delegation Intergovernmental relations, Mercury, accordance with the instructions
of Authority to New Mexico Reporting and recordkeeping provided in 40 CFR part 178 (see also
requirements, Vinyl chloride. Unit I.C. of the SUPPLEMENTARY
AGENCY: Environmental Protection
40 CFR Part 63 INFORMATION).
Agency (EPA).
Environmental protection, ADDRESSES: The docket for this action,
ACTION: Withdrawal of direct final rule. Administrative practice and procedure, identified by docket identification (ID)
Air pollution control, Hazardous number EPA–HQ–OPP–2017–0666, is
SUMMARY: On April 13, 2018, the available at http://www.regulations.gov
substances, Intergovernmental relations,
Environmental Protection Agency (EPA) or at the Office of Pesticide Programs
Reporting and recordkeeping
published a direct final rule approving Regulatory Public Docket (OPP Docket)
requirements.
the updated delegation of EPA authority in the Environmental Protection Agency
for implementation and enforcement of Dated: May 30, 2018.
Docket Center (EPA/DC), West William
certain New Source Performance Wren Stenger,
Jefferson Clinton Bldg., Rm. 3334, 1301
Standards (NSPS) and National Director, Multimedia Division, Region 6. Constitution Ave. NW, Washington, DC
Emission Standards for Hazardous Air ■ Accordingly, the direct final rule 20460–0001. The Public Reading Room
Pollutants (NESHAPs) for all sources published in the Federal Register on is open from 8:30 a.m. to 4:30 p.m.,
(both part 70 and non-part 70 sources) April 13, 2018 (83 FR 15964), amending Monday through Friday, excluding legal
to the New Mexico Environmental 40 CFR 60.4, 40 CFR 61.04, and 40 CFR holidays. The telephone number for the
Department (NMED). EPA stated in the 63.99, which was to become effective on Public Reading Room is (202) 566–1744,
direct final rule that if EPA received June 12, 2018, is withdrawn. and the telephone number for the OPP
relevant adverse comments by May 14, [FR Doc. 2018–12013 Filed 6–4–18; 8:45 am] Docket is (703) 305–5805. Please review
2018, EPA would publish a timely BILLING CODE 6560–50–P the visitor instructions and additional
withdrawal in the Federal Register. EPA information about the docket available
received an adverse comment on May at http://www.epa.gov/dockets.
14, 2018, and accordingly is ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT:
withdrawing the direct final rule. AGENCY Michael Goodis, Registration Division
DATES:The direct final rule published (7505P), Office of Pesticide Programs,
40 CFR Part 180
on April 13, 2018 (83 FR 15964), is Environmental Protection Agency, 1200
withdrawn effective June 5, 2018. [EPA–HQ–OPP–2017–0666; FRL–9976–39] Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
FOR FURTHER INFORMATION CONTACT: Mr. Ethoxylated Fatty Acid Methyl Esters; (703) 305–7090; email address:
Rick Barrett, (214) 665–7227, Exemption From the Requirement of a RDFRNotices@epa.gov.
barrett.richard@epa.gov. Tolerance SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION: On April AGENCY: Environmental Protection I. General Information
13, 2018, EPA published a direct final Agency (EPA).
rule approving the updated delegation ACTION: Final rule. A. Does this action apply to me?
of authority for implementation and You may be potentially affected by
enforcement of NSPS and NESHAPs for SUMMARY: This regulation establishes an this action if you are an agricultural
all sources (both part 70 and non-part 70 exemption from the requirement of a producer, food manufacturer, or
sources) to the NMED. The direct final tolerance for residues of poly(oxy-1,2- pesticide manufacturer. The following
rule was published without prior ethanediyl), a-(1-oxoalkyl)-w-methoxy-, list of North American Industrial
proposal because EPA anticipated no where the alkyl chain contains a Classification System (NAICS) codes is
relevant adverse comments. EPA stated minimum of 6 and a maximum of 18 not intended to be exhaustive, but rather
in the direct final rule that if relevant carbons and the oxyethylene content is provides a guide to help readers
adverse comments were received by 3–13 moles, when used as an inert determine whether this document
May 14, 2018, EPA would publish a ingredient (stabilizer and solubilizing applies to them. Potentially affected
timely withdrawal in the Federal agent) in pesticide formulations applied entities may include:
Register. EPA received an adverse to growing crops or raw agricultural • Crop production (NAICS code 111).
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comment on May 14, 2018. Accordingly, commodities after harvest at a • Animal production (NAICS code
EPA is withdrawing the direct final rule. concentration not to exceed 25% by 112).
In a separate subsequent final action weight in the formulation. This related • Food manufacturing (NAICS code
EPA will address the comment received. group of compounds are collectively 311).
The withdrawal is being taken pursuant known as the ethoxylated fatty acid • Pesticide manufacturing (NAICS
to sections 111 and112 of the CAA. methyl esters (EFAMEs). BASF code 32532).

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25940 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations

concern for EFAMEs is a MOE of 100 or Agency. The Office of Management and ‘‘Federalism’’ (64 FR 43255, August 10,
below, these MOEs are not of concern. Budget (OMB) has exempted these types 1999) and Executive Order 13175,
4. Aggregate cancer risk for U.S. of actions from review under Executive entitled ‘‘Consultation and Coordination
population. Based on the discussion in Order 12866, entitled ‘‘Regulatory with Indian Tribal Governments’’ (65 FR
Unit IV. A., EFAMEs is not expected to Planning and Review’’ (58 FR 51735, 67249, November 9, 2000) do not apply
pose a cancer risk. October 4, 1993). Because this action to this action. In addition, this action
5. Determination of safety. Based on has been exempted from review under does not impose any enforceable duty or
these risk assessments, EPA concludes Executive Order 12866, this action is contain any unfunded mandate as
that there is a reasonable certainty that not subject to Executive Order 13211, described under Title II of the Unfunded
no harm will result to the general entitled ‘‘Actions Concerning Mandates Reform Act (UMRA) (2 U.S.C.
population, or to infants and children Regulations That Significantly Affect 1501 et seq.).
from aggregate exposure to ethoxylated Energy Supply, Distribution, or Use’’ (66 This action does not involve any
fatty acid methyl esters residues. FR 28355, May 22, 2001); Executive technical standards that would require
V. Analytical Enforcement Methodology Order 13045, entitled ‘‘Protection of Agency consideration of voluntary
Children from Environmental Health consensus standards pursuant to section
An analytical method is not required Risks and Safety Risks’’ (62 FR 19885, 12(d) of the National Technology
for enforcement purposes since the April 23, 1997); or Executive Order Transfer and Advancement Act
Agency is establishing an exemption 13771, entitled ‘‘Reducing Regulations (NTTAA) (15 U.S.C. 272 note).
from the requirement of a tolerance and Controlling Regulatory Costs’’ (82
without any numerical limitation. EPA FR 9339, February 3, 2017). This action VIII. Congressional Review Act
is establishing limitations on the does not contain any information
amount of EFAMEs that may be used in Pursuant to the Congressional Review
collections subject to OMB approval Act (5 U.S.C. 801 et seq.), EPA will
pesticide formulations applied to under the Paperwork Reduction Act
growing crops. These limitations will be submit a report containing this rule and
(PRA) (44 U.S.C. 3501 et seq.), nor does other required information to the U.S.
enforced through the pesticide it require any special considerations
registration process under the Federal Senate, the U.S. House of
under Executive Order 12898, entitled Representatives, and the Comptroller
Insecticide, Fungicide, and Rodenticide ‘‘Federal Actions to Address
Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA General of the United States prior to
Environmental Justice in Minority publication of the rule in the Federal
will not register any pesticide Populations and Low-Income
formulation for use on growing crops or Register. This action is not a ‘‘major
Populations’’ (59 FR 7629, February 16, rule’’ as defined by 5 U.S.C. 804(2).
raw agricultural commodities after 1994).
harvest for sale or distribution that List of Subjects in 40 CFR Part 180
Since tolerances and exemptions that
exceeds 25% by weight of EFAMEs.
are established on the basis of a petition Environmental protection,
VI. Conclusion under FFDCA section 408(d), such as Administrative practice and procedure,
Therefore, an exemption from the the tolerance in this final rule, do not Agricultural commodities, Pesticides
requirement of a tolerance is established require the issuance of a proposed rule, and pests, Reporting and recordkeeping
under 40 CFR 180.910 for poly(oxy-1,2- the requirements of the Regulatory requirements.
ethanediyl), a-(1-oxoalkyl)-w-methoxy-, Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply. Dated: May 11, 2018.
where the alkyl chain contains a Donna Davis,
minimum of 6 and a maximum of 18 This action directly regulates growers,
food processors, food handlers, and food Acting Director, Registration Division, Office
carbons and the oxyethylene content is
retailers, not States or tribes, nor does of Pesticide Program.
3–13 moles (CAS Reg. No. 53100–65–5,
194289–64–0, 4398–00–0, 9006–27–3, this action alter the relationships or Therefore, 40 CFR chapter I is
32761–35–6, 53467–81–5, 518299–31–5, distribution of power and amended as follows:
and 34397–99–4) when used as an inert responsibilities established by Congress
ingredient (stabilizer and solubilizing in the preemption provisions of FFDCA PART 180—[AMENDED]
agent) in pesticide formulations applied section 408(n)(4). As such, the Agency
has determined that this action will not ■ 1. The authority citation for part 180
to growing crops or raw agricultural
have a substantial direct effect on States continues to read as follows:
commodities after harvest at a
concentration not to exceed 25% by or tribal governments, on the Authority: 21 U.S.C. 321(q), 346a and 371.
weight in the formulation. relationship between the national ■ 2. In § 180.910, add alphabetically the
government and the States or tribal inert ingredient to the table to read as
VII. Statutory and Executive Order governments, or on the distribution of
Reviews follows:
power and responsibilities among the
This action establishes an exemption various levels of government or between § 180.910 Inert ingredients used pre- and
from the requirement of a tolerance the Federal Government and Indian post-harvest; exemptions from the
under FFDCA section 408(d) in tribes. Thus, the Agency has determined requirement of a tolerance.
response to a petition submitted to the that Executive Order 13132, entitled * * * * *
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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations 25941

Inert ingredients Limits Uses

* * * * * * *

Poly(oxy-1,2-ethanediyl), a-(1-oxoalkyl)-w-methoxy-, where the alkyl Not to exceed 25% by weight in Stabilizer, solubilizing agent.
chain contains a minimum of 6 and a maximum of 18 carbons and pesticide formulation.
the oxyethylene content is 3–13 moles (CAS Reg. No. 53100–65–5,
194289–64–0, 34398–00–0, 9006–27–3, 32761–35–6, 53467–81–5,
518299–31–5, and 34397–99–4).

* * * * * * *

[FR Doc. 2018–12060 Filed 6–4–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: OPP–2010–0234 in the subject line on
BILLING CODE 6560–50–P Michael L. Goodis, Director, the first page of your submission. All
Registration Division (7505P), Office of objections and requests for a hearing
Pesticide Programs, Environmental must be in writing, and must be
ENVIRONMENTAL PROTECTION Protection Agency, 1200 Pennsylvania received by the Hearing Clerk on or
AGENCY Ave. NW, Washington, DC 20460–0001; before August 6, 2018. Addresses for
main telephone number: (703) 305– mail and hand delivery of objections
40 CFR Part 180 7090; email address: RDFRNotices@ and hearing requests are provided in 40
[EPA–HQ–OPP–2010–0234; FRL–9976–73] epa.gov. CFR 178.25(b).
In addition to filing an objection or
SUPPLEMENTARY INFORMATION:
Alpha-cypermethrin; Pesticide hearing request with the Hearing Clerk
Tolerances I. General Information as described in 40 CFR part 178, please
submit a copy of the filing (excluding
AGENCY: Environmental Protection A. Does this action apply to me?
any Confidential Business Information
Agency (EPA). You may be potentially affected by (CBI)) for inclusion in the public docket.
ACTION: Final rule. this action if you are an agricultural Information not marked confidential
producer, food manufacturer, or pursuant to 40 CFR part 2 may be
SUMMARY: This regulation amends pesticide manufacturer. The following disclosed publicly by EPA without prior
existing tolerances for residues of alpha- list of North American Industrial notice. Submit the non-CBI copy of your
cypermethrin in or on fruit, citrus group Classification System (NAICS) codes is objection or hearing request, identified
10–10 and hog fat. EPA is modifying not intended to be exhaustive, but rather by docket ID number EPA–HQ–OPP–
these tolerances under the Federal Food, provides a guide to help readers 2010–0234, by one of the following
Drug, and Cosmetic Act (FFDCA) to determine whether this document methods:
correct an error in a previous applies to them. Potentially affected • Federal eRulemaking Portal: http://
rulemaking that established these entities may include: www.regulations.gov. Follow the online
tolerances at an unintended level. • Crop production (NAICS code 111). instructions for submitting comments.
DATES: This regulation is effective June • Animal production (NAICS code Do not submit electronically any
5, 2018. Objections and requests for 112). information you consider to be CBI or
hearings must be received on or before • Food manufacturing (NAICS code other information whose disclosure is
August 6, 2018, and must be filed in 311). restricted by statute.
accordance with the instructions • Pesticide manufacturing (NAICS • Mail: OPP Docket, Environmental
provided in 40 CFR part 178 (see also code 32532). Protection Agency Docket Center (EPA/
Unit I.C. of the SUPPLEMENTARY DC), (28221T), 1200 Pennsylvania Ave.
B. How can I get electronic access to
INFORMATION). NW, Washington, DC 20460–0001.
other related information?
• Hand Delivery: To make special
ADDRESSES: The docket for this action, You may access a frequently updated arrangements for hand delivery or
identified by docket identification (ID) electronic version of EPA’s tolerance delivery of boxed information, please
number EPA–HQ–OPP–2010–0234, is regulations at 40 CFR part 180 through follow the instructions at http://
available at http://www.regulations.gov the Government Printing Office’s e-CFR www.epa.gov/dockets/contacts.html.
or at the Office of Pesticide Programs site at http://www.ecfr.gov/cgi-bin/text- Additional instructions on
Regulatory Public Docket (OPP Docket) idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ commenting or visiting the docket,
in the Environmental Protection Agency 40tab_02.tpl. along with more information about
Docket Center (EPA/DC), West William dockets generally, is available at http://
Jefferson Clinton Bldg., Rm. 3334, 1301 C. How can I file an objection or hearing
www.epa.gov/dockets.
Constitution Ave. NW, Washington, DC request?
20460–0001. The Public Reading Room Under FFDCA section 408(g), 21 II. Proposed Rule
is open from 8:30 a.m. to 4:30 p.m., U.S.C. 346a, any person may file an In the Federal Register of December
Monday through Friday, excluding legal objection to any aspect of this regulation 26, 2017 (82 FR 60940) (FRL–9969–97),
holidays. The telephone number for the and may also request a hearing on those EPA, pursuant to FFDCA section 408(e),
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Public Reading Room is (202) 566–1744, objections. You must file your objection 21 U.S.C. 346a(e), proposed revisions to
and the telephone number for the OPP or request a hearing on this regulation existing tolerances for the insecticide
Docket is (703) 305–5805. Please review in accordance with the instructions alpha-cypermethrin to reduce the
the visitor instructions and additional provided in 40 CFR part 178. To ensure allowable levels of the pesticide in or on
information about the docket available proper receipt by EPA, you must fruit, citrus, group 10–10 from 10 parts
at http://www.epa.gov/dockets. identify docket ID number EPA–HQ– per million (ppm) to 0.35 ppm and in

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Document Created: 2018-11-02 11:46:55
Document Modified: 2018-11-02 11:46:55

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 June 5, 2018. Objections and requests for hearings must be received on or before August 6, 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).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
FR Citation		83 FR 25936
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements