[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13671-13677]
[FR Doc No: 2018-06108]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0660, EPA-HQ-OPP-2015-0720, EPA-HQ-OPP-2015-0723; FRL-
9974-70]

N,N-Dimethyl 9-Decenamide; N,N-Dimethyldodecanamide; N,N-
Dimethyltetradecanamide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of N,N-dimethyl 9-decenamide (CAS Reg No.
1356964-77-6); N,N-dimethyldodecanamide (CAS Reg No. 3007-53-2); and
N,N-dimethyltetradecanamide (CAS Reg No. 3015-65-4) when used as inert
ingredients (surfactant, solvent) on growing crops and raw agricultural
commodities after harvest, with a limitation that the concentration of
the inert ingredient is at a concentration not

to exceed 20% by weight in a pesticide formulation. Technology Sciences
Group on behalf of Stepan 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. This regulation
eliminates the need to establish a maximum permissible level for
residues of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and
N,N-dimethyltetradecanamide when used in accordance with the
established limitations.

DATES: This regulation is effective March 30, 2018. Objections and
requests for hearings must be received on or before May 29, 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-2015-0660, EPA-HQ-OPP-2015-0720
and EPA-HQ-OPP-2015-0723 are 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:<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.

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-2015-0660, EPA-HQ-OPP-2015-0720 and EPA-HQ-
OPP-2015-0723 are 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 May 29,
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-2015-0660, EPA-HQ-
OPP-2015-0720 and EPA-HQ-OPP-2015-0723 are, 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 pesticide petitions IN-10791, IN-
10805, and IN-10806 by Technology Sciences Group, (1150 18th Street NW,
Suite 1000 Washington, DC 20036) on behalf of Stepan Company (22 West
Frontage Road, Northfield, Illinois 60093). The petitions requested
that 40 CFR 180.910 be amended by establishing exemptions from the
requirement of a tolerance for residues of N,N-dimethyl 9-decenamide
(CAS Reg No. 1356964-77-6) (IN-10791); N,N-dimethyldodecanamide (CAS
Reg No. 3007-53-2) (IN-10806); and N,N-dimethyltetradecanamide (CAS Reg
No. 3015-65-4) (IN-10805) when used as inert ingredients (surfactant/
solvent) in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest. That document referenced
summaries of the petitions prepared by Technology Sciences Group on
behalf of Stepan Company, the petitioner, which are available in the
corresponding dockets, http://www.regulations.gov. A comment was
received on the notice of filing. EPA's response to this comment is
discussed in Unit V.C.
    Based upon review of the data supporting the petitions, EPA has
limited the maximum concentration of N,N-dimethyl 9-decenamide; N,N-
dimethyldodecanamide; and N,N-dimethyltetradecanamide to not more than
20% by weight in pesticide formulations. The reason for this change is
explained in Unit V.B. below.

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,N-dimethyl 9-decenamide; N,N-
dimethyldodecanamide; and N,N-dimethyltetradecanamide including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with N,N-dimethyl 9-
decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide
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,N-dimethyl 9-decenamide; N,N-
dimethyldodecanamide and N,N-dimethyltetradecanamide 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,N-dimethyl 9-decenamide is very similar in structure to N,N-
dimethyldecanamide (differing only in the presence of a single double
bond), and to N,N-dimethyloctanamide (differeing only in alkyl group
carbon chain length and the presence of a terminal double bond). N,N-
dimethyldodecanamide is very similar in structure to N,N-
dimethyldecanamide and N,N-dimethyloctanamide, differing only in alkyl
group carbon chain length. Similarly, N,N-dimethyltetradecanamide is
very similar in structure to N,N-dimethyldecanamide and N,N-
dimethyloctanamide, differing only in alkyl group carbon chain length.
Based upon these close structural similarities, N,N-dimethyldecanamide
and N,N-dimethyloctanamide are considered suitable surrogates to
characterize toxicity due to exposure to N,N-dimethyl 9-decenamide,
N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide.
    N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide are not sensitizers. Based on the acute
toxicity data on surrogate chemicals N,N-dimethyldecanamide and N,N-
dimethyloctanamide, they are expected to be of low oral acute toxicity;
the lethal dose, (LD50) in rats is 1,770 milligrams/kilogram
(mg/kg). The acute dermal LD50 is greater than 400 mg/kg and
the acute inhalation lethal concentration, LC50 is greater
than 3.55 milligrams/liter (mg/L). They are expected to be a severe
irritant to the skin and corrosive to the eyes.
    Following subchronic exposure in the diet of the rat, toxicity is
manifested as an increased incidence of basophilic regenerative tubules
in the renal cortex as well as a slight increase in the amount of
protein excreted in the urine at 10,000 parts per million (ppm) (787.6
mg/kg/day). The no-observed-adverse effect level (NOAEL) is 2,000 ppm
(136.8 mg/kg/day). In the 6-weeks toxicity study in dogs via gavage,
decreased food consumption was seen at 1,000 mg/kg/day, the highest
dose tested. The NOAEL was 500 mg/kg/day.
    No fetal susceptibility is observed in developmental studies in
rats or rabbits. In rats, maternal and developmental toxicity are
observed at 450 mg/kg/day. In rats, maternal toxicity is manifested as
clinical signs, food consumption and increased post-implantation loss.
Developmental toxicity is manifested as decreased fetal body weight and
increased incidence of skeletal malformations/variations. In the
rabbit, neither maternal nor developmental toxicity is observed at dose
levels up to 1,000 mg/kg/day.
    In a 5-day repeat dose inhalation toxicity study in rats (nose
only, 6-hour exposure per day), marginally reduced body weight gains
and goblet cell hyperplasia in the nasal and paranasal cavities were
seen at 521.2 mg/m\3\ (approximately 426.8 mg/kg/day), the highest dose
tested. The NOAEL is 111.2 mg/m\3\).
    N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide are negative for gene mutations and
clastogenicity in the Ames test and the micronucleus assay,
respectively.
    A Derek Nexus structural alert analysis was conducted with N,N-
dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide and indicated no structural alerts for
carcinogenicity or mutagenicity. Therefore, N,N-dimethyl 9-decenamide;
N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are not
expected to be carcinogenic.
    No neurotoxicity or immunotoxicity studies are available for review
with N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide. However, evidence of potential neurotoxicity
or immunotoxicity was not observed in the submitted studies.

    Based on the chemical structure and known mammalian enzymatic
activities, N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and
N,N-dimethyltetradecanamide are expected to undergo carboxyamide
hydrolysis by amidase enzymes that have broad substrate specificity,
resulting in the corresponding carboxylic acid with a fatty acid
structure.

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.
    The chronic reference dose (cRfD) as well as all dermal exposure
scenarios, was based on the 90-day toxicity study in the rat. In this
study, the LOAEL was 10,000 ppm (equivalent to 787.6 mg/kg/day) based
on an increased incidence of basophilic regenerative tubules in the
renal cortex as well as a slight increase in the amount of protein
excreted in the urine. The NOAEL was 2,000 ppm (equivalent to 136.8 mg/
kg/day). 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 additional uncertainty factor was reduced to 3x to account for
extrapolation from subchronic to chronic exposures scenarios because
the kidney effects were reversible and observed in male rats only.
Additionally, in the dog following 6 weeks of oral exposure, no signs
of toxicity were observed up to 500 mg/kg/day and the only sign of
toxicity (decreased food consumption) was observed at the limit dose of
1,000 mg/kg/day. The 5-day inhalation toxicity study in rats was not
selected for inhalation exposure assessment because oral end point and
inhalation end points yielded comparable NOAEL. In addition, the nasal
effects seen in this study is primarily due to irritation and
marginally decreased in reduced body weight would have observed in the
oral study. A dermal absorption factor of 85% was applied based on a
dermal penetration study in rats and an in vitro dermal absorption
study with human skin. The default value of 100% absorption was used
for the inhalation absorption factor. The resultant chronic population
adjusted dose (cPAD) is 0.456 mg/kg/day. The MOEs for short-term and
intermediate-term occupational and residential exposures are 100.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and
N,N-dimethyltetradecanamide, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and
N,N-dimethyltetradecanamide in food as follows:
    Dietary exposure (food and drinking water) to N,N-dimethyl 9-
decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide
can occur following ingestion of foods with residues from treated
crops. Because no adverse effects attributable to a single exposure of
N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; or N,N-
dimethyltetradecanamide 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-FCIDTM,
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 N,N-dimethyl
9-decenamide; N,N-dimethyldodecanamide; or N,N-dimethyltetradecanamide.
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 20% 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.
    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 N,N-dimethyl 9-
decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide,
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).
    N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-
dimethyltetradecanamide 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 N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and
N,N-dimethyltetradecanamide 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 N,N-dimethyl 9-decenamide; N,N-
dimethyldodecanamide; and N,N-dimethyltetradecanamide to share a common
mechanism of toxicity with any other substances, and N,N-dimethyl 9-
decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide
do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide;
and N,N-dimethyltetradecanamide do 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 Food Quality
Protection Act Safety Factor (FQPA 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
N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-
dimethyltetradecanamide contains subchronic and developmental toxicity
studies conducted with surrogate chemicals. Increased fetal
susceptibility is not observed in either of the developmental toxicity
studies in rats or rabbits. In rats, maternal (clinical signs, food
consumption and increased post-implantation loss) and developmental
(fetal body weight, increased incidence of skeletal malformations/
variations) toxicity were observed at 450 mg/kg/day. In the rabbit,
neither maternal nor developmental toxicity was observed up to 1,000
mg/kg/day. Reproduction toxicity studies were not available; however,
increased post-implantation loss is observed at 450 mg/kg/day in the
developmental toxicity study in rats. The established cRfD will be
protective of the observed effect. 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, 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 for short
and intermediate-term exposure and 3 x for chronic exposure assessment.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    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,
N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide 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
N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide from food and water will utilize 62.3% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide may be used as inert ingredients in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to N,N-dimethyl 9-decenamide, N,N-
dimethyldodecanamide, and N,N-dimethyltetradecanamide.
    Using the exposure assumptions described above for short-term
exposures, EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate MOEs of 680 for both adult
males and females. EPA has concluded the combined short-term aggregated
food, water, and residential pesticide exposures result in an aggregate
MOE of 359 for children. Because EPA's level of concern for N,N-
dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-
dimethyltetradecanamide is a MOE of 100 or below, these MOEs are not of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide may be used as inert ingredients in pesticide
products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to N,N-dimethyl 9-
decenamide, N,N-

dimethyldodecanamide, and N,N-dimethyltetradecanamide.
    Using the exposure assumptions described above for intermediate-
term exposures, EPA has concluded that the combined intermediate-term
food, water, and residential exposures result in aggregate MOEs of 1475
for adult males and females. EPA has concluded the combined
intermediate-term aggregated food, water, and residential exposures
result in an aggregate MOE of 394 for children. Because EPA's level of
concern for N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and
N,N-dimethyltetradecanamide is a MOE of 100 or below, these MOEs are
not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts in a DEREK structural alert analysis and the lack of
mutagenicity, N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and
N,N-dimethyltetradecanamide is not expected to pose a cancer risk to
humans.
    6. 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 N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and
N,N-dimethyltetradecanamide 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,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide and N,N-
dimethyltetradecanamide in or on any food commodities. EPA is
establishing limitations on the amount of N,N-dimethyl 9-decenamide;
N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide 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 20% by weight of
N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-
dimethyltetradecanamide unless additional data are submitted that
demonstrate a higher concentration would be safe.

B. Revisions to Petitioned-For Tolerances

    Based upon an evaluation of the data included in the petition, EPA
is establishing an exemption from the requirement of a tolerance for
residues of N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide,and
N,N-dimethyltetradecanamide when used in pesticide formulations as
inert ingredients (surfactant/solvent), not to exceed 20% by weight of
the formulation, instead of the unlimited use requested. Because
unlimited use of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide;
or N,N-dimethyltetradecanamide resulted in aggregate risks of concern,
EPA is establishing a 20% limitation in formulation to support the
safety finding of these tolerance exemptions. The concern for unlimited
use of theses inert ingredients is documented on page 4 of the Agency's
risk assessment documents ``N,N-dimethyl 9-decenamide, N,N-
dimethyldodecanamide, and N,N-dimethyltetradecanamide; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,'' which can be found at http://www.regulations.gov in in docket ID number EPA-HQ-OPP-2015-0660, EPA-
HQ-OPP-2015-0720 and EPA-HQ-OPP-2015-0723, respectively.

C. Response to Comments

    The comment was received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency recognizes that some individuals believe that no residue of
pesticides should be allowed. However, under the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by the statute. EPA has evaluated all the available
data and concluded that there is a reasonable certainty of no harm from
the limited use of N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide,
and N,N-dimethyltetradecanamide as inert ingredients in pesticide
formulations. The commenter has not provided any information supporting
a conclusion that such exposure will not be safe.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for residues of N,N-dimethyl 9-
decenamide (CAS Reg No. 1356964-77-6), N,N-dimethyldodecanamide (CAS
Reg No. 3007-53-2), and N,N-dimethyltetradecanamide (CAS Reg No. 3015-
65-4) when used as inert ingredients (surfactant, solvent) at a maximum
concentration not to exceed 20% by weight in any pesticide formulation
applied to growing crops or raw agricultural commodities after harvest.

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 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: March 12, 2018.
Michael L. 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 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,N-Dimethyl 9-decenamide (CAS  Not to exceed 20% by    Surfactant,
 Reg. No. 1356964-77-6).         weight of pesticide     solvent
                                 formulation.
N,N-Dimethyldodecanamide (CAS   Not to exceed 20% by    Surfactant,
 Reg. No. 3007-53-2).            weight of pesticide     solvent
                                 formulation.

                              * * * * * * *
N,N-Dimethyltetradecanamide     Not to exceed 20% by    Surfactant,
 (CAS Reg. No. 3015-65-4).       weight of pesticide     solvent
                                 formulation.

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

[FR Doc. 2018-06108 Filed 3-29-18; 8:45 am]
 BILLING CODE 6560-50-P