N,N-Dimethyl 9-Decenamide; N,N-Dimethyldodecanamide; N,N-Dimethyltetradecanamide; Exemption From the Requirement of a Tolerance, 13671-13677 [2018-06108]
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List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
i. Removing the two entries entitled
‘‘Sturm, Ruger & Company’’; and
■ ii. Adding a new entry entitled
‘‘Sturm Ruger & Company’’ at the end of
the table.
The revisions and additions read as
follows:
■
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart EE—New Hampshire
Dated: March 20, 2018.
Alexandra Dapolito Dunn,
Regional Administrator, EPA Region 1.
§ 52.1520
2. Amend § 52.1520 by:
a. In paragraph (c), amend the table by
revising the entry ‘‘Env–A 900’’; and
■ b. In paragraph (d), amend the table
by:
■
*
■
Part 52 of chapter I, title 40 of the
Code of Federal Regulations is amended
as follows:
Identification of plan.
*
*
(c) * * *
*
*
EPA-APPROVED NEW HAMPSHIRE REGULATIONS
State
effective
date
State citation
Title/subject
*
Env–A 900 ........
*
*
Owner or Operator Obligations ......
*
*
EPA approval date 1
7/18/2015
*
Explanations
*
*
3/30/2018, [Insert Federal Register citation].
*
*
Approved sections Env–A 901
through 911, except for the following sections withdrawn by the
State and which are not part of
the
approved
SIP:
Env–A
907.01(d) and (e); 907.02(a)(1),
(d)(1) a. and c., (d)(2), and (e);
907.03; 911.04(b) and (c);
911.05.
*
*
*
*
1 In
order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision.
(d) * * *
EPA-APPROVED NEW HAMPSHIRE SOURCE SPECIFIC REQUIREMENTS
State
effective
date
Name of source
Permit No.
*
Sturm Ruger & Company.
*
*
ARD–03–001 .......................................
*
2/2/2017
Additional explanations/§ 52.1535
citation
EPA approval date 2
*
3/30/2018, [Insert
Federal Register
citation].
*
*
VOC RACT Order, as amended February 2, 2017, except sections D.1,
and introductory clauses to sections
D.2, D.3.b, D.5.a.i and b.i.
2 In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision.
*
*
*
*
*
[FR Doc. 2018–06381 Filed 3–29–18; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
ACTION:
Final rule.
This regulation establishes
exemptions from the requirement of a
tolerance for residues of N,N-dimethyl
[EPA–HQ–OPP–2015–0660, EPA–HQ–OPP–
9-decenamide (CAS Reg No. 1356964–
2015–0720, EPA–HQ–OPP–2015–0723; FRL– 77–6); N,N-dimethyldodecanamide
9974–70]
(CAS Reg No. 3007–53–2); and N,Ndimethyltetradecanamide (CAS Reg No.
N,N-Dimethyl 9-Decenamide; N,N3015–65–4) when used as inert
Dimethyldodecanamide; N,Ningredients (surfactant, solvent) on
Dimethyltetradecanamide; Exemption
growing crops and raw agricultural
From the Requirement of a Tolerance
commodities after harvest, with a
limitation that the concentration of the
AGENCY: Environmental Protection
inert ingredient is at a concentration not
Agency (EPA).
BILLING CODE 6560–50–P
SUMMARY:
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40 CFR Part 180
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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,Ndimethyl 9-decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide when used in
accordance with the established
limitations.
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).
DATES:
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
https://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 https://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:
ADDRESSES:
I. General Information
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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
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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 https://
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: https://
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.
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• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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,
https://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,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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
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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
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sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for N,N-dimethyl 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with N,N-dimethyl 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide and N,Ndimethyltetradecanamide as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
N,N-dimethyl 9-decenamide is very
similar in structure to N,Ndimethyldecanamide (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,Ndimethyldodecanamide is very similar
in structure to N,N-dimethyldecanamide
and N,N-dimethyloctanamide, differing
only in alkyl group carbon chain length.
Similarly, N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide.
N,N-dimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide are not
sensitizers. Based on the acute toxicity
data on surrogate chemicals N,Ndimethyldecanamide and N,Ndimethyloctanamide, they are expected
to be of low oral acute toxicity; the
lethal dose, (LD50) in rats is 1,770
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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/m3
(approximately 426.8 mg/kg/day), the
highest dose tested. The NOAEL is
111.2 mg/m3).
N,N-dimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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,Ndimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide and indicated
no structural alerts for carcinogenicity
or mutagenicity. Therefore, N,Ndimethyl 9-decenamide; N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide are not
expected to be carcinogenic.
No neurotoxicity or immunotoxicity
studies are available for review with
N,N-dimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide. However,
evidence of potential neurotoxicity or
immunotoxicity was not observed in the
submitted studies.
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Based on the chemical structure and
known mammalian enzymatic activities,
N,N-dimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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 https://
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
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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 shortterm 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 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from N,Ndimethyl 9-decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide in food as
follows:
Dietary exposure (food and drinking
water) to N,N-dimethyl 9-decenamide;
N,N-dimethyldodecanamide; and N,Ndimethyltetradecanamide can occur
following ingestion of foods with
residues from treated crops. Because no
adverse effects attributable to a single
exposure of N,N-dimethyl 9decenamide; N,Ndimethyldodecanamide; or N,Ndimethyltetradecanamide 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-
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decenamide; N,Ndimethyldodecanamide; or N,Ndimethyltetradecanamide. 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 https://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,Ndimethyl 9-decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide, 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 nonoccupational, 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,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide in pesticide
formulations (outdoor scenarios) and in
disinfectant-type uses (indoor
scenarios). The Agency’s assessment of
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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 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide to share a
common mechanism of toxicity with
any other substances, and N,N-dimethyl
9-decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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 https://
www.epa.gov/pesticides/cumulative.
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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
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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,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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 postimplantation 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-
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13675
decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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 9decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide.
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 9decenamide; N,Ndimethyldodecanamide; and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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-
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dimethyldodecanamide, and N,Ndimethyltetradecanamide.
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 9decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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 9decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide 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,Ndimethyl 9-decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide residues.
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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,Ndimethyldodecanamide and N,Ndimethyltetradecanamide in or on any
food commodities. EPA is establishing
limitations on the amount of N,Ndimethyl 9-decenamide; N,Ndimethyldodecanamide and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide unless
additional data are submitted that
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18:02 Mar 29, 2018
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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,Ndimethyldodecanamide,and N,Ndimethyltetradecanamide 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,Ndimethyldodecanamide; or N,Ndimethyltetradecanamide 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 9decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide; 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 https://
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 9decenamide, N,Ndimethyldodecanamide, and N,Ndimethyltetradecanamide as inert
ingredients in pesticide formulations.
The commenter has not provided any
information supporting a conclusion
that such exposure will not be safe.
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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,Ndimethyldodecanamide (CAS Reg No.
3007–53–2), and N,Ndimethyltetradecanamide (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
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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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredients to the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
*
N,N-Dimethyl 9-decenamide (CAS Reg. No. 1356964–
77–6).
N,N-Dimethyldodecanamide (CAS Reg. No. 3007–53–2)
*
*
*
Not to exceed 20% by weight of pesticide formulation ..
*
Surfactant, solvent
Not to exceed 20% by weight of pesticide formulation ..
Surfactant, solvent
*
*
*
N,N-Dimethyltetradecanamide (CAS Reg. No. 3015–65–
4).
*
*
*
Not to exceed 20% by weight of pesticide formulation ..
*
Surfactant, solvent
*
*
*
*
Uses
*
subject to Prior Authorization as a
condition of payment.
[FR Doc. 2018–06108 Filed 3–29–18; 8:45 am]
BILLING CODE 6560–50–P
This action is applicable on
April 30, 2018.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
Emily Calvert, (410) 786–4277.
Andre Damonze, (410) 786–1795.
SUPPLEMENTARY INFORMATION:
42 CFR Part 414
I. Background
[CMS–6078–N]
In the December 30, 2015 final rule
(80 FR 81674) titled ‘‘Medicare Program;
Prior Authorization Process for Certain
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies,’’
we implemented section 1834(a)(15) of
the Social Security Act (the Act) by
establishing an initial Master List
(called the Master List of Items
Frequently Subject to Unnecessary
Utilization) of certain DMEPOS that the
Secretary determined, on the basis of
prior payment experience, are
frequently subject to unnecessary
utilization and by establishing a prior
authorization process for these items.
The Master List includes items that
meet the following criteria:
Medicare Program; Prior Authorization
Process for Certain Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Items; Update to
the Master List of Items Frequently
Subject to Unnecessary Utilization
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Master list deletions.
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AGENCY:
This document announces the
deletion of four Healthcare Common
Procedure Coding System (HCPCS)
codes from the Master List of Items
Frequently Subject to Unnecessary
Utilization that could be potentially
SUMMARY:
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18:02 Mar 29, 2018
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Frm 00053
Fmt 4700
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*
*
• Appear on the DMEPOS Fee
Schedule list.
• Have an average purchase fee of
$1,000 or greater (adjusted annually for
inflation) or an average monthly rental
fee schedule of $100 or greater (adjusted
annually for inflation). (These dollar
amounts are referred to as the ‘‘payment
threshold’’.)
• Meet either of the following criteria:
++ Identified in a Government
Accountability Office (GAO) or
Department of Health and Human
Services Office of Inspector General
(OIG) report that is national in scope
and published in 2007 or later as having
a high rate of fraud or unnecessary
utilization.
++ Listed in the 2011 or later
Comprehensive Error Rate Testing
(CERT) program’s Annual Medicare FeeFor-Service (FFS) Improper Payment
Rate Report DME and/or DMEPOS
Service Specific Report(s).
The rule described the maintenance
process of the Master List as follows:
• The Master List is self-updating
annually. That is, items on the DMEPOS
Fee Schedule that meet the ‘‘payment
threshold’’ are added to the list when
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]]>Agencies
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13671-13677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06108]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 13672]]
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 https://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 https://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: [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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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
[[Page 13673]]
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.
[[Page 13674]]
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 https://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 https://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
[[Page 13675]]
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
https://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-
[[Page 13676]]
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 https://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
[[Page 13677]]
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
