Document ID: EPA-HQ-OPP-2013-0590-0004
Agency: epa
Document Type: Rule
Title: Exemptions from Requirements of Tolerances: Coco alkyl dimethyl amines
Posted Date: 2014-07-16T04:00Z

[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Rules and Regulations]
[Pages 41443-41448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16463]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0590; FRL-9911-54]

Coco alkyl dimethyl amines; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of coco alkyl dimethyl amines (CAS Reg. No. 
61788-93-0) when used as an inert ingredient (emulsifier) in pesticide 
formulations applied to crops preharvest at a concentration not to 
exceed 0.5% by weight. Technology Sciences Group Inc., 1150 18th St. 
NW., Suite 1000, Washington, DC 20036, 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 coco alkyl dimethyl amines.

DATES: This regulation is effective July 16, 2014. Objections and 
requests for hearings must be received on or before September 15, 2014, 
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-2013-0590, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0590 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 
September 15, 2014. 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-2013-0590, 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 October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10622) by Technology Sciences Group Inc., 1150 18th St. NW., Suite 
1000, Washington, DC 20036. The petition requested that 40 CFR 180.920 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of coco alkyl dimethyl amines (CAS Reg. No. 
61788-93-0) when used as an inert ingredient (emulsifier) in pesticide 
formulations applied to crops preharvest at a concentration not to 
exceed 0.5% by weight.
    That document referenced a summary of the petition prepared by 
Technology Sciences Group Inc., the petitioner, which is available in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
approved of the use of coco alkyl dimethyl amines at a maximum 
concentration not to exceed 0.5% by weight in the final end-use 
formulation. This limitation is based on the Agency's

[[Page 41444]]

risk assessment which can be found at http://www.regulations.gov in 
document Coco Alkyl Dimethyl Amines: CASRN 61788-93-0 Decision Document 
for the Proposed Use of Coco Alkyl Dimethyl Amines as an Inert 
Ingredient in Pesticide Formulations Under 40 CFR 180.920 in docket ID 
number EPA-HQ-OPP-2013-0590.

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 coco alkyl dimethyl amines, 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with coco 
alkyl dimethyl amines 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 coco alkyl dimethyl amines 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.
    In 2004, the Agency's High Production Volume (HPV) reviewed 23 
fatty nitrogen derived amines. Coco alkyl dimethyl amines was among the 
group of fatty nitrogen derived amines. In instances where complete 
data sets were not available, the American Chemistry Council (ACC), as 
part of the High Production Volume (HPV) Test Challenge Program for 
Fatty Nitrogen Derivatives, utilized data derived from structurally 
closely related compounds. The predominant alkyl species in coco alkyl 
dimethyl amines is the dodecyl (C12) group with the other 
alkyl species being the tetradecyl (C14), hexadecyl 
(C16), and octadecyl (C18) groups. N,N-dimethyl-
1-dodecanamine (CAS Reg. No. 112-18-5) is a closely related substance 
in that the chemical structure is similar, the carbon chain length is 
similar and its physical/chemical properties are similar. N,N-dimethyl-
1-dodecanamine and other related alkyl dimethyl amines were used in 
assessing coco alkyl dimethyl amines (CADA).
    The coco alkyl dimethyl amines exhibit low toxicity via the acute 
oral, dermal, and inhalation routes of exposure. In rats the acute oral 
LD50 is > 1,000 milligrams/kilogram body weight/day (mg/kg 
bw/day). The acute dermal LD50 is > 3,385 mg/kg bw/day in 
rabbits. It is corrosive to the skin and irritating to the eyes of 
rabbits. An acute inhalation study was not available with the coco 
alkyl dimethyl amines, however, data are available for an acceptable 
surrogate compound, n-tallow alkyl derivatives of 2,2'-iminobis ethanol 
(CAS Reg. No. 61791-44-4). The acute inhalation LC50 is > 
0.6 milligram/Liter (mg/L) in rats.
    A 28-day toxicity study was conducted using Sprague-Dawley rats 
which received an oral gavage dose of 0, 50, 150, or 300 mg/kg bw/day. 
At 150 mg/kg bw/day, animals displayed mild adverse behavior, including 
snout rubbing. A NOAEL of 50 mg/kg bw/day was observed in this study.
    There was no evidence of mutagenicity in the Ames test for N,N-
dimethyl 1-tetradecanamine (CAS Reg. No. 112-75-4), N,N-dimethyl 1-
hexadecanamine (CAS Reg. No. 112-69-6), and N,N-dimethyl 1-
octadecanamine (CAS Reg. No. 124-28-7). N,N-dimethyl-1-dodecanamine 
(CAS Reg. No. 112-18-5) was not clastogenic in an in vivo mammalian 
erythrocyte micronucleus test.
    A gavage reproductive/developmental toxicity screening study was 
conducted where N,N-dimethyl-1-dodecanamine (CAS Reg. No. 112-18-5) was 
administered to Sprague-Dawley rats. At 150 mg/kg bw/day, mortality, 
increased mean implantation loss, decreased mean viability index and 
abnormal maternal behavior was observed in the dams and reduced weight 
in pups. The maternal, developmental and reproduction NOAEL was 50 mg/
kg bw/day.
    None of the amines discussed in the American Chemistry Council High 
Production Volume challenge document were mutagenic. As noted in the 
HPV challenge, ``The vast majority of the in vitro and in vivo 
genotoxicity tests gave no indication of genotoxic potential for 
primary aliphatic amines'' (which includes coco alkyl diethyl amines). 
The available feeding study for cyclohexylamine and 2-year feeding

[[Page 41445]]

studies with sec-butylamine and octadecylamine showed no tumorigenic 
potential.''
    In addition, the Agency conducted additional review of coco alkyl 
dimethyl amines using DEREK software analysis to determine if there 
were any alerts for carcinogenicity or other chronic toxicity. The 
results of the DEREK analysis indicated that there were no ``ALERTS'' 
for carcinogenicity. Based on the lack of concern regarding 
mutagenicity and lack of carcinogenicity in animal studies for 
surrogate chemicals and lack of any carcinogenicity alerts in the DEREK 
analysis, the EPA concluded that coco alkyl diethyl amines are unlikely 
to pose a carcinogenic risk.
    No dermal toxicity or dermal absorption studies are available for 
coco alkyl diethyl amines. A dermal absorption study is available for 
1-dodecanamine which is structurally closely related. The dermal 
absorption of 1-dodecanamine was determined to be 60%. The coco alkyl 
diethyl amine is a larger molecule than 1-dodecanamine, therefore, it 
is not expected to be absorbed at a greater rate.
    No studies were found specific to the metabolic pathway or 
toxicokinetic properties of coco alkyl dimethyl amines in mammalian 
systems. However, based on the knowledge of metabolism of structurally 
similar compounds in mammals, hepatic dealkylation readily occurs with 
secondary and tertiary amines, with the methyl groups leaving 
preferentially. Oxidation of the alpha carbon via cytochrome P450, 
forms a carbinolamine intermediate that will spontaneously cleave to 
form a secondary amine and a carbonyl compound. Subsequent, 
dealkylation of the secondary amine will take place at a slower rate. 
In a more minor pathway, hydroxylation of the nitrogen atom by hepatic 
oxidases may take place. Fatty acids are primarily excreted as 
CO2.

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.
    No acute endpoint of concern was identified in the available 
database, therefore N,N-dimethyl-1-dodecanamine is not expected to pose 
an acute hazard. The chronic reference dose was based on data from co-
critical studies, a 28-day oral toxicity study and a reproduction and 
developmental screening study on N,N-dimethyldodecylamine (CAS Reg. No. 
112-18-5). In the 28-day repeat dose feeding study in rats, all animals 
showed rubbing of the snouts in the bedding material between test days 
2 and 28, immediately after dosing for a duration of approximately 5 
minutes. In a reproduction and developmental screening studies in rats, 
mortality, increased mean implantation loss, decreased mean viability 
index, reduced pup weight and abnormal maternal behavior were observed 
at 150 mg/kg bw/day. The NOAEL was 50 mg/kg bw/day in both studies. The 
uncertainty factor of 1,000X was used for chronic dietary assessment 
(10X for intra-individual variability, 10X for interspecies 
extrapolation and 10X Food Quality Protection Act Safety Factor (FQPA 
SF). No appropriate dermal or inhalation toxicity studies are available 
for the exposure assessment. However, the FQPA SF of 10X is retained 
due to the lack of guideline long-term study(ies) and lack of a 28-day 
inhalation toxicity study. Dermal absorption was assumed to be 60% and 
inhalation absorption is assumed to be 100% oral equivalent. The 
acceptable MOEs for dermal and inhalation exposure are 1,000.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to coco alkyl dimethyl amines, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from coco alkyl dimethyl amines in food as 
follows:
    Because an acute endpoint of concern was not identified, an acute 
dietary exposure assessment is not necessary. In conducting the chronic 
dietary exposure assessment using the Dietary Exposure Evaluation Model 
DEEM-FCID TM, Version 3.16, EPA used food consumption 
information from the U.S. Department of Agriculture's National Health 
and Nutrition Examination Survey, What We Eat in America (NHANES/
WWEIA). This dietary survey was conducted from 2003 to 2008. The Inert 
Dietary Exposure Evaluation Model (I-DEEM) is a highly conservative 
model with the assumption that the residue level of the inert 
ingredient would be no higher than the highest tolerance for a given 
commodity. Implicit in this assumption is that there would be similar 
rates of degradation between the active and inert ingredient (if any) 
and that the concentration of inert ingredient in the scenarios leading 
to these highest of tolerances would be no higher than the 
concentration of the active ingredient. The model assumes 100 percent 
crop treated (PCT) for all crops and that every food eaten by a person 
each day has tolerance-level residues. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    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 coco alkyl dimethyl 
amines, a conservative drinking water concentration value of 100 parts 
per billion (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).

[[Page 41446]]

    Based upon the requested use pattern coco alkyl diethyl amines as 
an emulsifier that aids in the spray application of pesticides, EPA 
does not expect non-occupational (i.e., residential) pesticide handler 
exposures. However, if it is used in pesticide formulations in 
residential setting then it could result in short- and intermediate-
term residential exposure and EPA has determined that it is appropriate 
to aggregate chronic exposure through food and water with short- and 
intermediate-term residential exposures to coco alkyl diethyl amines. 
It is possible that non-dietary exposure (primarily dermal) could occur 
as a result of non-pesticidal uses of coco alkyl dimethyl amines such 
as use in detergents, fabric softeners or anti-static agents. The 
dietary assessment indicates 3.8% of the RfD for the total U.S. 
population and 14.1% for children 1-2 years of age (the population most 
at risk). In light of the highly conservative dietary exposure 
assessment, the relatively low amount of projected dietary exposure 
compared to the RfD, and the primary route for non-dietary exposure 
(dermal), the EPA believes exposure from non-dietary sources will not 
exceed the Agency's level of concern. In addition, the combined dermal 
and inhalation MOEs from possible pesticidal residential uses are in 
the range of 13,000 to 1,666,000.
    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 coco alkyl dimethyl amines to share a common 
mechanism of toxicity with any other substances, and coco alkyl 
dimethyl amines does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has assumed that coco alkyl dimethyl amines does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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. In a reproductive toxicity/
developmental screening study in rats, neither qualitative nor 
quantitative fetal susceptibility was observed. Maternal toxicity 
(mortality and abnormal maternal behavior), developmental and 
reproduction toxicity (increased implantation loss, decreased mean 
viability index, reduced pup weight) effects were observed at the same 
dose, 150 mg/kg bw/day. The NOAEL was 50 mg/kg/day.
    3. Conclusion. EPA has determined that it lacks reliable data to 
apply an additional safety for the protection of infants and children 
lower than 10X. The decision is based on the following findings:
    i. The toxicity database for coco alkyl diethyl amines is 
incomplete. The following acceptable studies are available: 28-day Oral 
toxicity study in rats Reproduction/Developmental Screening study in 
rats.
    EPA has retained a FQPA factor of 10X due to lack of a long term 
study conducted evaluating all current guideline parameters, the 
limited number of animals used in the reproductive/developmental study 
and the lack of an inhalation toxicity study.
    ii. Neurotoxicity and immunotoxicity studies were not available for 
review.
    However, evidence of neurotoxicity or immunotoxicity was not 
observed in the submitted studies. Therefore, an immunotoxicity study 
or a developmental neurotoxicity study is not required at this time.
    iii. There is no evidence that coco alkyl dimethyl amines results 
in increased susceptibility in in utero rats. In a reproductive 
toxicity/developmental screening study in rats, neither qualitative nor 
quantitative fetal susceptibility was observed.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to coco alkyl diethyl amines in drinking water. EPA 
used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by coco alkyl dimethyl amines.
    Given the relatively low toxicity demonstrated by coco alkyl 
dimethyl amines and the very conservative exposure assessment used, EPA 
has determined that, despite the incompleteness of the toxicity 
database, an additional SF of 10X will be protective of infants and 
children.

E. Aggregate Risks and Determination of Safety Determination of Safety 
Section

    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, 
coco alkyl diethyl amines is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
coco alkyl dimethyl amines from food and water will utilize 14.1% of 
the cPAD for children 1-2 years of age, the population group receiving 
the greatest exposure. There are no residential uses for coco alkyl 
dimethyl amines. Based on the explanation in this unit, regarding 
residential use patterns, chronic residential exposure to residues of 
coco alkyl diethyl amines is not expected.
    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

[[Page 41447]]

exposure level). The quantitative short-term aggregate risk assessment 
is not necessary because the total dietary exposure for the U.S. 
population is 3.8% of the cPAD, and any possible short-term residential 
exposure from handler use would not be a significant contributer to 
overall risk nor exceed levels 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). The quantitative intermediate-term aggregate risk assessment is 
not necessary because the total dietary exposure for the U.S. 
population is 3.8% of the cPAD, the Agency believes any possible 
intermediate-term residential exposure from handler use would not be a 
significant contributor to overall risk nor exceed levels of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity, coco alkyl dimethyl amines 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 coco alkyl dimethyl amines 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 
coco alkyl dimethyl amines in or on any food commodities. EPA is 
establishing a limitation on the amount of coco alkyl dimethyl amines 
that may be used in pesticide formulations. The limitation will be 
enforced through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. EPA will not register any pesticide for sale or distribution that 
contains greater than 0.5% of coco alkyl dimethyl amines in the 
pesticide formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for coco alkyl dimethyl amines.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for coco alkyl diethyl amines (CAS 
Reg. No. 61788-93-0) when used as an inert ingredient (emulsifier) in 
pesticide formulations applied pre-harvest to growing crops at a 
maximum not to exceed 0.5% by weight in the final pesticide 
formulation.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 3, 2014.
Lois Rossi,
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:

[[Page 41448]]

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

0
2. In Sec.  180.920, the table is amended by alphabetically adding the 
following inert ingredient after the entry for ``Cis-isomer * * *'' to 
read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Coco alkyl dimethyl amines      Not to exceed 0.5% in   Emulsifier.
 (CAS Reg. No. 61788-93-0).      pesticide formulation.
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2014-16463 Filed 7-15-14; 8:45 am]
BILLING CODE 6560-50-P