Document ID: EPA-HQ-OPP-2012-0106-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Alkyl (C8-C18) dimethylamidopropylamines
Posted Date: 2012-12-06T05:00Z

[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Pages 72747-72752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29106]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0106; FRL-9369-2]

Alkyl(C8-C18) dimethylamidopropylamines; 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the N-alkyl(C8-
C18) dimethylamidopropylamines where the alkyl group is 
linear and may be saturated and/or unsaturated when used as an inert 
ingredient at levels not to exceed 20% in herbicide formulations 
applied to growing crops. Dow AgroSciences, LLC, 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 the N-alkyl(C8-
C18) dimethylamidopropylamines.

DATES: This regulation is effective December 6, 2012. Objections and 
requests for hearings must be received on or before February 4, 2013, 
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-2012-0106, 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: William Cutchin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7990; email address: cutchin.william@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://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0106 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 
February 4, 2013. 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 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

[[Page 72748]]

EPA-HQ-OPP-2012-0106, 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 Confidential Business 
Information (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.htm. 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 May 2, 2012 (77 FR 25957) (FRL-9346-1), 
EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7949) by Dow 
AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The 
petition requested that 40 CFR 180.920 be amended by establishing an 
exemption from the requirement of a tolerance for residues of the N-
alkyl(C8-C18) dimethylamidopropylamines where the 
alkyl group is linear and may be saturated and/or unsaturated (9-
octadecenamide, N-[3-(dimethylamino)propyl]-,(9Z)-, CAS Reg. No. 109-
28-4; dodecanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 3179-80-
4; octadecanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 7651-02-7; 
octanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 22890-10-4; 
decanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 22890-11-5; 
hexadecanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 39669-97-1; 
tetradecanamide, N-[3-(dimethylamino)propyl], CAS Reg. No. 45267-19-4; 
amides, coco, N-[3-(dimethylamino)propyl], CAS Reg. No. 68140-01-2; N-
[3-(dimethylamino)propyl]-C12-C18(even numbered)-
alkylamide, CAS Reg. No. 1147459-12-8; amides, C8-
C18 and C18-unsatd., N-[3-(dimethylamino)propyl], 
CAS Reg. No. 146987-98-6) when used as an inert ingredient at levels 
not to exceed 20% in herbicide formulations applied to growing crops. 
That notice referenced a summary of the petition prepared by Dow 
AgroSciences, LLC, the petitioner, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue * * *.''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the N-alkyl(C8-
C18) dimethylamidopropylamines including exposure resulting 
from the exemption established by this action. EPA's assessment of 
exposures and risks associated with of the N-alkyl(C8-
C18) dimethylamidopropylamines 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 the N-alkyl(C8-
C18) dimethylamidopropylamines 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.

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

[[Page 72749]]

with the POD to calculate a safe exposure level--generally referred to 
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The toxicity database for the N-alkyl(C8-C18) 
dimethylamidopropylamines includes acute toxicity studies, in vitro 
genotoxicity assays and a repeat dose developmental/reproductive 
screening test (OECD 422) toxicity study on a representative N-
alkyl(C8-C18) dimethylamidopropylamine member, 
Amides, coco, N-[3-(dimethylamino) propyl]; CAS Reg. No. 68140-01-2 
(also referred to as CADPMA). The database is augmented by analogue 
information in the public domain and EPA's High Production Volume (HPV) 
program. CAPDMA is included in subcategory 3 of Category I amides 
within the 2004 HPV submission for Fatty Nitrogen Derived Amides class. 
CAPDMA has moderate acute oral toxicity with an LD50 of 300 
milligrams/kilogram/body weight (mg/kg/bw) or greater and is corrosive 
to the skin and eye, respectively. CAPDMA and its broader class of HPV 
analogues are negative for genotoxicity across a series of in vitro 
assays. A combined repeated dose toxicity and reproduction and 
developmental toxicity screening test was conducted in rats with CAPDMA 
via oral gavage under OECD 422 guidelines. No treatment-related effects 
were observed in the reproductive or developmental parameters examined. 
No systemic toxicity was observed in this study. The NOAEL for repeat 
dose toxicity was 15 mg/kg/bw based on localized gastric irritation due 
to the irritation and corrosive nature of the material, typical of 
surfactants seen at the LOAEL of 45 mg/kg/day. The NOAEL for 
reproductive and mg/kg/day developmental toxicity was the highest dose 
tested (HDT), 45 mg/kg/day. CAPDMA was negative for mutagenicity in the 
Ames assay and in vitro mammalian chromosome aberration assay. No 
chronic studies are available for the N-alkyl(C8-
C18) dimethylamidopropylamines but negative findings for 
genotoxicity and no preneoplastic lesions were observed in the OECD 422 
study on CAPDMA that would suggest no potential for carcinogenicity for 
the N-alkyl(C8-C18) dimethylamidopropylamines. 
The Agency used a qualitative structure activity relationship (SAR) 
database, DEREK Version 11, to determine if there were structural 
alerts suggestive of carcinogenicity. No structural alerts were 
identified for the N-alkyl(C8-C18) 
dimethylamidopropylamines Neither IARC nor other authoritative bodies 
have classified the N-alkyl(C8-C18) 
dimethylamidopropylamines as carcinogens based on the SAR analysis, 
negative findings in both the mutagenicity and clastogenicity studies 
along with the lack of evidence of specific target organ toxicity. The 
Agency concluded that these inert ingredients are unlikely to pose a 
cancer risk to humans. No evidence of immunotoxicity or neurotoxicity 
was observed in the available database.
    A summary of the toxicological endpoints for the N-
alkyl(C8-C18) dimethylamidopropylamines used for 
human risk assessment is shown in the Table of this unit.

Table--Summary of Toxicological Doses and Endpoints for the N-alkyl(C8-C18) dimethylamidopropylamines for Use in
                                              Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effect
                                      safety factors       risk assessment
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Acute dietary (General population  No POD identified...  None...............  No endpoint of concern following a
 including infants and children                                                single exposure was identified in
 and Females 13-50 years of age).                                              the data base.
Chronic dietary (All populations)  NOAEL = 15 mg/kg/day  Chronic RfD = 0.15   MRID 48621602 Oral (Gavage)
                                   UFA = 10x...........   mg/kg/day.           Combined Repeat Dose Toxicity
                                   UFH = 10x...........  cPAD = 0.15 mg/kg/    Study with Reproduction/
                                   FQPA SF = 1x........   day..                Developmental Toxicity Screening
                                                                               Test in the Rat, NOAEL 15 mg/kg/
                                                                               day based on localized gastric
                                                                               irritation seen at the LOAEL of
                                                                               45 mg/kg/day.
All Inhalation Exposure Scenarios  NOAEL = 15 mg/kg/day  MOE = 100..........  MRID 48621602 Oral (Gavage)
                                   UFA = 10x...........                        Combined Repeat Dose Toxicity
                                   UFH = 10x...........                        Study with Reproduction/
                                   FQPA SF = 1x........                        Developmental Toxicity Screening
                                   100% inhalation                             Test in the Rat, NOAEL.
                                    absorption is                             15 mg/kg/day based on localized
                                    assumed..                                  gastric irritation seen at the
                                                                               LOAEL as of 45 mk/kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  There is no evidence for carcinogenic concern for the N-alkyl(C8-C18)
                                    dimethylamidopropylamines.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to the N-alkyl(C8-C18) 
dimethylamidopropylamines, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from the N-alkyl(C8-C18) 
dimethylamidopropylamines in food as using the I-Dietary Exposure 
Evaluation Model (I-DEEM). I-DEEM is a highly conservative model that 
is based on the assumption that the residue level of the

[[Page 72750]]

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. Model estimates were 
calculated for oral exposure from the use of the N-alkyl(C8-
C18) dimethylamidopropylamines at a maximum concentration of 
20% in herbicidal formulations for all crops (every food eaten by a 
person each day has tolerance-level residues; D361707, S. Piper, 2/25/
09).
    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 the N-
alkyl(C8-C18) dimethylamidopropylamines 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).
    The N-alkyl(C8-C18) dimethylamidopropylamines 
are not currently used, and are not proposed for use as inert 
ingredients in residential pesticide products. For the general 
population some exposure to the N-alkyl(C8-C18) 
dimethylamidopropylamines could occur via cosmetic use (at very low 
concentrations) including hair care dye kits. There is also potential 
for exposure to these chemicals through the use of personal soaps and 
shampoos. Incidential oral exposure to N-alkyl(C8-
C18) dimethylamidopropylamines resulting from cosmetic uses 
is not expected. Therefore, a quantitative oral risk assessment was not 
conducted. Since reliable data are not available, a quantitative 
dermal/inhalation exposure assessment was not conducted. The current 
dietary risk assessment is highly conservative and protective of any 
uses potential exposure via consumer products because the exposed 
population, children 1-2 years old utilize only 53% of the cPAD leaving 
about 47% of the cPAD for exposure via consumer products.
    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 the N-alkyl(C8-C18) 
dimethylamidopropylamines to share a common mechanism of toxicity with 
any other substances, and the N-alkyl(C8-C18) 
dimethylamidopropylamines do not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that the N-alkyl(C8-
C18) dimethylamidopropylamines 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 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No evidence of developmental 
or reproductive toxicity was observed at doses up to 45 mg/kg/day in 
the Reproduction/Developmental Toxicity Screening Test in Rats (OECD 
422 study). The corrosive nature of these chemicals precluded testing 
at higher doses.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for the N-alkyl(C8-
C18) dimethylamidopropylamines is adequate for FQPA 
assessment. The available data included acute toxicity studies, 
mutagenicity and the Reproduction/Developmental Toxicity Screening Test 
in rats (OECD 422). The available OECD 422 study evaluated reproductive 
parameters and developmental toxicity parameters in rats. In addition, 
it also evaluated hematology, clinical chemistry, organ weights and 
histopathological parameters. No effects on these parameters were 
observed at the HDT.
    ii. No effects on Functional Observation Battery and motor activity 
parameters were observed in the Reproduction/Developmental Toxicity 
Screening Test in rats (OECD 422). Since there is no indication that 
the N-alkyl(C8-C18) dimethylamidopropylamines are 
neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional uncertainty factor to account for 
neurotoxicity.
    iii. There is no evidence that the N-alkyl(C8-
C18) dimethylamidopropylamines result in increased 
susceptibility of infants and children based on the results of the 
Reproduction/Developmental Toxicity Screening Test in rats, in in utero 
rats or rabbits in the prenatal developmental studies.
    iv. There is no evidence of immunotoxicity in the available 
database. Therefore, there is no need for the immunotoxicity study or 
additional uncertainty factor.
    v. Although the duration of exposure was short in the OECD 422 
study, there is no need for an additional uncertainty factor because 
the effects observed were related to local irritation due to corrosive 
nature of these chemicals. Based on the lack of progression of severity 
of effects with time along with the considerable similarities of 
effects across the species tested and the observation that the vast 
majority of the effects observed were related to local irritation and 
corrosive effects, EPA has previously concluded that an additional 
uncertainty factor for extrapolation from subchronic toxicity study to 
a chronic exposure scenario would not be needed for highly irritating 
substances. As a result, the typical 100-fold uncertainty factor is 
sufficiently protective since it is not expected that humans' response 
to local irritation/corrosiveness effects would be markedly different 
based on duration of exposure.
    vi. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments

[[Page 72751]]

were performed using the highly conservative I-DEEM model. EPA also 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to the N-alkyl(C8-
C18) dimethylamidopropylamines in drinking water and with 
regard to potential residential exposures. These assessments will not 
underestimate the exposure and risks posed by the N-
alkyl(C8-C18) dimethylamidopropylamines.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
the N-alkyl(C8-C18) dimethylamidopropylamines 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-alkyl(C8-C18) dimethylamidopropylamines from 
food and water will utilize 16.5% of the cPAD for the general 
population, and 53% of the cPAD for children 1-2 years old, the 
population group receiving the greatest exposure. Based on the 
explanation in Unit IV.C.3., regarding residential use patterns, 
chronic residential exposure to N-alkyl(C8-C18) 
could occur via cosmetic use. While the lack of reliable exposure data 
precluded the ability to perform a quantitative risk assessment for 
these uses, the highly conservative nature of the chronic dietary risk 
assessment would be protective of any uses potential chronic exposure 
via consumer uses.
    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). A short-term 
adverse effect was identified; however, the N-alkyl(C8-
C18) dimethylamidopropylamines are not currently used as an 
inert ingredient in pesticide products that are registered for any use 
patterns that would result in short-term residential exposure. Based on 
the explanation in Unit IV.C.3., regarding residential use patterns, 
short-term residential exposure to N-alkyl(C8-
C18) could occur via cosmetic use. While the lack of 
reliable exposure data precluded the ability to perform a quantitative 
risk assessment for these uses, the highly conservative nature of the 
chronic dietary risk assessment would be protective of any uses 
potential short-term residential exposure via consumer uses, and EPA 
has determined that there are no concerns for short-term aggregate risk 
for the N-alkyl(C8-C18) 
dimethylamidopropylamines.
    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). An intermediate-term adverse effect was identified; however, 
the N-alkyl(C8-C18) dimethylamidopropylamines are 
not currently used as an inert ingredient in pesticide products that 
are registered for any use patterns that would result in intermediate-
term residential exposure. Based on the explanation in Unit IV.C.3., 
regarding residential use patterns, intermediate-term residential 
exposure to N-alkyl(C8-C18) could occur via 
cosmetic use. While the lack of reliable exposure data precluded the 
ability to perform a quantitative risk assessment for these uses, the 
highly conservative nature of the chronic dietary risk assessment would 
be protective of any intermediate-term residential exposure via 
consumer uses and EPA has determined that there are no concerns for 
intermediate-term aggregate risk for the N-alkyl(C8-
C18) dimethylamidopropylamines.
    5. Aggregate cancer risk for U.S. population. Based on the SAR 
analysis, negative findings in both the mutagenicity and clastogenicity 
studies along with the lack of evidence of specific target organ 
toxicity, the Agency concluded that the N-alkyl(C8-
C18) dimethylamidopropylamines are unlikely 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 the N-alkyl(C8-C18) 
dimethylamidopropylamines 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 
the N-alkyl(C8-C18) dimethylamidopropylamines in 
or on any food commodities. EPA is establishing a limitation on the 
amount of the N-alkyl(C8-C18) 
dimethylamidopropylamines that may be used in pesticide formulations. 
That 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 20% of the N-
alkyl(C8-C18) dimethylamidopropylamines by weight 
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 the N-alkyl(C8-
C18) dimethylamidopropylamines.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for the N-alkyl(C8-
C18) dimethylamidopropylamines when used as an inert 
ingredient in herbicide formulations applied to growing crops at levels 
not to exceed 20% of the 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

[[Page 72752]]

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: November 21, 2012.
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:

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

0
2. In Sec.  180.920, alphabetically add the following inert ingredients 
to the table to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
N-alkyl(C8-C18)                    Not to exceed 20%   Surfactants,
 dimethylamidopropylamines where    by weight in        related
 the alkyl group is linear and      herbicide           adjuvants of
 may be saturated and/or            formulations.       surfactants.
 unsaturated (CAS Reg. Nos. 109-
 28-4, 3179-80-4, 7651-02-7,
 22890-10-4, 22890-11-5, 39669-97-
 1, 45267-19-4, 68140-01-2,
 1147459-12-8, 146987-98-6).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2012-29106 Filed 12-5-12; 8:45 am]
BILLING CODE 6560-50-P