Document ID: EPA-HQ-OPP-2009-0046-0007
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: N-alkyl (C8-C18) Primary Amines and Acetate Salts
Posted Date: 2010-08-18T04:00Z

[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]               
[Page 50891-50896]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-22]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0046; FRL-8836-4]

 
N-alkyl (C8-C18) Primary Amines and Acetate Salts; 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 N-alkyl (C8-C18) primary amines and 
acetate salts where the alkyl group is linear and may be saturated and/
or unsaturated, herein referred to in this document as NAPAAS, when 
used as a surfactant and related adjuvants of surfactants for pre-
harvest and post-harvest uses under 40 CFR 180.910 and application to 
animals under 40 CFR 180.930 at a maximum concentration in formulated 
end-use products of 10% by weight in herbicide products, 4% by weight 
in insecticide products, and 4% by weight in fungicide products. The 
Joint Inerts Task Force (JITF), Cluster Support Team Number 25 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of NAPAAS.

DATES: This regulation is effective August 18, 2010. Objections and 
requests for hearings must be received on or before October 18, 2010, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0046. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Austin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7894; e-mail address: austin.lisa@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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 cite at http://
www.gpoaccess.gov/ecfr. To access the Harmonized Test Guidelines 
referenced in this document electronically, please go to http://
www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2009-0046 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 October 
18, 2010. 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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0046, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

     In the Federal Register of February 4, 2010, (75 FR 5793) (FRL-
8807-5), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP 9E7627) 
by The JITF, Cluster Support Team 25 (CST 25), c/o CropLife

[[Page 50892]]

America, 1156 15th Street, NW., Suite 400, Washington, DC 20005. The 
petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of NAPAAS when used as at surfactant and related adjuvants of 
surfactants in pesticide formulations applied to pre-harvest and post-
harvest crops and animals. These uses are considered inert ingredients 
in pesticide products. The concentration in formulated end-use products 
not to exceed 10% by weight in herbicide products, 4% by weight in 
other pesticidal products. That notice referenced a summary of the 
petition prepared by the JITF, Cluster Support Team Number 25 (CST 25), 
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 section 408(c)(2)(A) of FFDCA, 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 NAPAAS including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with NAPAAS 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 NAPAAS as well as the NOAEL and the 
LOAEL from the toxicity studies are discussed in this unit.
    The available mammalian toxicology database for NAPAAS consists of 
one Harmonized Test Guideline 870.3650 (combined repeated dose toxicity 
study with the reproduction/developmental toxicity screening test in 
rats); acute oral, dermal, and eye toxicity data; and in vitro 
mutagenicity data.
    The NAPAAS are not acutely toxic by the oral route of exposure but 
are corrosive to the skin and are severe eye irritants. There is no 
clear target organ identified for the NAPAAS. In the Harmonized Test 
Guideline 870.3650 study on the representative surfactant, treatment-
related microscopic lesions were observed in both sexes, which included 
histomorphologic changes in the stomach (hyperplasia and hyperkeratosis 
of the squamous mucosa of the forestomach), and erosions, ulcers, 
inflammatory cell infiltrations, and/or edema in the submucosa of the 
forestomach and glandular areas of the mucosa. The accumulation of 
macrophages was most prevalent in the mesenteric lymph nodes and small 
intestine where they were large with an abundant amount of pale foamy 
cytoplasm. In the mesenteric lymph node and liver, coalescence of the 
large macrophages occurred forming microgranulomas. Thymic atrophy was 
observed in both sexes. Histologically, the thymus was smaller due to a 
decrease in the amount of cortical lymphocytes, which may be an 
indirect or secondary phenomenon, as thymic atrophy often occurs in 
animals under stress. No evidence of potential neurotoxicity was 
observed in females, and the reduced motor activity observed in the 
high-dose males was considered to be secondary to the gastrointestinal 
irritation and general malaise and not a neurotoxic effect.
    There was no evidence of increased susceptibility to the offspring 
following prenatal and postnatal (four days) exposure and reproductive 
toxicity was not observed. There is no evidence of mutagenicity or 
carcinogenicity.
    Primary amines and primary amine acetates are biologically 
equivalent and follow the same metabolic pathways of oxidation by 
monoamine oxidases to generate the C8-C10 fatty acid and ammonia. The 
fatty acid would be degraded by well-known pathways ([beta]-oxidation) 
to successive releases of acetic acid, which enters into intermediary 
metabolism or is metabolized ultimately to carbon dioxide and water. 
The CST 25 NAPAAS primary amines and primary amine acetate salt may 
also be conjugated, whether by glucuronidation or sulfonation, and 
excreted directly.
     There are no chronic toxicity studies available for this series of 
surfactants. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK 11, to determine if there were 
structural alerts suggestive of

[[Page 50893]]

carcinogenicity. No structural alerts were identified.
    Specific information on the studies received and the nature of the 
adverse effects caused by the NAPAAS, as well as, the NOAEL and the 
LOAEL from the toxicity studies can be found at http://
www.regulations.gov in the document ``N-Alkyl (C8-C18) Primary Amines 
and Acetate Salts (NAPAAS - JITF CST 25 Inert Ingredients). Health Risk 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations,'' 
pp. 8-12 and 19-22 in docket ID number EPA-HQ-OPP-2009-0046.

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.
     A summary of the toxicological endpoints for NAPAAS used for human 
risk assessment is discussed in Unit IV.A of the final rule published 
in the Federal Register of July 29, 2009, (74 FR 37578) (FRL-8428-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to NAPAAS, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from NAPAAS in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of the NAPAAS inerts were seen in the toxicity databases; 
therefore, an acute exposure assessment for the NAPAAS is not 
necessary.
     ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for the NAPAAS. 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. 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.
    In the dietary exposure assessment, the Agency assumed 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 (if any) between the 
active and inert ingredient 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 Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentration of active ingredient in agricultural products is 
generally at least 50% of the product and often can be much higher. 
Further, pesticide products rarely have a single inert ingredient; 
rather there is generally a combination of different inert ingredients 
used which additionally reduces the concentration of any single inert 
ingredient in the pesticide product in relation to that of the active 
ingredient. In the case of NAPAAS, EPA made a specific adjustment to 
the dietary exposure assessment to account for the use limitations of 
the amount of NAPAAS that may be in formulations (to no more than 10% 
by weight in herbicide products, 4% by weight in insecticide products, 
and 4% by weight in fungicide products) and assumed that the NAPAAS are 
present at the maximum limitation rather than at equal quantities with 
the active ingredient. This remains a very conservative assumption 
because surfactants are generally used at levels far below this 
percentage. For example, EPA examined several of the pesticide products 
associated with the tolerance/commodity combination which are the 
driver of the risk assessment and found that these products did not 
contain surfactants at levels greater than 2.25% and that none of the 
surfactants were NAPAAS.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100% of all foods are treated with the inert 
ingredient at the rate and manner necessary to produce the highest 
residue legally possible for an active ingredient. In summary, EPA 
chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative

[[Page 50894]]

assumptions will lead to a significant exaggeration of actual 
exposures. EPA does not believe that this approach underestimates 
exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK 11, to determine if there were 
structural alerts suggestive of carcinogenicity. No structural alerts 
for carcinogenicity were identified. The Agency has not identified any 
concerns for carcinogenicity relating to the inerts NAPAAS. Therefore a 
cancer dietary exposure assessment is not necessary to assess cancer 
risk.
     iv. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for NAPAAS. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    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 NAPAAS, 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 Agency has reviewed the submitted petition as well as all 
available data on the use of these inert ingredients in pesticide 
formulations, and concludes that the NAPAAS inerts are not used in 
formulations that would be applied in and around the home or in a way 
that would result in residential exposures; therefore, a residential 
exposure risk assessment is not required for the NAPAAS inerts.
    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 NAPAAS to share a common mechanism of toxicity 
with any other substances, and NAPAAS does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that NAPAAS does not have 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. In the case of the NAPAAS, 
there was no increased susceptibility to the offspring of rats 
following prenatal and postnatal exposure in the Harmonized Test 
Guideline 870.3650 reproductive/developmental screening study. 
Decreased pup body weight was observed at 40 and 80 milligrams/
kilogram/day (mg/kg/day) where maternal/paternal toxicity was 
manifested as microscopic lesions in the stomach, jejunum, thymus, and 
lymph nodes at 20, 40, and 80 mg/kg/day. Since the rat reproduction/
developmental study identified a clear NOAEL of 20 mg/kg/day for 
offspring effects, and the selected point of departure of 5 mg/kg/day 
(parental NOAEL for stomach/jejunum/thymus/lymph node lesions) for the 
dietary risk assessment is protective of the offspring effects, there 
are no residual concerns.
    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 NAPAAS inerts is considered 
adequate for assessing the risks to infants and children. The toxicity 
data available on the NAPAAS consists of one Harmonized Test Guideline 
870.3650 combined repeated dose toxicity study with the reproduction/
development toxicity screening test (rat); acute oral, dermal, and eye 
toxicity data; and in vitro mutagenicity data. The Agency noted changes 
in thymus weight and thymus atrophy. However, these were determined to 
be non-specific changes not indicative of immunotoxicity. In addition, 
no blood parameters were affected. Furthermore, these compounds do not 
belong to a class of chemicals that would be expected to be 
immunotoxic. Therefore, these identified effects do not raise a concern 
necessitating an additional uncertainty.
    ii. There is no indication that NAPAAS is a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence that NAPAAS results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The food exposure assessments are considered to be highly 
conservative as they are based on the use of the highest tolerance 
level from the surrogate pesticides for every food and 100 PCT is 
assumed for all crops. EPA made conservative (protective) assumptions 
in the ground water and surface water modeling used to assess exposure 
to NAPAAS 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 NAPAAS.

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-term, 
intermediate-term, 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

[[Page 50895]]

a single oral exposure was identified and no acute dietary endpoint was 
selected. Therefore, NAPAAS 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 
NAPAAS from food and water will utilize 106% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for NAPAAS.
    3. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to NAPAAS.
    4. Determination of safety. EPA notes that the risk for children is 
slightly above a cPAD of 100%. The dietary exposure estimates overstate 
dietary risk because it assumes that the NAPAAS are present at the 
maximum limitation (10% by weight in herbicide products, 4% by weight 
in insecticide products, and 4% by weight in fungicide products) 
because surfactants are generally used at levels far below these 
percentages. EPA examined several of the pesticide products associated 
with the tolerance/commodity combinations which are the drivers of the 
risk assessment and found that these products did not contain 
surfactants at levels greater than 2.25% and that none of the 
surfactants were NAPAAS. Therefore, given the exceptionally 
conservative nature of the exposure assessment, EPA believes that 
actual risks are significantly lower and are not of concern. Based on 
this risk assessment, 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 NAPAAS residues.

V. Other Considerations

A. Analytical Enforcement Methodology

     EPA is establishing a limitation on the amount of NAPAAS that may 
be used in end-use 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 a maximum concentration in formulated end-use products of 
NAPAAS greater than 10% by weight in herbicide products, 4% by weight 
in insecticide products, and 4% by weight in fungicide products.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
NAPAAS nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 40 CFR 180.930 for N-alkyl (C8-
C18) primary amines and acetate salts where the alkyl group is linear 
and may be saturated and/or unsaturated when used as an inert 
ingredient (surfactant and related adjuvants of surfactants) in 
pesticide formulations applied to pre-harvest and post-harvest crops 
and animals at a maximum concentration in formulated end-use products 
of 10% by weight in herbicide products, 4% by weight in insecticide 
products, and 4% by weight in fungicide products.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: August 9, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 50896]]

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

0
2. In Sec. 180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.910  N-alkyl (C8-C18) primary amines and accetate salts; 
Exemption from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
N-alkyl (C8-C18) primary amines   Concentration in    Surfactants,
 and their acetate salts where     formulated end-     related adjuvants
 the alkyl group is linear and     use products not    of surfactants
 may be saturated and/or           to exceed 10% by
 unsaturated (CAS Reg. Nos.        weight in
 61790-57-6, 61790-58-7, 61790-    herbicide
 59-8, 61790-60-1, 61788-46-3,     products, 4% by
 61790-33-8, 68155-38-4)           weight in
                                   insecticide
                                   products, and 4%
                                   by weight in
                                   fungicide
                                   products.
                              * * * * * * *
------------------------------------------------------------------------

0
3. In Sec. 180.930, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.930  N-alkyl (C8-C18) primary amines and accetate salts; 
Exemption from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
N-alkyl (C8-C18) primary amines   Concentration in    Surfactants,
 and their acetate salts where     formulated end-     related adjuvants
 the alkyl group is linear and     use products not    of surfactants
 may be saturated and/or           to exceed 10% by
 unsaturated (CAS Reg. Nos.        weight in
 61790-57-6, 61790-58-7, 61790-    herbicide
 59-8, 61790-60-1, 61788-46-3,     products, 4% by
 61790-33-8, 68155-38-4)           weight in
                                   insecticide
                                   products, and 4%
                                   by weight in
                                   fungicide
                                   products.
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-20300 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S