[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37578-37584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18076]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0046; FRL-8428-9]


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 inert ingredients for pre-harvest uses 
under 40 CFR 180.920 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 (CST 25), 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting 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 July 29, 2009. Objections and 
requests for hearings must be received on or before September 28, 2009, 
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: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     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 to 
provide 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

[[Page 37579]]

(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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the Federal 
Register listings at http://www.epa.gov/fedrgstr. You may also 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 OPPTS Harmonized Guidelines referenced in this 
document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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. 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 requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before September 28, 2009.
    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 this copy, 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. Background

    In the Federal Register of March 4, 2009 (74 FR 9397) (FRL-8401-8), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7519) 
by The Joint Inerts Task Force (JITF), Cluster Support Team 25 (CST 
25), c/o CropLife America, 1156 15th Street, N.W., Suite 400, 
Washington, DC 20005. The petition requested that 40 CFR 180.920 be 
amended by establishing exemptions from the requirement of a tolerance 
for residues of the inert ingredients N-alkyl (C8-
C18) primary amines and acetate salts where the alkyl group 
is linear and may be saturated and/or unsaturated (NAPAAS). 
Concentration in formulated end-use products not to exceed 8% by weight 
in herbicide products, 5% by weight in insecticide products, and 30% by 
weight in fungicide products. That notice referenced a summary of the 
petition prepared by JITF, CST 25, the petitioner, which is available 
to the public 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 
modified the exemption requested by changing the use limitations in 
pesticide products as follows: 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. These 
limitations are based on the Agency's risk assessment which can be 
found at http://www.regulations.gov, in document N-alkyl 
(C8-C18) Primary Amines and Acetate Salts (NAPAAS 
- JITF CST 25 Inert Ingredients). Human Health Risk Assessment to 
Support Proposed Exemption from the Requirement of a Tolerance When 
Used as Inert Ingredients in Pesticide Formulations, in docket ID 
number EPA-HQ-OPP-2009-0046.
    This petition was submitted in response to a final rule of August 
9, 2006 (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under 
section 408(e)(1) of the FFDCA, the existing exemptions from the 
requirement of a tolerance for residues of certain inert ingredients 
because of insufficient data to make the determination of safety 
required by FFDCA section 408(b)(2). The expiration date for the 
tolerance exemptions subject to revocation was August 9, 2008, which 
was later extended to August 9, 2009 (73 FR 45311) (FRL-8372-7) to 
allow for data to be submitted to support the establishment of 
tolerance exemptions for these inert ingredients prior to the effective 
date of the tolerance exemption revocation.

 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(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of 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....''

[[Page 37580]]

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 petitioned-for 
exemption from the requirement of a tolerance for residues of NAPAAS 
provided that the concentration of the NAPAAS inerts are limited in 
formulated end-use product to no more than 10% by weight in herbicide 
products, 4% by weight in insecticide products, and 4% by weight in 
fungicide products. EPA's assessment of exposures and risks associated 
with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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.
    The available mammalian toxicology database for NAPAAS consists of 
one OPPTS Harmonized 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.
    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 NAPAAS inert compounds. In the OPPTS 
Harmonized 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 the 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-C18 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 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 no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document N-alkyl (C8-C18) 
Primary Amines and Acetate Salts (NAPAAS - JITF CST 25 Inert 
Ingredients). Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations at pp. 8-12 and pp. 19-22 in 
docket ID number EPA-HQ-OPP-2009-0046.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 the NAPAAS used for 
human health risk assessment is shown in Table 1. below:

[[Page 37581]]



  Table 1.--Summary of Toxicological Doses and Endpoints for the NAPAAS for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                              factors\1\               assessment                effects
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Acute dietary (all populations)           No appropriate endpoint was identified for acute dietary assessment
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 5 mg/kg/day       Chronic RfD = 0.05 mg/   OPPTS harmonized
                                       UFA = 10x..............   kg/day                   guideline 870.3650
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..   reproduction/
                                       FQPA SF = 1x...........                            developmental screen
                                                                                          in rats
                                                                                         LOAEL = 20 mg/kg/day,
                                                                                          based on microscopic
                                                                                          lesions in the
                                                                                          stomach, jejunum,
                                                                                          thymus, and lymph
                                                                                          nodes in both sexes
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Incidental oral short- (1-30 days)     Oral NOAEL= 5 mg/kg/day  Residential LOC for MOE  OPPTS harmonized
 and intermediate term (1-6 months)    UFA = 10x..............   = 100                    guideline 870.3650
                                       UFH = 10x..............                            reproduction/
                                       FQPA SF = 1x 5% dermal                             developmental screen
                                        and 100% inhalation                               in rats
                                        absorption assumed.                              LOAEL = 20 mg/kg/day,
                                                                                          based on microscopic
                                                                                          lesions in the
                                                                                          stomach, jejunum,
                                                                                          thymus, and lymph
                                                                                          nodes in both sexes
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                          Based on SAR analysis, the NAPAAS are not expected to be carcinogenic
----------------------------------------------------------------------------------------------------------------
\1\Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response
  data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a = acute, c = chronic). FQPA SF = FQPA safety factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to the NAPAAS, EPA considered exposure under the petitioned-
for 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 
concentrations 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 (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. The Agency does not expect that allowing a maximum of 10% 
in the final formulation for herbicides only will have a significant 
impact on the dietary exposure. Across the board it appears that 
selecting the highest fungicide tolerance and correcting for its 
limitation to 4% by weight as a maximum in the final formulation, 
results in a higher residue input into the dietary risk assessment than 
selecting the highest herbicide tolerance and correcting for 10% by 
weight as a maximum in the final formulation. 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

[[Page 37582]]

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 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 SAR database, DEREK11, 
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% 
crop treated were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for NAPAAS in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of NAPAAS. Further information regarding EPA drinking 
water models used in the pesticide exposure assessment can be found at 
http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide 
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was 
performed to calculate the estimated drinking water concentrations 
(EDWCs) of NAPAAS. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of the NAPAAS were conducted. Modeled acute drinking water values 
ranged from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic 
drinking water values ranged from 0.0002 ppb to 19 ppb. Further details 
of this drinking water analysis 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). Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations at pp. 13 and 25-27 in docket ID 
number EPA-HQ-OPP-2009-0046.
    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 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 compounds and for the metabolites of concern. 
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., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    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 necessary 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 do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that NAPAAS do not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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 post-natal exposure in the OPPTS Harmonized 
Guideline 870.3650 reproductive/developmental screening study. 
Decreased pup body weight was observed at 40 and 80 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

[[Page 37583]]

the NAPAAS consists of one OPPTS Harmonized 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. No quantitative or qualitative increased susceptibility was 
demonstrated in the offspring in the OPPTS Harmonized Guideline 
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats following prenatal and 
postnatal exposure.
    iii. Although the available mammalian toxicity database does not 
include any chronic toxicity data, the effects observed in the parental 
animals following gavage dosing are mainly portal-of-entry effects 
(stomach irritation), and gavage dosing is not a relevant exposure 
condition in humans. The effects observed would not be expected to 
occur at a lower dose with increased duration of exposure under 
relevant exposure conditions. Also, based on the very conservative 
exposure assessment, the 10X interspecies and 10X intraspecies 
uncertainty factor would be adequately protective, and no additional 
uncertainty factor is needed for extrapolating from subchronic to 
chronic exposure.
    iv. No neurotoxicity was demonstrated in the OPPTS Harmonized 
Guideline 870.3650 study. Thus, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    v. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. 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% 
crop treated is assumed for all crops. EPA also made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to NAPAAS in drinking water. These assessments will 
not underestimate the exposure and risks posed by NAPASS.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded. No residential 
aggregate exposure assessment was conducted because no residential uses 
for NAPAAS are anticipated. Therefore, the aggregate risk for these 
inerts includes exposures through food and drinking water only.
    1. Acute risk. There was no hazard attributable to a single 
exposure seen in the toxicity database for NAPAAS. Therefore, the 
NAPAAS are not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water using the exposure assumptions discussed in this unit 
for chronic exposure and the use limitations to no more than 4% in 
fungicide and insecticide formulations and 10% in herbicide 
formulations, the chronic dietary exposure from food and water to 
NAPAAS is 36% of the cPAD for the U.S. population and 106% of the cPAD 
for children 1-2 yrs old, the most highly exposed population subgroup. 
While the Agency notes that the risk for children is slightly above a 
cPAD of 100%, given the exceptionally conservative nature of the 
exposure assessment detailed above, the Agency believes that actual 
risks are significantly lower and are not of concern.
    3. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to NAPAAS.
    4. 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 residues of NAPAAS.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation..

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
NAPAAS nor have any CODEX maximum residue levels been established for 
any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established 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 when used as inert ingredients for 
pre-harvest uses under 40 CFR 180.920 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 tolerances 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,

[[Page 37584]]

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: July 21, 2009.
G. Jeffrey Herndon,
 Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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, the table is amended by adding alphabetically the 
following inert ingredient 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) 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. E9-18076 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S