[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Rules and Regulations]
[Pages 28616-28624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14113]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0738; FRL-8418-6]


Alkyl Amine Polyalkoxylates; 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 alkyl amine polyalkoxylates when used as 
inert ingredients in pesticide formulations applied to growing crops 
and animals. The Joint Inerts Task Force (JITF), Cluster Support Team 
Number 4 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 alkyl amine polyalkoxylates.

DATES: This regulation is effective June 17, 2009. Objections and 
requests for hearings must be received on or before August 17, 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-2008-0738. 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).

[[Page 28617]]

     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 
(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 EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

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-2008-0738 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 August 17, 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-2008-0738, 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 December 3, 2008 (73 FR 73644) (FRL-
8386-9), 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 
8E7382) by The Joint Inerts Task Force (JITF), Cluster Support Team 
Number 4 (CST 4), c/o CropLife America, 1156 15th Street, NW., Suite 
400, Washington, DC 20005, The petition requested that 40 CFR 180.920 
and 40 CFR 180.930 be amended by establishing exemptions from the 
requirement of a tolerance for residues of the inert ingredient N,N-
Bis-[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl) 
C8-C18 saturated and unsaturated alkylamines; the 
poly(oxy-1,2-ethanediyl) content is 2-60 moles and N,N-Bis-[alpha]-
ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl) 
C8-C18 saturated and unsaturated alkylamines; the 
poly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl) content is 2-60 
moles (these substances are referred to throughout this document as 
alkyl amine polyalkoxylates). That notice referenced a summary of the 
petition prepared by JITF, CST 4, 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.
    This petition was submitted in response to a final rule of August 
9, 2006, (71 FR 45415) in which the Agency revoked, under section 
408(e)(1) of 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 45312 ) 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....''
    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

[[Page 28618]]

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 alkyl 
amine polyalkoxylates when used as inert ingredients in pesticide 
formulations applied to growing crops or food-producing animals. 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.
    Alkyl amine polyalkoxylates are not acutely toxic by the oral and 
dermal routes of exposure, or via inhalation under normal use 
conditions. Concentrated materials are generally corrosive, eye and 
skin irritants and may be dermal sensitizers. There is no evidence that 
alkyl amine polyalkoxylates are neurotoxic, mutagenic, or clastogenic.
    Following subchronic exposure to rats, some gastrointestinal 
irritation was observed, but no specific target organ toxicity or 
neurotoxicity was seen. In subchronic studies in rats and/or dogs, the 
most sensitive effects noted were increased mortality, clinical signs 
(salivation, wheezing, emesis, and/or soft feces), cataracts, cellular 
changes in the stomach, and liver effects characterized by enzyme 
induction, and pigment accumulation in Kupffer cells and bile 
canaliculi. There was no increased susceptibility to the offspring of 
rats following in utero exposure in two prenatal developmental toxicity 
studies. However, there is evidence of increased susceptibility in a 
reproductive screening study in rats.
    Specific information on the studies received and the nature of the 
adverse effects caused by alkyl amine polyalkoxylates 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 Alkyl Amine Polyalkoxylates 
(JITF CST 4 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 10-17 in docket ID 
number EPA-HQ-OPP-2008-0738.

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 alkyl amine 
polyalkoxylates used for human risk assessment is shown in the 
following Table.

    Table--Summary of Toxicological Doses and Endpoints for Alkyl Amine Polyalkoxylates for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)        NOAEL = 72 milligrams/   Acute RfD = 0.72 mg/kg/  90-Day Oral Toxicity
                                        kilograms/day (mg/kg/    day                      Study in Rats LOAEL =
                                        day)                    aPAD = 0.72 mg/kg/day..   216 mg/kg/day based on
                                       UFA = 10x..............                            mortality (2 deaths
                                       UFH = 10x..............                            after 2 exposures;
                                       FQPA SF = 1x...........                            gestation day (GD) 2),
                                                                                          with a total of 6/25
                                                                                          deaths during GD 6-15.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL 15 mg/kg/day       Chronic RfD = 0.15 mg/   90-Day Oral (Gavage)
                                       UFA = 10x..............   kg/day                   Toxicity Study in Rats
                                       UFH = 10x..............  cPAD = 0.15 mg/kg/day..   LOAEL = 30 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                          mortality (2 deaths
                                                                                          (days 36, 78)),
                                                                                          salivation, and
                                                                                          posterior subcapsular
                                                                                          cataracts in males as
                                                                                          well as wheezing, and
                                                                                          macro- and microscopic
                                                                                          changes in the
                                                                                          nonglandular stomach
                                                                                          of both sexes.
----------------------------------------------------------------------------------------------------------------

[[Page 28619]]

 
Incidental oral short-term (1 to 30    NOAEL= 15 mg/kg/day      LOC for MOE = 100        90-Day Oral (Gavage)
 days) and intermediate-term (1 to 6   UFA = 10x..............                            Toxicity Study in Rats
 months)                               UFH = 10x..............                            LOAEL = 30 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                          mortality (2 deaths
                                                                                          (days 36, 78)),
                                                                                          salivation, and
                                                                                          posterior subcapsular
                                                                                          cataracts in males as
                                                                                          well as wheezing, and
                                                                                          macro- and microscopic
                                                                                          changes in the
                                                                                          nonglandular stomach
                                                                                          of both sexes.
----------------------------------------------------------------------------------------------------------------
Dermal and Inhalation (all durations)  Oral study NOAEL = 15    LOC for MOE = 100        90-Day Oral (Gavage)
                                        mg/kg/day (dermal                                 Toxicity Study in Rats
                                        absorption rate = 5%                              LOAEL = 30 mg/kg/day
                                        (inhalation absorption                            based on increased
                                        rate = 100%)                                      mortality (2 deaths
                                       UFA = 10x..............                            (days 36, 78)),
                                       UFH = 10x..............                            salivation, and
                                       FQPA SF = 1x...........                            posterior subcapsular
                                                                                          cataracts in males as
                                                                                          well as wheezing, and
                                                                                          macro- and microscopic
                                                                                          changes in the
                                                                                          nonglandular stomach
                                                                                          of both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment;
                                         Based on SAR analysis, alkyl amine polyalkoxylates are not expected to
                                                                    be carcinogenic.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to alkyl amine polyalkoxylates, EPA considered exposure under 
the petitioned-for exemptions from the requirement of a tolerance. EPA 
assessed dietary exposures from alkyl amine polyalkoxylates in food as 
follows:
    i. Acute and chronic exposure. In conducting the acute and chronic 
dietary exposure assessments, 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 alkyl amine polyalkoxylates. 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 
ingredients. 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 dietary 
exposure and risk assessment can be found at http://www.regulations.gov 
in Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic 
Aggregate (Food and Drinking Water) Dietary Exposure and Risk 
Assessments for the Inerts in docket ID number EPA-HQ-OPP-2008-0738.
    In the 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 percent 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 relative to that of 
the active ingredient. In the case of alkyl amine polyalkoxylates, EPA 
made a specific adjustment to the dietary exposure assessment to 
account for the use limitations of the amount of alkyl amine 
polyalkoxylates that may be in formulations (no more than 25 percent in 
herbicides and no more than 10 percent in fungicides and insecticides) 
and assumed the alkyl amine polyalkoxylates to be present at the 
maximum limitations rather than at equal quantities with the active 
ingredient. This remains a very conservative assumption because 
surfactants are generally used at levels far below these percentages. 
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 percent and that none of the 
surfactants were alkyl amine polyalkoxylates.
    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 percent 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 sum, 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

[[Page 28620]]

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.
    ii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts for potential carcinogenicity of both a 
representative alkyl amine polyalkoxylate, as well as a possible 
metabolite/degradate of alkyl amine polyalkoxylate that had been 
extensively dealkylated, with the amine group intact. No structural 
alerts for carcinogenicity were identified in either case. Alkyl amine 
polyalkoxylates are not expected to be carcinogenic. Therefore a cancer 
dietary exposure assessment is not necessary to assess cancer risk.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for alkyl amine polyalkoxylates. Tolerance 
level residues and/or 100 percent CT 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 alkyl amine polyalkoxylates in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of alkyl amine polyalkoxylates. Further 
information regarding EPA drinking water models used in 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 alkyl amine polyalkoxylates. Modeling runs on four surrogate 
inert ingredients using a range of physical chemical properties that 
would bracket those of the alkyl amine polyalkoxylates 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 document Alkyl Amine 
Polyalkoxylates (JITF CST 4 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 18 and 70-72 in docket ID number EPA-HQ-OPP-2008-0738.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for alkyl amine polyalkoxylates, a conservative drinking 
water concentration value of 100 ppb based on screening level modeling 
was used to assess the contribution to drinking water for both the 
acute and chronic dietary risk assessments. 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). Alkyl amine 
polyalkoxylates are not used as inert ingredients in pesticide products 
that are registered for specific uses that could result in indoor 
residential exposures but may have uses as inert ingredients in 
pesticide products that may result in outdoor residential exposures.
     A screening level residential exposure and risk assessment was 
completed for products containing alkyl amine polyalkoxylates as inert 
ingredients. In this assessment, representative scenarios, based on 
end-use product application methods and labeled application rates, were 
selected. For each of the use scenarios, the Agency assessed 
residential handler (applicator) inhalation and dermal exposure for 
outdoor scenarios with high exposure potential (i.e., exposure 
scenarios with high end unit exposure values) to serve as a screening 
assessment for all potential residential pesticides containing alkyl 
amine polyalkoxylates. Similarly, residential postapplication dermal 
and oral exposure assessments were also performed utilizing high end 
outdoor exposure scenarios. Further details of this residential 
exposure and risk analysis can be found at http://www.regulations.gov 
in document Alkyl Amine Polyalkoxylates (JITF CST 4 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 22-26 and 74-80 in docket ID number EPA-HQ-OPP-
2008-0738.
    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 alkyl amine polyalkoxylates to share a common 
mechanism of toxicity with any other substances, and alkyl amine 
polyalkoxylates do not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that alkyl amine polyalkoxylates 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. The toxicity database 
consists of a rat developmental toxicity study on an alkyl amine 
polyalkoxylate and a rat reproduction study on two different alkyl 
amine polyalkoxylates which covers the range of carbon chain lengths 
and polyalkoxylation within the group. No quantitative or qualitative 
increased susceptibility was demonstrated in the fetuses in the 
prenatal developmental toxicity study in rats following in utero 
exposure. There was some evidence of increased susceptibility in the 
rat reproductive toxicity study (where the offspring NOAEL of 300 ppm 
(12-14

[[Page 28621]]

mg/kg/day) was lower than the parental NOAEL of 1,000 ppm (41-48.6 mg/
kg/day). There are no neurotoxicity studies available for the alkyl 
amine polyalkoxylates; however, there is no indication of neurotoxicity 
in the available toxicity studies.
    Based on the evidence of increased susceptibility in the offspring 
relative to the parents in the rat reproduction study a Degree of 
Concern analysis was performed. The purpose of the Degree of Concern 
analysis was (1) to determine the level of concern for the effects 
observed when considered in the context of all available toxicity data; 
and (2) identify any residual uncertainties after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the risk 
assessment.
    There was no increased susceptibility to the offspring of rats 
following in utero exposure to alkyl amine polyalkoxylates in the 
prenatal development toxicity study. However, there was evidence of 
increased susceptibility in the reproduction toxicity studies in rats. 
Offspring effects include litter loss, increased mean number of 
unaccounted-for implantation sites and decreased mean number of pups 
born, live litter size and postnatal survival from birth to LD 4 (F1) 
at 1,000 ppm for one alkyl amine polyalkoxylate homologue (41-48.6 mg/
kg/day) and at 2,000 ppm (134-148 mg/kg/day) for a second homologue. 
However, the rat reproduction study identified a NOAEL of 300 ppm for 
both homologues (12-14 mg/kg/day and 23-26 mg/kg/day, respectively) for 
offspring effects, and the selected point of departure for the dietary, 
dermal and inhalation risk assessments is protective of these offspring 
effects, thus 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 alkyl amine polyalkoxylates is 
considered adequate for assessing the risks to infants and children 
(the available studies are described in Unit IV.4.D.2. above).
    ii. There is no indication that alkyl amine polyalkoxylates are 
neurotoxic chemicals and thus there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that alkyl amine polyalkoxylates result 
in increased susceptibility in in utero rats in prenatal developmental 
studies. Increased susceptibility of young rats in the 2-generation 
reproduction study was seen, however the selected point of departure 
for the dietary, dermal and inhalation risk assessments is protective 
of these offspring effects, thus there are no residual concerns.
    iv. No chronic studies on alkyl amine polyalkoxylates are 
available, however, there is no need to add additional UFs to account 
for an incomplete toxicity database because the adverse effects 
observed in the available toxicity studies do not seem to increase in 
severity over time (4 weeks to 13 weeks). 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 are related 
to local irritation and corrosive effects, EPA concludes that an 
additional UF for extrapolation from subchronic toxicity study to a 
chronic exposure scenario is not needed.
    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 
percent 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 alkyl amine polyalkoxylates 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 alkyl amine polyalkoxylates.

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.
    In conducting this aggregate risk assessment, the Agency has 
incorporated the petitioner's requested use limitations of alkyl amine 
polyalkoxylates as inert ingredients in pesticide product formulations 
into its exposure assessment. Specifically the petition includes a use 
limitation of alkyl amine polyalkoxylates at not more than 10 percent 
by weight in fungicide and insecticide formulations and at no more than 
25 percent in herbicide formulations.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, and the use limitations of not more than 10 percent 
by weight in fungicide and insecticide formulations and at no more than 
25 percent in herbicide formulations, the acute dietary exposure from 
food and water to alkyl amine polyalkoxylates at the 95th percentile 
for food and drinking water is 16 percent of the aPAD for the U.S. 
population and 44 percent of the aPAD for children 1 to 2 years old, 
the population group receiving the greatest exposure.
    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 of not more than 10 
percent by weight in fungicide and insecticide formulations and at no 
more than 25 percent in herbicide formulations, the chronic dietary 
exposure from food and water to alkyl amine polyalkoxylates is 27 
percent of the cPAD for the U.S. population and 85 percent of the cPAD 
for children 1 to 2 years old, the most highly exposed population 
subgroup.
    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).
    Alkyl amine polyalkoxylates are used as inert ingredients in 
pesticide products that are currently registered for uses that could 
result in short-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term residential exposures to alkyl amine 
polyalkoxylates.
    Using the exposure assumptions described in this unit for short-
term

[[Page 28622]]

exposures, EPA has concluded the combined short-term food, water, and 
residential exposures aggregated result in aggregate MOEs of 156 and 
172, for adult males and females respectively, for a combined high end 
dermal and inhalation handler exposure with a high end post application 
dermal exposure and an aggregate MOE of 90 for children for a combined 
turf dermal exposure with hand-to-mouth exposure. While the MOE for 
short-term aggregate exposure for children is slightly below 100, EPA 
does not consider this MOE to represent a risk of concern for the 
following reasons.
     The hazard assessment for the alkyl amine polyalkoxylates 
is conservative. The PODs used to calculate aggregate risks for alkyl 
amine polyalkoxylates were based on the most toxic surrogate chemical. 
The alkyl amine polyalkoxylates are actually a mixture of compounds, so 
it is likely that the POD is a conservative assessment of toxicity.
     The Agency traditionally considers a level of concern 
(LOC) for these risk assessments to be for an MOE of 100 based on the 
standard 10x inter- and 10x intraspecies extrapolation safety factors. 
However, for alkyl amine polyalkoxylates, the primary toxic effect seen 
is related to the surfactants' inherent function to disrupt cell 
membranes resulting in irritating properties to tissues. Given that a 
significant difference between species for this type of effect is not 
expected, an LOC lower than an MOE of 100 may be appropriate for the 
non-dietary risk assessments.
     The dietary (food and water) portion of the aggregate risk 
assessment is a driver in this aggregate assessment and is considered 
to be highly conservative.
     The highest tolerance level from the surrogate pesticides 
for every food is used adjusted by the limitation in formulation for 
alkyl amine polyalkoxylates specified in the exemption. Estimating 
alkyl amine polyalkoxylates exposure based on the assumption that alkyl 
amine polyalkoxylates will be present at the maximum permitted amount 
in the pesticide products producing the highest possible residue in 
food is very conservative. 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 
contained between 1 and 2.25 percent surfactant, none of which was 
alkyl amine polyalkoxylates.
    100 percent crop treated is assumed for all crops (every 
food eaten by a person each day has tolerance-level residues).
    Many of these high tolerances are based on very short pre-
harvest intervals where there is little time for degradation.
    No consideration was given to potential degradation between 
harvest and consumption (use of tolerance level residues which are 
typically one to two orders of magnitude higher than actual residues 
found in monitoring data).
    No consideration was given to potential reduction in 
residues from washing or cooking.
     The residential portion of the assessment is based on 
high-end application rates and assumes a dermal absorption of 5 percent 
which is a conservative, health protective value.
     Finally, the aggregate assessment assumes that a child 
would receive a high-end dietary exposure with high-end dermal and 
hand-to-mouth exposures concurrently.
    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).
    Alkyl amine polyalkoxylates are used as inert ingredients in 
pesticide products that are currently registered for uses that could 
result in intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with intermediate-term residential exposures to alkyl 
amine polyalkoxylates.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 156 
and 172, for adult males and females respectively, for a combined high 
end dermal and inhalation handler exposure with a high end post 
application dermal exposure and an MOE of 102 for children for a 
combined high end dermal exposure with hand-to-mouth exposure.
    5. 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 alkyl amine polyalkoxylates.

IV. 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 
alkyl amine polyalkoxylates nor have any CODEX Maximum Residue Levels 
been established for any food crops at this time.

V. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of alkyl amine polyalkoxylates when used as an 
inert ingredient in pesticide formulations applied to growing crops or 
to animals.

VI. 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, 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

[[Page 28623]]

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).

VII. 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: June 2, 2009.
 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:

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

0
2. In Sec.  180.920, the table is amended by adding alphabetically the 
new inert ingredients to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-    Not to exceed 25%   Surfactants,
 hydroxypoly(oxy-1,2-ethanediyl)   in herbicide        related adjuvants
 C8-C18 saturated and              formulations and    of surfactants
 unsaturated alkylamines; the      10% in
 poly(oxy-1,2-ethanediyl)          insecticide and
 content is 2-60 moles (CAS Reg.   fungicide
 Nos. 10213-78-2, 25307-17-9,      formulations
 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7,
 61791-14-8, 61791-24-0, 61791-
 26-2, 61791-31-9, 61791-44-4,
 68155-33-9, 68155-39-5, 68155-
 40-8,70955-14-5, 73246-96-5)
                              * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-    Not to exceed 25%   Surfactants,
 hydroxypoly(oxy-1,2-ethanediyl/   in herbicide        related adjuvants
 oxy(methyl-1,2-ethanediyl) C8-    formulations and    of surfactants
 C18 saturated and unsaturated     10% in
 alkylamines; the poly(oxy-1,2-    insecticide and
 ethanediyl/oxy(methyl-1,2-        fungicide
 ethanediyl) content is 2-60       formulations
 moles (CAS Reg. Nos. 68213-26-
 3, 68153-97-9, 75601-76-2)
                              * * * * * * *
------------------------------------------------------------------------

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


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-    Not to exceed 25%   Surfactants,
 hydroxypoly(oxy-1,2-ethanediyl)   in herbicide        related adjuvants
 C8-C18 saturated and              formulations and    of surfactants
 unsaturated alkylamines; the      10% in
 poly(oxy-1,2-ethanediyl)          insecticide and
 content is 2-60 moles (CAS Reg.   fungicide
 Nos. 10213-78-2, 25307-17-9,      formulations
 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7,
 61791-14-8, 61791-24-0, 61791-
 26-2, 61791-31-9, 61791-44-4,
 68155-33-9, 68155-39-5, 68155-
 40-8,70955-14-5, 73246-96-5)
                              * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-    Not to exceed 25%   Surfactants,
 hydroxypoly(oxy-1,2-ethanediyl/   in herbicide        related adjuvants
 oxy(methyl-1,2-ethanediyl) C8-    formulations and    of surfactants
 C18 saturated and unsaturated     10% in
 alkylamines; the poly(oxy-1,2-    insecticide and
 ethanediyl/oxy(methyl-1,2-        fungicide
 ethanediyl) content is 2-60       formulations
 moles (CAS Reg. Nos. 68213-26-
 3, 68153-97-9, 75601-76-2)
                              * * * * * * *
------------------------------------------------------------------------



[[Page 28624]]

[FR Doc. E9-14113 Filed 6-16-09; 8:45 am]
BILLING CODE 6560-50-S