Phosphate Ester, Tallowamine, Ethoxylated; Exemption from the Requirement of a Tolerance, 22234-22240 [2010-9834]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22234-22240]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9834]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0165; FRL-8816-4]


Phosphate Ester, Tallowamine, Ethoxylated; 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 phosphate ester, tallowamine, 
ethoxylated (CAS Reg. No. 68308-48-5), herein referred to in this 
document as PETAE when used as an inert ingredient at a maximum of 20% 
by weight in pesticide formulations applied in or on growing crops. 
Huntsman Corporation submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of PETAE.

DATES: This regulation is effective April 28, 2010. Objections and 
requests for hearings must be received on or before June 28, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0165. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available,

[[Page 22235]]

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 https://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: Alganesh Debesai, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address: 
debesai.alganesh@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines 
referenced in this document electronically, please go to https://www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2009-0165 in the subject line on the first page of 
your submission. All objections and requests for a hearing must be in 
writing, and must be received by the Hearing Clerk on or before June 
28, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0165, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of April 8, 2009 (74 FR 15975) (FRL-8407-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 8E7477) by 
Huntsman Corporation, 8600 Gosling Road, Woodlands, TX 77381. The 
petition requested that 40 CFR 180.920 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 
tallowamine, ethoxylated, mixture of dihydrogen phosphate and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
potassium, and sodium salts of the phosphate esters, where the 
poly(oxyethylene) content averages 2-20 moles, (CAS Reg. No. 68308-48-
5) when used as an inert ingredient as surfactants, related adjuvants 
of surfactants in pesticide formulations applied to growing crops at a 
maximum of 20% by weight in pesticide formulations. That notice 
referenced a summary of the petition prepared by Huntsman Corporation, 
the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is

[[Page 22236]]

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by PETAE as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of PETAE. The Agency's full 
decision document for this action is available in the Agency's 
electronic docket (regulations.gov) under the docket number EPA-HQ-OPP-
2009-0165. The database on PETAE is limited, however, the Agency has 
determined that studies on alkyl amine polyalkoxylates (AAPs) can be 
used to asses the toxicity of the PETAE because PETAE is a phosphate 
ester form of AAPs. The Agency has recently evaluated AAPs in docket ID 
number EPA-HQ-OPP-2008-0738.
    PETAE is not acutely toxic via oral, dermal, and inhalation routes 
of exposure. It is extremely irritating to the eyes and slightly 
irritating to the skin. It is not a dermal sensitizer. In a Combined 
Repeated Dose Toxicity Study with the Reproduction/Developmental 
Toxicity Screening Test, clinical signs of toxicity (abnormal 
respiratory sounds, dyspnea, piloerection, and emaciation), mortality 
and decreased food consumptions and decreased in body weights were 
observed in parental animals at 200 milligrams/kilogram/day (mg/kg/
day). The clinical signs observed in this study are indicative of local 
irritation. No effects on functional observation battery (FOB) 
parameters were observed. The gestation index was decreased primarily 
due to mortality of females. Decreased in corpora lutea and 
implantation sites were observed at the highest dose tested (200 mg/kg/
day). Decrease in pups' body weight gain was observed on day 4 at the 
high dose only. No mutagenicity studies are available in the database; 
however, there was no evidence that AAPs are mutagenic or clastogenic. 
There are no chronic toxicity or carcinogenicity studies available in 
the database. There is no evidence that the AAPs are carcinogenic. The 
Agency used a qualitative structure activity relationship (QSAR) 
database, DEREK11, to determine if there were structural alerts for a 
representative large molecule, as well as a smaller molecule that had 
been extensively dealkylated, with the amine group intact. No 
structural alerts were identified. Therefore, there are no triggers for 
carcinogenicity of PETAE in the database.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for PETAE used for human 
risk assessment is shown in the following table:

             Summary of Toxicological Doses and Endpoints for PETAE for Use in Human Risk Assessment
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                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                               No appropriate endpoints were identified for acute dietary risk
(General population including infants                                  assessment.
 and children).
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[[Page 22237]]

 
Chronic dietary                        NOAEL = 100 mg/kg/day    Chronic RfD = 1 mg/kg/   OECD 422 Reproduction/
(All populations)....................  UFA = 10x..............   day                      Developmental Screen
                                       UFH = 10x..............  cPAD = 0.33 mg/kg/day..   in rats (MRID
                                       FQPA SF = 3x...........                            47600707)
                                                                                         LOAEL = 200 mg/kg/day
                                                                                          based on mortalities,
                                                                                          clinical signs,
                                                                                          decreased body weight
                                                                                          and/or body weight
                                                                                          gain and decreased
                                                                                          food consumption in
                                                                                          both sexes
                                                                                         CAS 7664-38-2
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term and         NOAEL= 100 mg/kg/day     Residential/             OECD 422 Reproduction/
 Intermediate-Term Dermal and          UFA = 10x..............   Occupational LOC for     Developmental Screen
 Inhalation                            UFH = 10x..............   MOE = 300                in rats (MRID
                                       FQPA SF = 3x...........                            47600707)
                                       (10% Dermal absorption;                           LOAEL = 200 mg/kg/day
                                        100% inhalation and                               based on mortalities,
                                        oral toxicity assumed                             clinical signs,
                                        equivalent).                                      decreased body weight
                                                                                          and/or body weight
                                                                                          gain and decreased
                                                                                          food consumption in
                                                                                          both sexes
                                                                                         CAS 7664-38-2
----------------------------------------------------------------------------------------------------------------
Cancer                                    Classification: No animal toxicity data available for an assessment.
(Oral, dermal, inhalation)...........       Based on SAR analysis, PETAE is not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to PETAE, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from PETAE in food as follows:
    i. Acute exposure. No adverse effect attributable to a single 
exposure of the PETAE was seen in the toxicity databases; therefore, an 
acute dietary exposure assessment for the PETAE was not conducted.
    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 PETAE. 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 https://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 are 
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 the PETAE, EPA made a specific adjustment to 
the dietary exposure assessment to account for the use limitations of 
the amount of PETAE that may be in formulations (no more than 20% by 
weight in pesticide formulations) and assumed that the PETAE are 
present at the maximum limitation rather than at equal quantities with 
the active ingredient. This remains a very conservative assumption 
because surfactants are generally used at levels far below this 
percentage.
    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

[[Page 22238]]

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, and 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 QSAR database, DEREK11, to determine 
if there were structural alerts suggestive of carcinogenicity. No 
structural alerts for carcinogenicity were identified. Therefore, a 
quantitative dietary exposure assessment was not conducted for the 
purpose of evaluating cancer risk.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for PETAE, a conservative 
drinking water concentration value of 100 parts per billion (ppb) based 
on screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound. These values were directly entered into the dietary exposure 
model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). PETAE may be used in 
inert ingredients in pesticide products that are registered for 
specific uses that may result in both indoor and outdoor residential 
exposures.
     A screening level residential exposure and risk assessment was 
conducted for products containing the PETAE as inert ingredients. In 
this assessment, the Agency selected representative scenarios, based on 
end-use product application methods and labeled application rates. The 
residential products are typically formulated as liquids in 
concentrates or as wettable powders. PETAE has no pesticidal 
properties, and is added to pesticide formulations for its adjuvant 
property. PETAE is not generally added to any pesticides intended for 
indoor use (i.e., where the Agency would typically assess crack and 
crevice/pet uses). Therefore, EPA assumed no indoor uses exist. 
Similarly, residential post application dermal and oral exposure 
assessments were also performed utilizing high end indoor and outdoor 
exposure scenarios. Further details of this residential exposure and 
risk analysis can be found at https://www.regulations.gov in the 
memorandum entitled ``JITF Inert Ingredients. Residential and 
Occupational Exposure Assessment Algorithms and Assumptions Appendix 
for the Human Health Risk Assessments to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide Formulations'' (D364751, 5/7/09, Lloyd/LaMay) in docket ID 
number EPA-HQ-OPP-2008-0710.
    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 PETAE to share a common mechanism of toxicity 
with any other substances, and PETAE does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that PETAE does not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at https://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 PETAE, there 
was no increased susceptibility to the offspring of rats following 
prenatal and postnatal exposure in the OPPTS Harmonized Test Guideline 
870.3650 reproductive/developmental screening study. Decreased litter 
size and body weight gain in pups was observed at 200 mg/kg/day where 
maternal/paternal toxicity was manifested based on mortalities, 
clinical signs, decreased body weight and/or body weight gain and 
decreased food consumption in male and female rats at 200 mg/kg/day. 
There is no concern for residual uncertainties because clear NOAELs 
were established for parental and offspring toxicities.
    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 3X. That decision is based on the following 
findings:
    i. The toxicity data available on the PETAE consists of one OPPTS 
Harmonized Test Guideline 870.3650 combined repeated dose toxicity 
study with the reproduction/development toxicity screening test (rat); 
acute oral, dermal, inhalation skin irritation and sensitization, and 
eye toxicity data. The other studies were bridged from AAPs since PETAE 
is a phosphate ester form of AAPs which have been recently assessed by 
the Agency in docket ID number EPA-HQ-OPP-2008-0738. There was no 
evidence of immunotoxicity in the database. Furthermore, these 
compounds do not belong to a class of chemicals that would be expected 
to be immunotoxic and, there was no evidence that the AAPs are 
mutagenic or clastogenic.
    ii. No quantitative or qualitative increased susceptibility was 
demonstrated in the offspring in the OPPTS Harmonized Test Guideline

[[Page 22239]]

870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats following prenatal and 
postnatal exposure.
    iii. There are no chronic studies or carcinogenicity studies are 
available in the database. EPA has considerable information on the 
general toxicity of surfactants. These compounds are shown to cause 
local irritation and corrosive effects on membrane. EPA recently 
assessed the toxicity of AAPs. PETAE is a phosphate ester form of AAPs. 
The database on AAPs indicates that the effects do not 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 were related 
to local irritation and corrosive effects, EPA concludes that chronic 
data are unlikely to show significant differences from existing 
studies. In addition, the concern for chronic effects for PETAE is low 
based on SAR, DEREK11 analysis and available data on AAPs. Based on the 
above evidence, EPA concluded that the FQPA factor of 3X for the lack 
of chronic studies would be adequate and protective.
    iv. No treatment-related effects on FOB parameters were observed in 
the OPPTS Harmonized Test Guideline 870.3650. In addition, no evidence 
of treatment-related clinical signs of neurotoxicity were observed in 
the available toxicological studies. EPA concluded that 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 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 PETAE in drinking water. These assessments will 
not underestimate the exposure and risks posed by PETAE. Based on the 
above considerations, EPA has reduced the FQPA factor to 3X.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure. Short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
the estimated aggregate food, water, and residential exposure to the 
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified, and no acute dietary endpoint was selected. Therefore, 
PETAE is 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 of not more than 20% by 
weight in pesticide formulations, the chronic dietary exposure from 
food and water to PETAE is 23.2% of the cPAD for the U.S. population 
and 75.6% 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).
    PETAE is currently used as an inert ingredient in pesticide 
products that are 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 PETAE.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,040 and 1,147 
for adult males and females, respectively. Adult residential exposure 
combines high end dermal and inhalation handler exposure from indoor 
hand wiping with a high end post-application dermal exposure from 
contact with treated lawns. EPA has concluded the combined short-term 
aggregated food, water, and residential exposures result in an 
aggregate MOE of 600 for children. Children's residential exposure 
includes total exposures associated with contact with treated lawns 
(dermal and hand-to-mouth exposures). Because EPA's level of concern 
for PETAE is a MOE of 300 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    PETAE is currently used as an inert ingredient in pesticide 
products that are 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 PETAE.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 1,040 and 1,147 for adult males and females, 
respectively. Adult residential exposure includes high end post 
application dermal exposure from contact with treated lawns. EPA has 
concluded the combined intermediate-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 680 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated lawns (dermal and hand-to-mouth exposures). 
Because EPA's LOC for PETAE is a MOE of 300 or below, these MOEs are 
not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to PETAE.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to PETAE residues.

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 
PETAE

[[Page 22240]]

nor have any CODEX Maximum Residue Levels (MRLs) been established for 
any food crops at this time.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for PETAE (CAS Reg. No. 68308-48-5) 
when used as an inert ingredient (as surfactants, related adjuvants of 
surfactants) in pesticide formulations applied to growing crops at a 
maximum of 20% by weight in pesticide formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: April 15, 2010.
G. Jeffrey Herndon,
Acting 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 
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
------------------------------------------------------------------------
                                * * * * *
Tallowamine, ethoxylated,         Not to exceed 20%   Surfactants,
 mixture of dihydrogen phosphate   of pesticide        related adjuvants
 and monohydrogen phosphate        formulation         of surfactants
 esters and the corresponding
 ammonium, calcium, potassium,
 and sodium salts of the
 phosphate esters, where the
 poly(oxyethylene) content
 averages 2-20 moles (CAS Reg.
 No. 68308-48-5)
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 2010-9834 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S