Federal Register, Volume 74 Issue 144 (Wednesday, July 29, 2009)

[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37571-37578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18033]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0131; FRL-8424-6]

Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives;
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of alkyl alcohol alkoxylate phosphate
derivatives when used as inert ingredients in growing crops under 40
CFR 180.920 and for residues of alkyl alcohol alkoxylate sulfate
derivatives when used as inert ingredients in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals under 40 CFR 180.910 and 40 CFR 180.930. The Joint Inerts
Task Force (JITF), Cluster Support Team Number 2 (CST 2) 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 alcohol alkoxylate phosphate and sulfate
derivatives.

DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0131. 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: leifer.kerry @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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(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 part180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0131 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 28, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0131, 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 April 15, 2009 (74 FR 17487) (FRL-8409-
7), 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
9E7533) by JITF, CST 2, c/o CropLife America, 1156 15\th\ St., NW.,
Suite 400, Washington, DC 20005, The petition requested that 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930 be amended by establishing
exemptions from the

[[Page 37572]]

requirement of a tolerance for residues of various alkyl alcohol
alkoxylate phosphate and sulfate derivatives when used as inert
ingredients in pesticide formulations applied to raw agricultural
commodities, growing crops, and animals. The petition specifically
requested the establishment of an exemption from the requirement of a
tolerance under 40 CFR 180.920 for residues of [alpha]-alkyl (minimum
C6 linear, branched, saturated and/or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer with or without polyoxypropylene,
mixture of di- and monohydrogen phosphateesters and the corresponding
ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethylene content is 2
moles; minimum oxypropylene content is 0 moles (Chemical Abstract
Service Registry numbers (CAS Nos.) 9046-01-9, 39464-66-9, 50643-20-4,
52019-36-0, 68071-35-2, 68458-48-0, 68585-36-4, 68815-11-2, 68908-64-5,
68511-37-5,68130-47-2, 42612-52-2, 58318-92-6, 60267-55-2, 68070-99-5,
68186-36-7, 68186-37-8, 68610-65-1, 68071-17-0, 936100-29-7, 936100-30-
0, 73038-25-2, 78330-24-2, 154518-39-5, 317833-96-8, 108818-88-8,
873662-29-4, 61837-79-4, 68311-02-4, 68425-73-0, 37280-82-3, 68649-29-
6, 67711-84-6, 68891-13-4); and the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.910 and 40 CFR 180.930
for residues of [alpha]-alkyl(C6-C15)-[omega]-
hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium,
potassium, sodium, and zinc salts, poly(oxyethylene) content averages
2-4 moles (CAS Nos. 9004-82-4, 68585-34-2, 68891-38-3, 9004-84-6,
13150-00-0, 26183-44-8, 68611-55-2, 68511-39-7, 3088-31-1, 9004-82-4,
25446-78-0, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0, 73665-22-
2). For ease of reading, the alkyl alcohol alkoxylate phosphate and
sulfate derivatives are referred to throughout this document as AAAPDs
and AAASDs respectively, and collectively as AAAPSDs. That notice
referenced a summary of the petition prepared by JITF, CST 2, 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, which also included a limitation of the
concentration of alkyl alcohol alkoxylate phosphate and sulfate
derivatives to not exceed 30% by weight of the pesticide formulation,
was submitted in response to a final rule of August 9, 2006 (71 FR
45415) (FRL-8084-1) in which the Agency revoked, under FFDCA section
408(e)(1) 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, by a document published in the Federal Register issue of August
4, 2008 (73 FR 45312) (FRL-8372-7) to allow for data to be submitted to
support the establishment of tolerance exemptions for these inert
ingredients prior to the effective date of the tolerance exemption
revocation.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide chemical residues. First, EPA
determines the toxicity of pesticide chemicals. Second, EPA examines
exposure to the pesticide chemical through food, drinking water, and
through other exposures that occur as a result of the pesticide
chemical use in residential settings.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 AAAPSDs when used
as inert ingredients in pesticide formulations applied to growing
crops, raw agricultural commodities and 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.
The AAAPSDs are not acutely toxic by the oral and dermal routes of
exposure under normal use conditions; however, concentrated materials
are generally moderate to severe eye and skin irritants and may be skin
sensitizers. Following subchronic exposure to rats, gastrointestinal
irritation (increased incidences of hyperplasia, submucosal edema, and
ulceration) was observed, but no specific target organ toxicity or
neurotoxicity was seen. No neurotoxicological effects were detected in
a functional observational battery or a motor activity assessment. No
reproductive effects were noted in the database. There was a
qualitative increase in susceptibility to pups seen in a rat
developmental/reproductive toxicity screening study; however, effects
were seen only in one study and were in the presence of maternal
toxicity. Further, a clear no-observed-adverse-effect-level (NOAEL) was

[[Page 37573]]

established for the developmental effects and this NOAEL is
significantly higher than the toxicological points of departure
selected for risk assessment. There are no carcinogenicity concerns
based on structure activity modeling. Points of departure for chronic
dietary, incidental oral, inhalation, and dermal exposure were selected
from a 2-generation reproduction and fertility effects study in rats.
The endpoint was decreased absolute and relative liver weights and
increased incidence in the number of animals with minimal hepatocyte
necrosis in males.
Sufficient data were provided on the chemical identity of the
AAAPSDs; however, limited data are available on the metabolism and
environmental degradation of these compounds. The Agency relied
collectively on information provided on the representative chemical
structures, the submitted physicochemical data, structure activity
relationship (SAR) information, as well as information on other
surfactants and chemicals of similar size and functionality to
determine the residues of concern for the AAAPSDs. The Agency has
concluded that since metabolites and environmental degradates are not
likely to be more toxic than the parent compounds, a risk assessment
based on the parent compounds is not likely to underestimate risk.
Specific information on the studies received and the nature of the
adverse effects caused by the AAAPSDs as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document Alkyl Alcohol
Alkoxylate Phosphate and Sulfate Derivatives (AAAPDs and AAASDs--JITF
CST 2 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide, pages 11-17 in docket ID number EPA-HQ-
OPP-2009-0131.

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 AAAPSDs used for human
risk assessment is shown in Table 1 of this unit.

Table 1.--Summary of Toxicological Doses and Endpoints for AAAPSDs 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
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Acute dietary No appropriate endpoint was identified for acute dietary assessment
(all populations)...................
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Chronic dietary NOAEL= 87 millgrams/ Chronic RfD = 0.87 mg/ Reproduction/fertility
(all populations).................... kilograms/day (mg/kg/ kg/day effects in male rats
day) cPAD = 0.87 mg/kg/day.. (Master Record
UFA = 10x.............. Identification number
UFH = 10x.............. (MRID) 47060903))
FQPA SF = 1x........... LOAEL = 223 mg/kg/day
based on a dose-
related decrease in
absolute and relative
liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group
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Incidental oral short-term NOAEL= 87 mg/kg/day LOC for MOE = 100...... Reproduction/fertility
(1 to 30 days) and intermediate-term UFA = 10x.............. effects in male rats
(1 to 6 months). UFH = 10x.............. (MRID 47060903)
FQPA SF = 1x........... LOAEL = 223 mg/kg/day
based on a dose-
related decrease in
absolute and relative
liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group
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[[Page 37574]]

Dermal and inhalation Oral study NOAEL = 87 LOC for MOE = 100 Reproduction/fertility
(all durations)...................... mg/kg/day (dermal effects in male rats
absorption rate = 5% (MRID 47060903)
(inhalation absorption LOAEL = 223 mg/kg/day
rate = 100%) based on a dose-
UFA = 10x.............. related decrease in
UFH = 10x.............. absolute and relative
FQPA SF = 1x........... liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group.
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Cancer Classification: No animal toxicity data available for an assessment;
(oral, dermal, inhalation)........... based on SAR analysis, AAAPSDs 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). FQPA SF = FQPA 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 AAAPSDs, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from AAAPSDs 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 AAAPSDs. 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 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 comparison with the active
ingredient. In the case of AAAPSDs, EPA made a specific adjustment to
the dietary exposure assessment to account for the use limitations of
the amount of AAAPSDs that may be in formulations (no more than 30%)
and assumed that the AAAPSDs are 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%
and that none of the surfactants were AAAPSDs.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In sum, 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.
ii. Cancer. The Agency used a qualitative SAR database, DEREK11, to
determine if there were structural alerts for potential carcinogenicity
of a

[[Page 37575]]

representative AAAPSD. No structural alerts for carcinogenicity were
identified and the AAAPSDs are not expected to be carcinogenic.
Therefore a quantitative cancer exposure assessment is not necessary to
assess cancer risk.
iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue or PCT information in
the dietary assessment for AAAPSDs. Tolerance level residues or 100 PCT
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 AAAPSDs in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of AAAPSDs. 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 AAAPSDs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the AAAPSDs 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, pages 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 AAAPSDs, 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). AAAPSDs are used as
inert ingredients in pesticide products that are registered for
specific uses that could result in indoor residential exposures and 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 AAAPSDs 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 use 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 AAAPSDs. Similarly, residential
postapplication dermal and oral exposure assessments were also
performed utilizing high-end exposure scenarios. Further details of
this residential exposure and risk analysis can be found at http://www.regulations.gov in document 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 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 AAAPSDs to share a common mechanism of toxicity
with any other substances, and AAAPSDs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that AAAPSDs 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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The toxicity database
consists of OPPTS Harmonized Guideline 870.3650 (combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test) studies in rats conducted with representative AAAPDs, as well as
a 2-generation rat reproduction toxicity (OPPTS Harmonized Guideline
870.3800) study and a rat developmental toxicity study conducted with a
representative AAASD.
In an OPPTS Harmonized Guideline 870.3650 study conducted with a
representative AAAPD, no increased susceptibility to the offspring of
rats following prenatal and postnatal exposure was observed. In a
second OPPTS Harmonized Guideline 870.3650 study conducted with another
representative AAAPD, there was evidence of increased qualitative
susceptibility as indicated by the increased number of stillborn pups
and pups dying within lactation day (LD) 4/5 and clinical observations
(coldness to the touch, discolored heads, and a lack of nesting
behavior) at 800 mg/kg/day where lesions in the forestomach and thymus
atrophy was observed in the parental animals. However, this qualitative
susceptibility seen in the OPPTS Harmonized Guideline 870.3650 study
does not indicate a heightened risk for infants and children because a
clear NOAEL (200 mg/kg/day) was established for developmental effects
and an additional margin of safety is provided since the point of
departure selected from the 2-generation rat reproduction study for
chronic exposure is 87 mg/kg/day.
In a rat developmental study with AAASD, no maternal or
developmental toxicity was observed at the limit dose. In the 2-
generation reproduction study with AAASD, the only significant effects
observed were liver effects

[[Page 37576]]

characterized by dose-related decrease in absolute and relative liver
weight and an increased incidence in the number of animals with
``minimal'' hepatocyte necrosis in males. No treatment-related effects
were observed on reproduction or in the offspring.
There are no residual uncertainties identified in the exposure
databases. The food exposure assessments are considered to be
conservative. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children.
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 AAAPSDs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit IV.D.2.).
ii. No susceptibility was demonstrated in the offspring in the
reproductive/developmental screening test portion of an OPPTS
Harmonized Guideline 870.3650 study with one AAAPD following prenatal
and postnatal exposure at 800 mg/kg/day.
iii. Although increased qualitative susceptibility was demonstrated
in the offspring in a reproductive/developmental screening test portion
of an OPPTS Harmonized Guideline 870.3650 study with another AAAPD, the
Agency did not identify any residual uncertainties after establishing
toxicity endpoints and traditional UFs to be used in the risk
assessment of the AAAPSDs.
iv. There is no indication that AAAPSDs are neurotoxic chemicals
and thus there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to AAAPSDs 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 AAAPSDs.

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 AAAPSDs as
inert ingredients in pesticide product formulations into its exposure
assessment. Specifically the petition includes a use limitation of
AAAPSDs at not more than 30% by weight in pesticide formulations.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effects attributable to a single exposure to
the AAAPSDs were seen in the toxicity databases, therefore, AAAPSDs are
not expected to pose an acute risk.
2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure, and the use limitations of not more than 30% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to AAAPSDs is 13% of the cPAD for the U.S. population
and 43% of the cPAD for children 1-2 yrs 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).
AAAPSDs 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 AAAPSDs.
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 130
and 140, for adult males and females respectively, for a combined high-
end dermal and inhalation handler exposure with a high-end
postapplication dermal exposure and an aggregate MOE of 110 for
children for a combined turf dermal exposure with hand-to-mouth
exposure.
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).
AAAPSDs 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 AAAPSDs.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 270 and 280, for adult males and females
respectively, for a combined high-end dermal and inhalation handler
exposure with a high-end postapplication dermal exposure and an MOE of
110 for children for a combined high-end dermal exposure with hand-to-
mouth exposure.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity, AAAPSDs are not expected to pose
a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to residues of AAAPSDs.

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.

[[Page 37577]]

B. International Residue Limits

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

VI. Conclusion

Therefore, exemptions from the requirement of a tolerance are
established for residues of AAAPDs when used as inert ingredients in
pesticide formulations applied to growing crops only under 40 CFR
180.920 and residues of AAASDs when used as inert ingredients in raw
agricultural commodities, growing crops, and animals under 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930.

VII. Statutory and Executive Order Reviews

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

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

Dated: July 20, 2009.
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. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

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

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

* * * * *

[[Page 37578]]

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
[alpha]-Alkyl (minimum C6 Not to exceed 30% Surfactants,
linear, branched, saturated and/ of pesticide related adjuvants
or unsaturated)-[omega]- formulation. of surfactants
hydroxypolyoxyethylene polymer
with or without
polyoxypropylene, mixture of di-
and monohydrogen phosphate
esters and the corresponding
ammonium, calcium, magnesium,
monoethanolamine, potassium,
sodium, and zinc salts of the
phosphate esters; minimum
oxyethylene content is 2 moles;
minimum oxypropylene content is
0 moles (CAS Reg. Nos. 9046-01-
9, 37280-82-3, 39464-66-9,
42612-52-2, 50643-20-4, 52019-
36-0, 58318-92-6, 60267-55-2,
61837-79-4, 67711-84-6, 68070-
99-5, 68071-35-2, 68071-17-0,
68130-47-2, 68186-37-8, 68186-
36-7, 68311-02-4, 68425-73-0,
68458-48-0, 68511-37-5, 68610-
65-1, 68585-36-4, 68649-29-6,
68815-11-2, 68908-64-5, 68891-
13-4, 73038-25-2, 78330-24-2,
108818-88-8, 154518-39-5,
317833-96-8, 873662-29-4,
936100-29-7, 936100-30-0).
* * * * *
------------------------------------------------------------------------

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

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

* * * * *

[FR Doc. E9-18033 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S