[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Rules and Regulations]
[Pages 51382-51388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20708]
[[Page 51382]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0131; FRL-8836-5]
Alkyl Alcohol Alkoxylate Phosphate Derivatives; 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 alcohol alkoxylate phosphate
derivatives (AAAPD) when used under 40 CFR part 910 as an inert
ingredient--surfactant and related adjuvants of surfactants for pre-
and post-harvest uses and application to animals in pesticide
formulations under 40 CFR part 930, limited to a maximum of 30% by
weight in end-use products. 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 establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of AAAPDs.
DATES: This regulation is effective August 20, 2010. Objections and
requests for hearings must be received on or before October 19, 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-2009-0131. 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: Lisa Austin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7894; e-mail address: [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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/oppts and select ``Test Methods and Guidelines.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2009-0131 in the subject line on the first page of
your submission. All objections and requests for a hearing must be in
writing, and must be received by the Hearing Clerk on or before October
19, 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-2009-0131, 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. Petition for Exemption
In the Federal Register of February 4, 2010 (75 FR 5793) (FRL-8807-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E7628) by the
Joint Inerts Task Force, Cluster Support Team 2 (CST 2), c/o CropLife
America, 1156 15th Street, NW., Suite 400, Washington, DC 20005. The
petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by
establishing an exemption from the requirement of a tolerance for
residues of AAAPDs when used as an inert ingredient surfactant and
related adjuvants of surfactants in pesticide formulations applied to
growing crops, raw agricultural commodities and food-producing animals
limited to a maximum of 30% by weight in end-use
[[Page 51383]]
products for the [alpha]-alkyl (minimum C6 linear or
branched, saturated and or unsaturated)-[omega]-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 averages 2 moles; minimum
oxypropylene content is 0 moles, including: Poly(oxy-1 ,2-ethanediyl),
[alpha]-tridecyl- [omega] -hydroxy-, phosphate (9046-01-9); Poly(oxy-1
,2-ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate (39464-66-
9); Poly(oxy-1 ,2-ethanediyl), [alpha]-hexadecyl-[omega]-hydroxy-,
phosphate (50643-20-4); Poly(oxy-1 ,2-ethanediyl), [alpha]-decyl-
[omega]-hydroxy-, phosphate (52019-36-0); Poly(oxy-1 ,2-ethanediyl),
[alpha]-hydro-[omega]-hydroxy-, mono-C12-15-alkyl ethers,
phosphates (68071-35-2); Polyphosphoric acids, esters with polyethylene
glycol decyl ether (68458-48-0); Poly(oxy-1 ,2-ethanediyl), [alpha]-
hydro-[omega]-hydroxy-, mono-C10-14-alkyl ethers, phosphates
(68585-36-4); Poly(oxy-1,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-,
mono-C12-15-branched alkyl ethers, phosphates (68815-11-2);
Poly(oxy-1 ,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-
C10-12-alkyl ethers, phosphates (68908-64-5); Poly(oxy-1 ,2-
ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-C12-14-
aIkyl ethers, phosphates (68511-37-5); Poly(oxy-1 ,2-ethanediyl),
[alpha]-hydro-[omega]-hydroxy-, mono-C8-10-alkyl ethers,
phosphates (68130-47-2); Poly(oxy-1 ,2-ethanediyl), [alpha]-dodecyl-
[omega]-hydroxy-, phosphate, sodium salt (42612-52-2); Poly(oxy-1 ,2-
ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate, potassium
salt (58318-92-6); Poly(oxy-1 ,2-ethanediyl), [alpha]-hexadecyl-
[omega]-hydroxy-, phosphate, potassium salt (60267-55-2); Poly(oxy-1
,2-ethanediyl), [alpha]-decyl- [omega] hydroxy-, phosphate, potassium
salt (68070-99-5); Poly(oxy-1,2-ethanediyl), [alpha]-tridecyl-[omega]-
hydroxy-, phosphate, potassium salt (68186-36-7); Poly(oxy1,2-
ethanediyl), [alpha]-decyl-[omega]-hydroxy-, phosphate, sodium salt
(68186-37-8); Poly(oxy-1,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-,
mono-C12-15-alkyl ethers, phosphates, sodium salts (68610-
65-1); Poly(oxy-1 ,2-ethanediyl), [alpha]-isodecyl- [omega]-hydroxy-,
phosphate, potassium salt (68071-17-0); (branched C10)
Poly(oxy-1,2-ethanediyl), [alpha]-phosphono-[omega]-[(2-
propylheptyl)oxy]-, potassium salt (1:2) (936100-29-7); (branched
C10) Poly(oxy-1,2-ethanediyl), [alpha]-phosphono-[omega]-
[(2-propylheptyl)oxy]-, sodium salt (1:2) (936100-30-0); Poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-hydroxy-, phosphate (73038-25-
2); Poly(oxy-1 ,2- ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-
C11-14-isoalkyl ethers, C13-rich, phosphates
(78330-24-2); Poly(oxy-1 ,2-ethanediyl),[alpha]-hydro-[omega]-hydroxy-,
mono(C10-rich C9-11-isoalkyl) ethers, phosphates
(154518-39-5); Poly(oxy-1 ,2-ethanediyl), [alpha]-hydro-[omega]-
hydroxy-, mono-C12-14-sec-alkyl ethers, phosphates (317833-
96-8); Poly(oxy-1 ,2-ethanediyl), [alpha]-isodecyl-[omega]-hydroxy-,
phosphate (108818-88-8); Poly(oxy-1, 2- ethanediyl), [alpha]-phosphono-
[omega]-[(2- propylheptyl)oxy] (873662-29-4); Poly(oxy-1, 2-
ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate,
monoethanolamine salt (61837-79-4); Poly(oxy-1 ,2-ethanediyl), [alpha]-
tridecyl-[omega]-hydroxy-, phosphate monoethanolamine salt (68311-02-
4); Poly(oxy-1,2- ethanediyl), [alpha]-decyl-[omega]-hydroxy-,
phosphate, monoethanolamine salt (68425-73-0); Oxirane, methyl-,
polymer with oxirane, phosphate (37280-82-3); Oxirane, methyl-, polymer
with oxirane, mono-C10-16-alkyl ethers, phosphates (68649-
29-6); Oxirane, methyl-, polymer with oxirane, phosphate, potassium
salt (67711-84-6); and Oxirane, methyl-, polymer with oxirane, mono-
C10-16-alkyl ethers, phosphates, potassium salt (68891-13-
4). That notice referenced a summary of the petition prepared by The
Joint Inerts Task Force (JITF), Cluster Support Team Number 2 (CST 2),
the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for AAAPDs including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with AAAPDs 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
[[Page 51384]]
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 AAAPDs 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 AAAPDs 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 NOAEL was 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
AAAPDs; 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 AAAPDs. 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
LOAEL from the toxicity studies can be found at http://www.regulations.gov in the 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,'' pp. 11-17 in docket ID number EPA-HQ-OPP-
2009-0131.
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 (U/SF) are used in conjunction
with the POD to calculate a safe exposure level - generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD) - and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for AAADPs used for human
risk assessment is discussed in Unit IV. of the final rule published in
the Federal Register of July 29, 2009 (74 FR 37571) (FRL-8424-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to AAAPDs, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from AAAPDs 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 AAAPDs. 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 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 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 in relation to that of
the active ingredient. In the case of AAAPDs, EPA made a specific
adjustment to the dietary exposure assessment to account for the use
limitations of the amount of AAAPDs that may be in formulations (to no
more than 30% and assumed that the AAAPDs are present at the maximum
limitation rather than at equal quantities with the active ingredient.
This remains
[[Page 51385]]
a very conservative assumption because surfactants are generally used
at levels far below this percentage. For example, EPA examined several
of the pesticide products associated with the tolerance/commodity
combination which are the driver of the risk assessment and found that
these products did not contain surfactants at levels greater than 2.25%
and that none of the surfactants were AAAPDs.
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 summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
ii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. The Agency has not identified any
concerns for carcinogenicity relating to the inerts AAAPDs. 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 AAAPDs. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for AAAPDs, 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., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
AAAPDs 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 AAAPDs 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 AAAPDs. 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 AAAPDs to share a common mechanism of toxicity
with any other substances, and AAAPDs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that AAAPDs 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 Food Quality
Protection Act Safety Factor (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 Harmonized Test Guideline OPPTS 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 (Harmonized Test
Guideline OPPTS 870.3800) study and a rat developmental toxicity study
conducted with a representative AAASD.
In one Harmonized Test Guideline OPPTS 870.3650 study conducted
with a representative AAAPD, no increased susceptibility to the
offspring of rats following prenatal and postnatal
[[Page 51386]]
exposure was observed. In a second Harmonized Test Guideline OPPTS
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 milligrams/kilogram/day
(mg/kg/day) where lesions in the forestomach and thymus atrophy was
observed in the parental animals. However, this qualitative
susceptibility seen in the Harmonized Test Guideline OPPTS 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 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.
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 AAAPDs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit IV.D.2.).
ii. There is no indication that AAAPDs are neurotoxic chemicals and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
iii. Although increased qualitative susceptibility was demonstrated
in the offspring in a reproductive/developmental screening test portion
of an Harmonized Test Guideline OPPTS 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 AAAPDs.
iv. 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 AAAPDs 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 AAAPDs.
E. Aggregate Risks and Determination of Safety
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-, intermediate-, 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.
In conducting this aggregate risk assessment, the Agency has
incorporated the petitioner's requested use limitations of AAAPDs as
inert ingredients in pesticide product formulations into its exposure
assessment. Specifically the petition includes a use limitation of
AAAPDs at not more than 30% by weight in pesticide formulations.
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,
AAAPDs are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
AAAPDs from food and water will utilize 43% of the cPAD for children 1-
2 yrs old, the population group receiving the greatest exposure.
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).
AAAPDs are 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 AAAPDs.
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 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. Because EPA's level of
concern for AAAPDs is a MOE of 100 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).
AAAPDs are 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 AAAPDs.
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 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. Because EPA's level of concern for AAAPDs are a MOE of
100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack
ofstructural alerts for carcinogenicity, AAAPDs 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 AAAPDs residues.
[[Page 51387]]
V. Other Considerations
A. Analytical Enforcement Methodology
EPA is establishing a limitation on the amount of AAAPDs that may
be used in pesticide formulations. That limitation will be enforced
through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. EPA will not register any pesticide for sale or distribution that
contains greater than 30% of AAAPDs by weight in the end-use pesticide
formulation.
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
nor have any CODEX Maximum Residue Levels been established for any food
crops at this time.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 40 CFR 180.930 for AAAPDs when
used as an inert ingredient (surfactants, related adjuvants of
surfactants) in pesticide formulations applied to raw agricultural
commodities, growing crops, and animals.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
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.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
[alpha]-alkyl (minimum C6 linear Not to exceed 30% Surfactants,
or branched, saturated and or of pesticide related adjuvants
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 averages 2
moles; minimum oxypropylene
content is 0 moles (CAS Reg.
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.
[[Page 51388]]
* * * * *
------------------------------------------------------------------------
* * * * *
0
3. 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.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
[alpha]-alkyl (minimum C6 linear Not to exceed 30% Surfactants,
or branched, saturated and or of pesticide related adjuvants
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 averages 2
moles; minimum oxypropylene
content is 0 moles (CAS Reg.
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.
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-20708 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S