[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Rules and Regulations]
[Pages 42318-42324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17402]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0692; FRL-8830-6]
Poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy;
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 poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy (CAS Reg. No. 345642-79-7) when used as an
inert ingredient (surfactant) at a maximum concentration of 10% in
pesticide formulations under 40 CFR 180.920 on growing crops only.
Bayer CropScience 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 poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy.
DATES: This regulation is effective July 21, 2010. Objections and
requests for hearings must be received on or before September 20, 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-2009-0692. 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: Deirdre Sunderland, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0851; 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-2009-0692 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
September 20, 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
[[Page 42319]]
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-2009-0692, 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 January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E7580) by
Bayer CropScience, 2 T.X. Alexander Dr., P.O. Box 12014, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy (CAS No. 345642-79-7) when used as an inert
ingredient (surfactant) in pesticide formulations applied pre-harvest
to all crops without limitation. That notice referenced a summary of
the petition prepared by Bayer CropScience, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing. Based upon
review of the data supporting the petition, EPA has limited the amount
in formulation to 10%. This limitation is based on the Agency's risk
assessment which can be found at http://www.regulations.gov in document
``Decision Document for Petition Number 9E7580; Poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy (CAS Reg. No. 345642-
79-7)'' in docket ID number EPA-HQ-OPP-2009-0692.
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 poly(oxy-1,2-ethanediyl),
[alpha]-isotridecyl-[omega]-methoxy including exposure resulting from
the exemption established by this action. EPA's assessment of exposures
and risks associated with poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy 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 poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy 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 available toxicity data include an acute toxicity battery, a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OPPTS Harmonized Test Guideline
870.3650), and two mutagenicity studies (OPPTS Harmonized Test
Guideline 870.5100). In addition, sufficient toxicity data are
available on the metabolite. Acute studies (OPPTS Harmonized Test
Guidelines 870.1100 and 870.1200 (acute inhalation study not provided))
showed low acute toxicity (Toxicity Category III) with an oral
LD50 >2000 milligrams/kilogram (mg/kg) and acute dermal
LD50 >2000 mg/kg. Irritation studies (OPPTS Harmonized Test
Guidelines 870.2400 and 870.2500) on rabbits revealed slight skin
irritation (Toxicity Category IV) and severe eye irritation (Toxicity
Category II). In addition, a skin sensitization study (OPPTS Harmonized
Test Guidelines
[[Page 42320]]
870.2600) in guinea pigs showed skin sensitization when exposed to
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy.
In an OPPTS Harmonized Test Guideline 870.3650 poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega] -methoxy was administered by
gavage prior to mating through postnatal day 4 (~6-7 weeks). Clinical
signs of toxicity included increased incidences of oral and urine
staining (>=150 milligrams/kilogram/day (mg/kg/day)) and a slight
decrease in body weight and body weight gain (300 mg/kg/day male rats,
pre-mating period); however, no treatment-related effects were observed
during the remainder of the study. Additionally female rats (>=150 mg/
kg/day) exhibited a decrease in hind-limb strength and rearing in open-
field.
At necropsy females in the high dose (300 mg/kg/day) group showed
a statistically significant increase in absolute and relative adrenal
weight, relative kidney weight, and absolute liver weight. Females in
the mid and high dose group (>=150 mg/kg/day) showed a statistically
significant increase in relative liver weight. In the absence of any
collaborative blood or histopathologic findings the effect seen in the
liver is considered as an adaptive response. An increased incidence of
minimal to moderate epithelial cell hyperplasia was noted in the non-
glandular epithelium of the stomach of high-dose male and female rats
indicating local irritation which is likely due to the irritation
induced by gavage treatment of chemicals with irritative properties.
A LOAEL was not established for poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy in male Wistar rats. The NOAEL for male
rats is the highest dose tested, 300 mg/kg/day. The NOAEL for female
rats is 45 mg/kg/day based on the functional observational battery
observations (i.e. decrease in rearing in open field and hind limb grip
strength) seen at the LOAEL of 150 mg/kg/day.
The OPPTS 870.3650 study on poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy was also used to evaluate reproductive and
developmental toxicity. No test material-related effects were observed
on reproductive (e.g., mating, fertility, or gestation indices, days to
insemination, gestation length, or number of implants) or developmental
(e.g., mean litter size, viability, clinical signs of toxicity, or body
weight of the pups) parameters at any dose tested; therefore, the NOAEL
for poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega] -methoxy for
reproductive and developmental parameters is 300 mg/kg/day (highest
dose tested).
Evidence of neurotoxicity was observed in the OPPTS 870.3650 study
which showed a decrease in rearing in open field and hind limb grip
strength for mid- and high-dose female rats (>= 150 mg/kg/day). No
evidence of immunotoxicity was observed in the database.
There are no carcinogenicity studies available in the database;
however, poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy
tested negative in two mutagenicity assays (OPPTS Harmonized Test
Guideline 870.5100) and no evidence of specific target organ toxicity
was observed in the OPPTS 870.3650 study. In addition, no evidence of
carcinogenicity was observed in studies on the metabolite [alpha]-
isotridecyl-[omega]-hydroxy-poly(oxy-1 ,2-ethanediyl) (CAS Reg. No.
9043-30-5) (Federal Register, August 5, 2009 (74 FR 38935, FRL-8430-
1)). The Agency does not anticipate poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy to be carcinogenic.
Based on available information the Agency has concluded that
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy has a
higher toxicity than its metabolite; therefore, conducting the risk
assessment on the parent would be protective of the metabolite.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The POD for the risk assessment for all durations and routes of
exposure was from the OPPTS Harmonized Test Guideline 870.3650 toxicity
study in rats. The NOAEL was 45 mg/kg/day and the LOAEL was 150 mg/kg/
day based on rearing in the open field and hind limb grip strength. A
300 fold uncertainty factor was used for the chronic exposure (10X
interspecies extrapolation, 10X for intraspecies variability and 3X
FQPA factor).
The residential, occupational, and aggregate level of concern (LOC)
is for MOEs that are less than 300 and is based on 10X interspecies
extrapolation, 10X for intraspecies variability and 3X FQPA factor.
Dermal absorption was estimated to be 10% based on the large molecular
weight of the chemical and the lack of water solubility. A 100%
inhalation was assumed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy, EPA considered exposure under the proposed exemption from the
requirement of a tolerance. EPA assessed dietary exposures from
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy in food
as follows:
i. Acute exposure. No adverse effects attributable to a single
exposure of poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy was seen in the toxicity databases. Therefore, acute dietary
risk assessments for poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-
[omega]-methoxy is not required.
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 poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy. 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
[[Page 42321]]
Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments for the
Inerts.'' (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product in relation to that of the active
ingredient. In the case of poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy, EPA made a specific adjustment to the
dietary exposure assessment to account for the use limitations of the
amount of poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy
that may be in formulations (no more than 10% by weight in pesticide
formulations) and assumed that the poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy are present at the maximum limitations
rather than at equal quantities with the active ingredient. This
remains a very conservative assumption because surfactants are
generally used at levels far below 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 single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
iii. Cancer. Based on the lack of evidence of carcinogenicity and
specific organ toxicity in available studies, along with the lack of
carcinogenicity in metabolite studies, poly(oxy-1,2-ethanediyl),
[alpha]-isotridecyl-[omega]-methoxy is not expected to pose a cancer
risk to humans. Therefore, a cancer dietary exposure assessment is not
necessary to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-
[omega]-methoxy. Tolerance level residues and/or 100% 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 poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy, 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, and tables).
There are no known or anticipated residential uses and therefore,
a residential risk assessment was not conducted.
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 poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-
[omega]-methoxy to share a common mechanism of toxicity with any other
substances, and poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy 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 http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The OPPTS Harmonized Test
Guideline 870.3650 study on poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy was also used to evaluate reproductive and
developmental toxicity. There was
[[Page 42322]]
no evidence of increased susceptibility of infants and children in the
available database. No test material-related effects were observed on
reproductive or developmental parameters at any dose tested; therefore,
the NOAEL for poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega] -
methoxy for reproductive and developmental parameters is 300 mg/kg/day
(highest dose tested). The parental systemic toxicity NOAEL is 45 mg/
kg/day and the LOAEL of 150 mg/kg/day is based on clinical signs of
neurotoxicity.
3. Conclusion. Although there is no evidence of increased
susceptibility in infants and children, in order to be protective in
the absence of a developmental neurotoxicity study and the
extrapolation from subchronic to chronic, a 3X FQPA safety factor has
been retained.
EPA has determined that reliable data show the safety of infants
and children would be adequately protected if the FQPA SF was reduced
to 3X. That decision is based on the following findings:
i. There is no evidence that poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy results in increased susceptibility in in
utero rats in an OPPTS Harmonized Test Guideline 870.3650 study, a
combined repeated dose toxicity study with reproduction/developmental
toxicity test parameters.
ii. Evidence of neurotoxicity was observed in the OPPTS 870.3650
Harmonized Test Guideline study which showed a decrease in rearing in
open field and hind limb grip strength in females in the mid- and high-
dose groups (>= 150 mg/kg/day). EPA concluded that the 3X FQPA database
uncertainty factor is adequate because the evidence of neurotoxicity
was observed only in females while males had no effects at doses up to
and including 300 mg/kg/day and a lack of a significant dose response
in females. No chronic toxicity or carcinogenicity studies are
available in the database; however, the Agency notes that surfactants
are surface-active materials that can damage the structural integrity
of cellular membranes at high dose levels. Thus, surfactants are often
corrosive and irritating in concentrated solutions. The observed
toxicity seen in the repeated dose studies, such as microscopic lesions
or decreased body weight gain, are attributed to the corrosive and
irritating nature of these surfactants. The Agency has considerable
toxicity information on surfactants, which indicates that the effects
do not progressively increase in severity over time. In addition, use
of the full 10X interspecies factor will actually provide an additional
margin of safety because it is not expected that humans' response to
local irritation/corrosiveness effects would be markedly different from
animals. No evidence of immunotoxicity was observed in the database.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 10% in formulation and a default 100 ppb concentration in drinking
water. The I DEEM models uses highly conservative assumption and
assumes that all crop/crop groups are treated with all pesticide
classifications (e.g., fungicides, insecticides, herbicides). There are
no currently approved uses of poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy in pesticide products; therefore, this is a
highly conservative estimate. In addition, it is unlikely that
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy will
appear in drinking water. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy in drinking water. These assessments will not underestimate the
exposure and risks posed by poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy.
iv. Sufficient data exist on the metabolite [alpha]-isotridecyl-
[omega]-hydroxy-poly(oxy-1 ,2-ethanediyl) (CAS Reg. No. 9043-30-5) and
it has recently been assessed by the Agency (Federal Register, August
5, 2009 (74 FR 38935, FRL-8430-1)). Based on available information it
has been concluded that poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-
[omega]-methoxy has a higher toxicity than its metabolite and
therefore, conducting the risk assessment on the parent would be
protective of the metabolite.
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.
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,
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy is 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
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy from food
and water will utilize 84.9% of the cPAD for children 1-2 years old,
the population group receiving the greatest exposure. There are no
residential uses for poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-
[omega]-methoxy.
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).
A short-term adverse effect was identified; however, poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy is not currently used
as an inert ingredient in pesticide products that are registered for
any use patterns that would result in short-term residential exposure.
Short-term risk is assessed based on short-term residential exposure
plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy.
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).
An intermediate-term adverse effect was identified; however,
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy is not
currently used as an inert ingredient in pesticide products that are
registered for any use patterns that would result in intermediate-term
residential exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term
[[Page 42323]]
risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy.
5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to poly(oxy-1,2-
ethanediyl), [alpha]-isotridecyl-[omega]-methoxy. Therefore, an
aggregate cancer risk was not conducted.
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 poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-
methoxy residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes
since the Agency is not establishing a numerical tolerance for residues
of poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy in or
on any food commodities. EPA is establishing a limitation on the amount
of poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy 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 10% of poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy by weight in the pesticide formulation.
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
poly(oxy-1,2-ethanediyl), [alpha]-isotridecyl-[omega]-methoxy 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 poly(oxy-1,2-ethanediyl), [alpha]-
isotridecyl-[omega]-methoxy (CAS Reg. No. 345642-79-7) when used as an
inert ingredient (surfactant) in pesticide formulations applied to
growing crops at a maximum of 10% 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: July 8, 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. 180.920, 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.
* * * * *
[[Page 42324]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Poly(oxy-1,2-ethanediyl), At a maximum of Surfactant
[alpha]-isotridecyl-[omega]- 10% in
methoxy (CAS Reg. No. 345642-79- formulation
7)
* * * * * * *
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[FR Doc. 2010-17402 Filed 7-21-10; 8:45 am]
BILLING CODE 6560-50-S