Poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy; Exemption from the Requirement of a Tolerance, 42318-42324 [2010-17402]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Rules and Regulations]
[Pages 42318-42324]
From the Federal Register Online via the Government Printing 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 https://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 https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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: 
sunderland.deirdre@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2009-0692 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

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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: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of 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, https://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 https://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 https://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 https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products 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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. 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)
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2010-17402 Filed 7-21-10; 8:45 am]
BILLING CODE 6560-50-S