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[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5952-5957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02072]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0514; FRL-9920-44]

Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16) -alkyl ethers, disodium salts; 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]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16) alkyl ethers, disodium salts when used as an inert 
ingredient (surfactant) in pesticide formulations applied to growing 
crops (seed treatment use only) under 40 CFR 180.920 at a concentration 
not to exceed 0.125% by weight. BASF submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the 
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]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16) alkyl 
ethers, disodium salts.

DATES: This regulation is effective February 4, 2015. Objections and 
requests for hearings must be received on or before April 6, 2015, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0514, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0514 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 
April 6, 2015. 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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be

[[Page 5953]]

disclosed publicly by EPA without prior notice. Submit the non-CBI copy 
of your objection or hearing request, identified by docket ID number 
EPA-HQ-OPP-2014-0514, by one of the following methods:
     Federal eRulemaking Portal: 
http:[sol][sol]www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be CBI or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at 
http:[sol][sol]www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10671) by BASF, 26 Davis Dr., 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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C12) alkyl ethers, disodium salts, 
polyethoxylation content averages 4-5 moles, Chemical Abstracts Service 
Registry Number (CAS Reg. No.) 68954-91-6 and poly(oxy-1,2-ethanediyl), 
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts, polyethoxylation content 
averages 5 moles (CAS Reg. No. 68815-56-5), when used as an inert 
ingredient (surfactant) in pesticide formulations applied to growing 
crops (seed treatment use only) at a concentration not to exceed 0.125% 
by weight under 40 CFR 180.920. That document referenced a summary of 
the petition prepared by Exponent on behalf of BASF, the petitioner, 
which is available in the docket, http:[sol][sol]www.regulations.gov. 
Comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit V.C.

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 FFDCA section 408(c)(2)(A), 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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts 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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C16)-alkyl ethers, disodium salts 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]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts 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.
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers, 
disodium salts include CAS Reg. No. 68815-56-5, which consists of a 
C10-C16 linear carbon chain and average 
polyethoxylation (POE) = 4.5 and CAS Reg. No. 68954-91-6, which 
consists of a C10-C12 linear alkyl carbon chain 
and average polyethoxylation (POE) = 5. Although data are not available 
for CAS Reg. No. 68954-91-6, EPA relied on available subchronic 
toxicity studies on CAS Reg. No. 68815-56-5. These studies are 
sufficient to assess the subchronic toxicity of CAS Reg. No. 68954-91-6 
as the only difference between the compounds is the range of carbon 
chain lengths and the testing of the broader carbon chain length of 
C10-C16 in CAS Reg. No. 68815-56-5 would include 
any effects that might be seen in tests of the narrower linear carbon 
chain

[[Page 5954]]

length of C10-C12 (in CAS Reg. No. 68954-91-6). 
Reproduction and developmental toxicity studies were not available for 
review for either compound, so reproduction data for C12AE6 (CAS Reg. 
No. 9002-92-0), which is similar to poly(oxy-1,2-ethanediyl), [alpha]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts in carbon chain length and 
average ethoxylation, were used as surrogate data for potential 
reproductive effects of CAS Reg. Nos. 68815-56-5 and 68954-91-6. Based 
on analogy to well-known metabolic pathways for other linear alkyl 
ethers, the major pathway in the primary metabolism of both compounds 
is expected to be oxidative-reductive ether cleavage. Therefore, the 
metabolism of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl 
ethers, disodium salts would result in the formation of the 
corresponding alkyl alcohol alkoxylate such as C12AE6 (CAS Reg. No. 
9002-92-0).
    The acute oral and dermal toxicity of poly(oxy-1,2-ethanediyl), 
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts is low (toxicity category 
IV). The Lethal Dose (LD)50 is >5,000 milligram/kilogram 
(mg/kg) in the rat (oral) and rabbit (dermal). They are irritating to 
the eyes and non-irritating to the skin in rabbits. They are not dermal 
sensitizers. Acute inhalation toxicity studies were not available.
    Subchronic toxicity studies were available in the rat and dog for 
CAS Reg No. 68815-56-5. CAS Reg No. 68815-56-5 was administered via the 
diet in both studies. In a 90-day oral toxicity study in rats, 
decreased body weight gain was observed at 4% (equivalent to 2,000 mg/
kg/day (LOAEL)) of CAS Reg No. 68815-56-5. The NOAEL was 1% (equivalent 
to 500 mg/kg/day). In a 90-day toxicity study in dogs, toxicity was not 
observed at 500 mg/kg/day (NOAEL), the highest dose tested.
    An acceptable developmental toxicity study is not available; 
however, in a 2-generation reproduction study in rats on C12AE6, 
decreased body weight gain was observed in parental animals at 0.5% 
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Offspring toxicity was manifested as decreased weight gain in 
pups, increased embryo lethality and soft tissue anomalies at 0.5% 
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Although fetal qualitative susceptibility is observed in this 
study, the concern is low because effects occurred only in the presence 
of maternal toxicity.
    Chronic/carcinogenicity studies with poly(oxy-1,2-ethanediyl), 
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, 
disodium salts were not available. However, a DEREK structural alert 
analysis was conducted with poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C12)-alkyl ethers, disodium salt (CAS Reg No. 68954-91-6) 
and indicated no structural alerts for carcinogenicity or mutagenicity. 
Therefore, poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts are not 
expected to be carcinogenic.
    Mutagenicity studies were not available for poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C16)-alkyl ethers, disodium salts. However, 
an Ames test is available on CAS Reg. No. 68439-50-9, a surrogate alkyl 
alcohol alkoxylate. The test was negative.
    Neurotoxicity studies were not available for review. Although 
ataxia was observed in the dams in the developmental toxicity study in 
rabbits at 100 mg/kg/day, the onset and persistence of ataxia were not 
reported and thus could not be evaluated. Since evidence of ataxia or 
other signs of potential neurotoxicity were not observed in the 
subchronic studies conducted with rats or dogs at doses >=500 mg/kg/
day, it was concluded that the ataxia observed in the dams was not 
likely a result of neurotoxicity.
    Immunotoxicity studies were not available for review. However, 
evidence of immunotoxicity was not observed in the submitted studies.
    Metabolism studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-
1-oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-
alkyl ethers, disodium salts were not available for review. However, 
based on analogy to known metabolic pathways for linear alkyl ethers, 
the major pathway in the primary metabolism is expected to be 
oxidative-reductive ether cleavage. Therefore, the primary metabolism 
of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl ethers, disodium salts occurs via oxidative-
reductive ether hydrolysis resulting in the formation of linear alkyl 
alcohols and polyethylene glycol metabolites. The alcohols would 
undergo oxidation by alcohol dehydrogenase and aldehyde dehydrogenase 
to generate a fatty acid metabolite that is degraded by [beta]-
oxidation to carbon dioxide (CO2) and water 
(H2O). The polyethylene glycol metabolites would be degraded 
via oxidation by alcohol dehydrogenase and aldehyde dehydrogenase to 
generate a dienoic polyethylene ether acid that may be conjugated and 
excreted. Also, the alcohol function may be sulfated by 
sulfotransferases and excreted.

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 the NOAEL and the LOAEL are identified. 
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.
    An acute effect was not found in the database therefore an acute 
dietary assessment is not necessary. The 2-generation reproduction 
study in the rat was selected for the chronic exposure for this risk 
assessment. The NOAEL in this study was 50 mg/kg/day. The LOAEL was 250 
mg/kg/day based on decreased weight gain. This study represents the 
lowest NOAEL in the database in the most sensitive species. The dermal 
and inhalation absorption rates were assumed to be 100%. The standard 
inter- and intra-species uncertainty factors were applied. The Food 
Quality Protection Act Safety Factor (FQPA SF) of tenfold (10X) was 
retained for the lack of a developmental toxicity study.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl 
ethers, disodium salts, EPA considered exposure under the proposed 
exemption

[[Page 5955]]

from the requirement of a tolerance. EPA assessed dietary exposures 
from poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers, 
disodium salts in food as follows:
    Dietary exposure (food and drinking water) to poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C16)-alkyl ethers, disodium salts can occur 
following ingestion of foods with residues from seed-treated crops. 
Because no adverse effects attributable to a single exposure of 
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts 
were seen in the toxicity databases, an acute dietary risk assessment 
is not necessary. For the chronic dietary risk assessment, EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM), Version 3.16, and food 
consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). One hundred percent crop treated 
was assumed, default processing factors, and tolerance-level residues 
for all foods and use limitations of not more than 0.125% by weight in 
pesticide formulations.
    2. Cancer. A DEREK structural alert analysis indicated no 
structural alerts for carcinogenicity or mutagenicity. Therefore, 
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts 
are not expected to be carcinogenic and a cancer risk assessment is 
unnecessary.
    3. 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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C16)-alkyl ethers, disodium salts, 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.
    4. 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).
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers, 
disodium salts are not expected to result in residential exposure based 
on its use pattern as a seed treatment for agricultural crops.
    5. 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]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts to share 
a common mechanism of toxicity with any other substances, and poly(oxy-
1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
alkyl ethers, disodium salts 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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
alkyl ethers, disodium salts 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 Web site 
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 10X margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA SF. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for 
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts contains two subchronic studies, 
a reproductive toxicity study, a developmental toxicity study and 
mutagenicity studies. Qualitative fetal susceptibility was observed in 
the 2-generation toxicity study in rats. However, concern for fetal 
effects are low since they only occurred in the presence of maternal 
toxicity and protecting against maternal toxicity will subsequently 
prevent fetal toxicity. In addition, the chronic reference dose (cRfD) 
was based on this study and will be protective of fetal effects. 
However, since the developmental study in rabbits was unacceptable, the 
FQPA SF of 10X was retained to account for an incomplete database.

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]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts 
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]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts from food and water will utilize 
16.2% of the cPAD for non-nursing infants, the population group 
receiving the greatest exposure. There are no residential uses for 
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts.
    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). Since 
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts 
have no uses that would result in short-term residential exposure, the 
Agency has determined that it is appropriate to

[[Page 5956]]

aggregate chronic exposure through food and water only.
    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). Since poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl 
ethers, disodium salts have no uses that would result in intermediate-
term residential exposure, the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water only.
    5. Aggregate cancer risk for U.S. population. Based on a DEREK 
structural alert analysis and the lack of mutagenicity, poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, 
(C10-C16)-alkyl ethers, disodium salts are 
considered not likely to be carcinogenic.
    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]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl 
ethers, disodium salts residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. Response to Comments

    A comment was received from a private citizen who was concerned 
about the reaction of fatty acid esters to any future chemicals added 
to the environment. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that no residue of pesticides 
should be allowed because of potential interactions with other 
chemicals. However, under the existing legal framework provided by 
FFDCA section 408, EPA is authorized to establish pesticide tolerances 
or exemptions where persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
the statute, which EPA has determined here.

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]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts (CAS Reg. Nos. 68954-91-6 
and 68815-56-5) when used as inert ingredients (surfactant) in 
pesticide products used for seed treatment only at a concentration not 
to exceed 0.125% in the end-use formulation.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions to the requirement for a 
tolerance under FFDCA section 408(d) 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 action has been exempted from review 
under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the exemptions 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: January 15, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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, add alphabetically to the table after ``Poly(oxy-
1,2-ethanediyl),[alpha]-isotridecyl-[omega]-methoxy (CAS Reg. No. 
345642-79-7)'' the two inert ingredients listed below to read as 
follows:

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

* * * * *

[[Page 5957]]

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl),         Not to exceed       Surfactant.
 [alpha]-(3-carboxy-1-             0.125% for seed
 oxosulfopropyl)-[omega]-hydroxy-  treatment use
 , (C10-C12)-alkyl ethers,         only.
 disodium salts, polyoxylene
 content averages 4-5 moles (CAS
 Reg. No. 68815-56-5).
Poly(oxy-1,2-ethanediyl),         Not to exceed       Surfactant
 [alpha]-(3-carboxy-1-             0.125% for seed
 oxosulfopropyl)-[omega]-hydroxy-  treatment use
 , (C10-C16)-alkyl ethers,         only.
 disodium salts, polyoxyethylene
 content averages 5 moles (CAS
 Reg. No. 68954-91-6).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-02072 Filed 2-3-15; 8:45 am]
BILLING CODE 6560-50-P
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