Poly(oxy-1,2-ethanediyl), α-(3-carboxy-1-oxosulfopropyl)-ω-hydroxy-, alkyl (C10, 7032-7037 [2016-02569]
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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations
BUREAU OF CONSUMER FINANCIAL
PROTECTION
12 CFR Parts 1024 and 1026
RIN 3170–AA19
2013 Integrated Mortgage Disclosures
Rule Under the Real Estate Settlement
Procedures Act (Regulation X) and the
Truth in Lending Act (Regulation Z);
Correction of Supplementary
Information
Bureau of Consumer Financial
Protection.
ACTION: Correction of supplementary
information.
AGENCY:
In 2013, the Consumer
Financial Protection Bureau (Bureau)
issued the ‘‘Integrated Mortgage
Disclosures Under the Real Estate
Settlement Procedures Act (Regulation
X) and the Truth in Lending Act
(Regulation Z)’’ final rule (TILA–RESPA
Final Rule).1 The Supplementary
Information to the TILA–RESPA Final
Rule contained a typographical error,
which this document corrects, regarding
the application of tolerances to property
insurance premiums, property taxes,
homeowner’s association dues,
condominium fees, and cooperative
fees.
DATES: This correction is effective on
February 10, 2016.
FOR FURTHER INFORMATION CONTACT:
Pedro De Oliveira or David Friend,
Counsels, Office of Regulations,
Consumer Financial Protection Bureau,
1700 G Street NW., Washington, DC
20552, at (202) 435–7700.
SUPPLEMENTARY INFORMATION: In 2013,
the Bureau issued the ‘‘Integrated
Mortgage Disclosures Under the Real
Estate Settlement Procedures Act
(Regulation X) and the Truth in Lending
Act (Regulation Z)’’ final rule (TILA–
RESPA Final Rule), combining certain
disclosures that consumers receive in
connection with applying for and
closing on a mortgage loan.2 The
Supplementary Information to the
TILA–RESPA Final Rule (2013 Supp.
Information) contained a typographical
error, which this notice corrects.
Specifically, on page 79829 of Volume
78 of the Federal Register, in the first
column, in the sentence containing
‘‘property insurance premiums,
property taxes, homeowner’s association
dues, condominium fees, and
cooperative fees,’’ the phrase ‘‘are
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SUMMARY:
1 78
FR 79730 (Dec. 31, 2013).
FR 79730 (Dec. 31, 2013). The Bureau
published subsequent amendments to the TILA–
RESPA Final Rule at 80 FR 8767 (Feb. 19, 2015) and
80 FR 43911 (July 24, 2015).
2 78
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subject to tolerances’’ should read ‘‘are
not subject to tolerances.’’
Section 1026.19(e)(3)(iii) is titled
‘‘Variations permitted for certain
charges’’ and lists certain charges—
including property insurance premiums,
‘‘[a]mounts placed into an escrow,
impound, reserve, or similar account,’’
and ‘‘[c]harges paid for third-party
services not required by the creditor’’—
in the category of charges not subject to
tolerance.3 Property taxes, homeowner’s
association dues, condominium fees,
and cooperative fees are all ‘‘[c]harges
paid for third-party services not
required by the creditor.’’ Additionally,
the 2013 Supp. Information sentence
being corrected here is inconsistent with
the sentence that precedes it, because
the preceding sentence states that
‘‘property insurance premiums are
included in the category of settlement
charges not subject to a tolerance,
whether or not the insurance provider is
a lender affiliate.’’ 4 Consequently, on
page 79829 of the 2013 Supp.
Information, regarding ‘‘property
insurance premiums, property taxes,
homeowner’s association dues,
condominium fees, and cooperative
fees,’’ the phrase ‘‘are subject to
tolerances’’ should read ‘‘are not subject
to tolerances.’’
Accordingly, the Bureau makes the
following correction to FR Doc. 2013–
28210 published on December 31, 2013
(78 FR 79730):
1. On page 79829, in the first column,
in the 48th, 49th, and 50th lines, revise
‘‘are subject to tolerances whether or not
they are placed into an escrow,
impound, reserve, or similar account’’ to
read ‘‘are not subject to tolerances
whether or not they are placed into an
escrow, impound, reserve, or similar
account’’.
Dated: February 2, 2016.
Richard Cordray,
Director, Bureau of Consumer Financial
Protection.
[FR Doc. 2016–02630 Filed 2–9–16; 8:45 am]
BILLING CODE 4810–AM–P
3 Such charge is in good faith so long as such
charge is ‘‘consistent with the best information
reasonably available to the creditor at the time it is
disclosed, regardless of whether the amount paid by
the consumer exceeds the amount disclosed’’ on the
Loan Estimate. 12 CFR 1026.19(e)(3)(iii) (emphasis
added).
4 78 FR 79730, 79829 (Dec. 31, 2013) (emphasis
added).
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0232; FRL–9941–15]
Poly(oxy-1,2-ethanediyl), α-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) Ethers, Disodium Salts;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts with a
polyoxyethylene (POE) content
averaging 5–15 moles, specifically CAS
Reg. Nos. 68815–56–5, 68954–91–6,
1013906–64–3, and 1024612–24–5,
when used as inert ingredients
(surfactants) in pesticide formulations
applied to crops at a concentration not
to exceed 10% by weight under 40 CFR
180.910. Keller and Heckman LLP on
behalf of Cytec Industries, Inc.,
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the establishment
of exemptions from the requirement of
a tolerance. This regulation eliminates
the need to establish a maximum
permissible level for residues of these
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) ethers, disodium salts.
DATES: This regulation is effective
February 10, 2016. Objections and
requests for hearings must be received
on or before April 11, 2016, 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–2015–0232, is
available at https://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
SUMMARY:
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information about the docket available
at https://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 https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2015–0232 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 11, 2016. 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
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any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
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–
2015–0232, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Petition for Exemption
In the Federal Register of May 20,
2015 (80 FR 28925) (FRL–9927–39),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–10759) by Keller and
Heckman LLP, 1001 G Street NW., Suite
500 West, Washington, DC 20001 on
behalf of Cytec Industries, Inc., 5 Garret
Mountain Plaza, Woodland Park, NJ
07424. The petition requested that 40
CFR 180.910 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10-C16) alkylethers, disodium salts
with a polyoxyethylene (POE) content
averaging 5–15 specifically poly(oxy1,2-ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, C10-12-alkyl
ethers, disodium salts, the
poly(oxyethylene) content averages 5–
15 moles (CAS Reg. No. 68954–91–6);
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, C10-16alkyl ethers, disodium salts, the
poly(oxyethylene) content averages 5–
15 moles (CAS Reg, No. 68815–56–5);
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, C12-14alkyl ethers, disodium salts, the
poly(oxyethylene) content averages 5–
15 moles (CAS Reg. No. 1024612–24–5);
and poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-
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(isotridecyloxy)-, sodium salt (1:2), the
poly(oxyethylene) content averages 5–
15 moles (CAS Reg. No. 1013906–64–3)
when used as an inert ingredient
(surfactant) in pesticide formulations
applied to growing crops and raw
agricultural commodities at a
concentration not to exceed 10% by
weight. That document referenced a
summary of the petition prepared by
Keller and Heckman LLP, on behalf of
Cytec Industries, Inc., the petitioner,
which is available in the docket, https://
www.regulations.gov. Comments were
not received on the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
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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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, 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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, 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), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
The acute oral and dermal toxicity in
rats are low for poly(oxy-1,2ethanediyl), a- (3-carboxy-1oxosulfopropyl)-w-hydroxy-, -alkyl (C10-
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C16) ethers, disodium salts. They are not
irritating to the eyes and moderately
irritating to the skin in rabbits. They are
weak dermal sensitizers. Acute
inhalation toxicity studies were not
available.
In subchronic toxicity studies, are
available in rats and dogs. (CAS Reg No.
68815–56–5) was administered via the
diet in both studies and similar effects
are seen in both. Bodyweight decreases
are seen in dogs at 565 milligrams/
kilogram/day (mg/kg/day) and in rats at
4% (equivalent to 3,519 mg/kg/day,
lowest observed adverse effect level
(LOAEL)). Decreased feed efficiency is
also observed at this dose in rats. The
NOAELs are 140 mg/kg/day and 1%
(equivalent to 770 mg/kg/day) in dogs
and rats, respectively. The chronic
reference dose (cRfD) is based on the 90day oral toxicity study in dogs.
The Organization for Economic
Cooperation and Development (OECD)
421 Reproduction/Developmental
Toxicity Screening Test, ‘‘secondary
alcohol ethoxylate’’, shows that
parental, offspring and reproduction
toxicity occur at 470 mg/kg/day.
Maternal toxicity is manifested as
decreased body weight and body weight
gain, decreased food consumption, and
clinical signs (ptosis and hypoactivity);
offspring toxicity is manifested as
decreased litter size, increased postimplantation loss, and microscopic
changes of the testes and epididymides;
and reproduction toxicity is manifested
as a slightly increased incidence of
microscopic changes of the testes and
epididymides (testicular atrophy,
increased intraluminal exfoliated
spermatogenic cells in epididymides,
and dilated seminiferous tubules). The
parental, offspring and reproduction
NOAELs are 168 mg/kg/day. Although
fetal qualitative susceptibility is
observed in this study, concern is low
because it occurs only in the presence
of maternal toxicity. Also, the cRfD is
protective of these effects.
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts are
not expected to be carcinogenic based
on the lack of structural alerts for
carcinogenicity in the Derek Nexus
analysis. Also, they are not mutagenic
based on the Ames and chromosomal
aberration tests.
Neurotoxicity and immunotoxicity
studies are not available for review.
However, evidence of neurotoxicity and
immunotoxicity is not observed in the
submitted studies.
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts are
expected to be metabolized similar to
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alkyl alcohol alkoxylates. These
metabolites are expected to be further
metabolized through degradation of the
ether linkage resulting in the
corresponding alkyl alcohol and
polyalkoxylate group which would
undergo further oxidative degradation
and/or excretion. Excreted materials are
mainly lower molecular weight POElike compounds, carbon dioxide and
water. Longer alkyl chain lengths are
excreted at a higher proportion into
expired air and less in urine and longer
POE chain lengths lead to more being
excreted via the feces and expired air.
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.
An acute effect was not found in the
database therefore an acute dietary
assessment is not necessary. The 90-day
oral toxicity study in dogs was selected
for the chronic exposure for this risk
assessment. The NOAEL in this study
was 140 mg/kg/day. The LOAEL was
565 mg/kg/day based on decreased
bodyweight. 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 FQPA safety
factor of 10X was reduced to 1X.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl (C10-C16) ethers,
disodium salts, EPA considered
exposure under the proposed exemption
from the requirement of a tolerance.
EPA assessed dietary exposures from
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) ethers, disodium salts in food
as follows:
Dietary exposure (food and drinking
water) to poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts can
occur following ingestion of foods with
residues from treated crops. Because no
adverse effects attributable to a single
exposure of poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl (C10-C16) ethers,
disodium salts are 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 10% by
weight in pesticide formulations.
2. Dietary exposure from drinking
water. For the purpose of the screeninglevel dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for poly(oxy1,2-ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts, a
conservative drinking water
concentration value of 100 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 nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
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alkyl (C10-C16) ethers, disodium salts
may be used in inert ingredients in
products that are registered for specific
uses that may result in residential
exposure, such as pesticides used in and
round the home, personal (care)
products, and cosmetics. The Agency
conducted an assessment to represent
worst-case residential exposure by
assessing poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts in
pesticideformulations (outdoor
scenarios) and in disinfectant-type uses
(indoor scenarios).
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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts to share a
common mechanism of toxicity with
any other substances, and poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts do 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), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) ethers, disodium salts do not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site 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
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7035
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The toxicity database for poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts contains two
subchronic studies, a reproduction/
developmental toxicity screening study,
and mutagenicity studies. There is no
indication of neurotoxicity or
immunotoxicity in the available studies;
therefore, there is no need to require
neurotoxicity or immunotoxicity
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 cRfD, 1.40 mg/
kg/day, will be protective of fetal effects.
In addition, the Agency used
conservative exposure estimates, with
100 percent crop treated, tolerance-level
residues, conservative drinking water
modeling numbers, and a worst-case
assessment of potential residential
exposure for infants and children.
Therefore, the FQPA SF of 10X is
reduced to 1X.
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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) 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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts from food
and water will utilize 10.3% of the
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cPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl(C10-C16) ethers, disodium salts
may be used as inert ingredients in
pesticide products that could result in
short-term residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) ethers, disodium salts. Using
the exposure assumptions described
above, EPA has concluded that the
combined short-term aggregated food,
water, and residential exposures result
in MOEs of 151 for both adult males and
females respectively. Adult residential
exposure combines high-end dermal
and inhalation handler exposure from
indoor hard surface, wiping with a highend post application dermal exposure
from contact with treated lawns. As the
level of concern is for MOEs that are
lower than 100, this MOE is not of
concern. EPA has concluded the
combined short-term aggregated food,
water, and residential exposures result
in an aggregate MOE of 430 for children.
Children’s residential exposure includes
total exposures associated with contact
with treated lawns (dermal and hand-tomouth exposures). As the level of
concern is for MOEs that are lower than
100, this MOEs is not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts
may be used as inert ingredients in
pesticide products that could result in
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
alkyl (C10-C16) ethers, disodium salts.
Using the exposure assumptions
described above, EPA has concluded
that the combined intermediate-term
aggregated food, water, and residential
exposures result in aggregate MOEs of
VerDate Sep<11>2014
13:49 Feb 09, 2016
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1637 for adult males and females. Adult
residential exposure combines Indoor
hard surface, wiping with a high end
post application dermal exposure from
contact with treated lawns. As the level
of concern is for MOEs that are lower
than 100, this MOE is not of concern.
EPA has concluded the combined
intermediate-term aggregated food,
water, and residential exposures result
in an aggregate MOE of 597 for children.
Children’s residential exposure includes
total exposures associated with contact
with treated surfaces (dermal and handto-mouth exposures). As the level of
concern is for MOEs that are lower than
100, this MOE is not of concern.
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),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl (C10-C16) ethers,
disodium salts are considered not
expected to pose a cancer risk to
humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts residues.
V. Other Considerations
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-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts in or on any
food commodities. EPA is establishing a
limitation on the amount of poly(oxy1,2-ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl (C10C16) ethers, disodium salts that may be
used in pesticide formulations applied
to growing crops. 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
formulation for use on growing crops for
sale or distribution that exceed 10% of
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
(C10-C16) ethers, disodium salts.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 for the following
when used as inert ingredients
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(surfactants) in pesticide products at a
concentration not to exceed 10% 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
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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations
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).
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
following inert ingredient(s) to the table
to read as follows:
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 19, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
*
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
Therefore, 40 CFR chapter I is
amended as follows:
Inert ingredients
Limits
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C10-12-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS
Reg. No. 68954–91–6).
*
*
Not to exceed 10% by weight of pesticide
formulation.
*
Surfactant.
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C10-16-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS
Reg, No. 68815–56–5).
*
*
Not to exceed 10% by weight of pesticide
formulation.
*
Surfactant.
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C12-14-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS
Reg. No. 1024612–24–5).
*
*
Not to exceed 10% by weight of pesticide
formulation.
*
Surfactant.
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-(isotridecyloxy)-, sodium
salt (1:2), the poly(oxyethylene) content averages 5–15 moles (CAS Reg. No.
1013906–64–3).
*
*
Not to exceed 10% by weight of pesticide
formulation.
*
Surfactant.
*
*
*
BILLING CODE 6560–50–P
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 141021887–5172–02]
jstallworth on DSK7TPTVN1PROD with RULES
RIN 0648–XE430
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod by
Catcher Vessels Less Than 60 Feet
(18.3 Meters) Length Overall Using
Hook-and-Line or Pot Gear in the
Bering Sea and Aleutian Islands
Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
13:49 Feb 09, 2016
Jkt 238001
NMFS is prohibiting directed
fishing for Pacific cod by catcher vessels
less than 60 feet (18.3 meters (m)) length
overall (LOA) using hook-and-line or
pot gear in the Bering Sea and Aleutian
Islands management area (BSAI). This
action is necessary to prevent exceeding
the 2016 Pacific cod total allowable
catch allocated to catcher vessels less
than 60 feet (18.3 m) LOA using hookand-line or pot gear in the BSAI.
DATES: Effective 1200 hours, Alaska
local time (A.l.t.), February 5, 2016,
through 2400 hours, A.l.t., December 31,
2016.
FOR FURTHER INFORMATION CONTACT: Josh
Keaton, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
SUMMARY:
DEPARTMENT OF COMMERCE
VerDate Sep<11>2014
*
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
[FR Doc. 2016–02569 Filed 2–9–16; 8:45 am]
AGENCY:
*
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Uses
*
*
BSAI exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands Management Area
(FMP) prepared by the North Pacific
Fishery Management Council under
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act. Regulations governing fishing by
U.S. vessels in accordance with the FMP
appear at subpart H of 50 CFR part 600
and 50 CFR part 679.
The 2016 Pacific cod total allowable
catch (TAC) allocated to catcher vessels
less than 60 feet (18.3 m) LOA using
hook-and-line or pot gear in the BSAI is
6,226 metric tons (mt) as established by
the final 2015 and 2016 harvest
specifications for groundfish in the
BSAI (80 FR 11919, March 5, 2015),
inseason adjustment (81 FR 184, January
5, 2016), and reallocation (81 FR 5627,
February 3, 2016).
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Agencies
[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Rules and Regulations]
[Pages 7032-7037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02569]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0232; FRL-9941-15]
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl (C10-C16) Ethers,
Disodium Salts; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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-, alkyl (C10-
C16) ethers, disodium salts with a polyoxyethylene (POE)
content averaging 5-15 moles, specifically CAS Reg. Nos. 68815-56-5,
68954-91-6, 1013906-64-3, and 1024612-24-5, when used as inert
ingredients (surfactants) in pesticide formulations applied to crops at
a concentration not to exceed 10% by weight under 40 CFR 180.910.
Keller and Heckman LLP on behalf of Cytec Industries, Inc., submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting the establishment of exemptions from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of these poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, alkyl
(C10-C16) ethers, disodium salts.
DATES: This regulation is effective February 10, 2016. Objections and
requests for hearings must be received on or before April 11, 2016, 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-2015-0232, is available at https://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
[[Page 7033]]
information about the docket available at https://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 https://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-2015-0232 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 11, 2016. 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 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-2015-0232, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10759) by
Keller and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington,
DC 20001 on behalf of Cytec Industries, Inc., 5 Garret Mountain Plaza,
Woodland Park, NJ 07424. The petition requested that 40 CFR 180.910 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-C16)
alkylethers, disodium salts with a polyoxyethylene (POE) content
averaging 5-15 specifically poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, C10-12-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5-15
moles (CAS Reg. No. 68954-91-6); poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, C10-16-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5-15
moles (CAS Reg, No. 68815-56-5); poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, C12-14-alkyl
ethers, disodium salts, the poly(oxyethylene) content averages 5-15
moles (CAS Reg. No. 1024612-24-5); and poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-(isotridecyloxy)-, sodium
salt (1:2), the poly(oxyethylene) content averages 5-15 moles (CAS Reg.
No. 1013906-64-3) when used as an inert ingredient (surfactant) in
pesticide formulations applied to growing crops and raw agricultural
commodities at a concentration not to exceed 10% by weight. That
document referenced a summary of the petition prepared by Keller and
Heckman LLP, on behalf of Cytec Industries, Inc., the petitioner, which
is available in the docket, https://www.regulations.gov. Comments were
not received on the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
[[Page 7034]]
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-, 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-, 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-, alkyl (C10-
C16) 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.
The acute oral and dermal toxicity in rats are low for poly(oxy-
1,2-ethanediyl), [alpha]- (3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-
, -alkyl (C10-C16) ethers, disodium salts. They
are not irritating to the eyes and moderately irritating to the skin in
rabbits. They are weak dermal sensitizers. Acute inhalation toxicity
studies were not available.
In subchronic toxicity studies, are available in rats and dogs.
(CAS Reg No. 68815-56-5) was administered via the diet in both studies
and similar effects are seen in both. Bodyweight decreases are seen in
dogs at 565 milligrams/kilogram/day (mg/kg/day) and in rats at 4%
(equivalent to 3,519 mg/kg/day, lowest observed adverse effect level
(LOAEL)). Decreased feed efficiency is also observed at this dose in
rats. The NOAELs are 140 mg/kg/day and 1% (equivalent to 770 mg/kg/day)
in dogs and rats, respectively. The chronic reference dose (cRfD) is
based on the 90-day oral toxicity study in dogs.
The Organization for Economic Cooperation and Development (OECD)
421 Reproduction/Developmental Toxicity Screening Test, ``secondary
alcohol ethoxylate'', shows that parental, offspring and reproduction
toxicity occur at 470 mg/kg/day. Maternal toxicity is manifested as
decreased body weight and body weight gain, decreased food consumption,
and clinical signs (ptosis and hypoactivity); offspring toxicity is
manifested as decreased litter size, increased post-implantation loss,
and microscopic changes of the testes and epididymides; and
reproduction toxicity is manifested as a slightly increased incidence
of microscopic changes of the testes and epididymides (testicular
atrophy, increased intraluminal exfoliated spermatogenic cells in
epididymides, and dilated seminiferous tubules). The parental,
offspring and reproduction NOAELs are 168 mg/kg/day. Although fetal
qualitative susceptibility is observed in this study, concern is low
because it occurs only in the presence of maternal toxicity. Also, the
cRfD is protective of these effects.
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl (C10-C16) ethers,
disodium salts are not expected to be carcinogenic based on the lack of
structural alerts for carcinogenicity in the Derek Nexus analysis.
Also, they are not mutagenic based on the Ames and chromosomal
aberration tests.
Neurotoxicity and immunotoxicity studies are not available for
review. However, evidence of neurotoxicity and immunotoxicity is not
observed in the submitted studies.
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl (C10-C16) ethers,
disodium salts are expected to be metabolized similar to alkyl alcohol
alkoxylates. These metabolites are expected to be further metabolized
through degradation of the ether linkage resulting in the corresponding
alkyl alcohol and polyalkoxylate group which would undergo further
oxidative degradation and/or excretion. Excreted materials are mainly
lower molecular weight POE-like compounds, carbon dioxide and water.
Longer alkyl chain lengths are excreted at a higher proportion into
expired air and less in urine and longer POE chain lengths lead to more
being excreted via the feces and expired air.
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.
An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. The 90-day oral toxicity study in
dogs was selected for the chronic exposure for this risk assessment.
The NOAEL in this study was 140 mg/kg/day. The LOAEL was 565 mg/kg/day
based on decreased bodyweight. 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 FQPA
safety factor of 10X was reduced to 1X.
[[Page 7035]]
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-, alkyl (C10-C16)
ethers, disodium salts, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl (C10-C16)
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-,
alkyl (C10-C16) ethers, disodium salts can occur
following ingestion of foods with residues from treated crops. Because
no adverse effects attributable to a single exposure of poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl (C10-C16) ethers, disodium salts are 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 10% by weight in
pesticide formulations.
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]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl (C10-C16) ethers, disodium salts, a
conservative drinking water concentration value of 100 ppb based on
screening-level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl (C10-C16) ethers,
disodium salts may be used in inert ingredients in products that are
registered for specific uses that may result in residential exposure,
such as pesticides used in and round the home, personal (care)
products, and cosmetics. The Agency conducted an assessment to
represent worst-case residential exposure by assessing poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl (C10-C16) ethers, disodium salts in
pesticideformulations (outdoor scenarios) and in disinfectant-type uses
(indoor scenarios).
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]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl (C10-C16)
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 (C10-C16)
ethers, disodium salts do 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
(C10-C16) ethers, disodium salts do not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site 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 toxicity database for
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl (C10-C16) ethers, disodium salts
contains two subchronic studies, a reproduction/developmental toxicity
screening study, and mutagenicity studies. There is no indication of
neurotoxicity or immunotoxicity in the available studies; therefore,
there is no need to require neurotoxicity or immunotoxicity 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 cRfD, 1.40 mg/kg/day, will be protective of
fetal effects. In addition, the Agency used conservative exposure
estimates, with 100 percent crop treated, tolerance-level residues,
conservative drinking water modeling numbers, and a worst-case
assessment of potential residential exposure for infants and children.
Therefore, the FQPA SF of 10X is reduced to 1X.
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-, alkyl (C10-C16) 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 (C10-C16) ethers, disodium salts
from food and water will utilize 10.3% of the
[[Page 7036]]
cPAD for children 1 to 2 years old, the population group receiving the
greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl(C10-C16) ethers, disodium
salts may be used as inert ingredients in pesticide products that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl (C10-C16) ethers, disodium salts. Using the
exposure assumptions described above, EPA has concluded that the
combined short-term aggregated food, water, and residential exposures
result in MOEs of 151 for both adult males and females respectively.
Adult residential exposure combines high-end dermal and inhalation
handler exposure from indoor hard surface, wiping with a high-end post
application dermal exposure from contact with treated lawns. As the
level of concern is for MOEs that are lower than 100, this MOE is not
of concern. EPA has concluded the combined short-term aggregated food,
water, and residential exposures result in an aggregate MOE of 430 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). As the level of concern is for MOEs that are lower than
100, this MOEs is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl (C10-C16) ethers,
disodium salts may be used as inert ingredients in pesticide products
that could result in intermediate-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with intermediate-term residential
exposures to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl (C10-C16)
ethers, disodium salts. Using the exposure assumptions described above,
EPA has concluded that the combined intermediate-term aggregated food,
water, and residential exposures result in aggregate MOEs of 1637 for
adult males and females. Adult residential exposure combines Indoor
hard surface, wiping with a high end post application dermal exposure
from contact with treated lawns. As the level of concern is for MOEs
that are lower than 100, this MOE is not of concern. EPA has concluded
the combined intermediate-term aggregated food, water, and residential
exposures result in an aggregate MOE of 597 for children. Children's
residential exposure includes total exposures associated with contact
with treated surfaces (dermal and hand-to-mouth exposures). As the
level of concern is for MOEs that are lower than 100, this MOE is not
of concern.
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-,
alkyl (C10-C16) ethers, disodium salts are
considered not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl (C10-C16)
ethers, disodium salts residues.
V. Other Considerations
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]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl (C10-C16) ethers, disodium salts
in or on any food commodities. EPA is establishing a limitation on the
amount of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl (C10-C16)
ethers, disodium salts that may be used in pesticide formulations
applied to growing crops. 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 formulation for use on growing crops for
sale or distribution that exceed 10% of poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, alkyl
(C10-C16) ethers, disodium salts.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for the following when used as inert
ingredients (surfactants) in pesticide products at a concentration not
to exceed 10% 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
[[Page 7037]]
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 19, 2016.
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. 180.910, add alphabetically the following inert
ingredient(s) to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Poly(oxy-1,2-ethanediyl), Not to exceed 10% Surfactant.
[alpha]-(3-carboxy-1- by weight of
oxosulfopropyl)-[omega]- pesticide
hydroxy-, C10-12-alkyl ethers, formulation.
disodium salts, the
poly(oxyethylene) content
averages 5-15 moles (CAS Reg.
No. 68954-91-6).
* * * * * * *
Poly(oxy-1,2-ethanediyl), Not to exceed 10% Surfactant.
[alpha]-(3-carboxy-1- by weight of
oxosulfopropyl)-[omega]- pesticide
hydroxy-, C10-16-alkyl ethers, formulation.
disodium salts, the
poly(oxyethylene) content
averages 5-15 moles (CAS Reg,
No. 68815-56-5).
* * * * * * *
Poly(oxy-1,2-ethanediyl), Not to exceed 10% Surfactant.
[alpha]-(3-carboxy-1- by weight of
oxosulfopropyl)-[omega]- pesticide
hydroxy-, C12-14-alkyl ethers, formulation.
disodium salts, the
poly(oxyethylene) content
averages 5-15 moles (CAS Reg.
No. 1024612-24-5).
* * * * * * *
Poly(oxy-1,2-ethanediyl), Not to exceed 10% Surfactant.
[alpha]-(3-carboxy-1- by weight of
oxosulfopropyl)-[omega]- pesticide
(isotridecyloxy)-, sodium salt formulation.
(1:2), the poly(oxyethylene)
content averages 5-15 moles
(CAS Reg. No. 1013906-64-3).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-02569 Filed 2-9-16; 8:45 am]
BILLING CODE 6560-50-P