Sodium 1,4-Dialkyl Sulfosuccinates; Exemption from the Requirement of a Tolerance, 34045-34049 [2010-14093]
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Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations
List of Subjects in 40 CFR Part 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 1, 2010.
Steven Bradbury,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 174.532 to subpart W to read
as follows:
■
§ 174.532 Bacillus thuringiensis eCry3.1Ab
protein in corn; temporary exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis
eCry3.1Ab protein in corn, in or on the
food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop
are exempt temporarily from the
requirement of a tolerance when
Bacillus thuringiensis eCry3.1Ab
protein in corn is used as a plantincorporated protectant in accordance
with the terms of Experimental Use
Permit 67979-EUP-8. This temporary
exemption from the requirement of a
tolerance expires and is revoked on June
1, 2012.
[FR Doc. 2010–14330 Filed 6–15–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0739; FRL–8825–2]
Sodium 1,4-Dialkyl Sulfosuccinates;
Exemption from the Requirement of a
Tolerance
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AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of sodium 1,4dialkyl sulfosuccinates including
sodium 1,4-dihexyl sulfosuccinate (CAS
Reg. No. 3006–15–3); sodium 1,4diisobutyl sulfosuccinate (CAS Reg. No.
127–39–9); and sodium 1,4-dipentyl
sulfosuccinate (CAS Reg. No. 922–80–5)
when used as an inert ingredient in
pesticide formulations for pre-harvest
and post-harvest uses, as well as, for
application to animals under 40 CFR
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180.910 and 40 CFR 180.930,
respectively. The Joint Inerts Task Force
(JITF), Cluster Support Team 13
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of the
sodium 1,4-dialkyl sulfosuccinates.
DATES: This regulation is effective June
16, 2010. Objections and requests for
hearings must be received on or before
August 16, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0739. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Karen Samek, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8825; e-mail address:
samek.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
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34045
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR cite at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS harmonized test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods and Guidelines.’’
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. The EPA procedural
regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0739 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 August 16, 2010. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
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EPA–HQ–OPP–2008–0739, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Exemption
In the Federal Register of March 19,
2010 (75 FR 13277) (FRL–8813–2), EPA
issued a notice pursuant to section 408
of FFDCA, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
9E7647) by the Joint Inerts Task Force,
Cluster Support Team 13, EPA
Company Number 84949, c/o CropLife
America, 1156 15th St., NW., Suite 400,
Washington, DC 20005. The petition
requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by
establishing exemptions from the
requirement of a tolerances for residues
of sodium 1,4-dialkyl sulfosuccinates
including sodium 1,4-dihexyl
sulfosuccinate (CAS Reg. No. 3006–15–
3); sodium 1,4-diisobutyl sulfosuccinate
(CAS Reg. No. 127–39–9); and sodium
1,4-dipentyl sulfosuccinate (CAS Reg.
No. 922–80–5) when used as inert
ingredients in pesticide formulations for
pre-harvest and post-harvest uses, as
well as, for application to animals. For
ease of reading this document the
sodium 1,4-dialkyl sulfosuccinates will
be referred to as SDSS. That notice
referenced a summary of the petition
prepared by the Joint Inerts Task Force
(JITF), Cluster Support Team Number 13
(CST 13), the petitioner, which is
available in the docket, https://
www.regulations.gov. No comments
were received in the docket. However,
the Agency received one comment by email. The comment was received from
a private citizen who opposed the
authorization to sell any pesticide that
leaves a residue on food. The Agency
understands the commenter’s concerns
and recognizes that some individuals
believe that no residue of pesticides
should be allowed. However, under the
existing legal framework provided by
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section 408 of the FFDCA 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
that statute.
EPA previously published a final rule
to establish a tolerance for SDSS under
40 CFR 180.920 in the Federal Register
of July 8, 2009 (74 FR 32433) (FRL–
8423–3). That final rule established a
tolerance exemption for SDSS when
used as an inert ingredient in pesticide
formulations applied to growing crops
only.
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
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aggregate exposure to the pesticide
chemical residue....’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with section 408(c)(2)(A)
of FFDCA, and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for SDSS including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with SDSS 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.
SDSS have moderate to low acute oral
toxicity and low dermal acute toxicity.
There was no hazard identified in a
combined repeat dose rat reproductive/
developmental screening study at the
limit dose of 1,000 milligrams/kilogram/
day (mg/kg/day) to either parental
animals or their offspring. There is no
concern for neurotoxicity,
immunotoxicity or carcinogenicity for
SDSS.
Specific information on the studies
received and the nature of any observed
effects caused by SDSS as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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www.regulations.gov in the document
‘‘Sodium 1,4-Dialkyl Sulfosuccinates
(JITF CST 13 Inert Ingredients). Human
Health Risk Assessment to Support
Proposed Exemption from the
Requirement of a Tolerance When Used
as Inert Ingredients in Pesticide
Formulations’’ pages 6–8 in docket ID
number EPA–HQ–OPP–2008–0739.
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.
There was no hazard identified in a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test in rats with SDSS
at the limit dose of 1,000 mg/kg/day to
either parental animals or their
offspring. Thus, due to their low
potential hazard and lack of a hazard
endpoint, the Agency has determined
that a quantitative risk assessment using
safety factors applied to a POD
protective of an identified hazard
endpoint is not appropriate.
No mutagenicity, genotoxicity, or
chronic toxicity data have been located
for any of the SDSS. However, no
structural alerts for genotoxicity or
carcinogenicity were identified in a
qualitative structure activity
relationship (SAR) database, DEREK
Version 11. In addition, data for similar
compounds showed they are not
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mutagenic or carcinogenic. The primary
alcohol mammalian metabolites of SDSS
have been shown to be negative in the
in vitro Ames test. Furthermore, a
structurally similar compound that is
also used as an inert ingredient, sodium
dioctyl sulfosuccinate (CAS Reg. No.
577–11–7) was not mutagenic, or
carcinogenic in a chronic rat study or a
tumor promotion study. Based on the
above, SDSS are not expected to be
carcinogenic.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses and drinking water. Since an
endpoint for risk assessment was not
identified, an exposure assessment for
SDSS was not conducted. Any possible
dietary exposure of SDSS from their use
as inert ingredients in pesticide
products would be through
consumption of food to which pesticide
products containing SDSS have been
applied and through drinking water
(from runoff).
2. 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).
Since an endpoint for risk assessment
was not identified, a quantitative
residential exposure assessment for
SDSS was not conducted. Residential
exposures to SDSS may occur as a result
of the use of pesticide products
containing SDSS as inert ingredients
(such as antimicrobial hard surface
cleaners) as well as from other,
nonpesticidal, residential use products
containing SDSS.
3. 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 SDSS to share a
common mechanism of toxicity with
any other substances, and SDSS does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that SDSS
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
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34047
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold (10X) margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
The toxicity database for SDSS is
adequate for FQPA assessment and the
potential exposure is adequately
characterized given the low toxicity of
the chemical. There was no hazard
identified in a combined repeat dose rat
reproductive/developmental screening
study at the limit dose of 1,000 mg/kg/
day to either parental animals or their
offspring. There is no concern for
neurotoxicity, immunotoxicity or
carcinogenicity for SDSS.
Based on this information, there is no
concern, at this time, for increased
sensitivity to infants and children to
SDSS when used as inert ingredients in
pesticide formulations for pre-harvest
and post-harvest uses, as well as for
application to animals, therefore a safety
factor analysis has not been used to
assess risk. For the same reason, EPA
has determined that an additional safety
factor is not needed to protect the safety
of infants and children.
E. Aggregate Risks and Determination of
Safety
Given the lack of concern for hazard
posed by SDSS, EPA concludes that
there are no dietary or aggregate dietary/
non-dietary risks of concern as a result
of exposure to SDSS in food and water
or from residential exposure.
Taking into consideration all available
information on SDSS, EPA has
determined that there is a reasonable
certainty that no harm to any population
subgroup will result from aggregate
exposure to SDSS under reasonable
foreseeable circumstances. Therefore,
the establishment of an exemption from
tolerance under 40 CFR 180.910 and 40
CFR 180.930 for residues of sodium 1,4dialkyl sulfosuccinates including
sodium 1,4-dihexyl sulfosuccinate (CAS
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Reg. No. 3006–15–3); sodium 1,4diisobutyl sulfosuccinate (CAS Reg. No.
127–39–9); and sodium 1,4-dipentyl
sulfosuccinate (CAS Reg. No. 922–80–5)
when used as an inert ingredient in
pesticide formulations for pre-harvest
and post-harvest uses, as well as, for
application to animals, is safe under
FFDCA section 408.
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. International Residue Limits
The Agency is not aware of any
country requiring a tolerance for SDSS
nor have any CODEX Maximum Residue
Levels been established for any food
crops at this time.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 and 40 CFR
180.930 for sodium 1,4-dialkyl
sulfosuccinates including sodium 1,4dihexyl sulfosuccinate (CAS Reg. No.
3006–15–3); sodium 1,4-diisobutyl
sulfosuccinate (CAS Reg. No. 127–39–
9); and sodium 1,4-dipentyl
sulfosuccinate (CAS Reg. No. 922–80–5)
when used as an inert ingredient in
pesticide formulations for pre-harvest
and post-harvest uses, as well as, for
application to animals.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the 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 final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
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VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 28, 2010.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
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, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
Limits
*
*
*
Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15–
3).
Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127–
39–9).
Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80–
5).
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This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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surfactants
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surfactants
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surfactants
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34049
Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations
*
*
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3. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
Inert Ingredients
*
*
*
*
*
[FR Doc. 2010–14093 Filed 6–15–10; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 10–786; MB Docket No. 05–10; RM–
11279]
FM Table of Allotments (The Dalles,
Tualatin, Eugene, Albany, Lebanon,
Paisley, and Diamond Lake, Oregon
and Goldendale, WA)
mstockstill on DSKH9S0YB1PROD with RULES
AGENCY: Federal Communications
Commission
ACTION: Final rule; dismissal of petition
for reconsideration.
SUMMARY: The Audio Division dismisses
a Petition for Reconsideration jointly
filed by Portland Broadcasting, LLC
(‘‘Portland Broadcasting’’), licensee of
Station KXPC–FM, Channel 279C,
Lebanon, Oregon, Bicoastal Media
Licenses IV, LLC (‘‘Bicoastal’’), licensee
of Station KACI–FM, Channel 249C2,
The Dalles, Oregon, and Station
KMSW(FM), Channel 224C3, The
Dalles, Oregon, and Extra Mile Media,
Inc., licensee of Station KHPE(FM),
Channel 300C, Albany, Oregon,
collectively (the ‘‘Joint Petitioners’’). In
this regard, Portland Broadcasting,
Columbia Gorge Broadcasters, Inc.,
M.S.W Communications, LLC, Bicoastal,
and Extra Media, Inc. (the ‘‘Joint
Parties’’) filed a Motion to Dismiss the
Petition for Reconsideration. The Joint
Parties’ Motion to Dismiss the Petition
for Reconsideration contained a
Settlement Agreement between
Cumulus and the Joint Parties. In
accordance with Section 1.420(j) of the
Commission’s Rules, we are granting the
Joint Parties’ Motion to Dismiss. In
doing so, we approve the Settlement
Agreement. The Joint Parties will
VerDate Mar<15>2010
16:21 Jun 15, 2010
Jkt 220001
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Limits
*
*
*
Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15–
3).
Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127–
39–9).
Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80–
5).
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
Uses
*
*
*
*
...........................................................
...........................................................
...........................................................
*
*
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collectively and individually receive
payments that are less than their
respective legitimate and prudent
expenses incurred in connection with
the preparation, filing and advocacy of
the Counterproposal. Each party filed a
declaration in accordance with Section
1.420(j), containing an itemization of its
respective legal, engineering and other
legitimate and prudent expenses. The
Joint Parties and Cumulus each state in
its respective declaration that aside from
the Settlement Agreement, neither
respective licensee nor any of its
members, officers, or employees is a
party to any agreement, written or oral,
that will require the respective licensee
to pay or receive any monies or provide
or receive any other consideration from
or to the existing and former licensee for
the actions described in each respective
declaration.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Rolanda F. Smith, Media Bureau, (202)
418–2180.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s
Memorandum Opinion and Order, MB
Docket No. 05–10, adopted May 21,
2010, and released May 24, 2010. The
full text of this Commission document
is available for inspection and copying
during normal business hours in the
FCC Reference Information Center
(Room CY–A257), 445 12th Street, SW.,
Washington, DC.
The complete text of this decision
may also be purchased from the
Commission’s copy contractor, Best
Copy and Printing, Inc., 445 12th Street,
SW, Room CY–B402, Washington, DC
20554, 800–378–3160 or via the
company’s website, <https://
www.bcpiweb.com>.
The Commission will not send a copy
of this Memorandum Opinion and
Order pursuant to the Congressional
PO 00000
Frm 00061
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Sfmt 4700
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surfactants
adjuvants
of
adjuvants
of
adjuvants
of
*
Review Act, see 5 U.S.C. 801(a)(1)(A),
because the aforementioned petition for
reconsideration was dismissed.
This document does not contain
proposed information collection
requirements subject to the Paperwork
Reduction Act of 1995, Public Law 104–
13. In addition, therefore, it does not
contain any proposed information
collection burden ‘‘for small business
concerns with fewer than 25
employees,’’ pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C.
3506(c)(4).
Provisions of the Regulatory
Flexibility Act of 1980 do not apply to
this proceeding.
List of Subjects in 47 CFR Part 73
Federal Communications Commission.
John A. Karousos,
Assistant Chief,
Audio Division,
Media Bureau.
[FR Doc. 2010–14512 Filed 6–15–10– 8:45 am]
BILLING CODE 6712–01–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 080228326–0108–03]
RIN 0648–AW30
Magnuson-Stevens Fishery
Conservation and Management Act
Provisions; Fisheries of the
Northeastern United States; Northeast
Skate Complex Fishery; Amendment 3
AGENCY: National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
E:\FR\FM\16JNR1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 115 (Wednesday, June 16, 2010)]
[Rules and Regulations]
[Pages 34045-34049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14093]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0739; FRL-8825-2]
Sodium 1,4-Dialkyl Sulfosuccinates; 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 sodium 1,4-dialkyl sulfosuccinates
including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3);
sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and
sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as
an inert ingredient in pesticide formulations for pre-harvest and post-
harvest uses, as well as, for application to animals under 40 CFR
180.910 and 40 CFR 180.930, respectively. The Joint Inerts Task Force
(JITF), Cluster Support Team 13 submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of the sodium 1,4-dialkyl sulfosuccinates.
DATES: This regulation is effective June 16, 2010. Objections and
requests for hearings must be received on or before August 16, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0739. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8825; e-mail address: samek.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to https://www.epa.gov/oppts and select ``Test Methods and Guidelines.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0739 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 August
16, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number
[[Page 34046]]
EPA-HQ-OPP-2008-0739, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption
In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E7647) by the
Joint Inerts Task Force, Cluster Support Team 13, EPA Company Number
84949, c/o CropLife America, 1156 15th St., NW., Suite 400, Washington,
DC 20005. The petition requested that 40 CFR 180.910 and 40 CFR 180.930
be amended by establishing exemptions from the requirement of a
tolerances for residues of sodium 1,4-dialkyl sulfosuccinates including
sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); sodium 1,4-
diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and sodium 1,4-
dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as inert
ingredients in pesticide formulations for pre-harvest and post-harvest
uses, as well as, for application to animals. For ease of reading this
document the sodium 1,4-dialkyl sulfosuccinates will be referred to as
SDSS. That notice referenced a summary of the petition prepared by the
Joint Inerts Task Force (JITF), Cluster Support Team Number 13 (CST
13), the petitioner, which is available in the docket, https://www.regulations.gov. No comments were received in the docket. However,
the Agency received one comment by e-mail. The comment was received
from a private citizen who opposed the authorization to sell any
pesticide that leaves a residue on food. The Agency understands the
commenter's concerns and recognizes that some individuals believe that
no residue of pesticides should be allowed. However, under the existing
legal framework provided by section 408 of the FFDCA 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 that statute.
EPA previously published a final rule to establish a tolerance for
SDSS under 40 CFR 180.920 in the Federal Register of July 8, 2009 (74
FR 32433) (FRL-8423-3). That final rule established a tolerance
exemption for SDSS when used as an inert ingredient in pesticide
formulations applied to growing crops only.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for SDSS including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with SDSS 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.
SDSS have moderate to low acute oral toxicity and low dermal acute
toxicity. There was no hazard identified in a combined repeat dose rat
reproductive/developmental screening study at the limit dose of 1,000
milligrams/kilogram/day (mg/kg/day) to either parental animals or their
offspring. There is no concern for neurotoxicity, immunotoxicity or
carcinogenicity for SDSS.
Specific information on the studies received and the nature of any
observed effects caused by SDSS as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://
[[Page 34047]]
www.regulations.gov in the document ``Sodium 1,4-Dialkyl
Sulfosuccinates (JITF CST 13 Inert Ingredients). Human Health Risk
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations''
pages 6-8 in docket ID number EPA-HQ-OPP-2008-0739.
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.
There was no hazard identified in a combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats with SDSS at the limit dose of 1,000 mg/kg/day to either parental
animals or their offspring. Thus, due to their low potential hazard and
lack of a hazard endpoint, the Agency has determined that a
quantitative risk assessment using safety factors applied to a POD
protective of an identified hazard endpoint is not appropriate.
No mutagenicity, genotoxicity, or chronic toxicity data have been
located for any of the SDSS. However, no structural alerts for
genotoxicity or carcinogenicity were identified in a qualitative
structure activity relationship (SAR) database, DEREK Version 11. In
addition, data for similar compounds showed they are not mutagenic or
carcinogenic. The primary alcohol mammalian metabolites of SDSS have
been shown to be negative in the in vitro Ames test. Furthermore, a
structurally similar compound that is also used as an inert ingredient,
sodium dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) was not
mutagenic, or carcinogenic in a chronic rat study or a tumor promotion
study. Based on the above, SDSS are not expected to be carcinogenic.
C. Exposure Assessment
1. Dietary exposure from food and feed uses and drinking water.
Since an endpoint for risk assessment was not identified, an exposure
assessment for SDSS was not conducted. Any possible dietary exposure of
SDSS from their use as inert ingredients in pesticide products would be
through consumption of food to which pesticide products containing SDSS
have been applied and through drinking water (from runoff).
2. 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).
Since an endpoint for risk assessment was not identified, a
quantitative residential exposure assessment for SDSS was not
conducted. Residential exposures to SDSS may occur as a result of the
use of pesticide products containing SDSS as inert ingredients (such as
antimicrobial hard surface cleaners) as well as from other,
nonpesticidal, residential use products containing SDSS.
3. 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 SDSS to share a common mechanism of toxicity
with any other substances, and SDSS does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that SDSS does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
Safety Factor (FQPA SF). In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
The toxicity database for SDSS is adequate for FQPA assessment and
the potential exposure is adequately characterized given the low
toxicity of the chemical. There was no hazard identified in a combined
repeat dose rat reproductive/developmental screening study at the limit
dose of 1,000 mg/kg/day to either parental animals or their offspring.
There is no concern for neurotoxicity, immunotoxicity or
carcinogenicity for SDSS.
Based on this information, there is no concern, at this time, for
increased sensitivity to infants and children to SDSS when used as
inert ingredients in pesticide formulations for pre-harvest and post-
harvest uses, as well as for application to animals, therefore a safety
factor analysis has not been used to assess risk. For the same reason,
EPA has determined that an additional safety factor is not needed to
protect the safety of infants and children.
E. Aggregate Risks and Determination of Safety
Given the lack of concern for hazard posed by SDSS, EPA concludes
that there are no dietary or aggregate dietary/non-dietary risks of
concern as a result of exposure to SDSS in food and water or from
residential exposure.
Taking into consideration all available information on SDSS, EPA
has determined that there is a reasonable certainty that no harm to any
population subgroup will result from aggregate exposure to SDSS under
reasonable foreseeable circumstances. Therefore, the establishment of
an exemption from tolerance under 40 CFR 180.910 and 40 CFR 180.930 for
residues of sodium 1,4-dialkyl sulfosuccinates including sodium 1,4-
dihexyl sulfosuccinate (CAS
[[Page 34048]]
Reg. No. 3006-15-3); sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No.
127-39-9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-
5) when used as an inert ingredient in pesticide formulations for pre-
harvest and post-harvest uses, as well as, for application to animals,
is safe under FFDCA section 408.
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. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
SDSS nor have any CODEX Maximum Residue Levels been established for any
food crops at this time.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 40 CFR 180.930 for sodium 1,4-
dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate
(CAS Reg. No. 3006-15-3); sodium 1,4-diisobutyl sulfosuccinate (CAS
Reg. No. 127-39-9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg.
No. 922-80-5) when used as an inert ingredient in pesticide
formulations for pre-harvest and post-harvest uses, as well as, for
application to animals.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the 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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 28, 2010.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * ..................
Sodium 1,4-dihexyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
3006-15-3). of surfactants
Sodium 1,4-diisobutyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
127-39-9). of surfactants
Sodium 1,4-dipentyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
922-80-5). of surfactants
* * * * * * *
------------------------------------------------------------------------
[[Page 34049]]
* * * * *
0
3. In Sec. 180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Sodium 1,4-dihexyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
3006-15-3). of surfactants
Sodium 1,4-diisobutyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
127-39-9). of surfactants
Sodium 1,4-dipentyl .................. Surfactants,
sulfosuccinate (CAS Reg. No. related adjuvants
922-80-5). of surfactants
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-14093 Filed 6-15-10; 8:45 am]
BILLING CODE 6560-50-S
