2-methyl-1,3-propanediol; Exemption from the Requirement of a Tolerance, 51388-51392 [2010-20581]
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Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations
Inert ingredients
Limits
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Uses
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
3. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
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Inert ingredients
Limits
Uses
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a-alkyl (minimum C6 linear or branched, saturated and or unsaturated)-w-hydroxypolyoxyethylene
polymer
with
or
without
polyoxypropylene, mixture of di- and monohydrogen phosphate
esters and the corresponding ammonium, calcium, magnesium,
monoethanolamine, potassium, sodium and zinc salts of the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles (CAS Reg. Nos. 9046–01–9,
39464–66–9, 50643–20–4, 52019–36–0, 68071–35–2, 68458–48–0,
68585–36–4, 68815–11–2, 68908–64–5, 68511–37–5, 68130–47–2,
42612–52–2, 58318–92–6, 60267–55–2, 68070–99–5, 68186–36–7,
68186–37–8, 68610–65–1, 68071–17–0, 936100–29–7, 936100–
30–0, 73038–25–2, 78330–24–2, 154518–39–5, 317833–96–8,
108818–88–8, 873662–29–4, 61837–79–4, 68311–02–4, 68425–
73–0, 37280–82–3, 68649–29–6, 67711–84–6, 68891–13–4.
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Not to exceed 30% of pesticide
formulation
Surfactants, related adjuvants of
surfactants
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[FR Doc. 2010–20708 Filed 8–19–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2002–0185; FRL–8838–3]
2-methyl-1,3-propanediol; 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 2-methyl-1,3propanediol (CAS Reg. No. 2163-42-0)
when used as an inert ingredient in
pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest, and when
used as an inert ingredient solvent and/
or surfactant in pesticide formulations
applied to animals (used for food).
Lyondell Chemical Company 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 2methyl-1,3-propanediol.
DATES: This regulation is effective
August 20, 2010. Objections and
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SUMMARY:
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requests for hearings must be received
on or before October 19, 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–2002–0185. 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: Keri
Grinstead, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
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(703) 308–8373; e-mail address:
grinstead.keri@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
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through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr.
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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–2002–0185 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 October 19, 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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2002–0185, 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 August 28,
2002 (67 FR 55243) (FRL–7194–6), EPA
issued a notice pursuant to section 408
of FFDCA, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
2E6484) by Lyondell Chemical
Company, 1221 McKinney Street, Suite
1600, Houston, TX 77253-2583. The
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petition requested that 40 CFR part 180
be amended by establishing an
exemption from the requirement of a
tolerance for residues of 2-methyl-1,3propanediol (CAS Reg. No. 2163–42–0)
in or on all raw agricultural
commodities. That notice referenced a
summary of the petition prepared by
Lyondell Chemical Company, the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to 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....’’
EPA establishes exemptions from the
requirement of a tolerance only in those
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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 2-methyl-1,3propanediol including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with 2-methyl-1,3propanediol 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.
Acute toxicity studies of 2-methyl-1,3propanediol in the rat indicate that this
compound is practically non-toxic (EPA
Toxicity Category IV) by the oral and
inhalation exposure routes. The oral
LD50 is greater than 5,000 milligrams/
kilogram (mg/kg) and the inhalation
LC50 is greater than 5,100 mg/m3. It is
slightly toxic by the dermal exposure
route (EPA Toxicity Category III) with
an acute dermal LD50 in rabbits of
greater than 2,000 mg/kg. Acute
irritation studies in rabbits indicate that
2-methyl-1,3-propanediol is not
irritating to the skin and eyes. Based on
the results of a dermal sensitization
study in guinea pigs, 2-methyl-1,3propanediol was determined to have
mild sensitizing potential.
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Repeat oral exposure produced no
toxicity at doses up to and including
1,000 mg/kg/day. No neurotoxicity
studies are available; however, no
clinical signs of neurotoxicity or any
systemic toxicity were observed in any
of the available studies. 2-methyl-1,3propanediol was not mutagenic in an in
vitro chromosome aberration test,
bacterial gene mutation test, and
mammalian cell gene mutation assay.
No developmental, reproductive, or
teratogenic effects were seen in the
available studies at doses up to and
including 1,000 mg/kg/day (highest
dose tested).
No carcinogenicity studies are
available for 2-methyl-1,3-propanediol
and it has not been evaluated by the
International Agency for Research on
Cancer (IARC). Based on available
studies, there is no evidence of
genotoxic activity. There is no evidence
of systemic toxicity at doses up to and
including 1,000 mg/kg/day in the
available toxicity studies, such as 14–
day oral gavage study in rats, 90–day
oral gavage study in rats, developmental
toxicity studies in rats and rabbits and
2-generation reproduction study in rats.
In addition, a qualitative structure
activity relationship database, DEREK
Version 11, identified no structural
alerts suggestive of carcinogenicity.
Based on the weight of the evidence, the
Agency has determined that 2-methyl1,3-propanediol is not anticipated to be
carcinogenic.
Specific information on the studies
received and the nature of the adverse
effects caused by 2-methyl-1,3propanediol as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at https://www.regulations.gov
in the document ‘‘Decision Document
for Petition Number 2E6484; 2-methyl1,3-propanediol [CAS Reg. No. 2163–
42–0], requesting the establishment of
an inert ingredient exemption from the
requirement of a tolerance’’ in docket ID
number EPA–HQ–OPP–2002–0185.
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
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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
repeat dose toxicity and reproductive/
developmental studies at the limit dose
of 1,000 mg/kg/day to either parental
animals or their offspring. Thus, due to
its low potential hazard and lack of a
hazard endpoint, the Agency has
determined that a quantitative risk
assessment using safety factors applied
to a point of departure protective of an
identified hazard endpoint is not
appropriate.
2-methyl-1,3-propanediol was not
mutagenic in an in vitro chromosome
aberration test, bacterial gene mutation
test, and mammalian cell gene mutation
assay and based on the available
information, it is not anticipated to be
carcinogenic.
C. Exposure Assessment
No hazard was identified for the acute
and chronic dietary assessment (food
and drinking water), or for the short,
intermediate, and long term residential
assessments, and therefore no aggregate
risk assessments were performed.
1. Dietary exposure from food and
feed uses and drinking water. Since an
endpoint for risk assessment was not
identified, an exposure assessment for
2-methyl-1,3-propanediol was not
conducted. The primary route of
exposure to 2-methyl-1,3-propanediol
from its use as an inert ingredient in
pesticide products would most likely be
through consumption of food to which
pesticide products containing it have
been applied, and possibly 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).
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Since an endpoint for risk assessment
was not identified, a quantitative
residential exposure assessment for 2methyl-1,3-propanediol was not
conducted. Residential (dermal and
inhalation) exposures from home garden
uses are possible.
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 2-methyl-1,3propanediol to share a common
mechanism of toxicity with any other
substances, and 2-methyl-1,3propanediol does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that 2-methyl-1,3-propanediol
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
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.
The toxicity database for 2-methyl1,3-propanediol is adequate for FQPA
assessment and the potential exposure
is adequately characterized given the
low toxicity of the chemical. No hazard
was identified and there is no residual
uncertainty regarding prenatal and/or
postnatal toxicity. No acute or
subchronic neurotoxicity studies are
available, but there were no clinical
signs of neurotoxicity or any systemic
toxicity observed in the available
database at doses up to 1,000 mg/kg/
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day. No developmental, reproductive, or
teratogenic effects were seen in the
available studies at doses up to and
including 1,000 mg/kg/day.
Based on this information, there is no
concern, at this time, for increased
sensitivity to infants and children to 2methyl-1,3-propanediol when used as
an inert ingredient in pesticide
formulations for pre-harvest and postharvest uses, as well as, for application
to animals, and 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 2-methyl-1,3-propanediol,
EPA concludes that there are no dietary
or aggregate dietary/non-dietary risks of
concern as a result of exposure to 2methyl-1,3-propanediol in food and
water or from residential exposure.
Residues of concern are not anticipated
for dietary exposure (food and drinking
water) or for residential exposure from
the use of 2-methyl-1,3-propanediol as
an inert ingredient in pesticide
products. As discussed above, EPA
expects aggregate exposure to 2-methyl1,3-propanediol to pose no appreciable
dietary risk given that the data show a
lack of any systemic toxicity at doses up
to 1,000 mg/kg/day and a lack of any
apparent developmental effects.
Taking into consideration all available
information on 2-methyl-1,3propanediol, EPA has determined that
there is a reasonable certainty that no
harm to any population subgroup will
result from aggregate exposure to 2methyl-1,3-propanediol under
reasonably foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance under 40 CFR
180.910 and 180.930 for residues of 2methyl-1,3-propanediol when used as
an inert ingredient in pesticide
formulations applied to growing crops,
raw agricultural commodities after
harvest, and to animals (used for food),
is safe under FFDCA section 408.
V. Other Considerations
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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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
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international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for 2-methyl-1,3-propanediol.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 and 40 CFR
180.930 for 2-methyl-1,3-propanediol
(CAS Reg. No. 2163–42–0) when used as
an inert ingredient in pesticide
formulations applied to growing crops,
raw agricultural commodities after
harvest, and to animals (used for food).
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
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51391
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
E:\FR\FM\20AUR1.SGM
20AUR1
51392
Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations
Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
Therefore, 40 CFR chapter I is
amended as follows:
■
*
*
*
*
*
*
*
3. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
Inert ingredients
*
*
*
*
41 CFR Part 102–117
[FMR Amendment 2010–03; FMR Case
2010–102–2; Docket Number 2010–0011,
sequence 1]
40 CFR Part 272
RIN 3090–AJ03
[EPA–R02–RCRA–2010–0249; FRL–9178–8]
New York: Incorporation by Reference
of State Hazardous Waste Management
Program
Correction
In rule document 2010–18927
beginning on page 45489 in the issue of
Tuesday, August 3, 2010, make the
following correction:
Appendix A to Part 272
[Corrected]
On page 45494, in Appendix A to Part
272, in the first column, in the second
paragraph ‘‘Note:’’ should read ‘‘1Note:’’.
[FR Doc. C1–2010–18927 Filed 8–19–10; 8:45 am]
jdjones on DSK8KYBLC1PROD with RULES
BILLING CODE 1505–01–D
Federal Management Regulation;
Transportation Management
Office of Governmentwide
Policy, General Services Administration
(GSA).
ACTION: Final rule.
AGENCY:
The General Services
Administration (GSA) is amending the
Federal Management Regulation (FMR)
by updating its coverage on
transportation management. This final
rule updates definitions and corrects
mailing and Web site addresses.
DATES: Effective Date: This final rule is
effective August 20, 2010.
FOR FURTHER INFORMATION CONTACT: The
Regulatory Secretariat, Room 4041, GS
Building, Washington, DC 20405, (202)
501–4755, for information pertaining to
status or publication schedules. For
clarification of content, contact Patrick
O’Grady at (202) 208–4493. Please cite
FMR case 2010–102–2, Amendment
2001–03.
SUPPLEMENTARY INFORMATION:
SUMMARY:
A. Background
Part 102–117 of the Federal
Management Regulation (FMR) (41 CFR
part 102–117, Transportation
VerDate Mar<15>2010
18:27 Aug 19, 2010
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Frm 00024
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Solvent, surfactant
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
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Uses
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GENERAL SERVICES
ADMINISTRATION
ENVIRONMENTAL PROTECTION
AGENCY
*
Limits
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*
2-methyl-1,3-propanediol (CAS Reg. No. 2163–42–0)
*
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BILLING CODE 6560–50–S
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Uses
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■
[FR Doc. 2010–20581 Filed 8–19–10; 8:45 am]
*
Limits
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2-methyl-1,3-propanediol (CAS Reg. No. 2163–42–0)
*
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*
§ 180.910 Inert Ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
Inert ingredients
*
2. In § 180.910, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
■
PART 180—[AMENDED]
*
Solvent, surfactant
*
Management) was last reviewed and
amended in 2004. GSA collaborated
with eight agencies to conduct a review
and determine if 41 CFR part 102–117
is still current and accurate. This final
rule reflects the changes recommended
by GSA and the other eight agencies.
B. Substantive changes
This final rule—
• Revises the definitions of the
following terms: Accessorial charges,
Agency, Consignor, Detention,
Government Bill of Lading; and
• Revises addresses and Web sites for
the GSA Federal Acquisition Service
(FAS) and other GSA business lines that
were reorganized, as well as the
Department of Transportation, Maritime
Administration (MARAD).
C. Executive Order 12866
GSA has determined that this final
rule is a significant regulatory action for
the purposes of Executive Order 12866.
D. Regulatory Flexibility Act
This final rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.,
because the revisions are not considered
substantive. This final rule is also
exempt from the Regulatory Flexibility
Act per 5 U.S.C. 553(a)(2) because it
applies to agency management.
E. Paperwork Reduction Act
The Paperwork Reduction Act does
not apply because the changes to the
FMR do not impose information
E:\FR\FM\20AUR1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Rules and Regulations]
[Pages 51388-51392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20581]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2002-0185; FRL-8838-3]
2-methyl-1,3-propanediol; 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 2-methyl-1,3-propanediol (CAS Reg. No.
2163-42-0) when used as an inert ingredient in pesticide formulations
applied to growing crops and raw agricultural commodities after
harvest, and when used as an inert ingredient solvent and/or surfactant
in pesticide formulations applied to animals (used for food). Lyondell
Chemical Company 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 2-methyl-1,3-propanediol.
DATES: This regulation is effective August 20, 2010. Objections and
requests for hearings must be received on or before October 19, 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-2002-0185. 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: Keri Grinstead, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8373; e-mail address: grinstead.keri@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
[[Page 51389]]
through the Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.
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-2002-0185 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
October 19, 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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2002-0185, 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 August 28, 2002 (67 FR 55243) (FRL-7194-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E6484) by
Lyondell Chemical Company, 1221 McKinney Street, Suite 1600, Houston,
TX 77253-2583. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) in or on
all raw agricultural commodities. That notice referenced a summary of
the petition prepared by Lyondell Chemical Company, the petitioner,
which is available in the docket, https://www.regulations.gov. There
were no comments received in response to 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....''
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 2-methyl-1,3-propanediol
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with 2-
methyl-1,3-propanediol 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.
Acute toxicity studies of 2-methyl-1,3-propanediol in the rat
indicate that this compound is practically non-toxic (EPA Toxicity
Category IV) by the oral and inhalation exposure routes. The oral
LD50 is greater than 5,000 milligrams/kilogram (mg/kg) and
the inhalation LC50 is greater than 5,100 mg/m3.
It is slightly toxic by the dermal exposure route (EPA Toxicity
Category III) with an acute dermal LD50 in rabbits of
greater than 2,000 mg/kg. Acute irritation studies in rabbits indicate
that 2-methyl-1,3-propanediol is not irritating to the skin and eyes.
Based on the results of a dermal sensitization study in guinea pigs, 2-
methyl-1,3-propanediol was determined to have mild sensitizing
potential.
[[Page 51390]]
Repeat oral exposure produced no toxicity at doses up to and
including 1,000 mg/kg/day. No neurotoxicity studies are available;
however, no clinical signs of neurotoxicity or any systemic toxicity
were observed in any of the available studies. 2-methyl-1,3-propanediol
was not mutagenic in an in vitro chromosome aberration test, bacterial
gene mutation test, and mammalian cell gene mutation assay. No
developmental, reproductive, or teratogenic effects were seen in the
available studies at doses up to and including 1,000 mg/kg/day (highest
dose tested).
No carcinogenicity studies are available for 2-methyl-1,3-
propanediol and it has not been evaluated by the International Agency
for Research on Cancer (IARC). Based on available studies, there is no
evidence of genotoxic activity. There is no evidence of systemic
toxicity at doses up to and including 1,000 mg/kg/day in the available
toxicity studies, such as 14-day oral gavage study in rats, 90-day oral
gavage study in rats, developmental toxicity studies in rats and
rabbits and 2-generation reproduction study in rats. In addition, a
qualitative structure activity relationship database, DEREK Version 11,
identified no structural alerts suggestive of carcinogenicity. Based on
the weight of the evidence, the Agency has determined that 2-methyl-
1,3-propanediol is not anticipated to be carcinogenic.
Specific information on the studies received and the nature of the
adverse effects caused by 2-methyl-1,3-propanediol 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://www.regulations.gov in the document ``Decision Document for Petition
Number 2E6484; 2-methyl-1,3-propanediol [CAS Reg. No. 2163-42-0],
requesting the establishment of an inert ingredient exemption from the
requirement of a tolerance'' in docket ID number EPA-HQ-OPP-2002-0185.
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 repeat dose toxicity and
reproductive/developmental studies at the limit dose of 1,000 mg/kg/day
to either parental animals or their offspring. Thus, due to its low
potential hazard and lack of a hazard endpoint, the Agency has
determined that a quantitative risk assessment using safety factors
applied to a point of departure protective of an identified hazard
endpoint is not appropriate.
2-methyl-1,3-propanediol was not mutagenic in an in vitro
chromosome aberration test, bacterial gene mutation test, and mammalian
cell gene mutation assay and based on the available information, it is
not anticipated to be carcinogenic.
C. Exposure Assessment
No hazard was identified for the acute and chronic dietary
assessment (food and drinking water), or for the short, intermediate,
and long term residential assessments, and therefore no aggregate risk
assessments were performed.
1. Dietary exposure from food and feed uses and drinking water.
Since an endpoint for risk assessment was not identified, an exposure
assessment for 2-methyl-1,3-propanediol was not conducted. The primary
route of exposure to 2-methyl-1,3-propanediol from its use as an inert
ingredient in pesticide products would most likely be through
consumption of food to which pesticide products containing it have been
applied, and possibly 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 2-methyl-1,3-propanediol was not
conducted. Residential (dermal and inhalation) exposures from home
garden uses are possible.
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 2-methyl-1,3-propanediol to share a common
mechanism of toxicity with any other substances, and 2-methyl-1,3-
propanediol does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that 2-methyl-1,3-propanediol 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 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.
The toxicity database for 2-methyl-1,3-propanediol is adequate for
FQPA assessment and the potential exposure is adequately characterized
given the low toxicity of the chemical. No hazard was identified and
there is no residual uncertainty regarding prenatal and/or postnatal
toxicity. No acute or subchronic neurotoxicity studies are available,
but there were no clinical signs of neurotoxicity or any systemic
toxicity observed in the available database at doses up to 1,000 mg/kg/
[[Page 51391]]
day. No developmental, reproductive, or teratogenic effects were seen
in the available studies at doses up to and including 1,000 mg/kg/day.
Based on this information, there is no concern, at this time, for
increased sensitivity to infants and children to 2-methyl-1,3-
propanediol when used as an inert ingredient in pesticide formulations
for pre-harvest and post-harvest uses, as well as, for application to
animals, and 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 2-methyl-1,3-
propanediol, EPA concludes that there are no dietary or aggregate
dietary/non-dietary risks of concern as a result of exposure to 2-
methyl-1,3-propanediol in food and water or from residential exposure.
Residues of concern are not anticipated for dietary exposure (food and
drinking water) or for residential exposure from the use of 2-methyl-
1,3-propanediol as an inert ingredient in pesticide products. As
discussed above, EPA expects aggregate exposure to 2-methyl-1,3-
propanediol to pose no appreciable dietary risk given that the data
show a lack of any systemic toxicity at doses up to 1,000 mg/kg/day and
a lack of any apparent developmental effects.
Taking into consideration all available information on 2-methyl-
1,3-propanediol, EPA has determined that there is a reasonable
certainty that no harm to any population subgroup will result from
aggregate exposure to 2-methyl-1,3-propanediol under reasonably
foreseeable circumstances. Therefore, the establishment of an exemption
from tolerance under 40 CFR 180.910 and 180.930 for residues of 2-
methyl-1,3-propanediol when used as an inert ingredient in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, and to animals (used for food), 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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for 2-methyl-1,3-propanediol.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 40 CFR 180.930 for 2-methyl-1,3-
propanediol (CAS Reg. No. 2163-42-0) when used as an inert ingredient
in pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and to animals (used for food).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 51392]]
Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, the table is amended by adding alphabetically the
following inert ingredient 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
------------------------------------------------------------------------
* * * * * * *
2-methyl-1,3-propanediol (CAS .................. Solvent,
Reg. No. 2163-42-0) surfactant
* * * * * * *
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 180.930, the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
2-methyl-1,3-propanediol (CAS .................. Solvent,
Reg. No. 2163-42-0) surfactant
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2010-20581 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S
