Titanium Dioxide; Exemption From the Requirement of a Tolerance, 44151-44155 [2012-18374]
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Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
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B. Submission to Congress and the
Comptroller General
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by September 25, 2012. Filing a
petition for reconsideration by the
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Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. Parties with
objections to this direct final rule are
encouraged to file a comment in
response to the parallel notice of
proposed rulemaking for this action
published in the proposed rules section
of today’s Federal Register, rather than
file an immediate petition for judicial
review of this direct final rule, so that
EPA can withdraw this direct final rule
and address the comment in the
proposed rulemaking.
This action to remove four internal
administrative requirements from the
regulation for the control of motor
vehicle emissions in the Northern
Virginia Area may not be challenged
later in proceedings to enforce its
requirements. (See section 307(b)(2).)
44151
when used as an inert ingredient
(Ultraviolet-stabilizer) (UV), at no more
than 5% in pesticide formulations
containing the active ingredient
napropamide, used in or on growing
crops. United Phosphorus, Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an amendment to
an existing requirement of a tolerance.
This regulation eliminates the need to
establish a maximum permissible level
for residues of titanium dioxide.
DATES: This regulation is effective July
27, 2012. Objections and requests for
hearings must be received on or before
September 25, 2012, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
[FR Doc. 2012–18104 Filed 7–26–12; 8:45 am]
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0829, is
available at https://www.regulations.gov
or at the OPP Docket in the
Environmental Protection Agency
Docket Center (EPA/DC), located in EPA
West, Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
David Lieu, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–0079; email address:
lieu.david@epa.gov.
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION:
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference.
Dated: July 10, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
Therefore, 40 CFR part 52 is amended
as follows:
PART 52—[AMENDED]
1. The authority citation for 40 CFR
part 52 continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
§ 52.2420
[Amended]
2. In § 52.2420, the table in paragraph
(c) is amended by removing the entries
for Sections ‘‘5–91–40’’, ‘‘5–91–60’’, ‘‘5–
91–80’’, and ‘‘5–91–110’’ from the table.
■
ADDRESSES:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0829; FRL–9354–6]
Titanium Dioxide; 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 titanium
dioxide (CAS Reg. No. 13463–67–7)
SUMMARY:
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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
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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.
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2011–0829 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before September 25, 2012. 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–2011–0829, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statue.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), Mail Code: 28221T, 1200
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Pennsylvania Ave. NW., Washington,
DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of November
9, 2011 (76 FR 69692) (FRL–9325–1),
EPA issued a notice pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
1E7918) by United Phosphorus, Inc.,
630 Freedom Business Center, Suite
402, King of Prussia, PA 19406. The
petition requested that 40 CFR 180.1195
be amended by modifying an exemption
from the requirement of a tolerance for
residues of titanium dioxide (CAS Reg.
No. 13463–67–7) when used as an inert
ingredient, UV-stabilizer, at no more
than 5% in pesticide formulations
containing the active ingredient
napropamide. That notice referenced a
summary of the petition prepared by
United Phosphorus, Inc., 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
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residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. * * *’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for titanium dioxide
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with titanium dioxide
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
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sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by titanium dioxide as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
A substantial proportion of the
toxicity data provided in this unit has
been taken from comprehensive reviews
and publications from The International
Agency for Research on Cancer (IARC),
World Health Organization (WHO) and
National Cancer Institute (NCI). The
titanium dioxide acute toxicity studies
show low toxicity near limit doses.
Titanium dioxide is also not a skin
sensitizer. A 28-day lung instillation
studies demonstrated slight fibrogenic
effects comparable to that of a nuisance
dust. A 90-day lung instillation study
showed statistically significant signs of
inflammation immediately after
exposure but they were absent after 1month. Many subchronic and chronic
oral toxicity studies were performed on
different species including rats, mice,
dogs, cats, rabbits and guinea pigs. The
doses ranged up to 100,000 parts per
million (ppm) (5,000 milligrams/
kilograms/day (mg/kg/day)) with study
durations up to 2 years. None of these
studies showed mortality or adverse
toxicological effects caused by titanium
dioxide. No reproductive or
developmental studies were available
for review in the toxicity database.
Mutagenicity studies including sister
chromatid exchange assays, in vitro
micronucleus assays, comet assays,
reverse mutation tests and chromosome
aberration test produced mixed results
but overall these tests showed that
titanium dioxide is not mutagenic.
Titanium dioxide is not carcinogenic via
the oral, intraperitoneal or subcutaneous
routes of exposure in rats or mice;
however, there is concern via the
inhalation route. In inhalation studies,
tumors present in the lungs are thought
to have been a localized fibrogenic effect
caused by overloading of the lungs with
high concentrations of titanium dioxide
particles over a prolonged period of
time. The concentrations used in these
studies are near limit dose levels. Actual
environmentally anticipated exposures
of titanium dioxide based on the use
patterns of products that would contain
titanium dioxide are orders of
magnitude less than that allowed by the
Occupational Safety and Health
Administration’s (OSHA) Permissible
Exposure Limit (PEL). Specific
information on the studies received and
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the nature of the adverse effects caused
by titanium dioxide can be found at
https://www.regulations.gov in the
document ‘‘Titanium Dioxide (TiO2).
Risk Assessment to Support Proposed
Amendment to Exemption from the
Requirement of a Tolerance When used
as an Inert Ingredient in Pesticide
Formulations under 40 CFR 180.1195,’’
in docket ID number EPA–HQ–OPP–
2011–0829.
B. Toxicological Points of Departure/
Levels of Concern
The available toxicity studies on
titanium dioxide via oral route of
exposure clearly demonstrate lack of
toxicity. The several studies in mice,
rats, dogs, cats, rabbits and other species
of varying durations do not indicate
toxicity at very high doses (e.g., 50,000
ppm or 2,500 mg/kg/day dietary
exposure for 2 years in rats). No end
point of concern via oral route of
exposure has been identified in the
available database. Therefore, dietary
exposure was not estimated. This
conclusion is in agreement with the
conclusion of the WHO Committee on
Food Coloring Materials that no
Acceptable Daily Intake (ADI) need be
set for the use of titanium dioxide based
on the range of acute, sub-acute and
chronic toxicity assays, all showing low
mammalian toxicity. Similarly, no
significant toxicity of titanium dioxide
is expected via the dermal route of
exposure. The available inhalation
studies indicate that the primary
toxicity of titanium dioxide is due to
deposition of the inhaled particles and
also suggest equivocal evidence of
carcinogenicity due to prolonged
exposure to titanium dioxide particles.
No direct exposure to titanium dioxide
particles is expected in pesticide
napropamide formulations (less than
5% in formulations).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses and drinking water. In
evaluating dietary exposure to titanium
dioxide, EPA considered exposure
under the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
titanium dioxide in food as follows:
An exposure assessment for titanium
dioxide was not conducted because no
endpoint of concern was identified in
the database.
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,
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tables). Based on the use pattern
provided by the registrant and use
limitations/restrictions there are no
residential uses and thus no residential
exposures are expected.
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 titanium dioxide
to share a common mechanism of
toxicity with any other substances, and
titanium dioxide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that titanium dioxide does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act (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.
There were no significant hazards
identified in the available data at levels
at or below the limit dose of 1,000 mg/
kg/day. Thus, due to its low potential
hazard and the lack of a hazard
endpoint, it was determined that a
quantitative risk assessment using safety
factors applied to a point of departure
protective of an identified hazard
endpoint is not appropriate for titanium
dioxide. For the same reasons that a
quantitative risk assessment based on a
safety factor approach is not appropriate
for titanium dioxide, an FQPA SF is not
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needed to protect the safety of infants
and children.
E. Aggregate Risks and Determination of
Safety
Titanium dioxide has two exemptions
from the requirement of a tolerance:
pesticide formulations applied to
growing crops, 40 CFR 180.920; and
pesticide formulations applied to
animals, 40 CFR 180.930. Titanium
dioxide is also approved for use as a
colorant in food (21 CFR 73.575), in
drugs (21 CFR 73.1575), and in
cosmetics (21 CFR 73.2575; 21 CFR
73.3126). There has also been a previous
exemption from requirement of a
tolerance for residues in or on growing
crops, when used as an inert ingredient
(UV protectant) in microencapsulated
formulations of the insecticide lambdacyhalothrin at no more than 3.0% by
weight or the formulations (40 CFR
180.1195). There was also no aggregate
risk assessments performed since there
was no single exposure, dietary or
drinking water endpoints of concern.
Taking into consideration all available
information on titanium dioxide, EPA
has determined that there is a
reasonable certainty that no harm to any
population subgroup, including infants
and children, will result from aggregate
exposure to titanium dioxide under
reasonable foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance under 40 CFR
180.1195 for residues of titanium
dioxide when used as an inert
ingredient (UV stabilizer) in pesticide
formulations of napropamide at no more
than 5% of the product formulation is
considered 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.
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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
United Nation Food and Agriculture
Organization/World Health
Organization food standards program,
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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 titanium dioxide.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.1195 for titanium
dioxide (CAS Reg. No.13463–67–7)
when used as an inert ingredient (UVstabilizer) at no more than 5% in
pesticide formulations containing the
active ingredient napropamide in
pesticide formulations.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this 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 FFDCA section 408(d), 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
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Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this 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) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 18, 2012.
G. Jeffrey Herndon,
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:
■
E:\FR\FM\27JYR1.SGM
27JYR1
Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1195 is revised to read
as follows:
■
§ 180.1195
Titanium dioxide.
Titanium dioxide (CAS Reg. No.
13463–67–7) is exempted from the
requirement of a tolerance for residues
in or on growing crops, when used as an
inert ingredient (UV protectant) in
microencapsulated formulations of the
insecticide lambda cyhalothrin at no
more than 3.0% by weight of the
formulation and as an inert ingredient
(UV-stabilizer) at no more than 5% in
pesticide formulations containing the
active ingredient napropamide.
[FR Doc. 2012–18374 Filed 7–26–12; 8:45 am]
BILLING CODE 6560–50–P
Land Management, 20 M St. SE., Room
2134LM, Attention: Regulatory Affairs,
Washington, DC 20003.
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions at this Web site.
FOR FURTHER INFORMATION CONTACT:
Sonia Santillan at 202–912–7123, in the
Solid Minerals Group as to program
matters or the substance of the interim
final rule or Ian Senio in the Division of
Regulatory Affairs at 202–912–7440 for
information relating to the rulemaking
process generally. Persons who use a
telecommunications device for the deaf
(TDD) may call the Federal Information
Relay Service (FIRS) at 1–800–877–
8339, 24 hours a day, 7 days a week to
contact the above individuals.
SUPPLEMENTARY INFORMATION:
Bureau of Land Management
I. Public Comment Procedures
II. Background
III. Discussion of Interim Final Rule
IV. Procedural Matters
43 CFR Part 3830
I. Public Comment Procedures
DEPARTMENT OF THE INTERIOR
[WO–620–1990–00–24 1A]
RIN 1004–AE27
Administration of Mining Claims and
Sites
Bureau of Land Management,
Interior.
ACTION: Interim final rule.
AGENCY:
The Bureau of Land
Management (BLM) is issuing this rule
to amend regulations on locating,
recording, and maintaining mining
claims or sites. In this rule, the BLM
amends its regulations to respond to a
recent law that changes the way the
maintenance fee is calculated for
unpatented placer mining claims. The
law specifies that the holder of an
unpatented placer mining claim must
pay the initial and annual maintenance
fee for each 20 acres or portion thereof
contained in the claim; and reiterates
that an initial maintenance fee payment
is due at the time of recording the claim
with the BLM and that the annual
maintenance fee is due on or before
September 1 of each year.
DATES: The interim final rule is effective
July 27, 2012. If you wish to comment
on the interim final rule, you should
submit your comments by September
25, 2012.
ADDRESSES: Mail: Director (630), Bureau
of Land Management, U.S. Department
of the Interior, 1849 C St. NW.,
Washington, DC 20240, Attention:
1004–AE27.
Personal or messenger delivery: U.S.
Department of the Interior, Bureau of
erowe on DSK2VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
14:46 Jul 26, 2012
Jkt 226001
If you wish to comment, you may
submit your comments by one of several
methods:
You may mail comments to Director
(630), Bureau of Land Management, U.S.
Department of the Interior, 1849 C St.
NW., Washington, DC 20240, Attention:
1004–AE27;
You may deliver comments to U.S.
Department of the Interior, Bureau of
Land Management, 20 M St. SE., Room
2134LM, Attention: Regulatory Affairs,
Washington, DC 20003; or
You may access and comment on the
interim final rule at the Federal
eRulemaking Portal by following the
instructions at that site (see ADDRESSES).
Written comments on the interim
final rule should be specific, should be
confined to issues pertinent to the
interim final rule, and should explain
the reason for any recommended
change. Where possible, comments
should reference the specific section or
paragraph of the proposal which the
commenter is addressing.
The BLM need not consider, or
include in the administrative record for
the final rule, comments that the BLM
receives after September 25, 2012 or
comments delivered to an address other
than those listed above.
Public Availability of Comments
Comments, including names, street
addresses, and other contact
information of respondents, will be
available for public review at BLM’s
offices at the U.S. Department of the
Interior, Bureau of Land Management,
20 M St. SE., Room 2134LM,
Washington, DC 20003, during regular
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
44155
business hours (7:45 a.m. to 4:15 p.m.),
Monday through Friday, except Federal
holidays. They will also be available at
the Federal eRulemaking Portal https://
www.regulations.gov. Follow the
instructions at this Web site.
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment, including your
personal identifying information, may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
II. Background
The BLM has responsibility for the
collection of fees for placer and lode
mining claims and mill and tunnel sites
on Federal lands. During fiscal year (FY)
2011, claimants recorded 58,775 new
claims and sites with the BLM. In
addition, the BLM processed
maintenance fee payments for 375,958
claims and sites. The BLM deposits the
collected fees into a special fund, and
Congress appropriates money to the
BLM from the fund to pay for the
administration of the Mining Law
program, which includes mining claim
recording and fee collection, processing
grandfathered patent applications,
processing applications for plans of
operations, inspecting operations, and
enforcing the regulations.
Since 1992, Congress has passed
several laws requiring claimants to pay
various fees when locating, recording,
and maintaining mining claims or sites
on Federal lands. This rule implements
Section 430 of the Consolidated
Appropriations Act, 2012 (the FY2012
Appropriations Act), Public Law 112–
74, 125 Stat. 786, enacted on December
23, 2011, which amended 30 U.S.C. 28f.
III. Discussion of Interim Final Rule
Why the Rule Is Being Published on an
Interim Final Basis
The BLM is adopting this interim
final rule solely to implement the
requirements of Section 430 of the
FY2012 Appropriations Act, which
amended 30 U.S.C. 28f. The BLM is not
making any other changes to the
regulations at 43 CFR part 3830.
The Department of the Interior for
good cause finds under 5 U.S.C.
553(b)(3)(B) that notice and public
procedure for this rule are unnecessary
and that this rule may properly take
effect upon publication. The reasons are
as follows:
• This rule merely codifies statutorily
imposed procedural changes;
E:\FR\FM\27JYR1.SGM
27JYR1
]]>Agencies
[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Rules and Regulations]
[Pages 44151-44155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18374]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0829; FRL-9354-6]
Titanium Dioxide; 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 titanium dioxide (CAS Reg. No. 13463-67-
7) when used as an inert ingredient (Ultraviolet-stabilizer) (UV), at
no more than 5% in pesticide formulations containing the active
ingredient napropamide, used in or on growing crops. United Phosphorus,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an amendment to an existing
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of titanium dioxide.
DATES: This regulation is effective July 27, 2012. Objections and
requests for hearings must be received on or before September 25, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0829, is available at https://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: David Lieu, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-0079; email address: lieu.david@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
[[Page 44152]]
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 site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0829 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 25, 2012. 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-2011-0829, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statue.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of November 9, 2011 (76 FR 69692) (FRL-
9325-1), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 1E7918) by
United Phosphorus, Inc., 630 Freedom Business Center, Suite 402, King
of Prussia, PA 19406. The petition requested that 40 CFR 180.1195 be
amended by modifying an exemption from the requirement of a tolerance
for residues of titanium dioxide (CAS Reg. No. 13463-67-7) when used as
an inert ingredient, UV-stabilizer, at no more than 5% in pesticide
formulations containing the active ingredient napropamide. That notice
referenced a summary of the petition prepared by United Phosphorus,
Inc., 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 FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for titanium dioxide including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with titanium dioxide
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
[[Page 44153]]
sensitivities of major identifiable subgroups of consumers, including
infants and children. Specific information on the studies received and
the nature of the adverse effects caused by titanium dioxide as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
A substantial proportion of the toxicity data provided in this unit
has been taken from comprehensive reviews and publications from The
International Agency for Research on Cancer (IARC), World Health
Organization (WHO) and National Cancer Institute (NCI). The titanium
dioxide acute toxicity studies show low toxicity near limit doses.
Titanium dioxide is also not a skin sensitizer. A 28-day lung
instillation studies demonstrated slight fibrogenic effects comparable
to that of a nuisance dust. A 90-day lung instillation study showed
statistically significant signs of inflammation immediately after
exposure but they were absent after 1-month. Many subchronic and
chronic oral toxicity studies were performed on different species
including rats, mice, dogs, cats, rabbits and guinea pigs. The doses
ranged up to 100,000 parts per million (ppm) (5,000 milligrams/
kilograms/day (mg/kg/day)) with study durations up to 2 years. None of
these studies showed mortality or adverse toxicological effects caused
by titanium dioxide. No reproductive or developmental studies were
available for review in the toxicity database. Mutagenicity studies
including sister chromatid exchange assays, in vitro micronucleus
assays, comet assays, reverse mutation tests and chromosome aberration
test produced mixed results but overall these tests showed that
titanium dioxide is not mutagenic. Titanium dioxide is not carcinogenic
via the oral, intraperitoneal or subcutaneous routes of exposure in
rats or mice; however, there is concern via the inhalation route. In
inhalation studies, tumors present in the lungs are thought to have
been a localized fibrogenic effect caused by overloading of the lungs
with high concentrations of titanium dioxide particles over a prolonged
period of time. The concentrations used in these studies are near limit
dose levels. Actual environmentally anticipated exposures of titanium
dioxide based on the use patterns of products that would contain
titanium dioxide are orders of magnitude less than that allowed by the
Occupational Safety and Health Administration's (OSHA) Permissible
Exposure Limit (PEL). Specific information on the studies received and
the nature of the adverse effects caused by titanium dioxide can be
found at https://www.regulations.gov in the document ``Titanium Dioxide
(TiO2). Risk Assessment to Support Proposed Amendment to
Exemption from the Requirement of a Tolerance When used as an Inert
Ingredient in Pesticide Formulations under 40 CFR 180.1195,'' in docket
ID number EPA-HQ-OPP-2011-0829.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies on titanium dioxide via oral route
of exposure clearly demonstrate lack of toxicity. The several studies
in mice, rats, dogs, cats, rabbits and other species of varying
durations do not indicate toxicity at very high doses (e.g., 50,000 ppm
or 2,500 mg/kg/day dietary exposure for 2 years in rats). No end point
of concern via oral route of exposure has been identified in the
available database. Therefore, dietary exposure was not estimated. This
conclusion is in agreement with the conclusion of the WHO Committee on
Food Coloring Materials that no Acceptable Daily Intake (ADI) need be
set for the use of titanium dioxide based on the range of acute, sub-
acute and chronic toxicity assays, all showing low mammalian toxicity.
Similarly, no significant toxicity of titanium dioxide is expected via
the dermal route of exposure. The available inhalation studies indicate
that the primary toxicity of titanium dioxide is due to deposition of
the inhaled particles and also suggest equivocal evidence of
carcinogenicity due to prolonged exposure to titanium dioxide
particles. No direct exposure to titanium dioxide particles is expected
in pesticide napropamide formulations (less than 5% in formulations).
C. Exposure Assessment
1. Dietary exposure from food and feed uses and drinking water. In
evaluating dietary exposure to titanium dioxide, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from titanium dioxide in food
as follows:
An exposure assessment for titanium dioxide was not conducted
because no endpoint of concern was identified in the database.
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). Based
on the use pattern provided by the registrant and use limitations/
restrictions there are no residential uses and thus no residential
exposures are expected.
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 titanium dioxide to share a common mechanism of
toxicity with any other substances, and titanium dioxide does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
titanium dioxide does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall
apply an additional tenfold (10X) margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the Food Quality Protection
Act (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.
There were no significant hazards identified in the available data
at levels at or below the limit dose of 1,000 mg/kg/day. Thus, due to
its low potential hazard and the lack of a hazard endpoint, it was
determined that a quantitative risk assessment using safety factors
applied to a point of departure protective of an identified hazard
endpoint is not appropriate for titanium dioxide. For the same reasons
that a quantitative risk assessment based on a safety factor approach
is not appropriate for titanium dioxide, an FQPA SF is not
[[Page 44154]]
needed to protect the safety of infants and children.
E. Aggregate Risks and Determination of Safety
Titanium dioxide has two exemptions from the requirement of a
tolerance: pesticide formulations applied to growing crops, 40 CFR
180.920; and pesticide formulations applied to animals, 40 CFR 180.930.
Titanium dioxide is also approved for use as a colorant in food (21 CFR
73.575), in drugs (21 CFR 73.1575), and in cosmetics (21 CFR 73.2575;
21 CFR 73.3126). There has also been a previous exemption from
requirement of a tolerance for residues in or on growing crops, when
used as an inert ingredient (UV protectant) in microencapsulated
formulations of the insecticide lambda-cyhalothrin at no more than 3.0%
by weight or the formulations (40 CFR 180.1195). There was also no
aggregate risk assessments performed since there was no single
exposure, dietary or drinking water endpoints of concern.
Taking into consideration all available information on titanium
dioxide, EPA has determined that there is a reasonable certainty that
no harm to any population subgroup, including infants and children,
will result from aggregate exposure to titanium dioxide under
reasonable foreseeable circumstances. Therefore, the establishment of
an exemption from tolerance under 40 CFR 180.1195 for residues of
titanium dioxide when used as an inert ingredient (UV stabilizer) in
pesticide formulations of napropamide at no more than 5% of the product
formulation is considered 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 United Nation 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 titanium dioxide.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.1195 for titanium dioxide (CAS Reg.
No.13463-67-7) when used as an inert ingredient (UV-stabilizer) at no
more than 5% in pesticide formulations containing the active ingredient
napropamide in pesticide formulations.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this 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) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 18, 2012.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
[[Page 44155]]
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1195 is revised to read as follows:
Sec. 180.1195 Titanium dioxide.
Titanium dioxide (CAS Reg. No. 13463-67-7) is exempted from the
requirement of a tolerance for residues in or on growing crops, when
used as an inert ingredient (UV protectant) in microencapsulated
formulations of the insecticide lambda cyhalothrin at no more than 3.0%
by weight of the formulation and as an inert ingredient (UV-stabilizer)
at no more than 5% in pesticide formulations containing the active
ingredient napropamide.
[FR Doc. 2012-18374 Filed 7-26-12; 8:45 am]
BILLING CODE 6560-50-P
