[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Rules and Regulations]
[Pages 44151-44155]
From the Federal Register Online via the Government Publishing 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 http://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 http://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: [email protected].
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 http://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: http://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 http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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, http://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 http://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 http://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