Document ID: EPA-HQ-OPP-2011-0829-0003
Agency: epa
Document Type: Rule
Title: Exemptions From Requirements of Tolerances: Titanium Dioxide
Posted Date: 2012-07-27T04:00Z

[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]

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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.

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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: 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 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