[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04108]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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) in pre-harvest crops when used as an inert ingredient (colorant) at
a concentration of not more than 45% in foliar applications of
pesticide formulations containing anthraquinone. Landis International,
Inc., on behalf of Arkion Life Sciences, LLC submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of titanium dioxide resulting from this use.
DATES: This regulation is effective February 28, 2018. Objections and
requests for hearings must be received on or before April 30, 2018, 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-2017-0257, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 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: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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://www.ecfr.gov/cgi-bin/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-2017-0257 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
April 30, 2018. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0257, 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 CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
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.html.
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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11010) by Landis International, Inc., on behalf of Arkion Life
Sciences, LLC., 551 Mews Drive, Suite J, New Castle DE 19720. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of titanium
dioxide (CAS Reg. No. 13463-67-7) in pre-harvest crops when used as an
inert ingredient (colorant) at a concentration not more than 45% by
weight in pesticide formulations containing anthraquinone. That
document referenced a summary of the petition prepared by Landis
International Inc., on behalf of Arkion Life Sciences, LLC, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing an exemption from the requirement of a tolerance in 40 CFR
180.1195, instead of 40 CFR 180.920 as requested. Exemptions under
section 180.920 cover residues applied to growing crops. Because the
petitioner requested an exemption to cover residues only in pre-harvest
crops with foliar pesticide applications containing anthraquinone, the
Agency has determined that the broader exemption in section 180.920 is
not appropriate. For ease of reference, the Agency is establishing this
exemption in section 180.1195, which contains other limited exemptions
for residues of titanium dioxide.
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
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
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
The available toxicity studies on titanium dioxide via the oral
route of exposure clearly demonstrate a lack of toxicity. The several
studies in mice, rats, dogs, cats, rabbits and other species of varying
durations do not indicate toxicity, even at very high doses (e.g.
50,000 ppm or 2,500 mg/kg/day dietary exposure for two years in rats).
There are no studies on the dermal toxicity of titanium dioxide and
there is no expected toxicity via the dermal route of exposure because
as an insoluble solid material, titanium dioxide is not absorbed via
The available inhalation studies indicate that the primary toxicity
of titanium dioxide is due to deposition of the inhaled particles.
Although these studies suggest equivocal evidence of carcinogenicity
due to prolonged exposure to titanium dioxide particles, EPA has
determined that these effects are not relevant for assessing risk from
exposure to titanium dioxide when used as an inert ingredient in
pesticide formulations based on the following. First, tumors were only
observed in two of the available studies and only in one species. In
one study, those tumors were only observed in rats continually exposed
to ultrafine particles of titanium dioxide. In the second study, tumors
were only observed from exposure to fine particles of titanium dioxide
at extremely high concentrations (250 mg/m\3\), in which the animals
experienced overloading of lung clearance, with chronic inflammation
resulting in lung tumors. All but one of the tumors in the second study
were subsequently reclassified as non-neoplastic or non-cancerous in
nature. No tumors were observed in studies involving mice.
The titanium dioxide used in pesticide formulations is considered
pigmentary grade, not ultrafine or nanoscale. Consequently, the tumors
observed from exposure to ultrafine particles of titanium dioxide are
not relevant for assessing exposure to the type of titanium dioxide
used in pesticide formulations. Following the reclassification of the
tumors observed in the second inhalation study, EPA does not consider
these effects to be strong evidence of carcinogenicity from exposure to
fine-particle-sized titanium dioxide. Even assuming this study
indicates the potential for carcinogenicity, EPA does not expect any
reasonably foreseeable uses of titanium dioxide in pesticide
formulations that might result in residential exposures to approach the
levels of exposure necessary to elicit the effects seen in the
available inhalation study. The levels at which effects were observed
in that study greatly exceed any reasonable dose for toxicity testing
and any likely residential exposure levels. Moreover, when used as an
inert in pesticide formulations, titanium dioxide will be bound to
other materials, which means there will not be significant inhalation
exposure to titanium dioxide particles themselves.
This position is consistent with the National Institute of
Occupational Health and Safety's (NIOSH) recent assessment that
ultrafine but not fine titanium dioxide would be considered a
``potential occupational carcinogen.'' The NIOSH Current Intelligence
Bulletin ``Occupational Exposure to Titanium Dioxide'' concludes that
``[t]he lung tumors observed in rats after exposure to 250 mg/m\3\ of
fine TiO2 [titanium dioxide] were the basis for the original
NIOSH designation of TiO2 as a ``potential occupational
carcinogen.'' However, because this dose is considered to be
significantly higher than currently accepted inhalation toxicology
practice, NIOSH concluded that the response at such a high dose should
not be used in making its hazard identification.'' NIOSH concluded that
the data is insufficient to classify fine titanium dioxide as a
potential occupational carcinogen.
Because the predominant form of titanium dioxide used commercially,
and the form used as an inert ingredient in pesticide formulations is
pigment grade, which is not in the ultrafine or nanoscale particle size
range but rather in the fine particle size range, EPA concludes that
carcinogenicity is not a concern from exposure to titanium dioxide
resulting from its use as an inert ingredient in pesticides.
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 the final rule
published in the Federal Register of July 27, 2012 (77 FR 44151) (FRL-
9354-6) and in the Agency's risk assessment which can be found at
http://www.regulations.gov in document Titanium Dioxide; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When used as an Inert
Ingredient in Pesticide Formulations in docket ID number EPA-HQ-OPP-
B. Toxicological Points of Departure/Levels of Concern
Because the available data indicate no toxicity via the oral route
of exposure, no endpoint of concern for that route of exposure has been
identified in the available database. This conclusion is in agreement
with the conclusion of the World Health Organization (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, so no endpoint was identified.
Because the effects seen in inhalation studies occurred at doses
above the levels at which pesticide exposure is expected and for
particle sizes that are different from the size of titanium dioxide
used in pesticide formulations, the Agency has concluded that those
risks are not relevant for assessing risk from pesticide exposure and
therefore, did not identify an endpoint for assessing inhalation
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to titanium dioxide, EPA considered exposure under the
proposed exemption from the requirement of a tolerance and all other
existing exemptions from the requirement of a tolerance for residues of
titanium dioxide. EPA assessed dietary exposures from titanium dioxide
in food as follows:
Residues of titanium dioxide are exempt from the requirement of a
tolerance when used as an inert ingredient in many different
circumstances: When used in pesticide formulations applied to growing
crops as a pigment/coloring agent in plastic bags used to wrap growing
bananas or colorant on seeds for planting (40 CFR 180.920); when used
in pesticide formulations applied to animals (40 CFR 180.930); when
used as a Ultraviolet (UV) protectant in microencapsulated formulations
of the insecticide lambda-cyhalothrin at no more than 3.0% by weight
(40 CFR 180.1195); when used as a UV stabilizer in pesticide
formulations of napropamide at no more than 5% of the product
formulation (40 CFR 180.1195); and when used in pesticide placed at
entrance to bee hives intended to control varroa mites in hive at a
maximum of 0.1% weight/weight (wt/wt) (40 CFR 180.1195). 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 and
Although dietary exposure may be expected from use of titanium
dioxide in pesticide formulations applied to bee hives and on other
crops (as well as from other non-pesticidal sources), a quantitative
exposure assessment for titanium dioxide was not conducted because no
endpoint of concern was identified in the database.
2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures from drinking
water may be expected from use on food crops.
3. 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).
Titanium dioxide may be used in non-pesticide products such as
paints, printing inks, paper and plastic products around the home.
Additionally titanium dioxide may be used as an inert ingredient in
pesticides that include residential uses, however based on the
discussion in Unit IV.B., a quantitative residential exposure
assessment for titanium dioxide was not conducted.
4. 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.''
Because titanium dioxide does not have a toxic mode of action or a
mechanism of toxicity, this provision does not apply.
D. Safety Factor for Infants and Children
Due to titanium dioxide's 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, a Food Quality
Protection Act Safety Factor (FQPA SF) is not needed to protect the
safety of infants and children.
E. Aggregate Risks and Determination of Safety
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 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 pre-harvest crops of titanium dioxide, when
used as an inert ingredient (colorant) up to 45% in foliar pesticide
formulations containing anthraquinone, is safe under FFDCA section 408.
V. Analytical Enforcement Methodology
Although EPA is establishing a limitation on the amount of titanium
dioxide that may be used in pesticide formulations, an analytical
enforcement methodology is not necessary for this exemption from the
requirement of tolerance. The limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will
not register any pesticide for sale or distribution for use in pre-
with concentrations of titanium dioxide exceeding 45% by weight of the
formulations containing anthraquinone.
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 (colorant) up to 45% in
foliar pesticide formulations containing anthraquinone.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of 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 action has been exempted from review
under Executive Order 12866, this action 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 action 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 exemption 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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
Dated: February 15, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1195 is amended by adding paragraph (c) to read as
Sec. 180.1195 Titanium dioxide.
* * * * *
(c) 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 (colorant) in foliar applications at no
more than 45% of the formulations containing anthraquinone.
[FR Doc. 2018-04108 Filed 2-27-18; 8:45 am]
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