82 FR 30993 - Titanium Dioxide; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 127 (July 5, 2017)

This regulation establishes an exemption from the requirement of a tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67- 7) in honey when used as an inert ingredient (colorant) at a concentration of not more than 0.1% by weight in pesticide formulations intended for varroa mite control around bee hives. Bayer Healthcare, 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.

[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30993-30997]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14099]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0252; FRL-9961-82]


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) in honey when used as an inert ingredient (colorant) at a 
concentration of not more than 0.1% by weight in pesticide formulations 
intended for varroa mite control around bee hives. Bayer Healthcare, 
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 July 5, 2017. Objections and 
requests for hearings must be received on or before September 5, 2017, 
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-2016-0252, 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: [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. 
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-2016-0252 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

[[Page 30994]]

before September 5, 2017. 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-2016-0252, 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 
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.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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10888) by 
Technology Sciences Group Inc., on behalf of Bayer HealthCare, LLC, 
P.O. Box 390, Shawnee Mission, KS 66201. The petition requested that 40 
CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of titanium dioxide (CAS Reg. 
No. 13463-67-7) in honey when used as an inert ingredient (colorant) at 
a concentration not more than 0.1% by weight in pesticide formulations 
intended for varroa mite control around bee hives. That document 
referenced a summary of the petition prepared by Technology Sciences 
Group 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.
    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 180.910 as requested. Exemptions under 
section 180.910 cover residues applied to growing crops and raw 
agricultural crops after harvest. Because the petitioner requested an 
exemption to cover residues only in honey resulting specifically from 
the use in hives, the Agency has determined that the broader exemption 
in section 180.910 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 
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 sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    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 skin.
    The available inhalation studies indicate that the primary toxicity 
of

[[Page 30995]]

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 carcinogenicity is not a concern 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-size titanium dioxide. Even assuming the 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 [titanium dioxide] 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-
2016-0252.

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 
exposure risk.

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 (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); and when used as a UV 
stabilizer in pesticide formulations of napropamide at no more than 5% 
of the product formulation (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 73.3126).
    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),

[[Page 30996]]

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, an 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 in honey of titanium dioxide, when used as an 
inert ingredient (colorant) in pesticide formulations intended for 
varroa mite control around bee hives at a maximum concentration of 0.1% 
by weight, 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 beehives 
with concentrations of titanium dioxide exceeding 0.1% by weight of the 
formulation.

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 (colorant) in pesticide 
formulations intended for varroa mite control around bee hives at a 
maximum concentration of 0.1% by weight in the pesticide formulation.

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 
recordkeeping requirements.

    Dated: May 8, 2017.
Michael L. Goodis,
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:

    Authority: 21 U.S.C. 321(q), 346a and 371.


[[Page 30997]]



0
2. Section 180.1195 is revised to read as follows:


Sec.  180.1195  Titanium dioxide.

    (a) 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.
    (b) Residues of titanium dioxide (CAS Reg. No. 13463-67-7) in honey 
are exempted from the requirement of a tolerance, when used as an inert 
ingredient (colorant) in pesticide formulations intended for varroa 
mite control around bee hives at no more than 0.1% by weight in the 
pesticide formulation.

[FR Doc. 2017-14099 Filed 7-3-17; 8:45 am]
BILLING CODE 6560-50-P