[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Rules and Regulations]
[Pages 37440-37443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16470]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0150; FRL-9980-39]


Titanium dioxide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a 
tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7) 
when used as an inert ingredient in pesticide formulations applied to 
growing crops to allow for use as a carrier. SciReg. Inc., on behalf of 
Bayer CropScience Biologics GmbH, 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 August 1, 2018. Objections and 
requests for hearings must be received on or before October 1, 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-2018-0150, 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: <a href="/cdn-cgi/l/email-protection#66342220342809120f0503152603160748010910"><span class="__cf_email__" data-cfemail="184a5c5e4a56776c717b7d6b587d6879367f776e">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2018-0150 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 
October 1, 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-2018-0150, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> Hand Delivery: To make special arrangements for hand 
delivery or

[[Page 37441]]

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 May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11085) by 
SciReg. Inc., on behalf of Bayer CropScience Biologics GmbH, Lukaswiese 
4, 23970 Wismar, Germany. The petition requested that the 40 CFR 
180.920 exemption from the requirement of a tolerance for residues of 
titanium dioxide (CAS Reg. No. 13463-67-7) be amended to allow for use 
as a carrier when used as an inert ingredient in pesticide formulations 
applied to growing crops only. That document referenced a summary of 
the petition prepared by SciReg. Inc., on behalf of Bayer CropScience 
Biologics GmbH, 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 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 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 
fineparticle-sized titanium dioxide. Further, EPA does not expect any 
reasonably foreseeable uses of titanium dioxide in pesticide 
formulations that might result in residential exposures that would 
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

[[Page 37442]]

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, with no 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 TiO<INF>2</INF> [titanium dioxide] were the basis for the original 
NIOSH designation of TiO<INF>2</INF> 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 pesticide 
formulations.
    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-
2018-0150.

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 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 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); when used in pesticide placed at entrance to bee hives 
intended to control varroa mites in hive at a maximum of 0.1% wt/wt (40 
CFR 180.1195); and when used in anthraquinone pesticide formulations at 
a maximum of 45% wt/wt (40 CFR 180.1195). Titanium dioxide is also 
approved for use as a colorant in food (21 CFR 73.575).
    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. It 
has also been approved for use in drugs (21 CFR 73.1575) and in 
cosmetics (21 CFR 73.2575 and 73.3126). 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.

[[Page 37443]]

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 exemption from tolerance under 40 CFR 180.920 for 
residues of titanium dioxide, when used as an inert ingredient in 
pesticide formulations is safe under FFDCA section 408.

V. 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.

VI. Conclusions

    Therefore, EPA is amending the exemption from the requirement of a 
tolerance in 40 CFR 180.920 for residues of titanium dioxide (CAS Reg. 
No. 13463-67-7) when used as an inert ingredient (carrier) in pesticide 
formulations.

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); Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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: July 11, 2018.
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.


0
2. In Sec.  180.920, revise the inert ingredient ``Titanium dioxide 
(CAS Reg. No. 13463-67-7)'' in the table to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

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           Inert ingredients                      Limits                                Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  . . . . . . .
Titanium dioxide (CAS Reg. No. 13463-   .........................  Pigment, colorant, carrier.
 67-7).
 
                                                  . . . . . . .
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[FR Doc. 2018-16470 Filed 7-31-18; 8:45 a.m.]
 BILLING CODE 6560-50-P


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