Titanium Dioxide; Exemption From the Requirement of a Tolerance, 30993-30997 [2017-14099]
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Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
XI. 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 18, 2017.
Donna Davis,
Acting Associate Director, Registration
Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, add alphabetically the
polymers ‘‘Oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt; average molecular
weight (in amu), 1800’’ and ‘‘Oxirane, 2methyl, polymer with oxirane, hydrogen
sulfate, potassium salt; average
molecular weight (in amu), 2100’’ to the
table to read as follows:
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§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
PART 180—[AMENDED]
*
*
*
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1. The authority citation for part 180
continues to read as follows:
■
Polymer
CAS No.
*
*
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*
*
*
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, ammonium salt; average molecular weight (in amu), 1800 .................
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, potassium salt; average molecular weight (in amu), 2100 ..................
*
57608–14–7
1838191–48–2
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[FR Doc. 2017–14111 Filed 7–3–17; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 6560–50–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0252, is
available at https://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 https://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.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0252; FRL–9961–82]
Titanium Dioxide; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
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SUMMARY:
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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
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*
*
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 https://
www.ecfr.gov/cgi-bin/textidx?&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
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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, https://
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
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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
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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
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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/m3), 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
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Titanium Dioxide’’ concludes that ‘‘[t]he
lung tumors observed in rats after
exposure to 250 mg/m3 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-observedadverse-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
https://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.
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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 nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
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carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Titanium dioxide may be used in nonpesticide 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.
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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
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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.
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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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1195 is revised to read
as follows:
■
§ 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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 441
[EPA–HQ–OW–2014–0693; FRL–9957–10–
OW]
RIN 2040–AF26
Effluent Limitations Guidelines and
Standards for the Dental Category
Correction
In rule document C1–2017–12338,
beginning on page 28777, in the issue of
Monday, June 26, 2017 make the
following corrections:
§ 441.30 Pretreatment standards for
existing sources (PSES) [Corrected]
1. On page 28777, in the second
column, ‘‘§ 441.20 General definitions
[Corrected]’’ should read ‘‘§ 441.30
Pretreatment standards for existing
sources (PSES) [Corrected]’’.
2. On page 28777, in the second
column, ‘‘the 18th line of paragraph
(iii)’’ should read ‘‘in the 9th line of
paragraph (iii)’’.
[FR Doc. C2–2017–12338 Filed 7–3–17; 8:45 am]
sradovich on DSK3GMQ082PROD with RULES
BILLING CODE 1301–00–D
SURFACE TRANSPORTATION BOARD
49 CFR Part 1152
[Docket No. EP 729]
Offers of Financial Assistance
AGENCY:
Surface Transportation Board.
VerDate Sep<11>2014
16:11 Jul 03, 2017
Jkt 241001
ACTION:
Final rule.
The Surface Transportation
Board (Board or STB) adopts changes to
its rules pertaining to Offers of Financial
Assistance to improve the process and
protect it against abuse.
DATES: This rule is effective on July 29,
2017.
ADDRESSES: Information or questions
regarding this final rule should
reference Docket No. EP 729 and be in
writing addressed to: Chief, Section of
Administration, Office of Proceedings,
Surface Transportation Board, 395 E
Street SW., Washington, DC 20423–
0001.
FOR FURTHER INFORMATION CONTACT:
Jonathon Binet, (202) 245–0368.
Assistance for the hearing impaired is
available through the Federal
Information Relay Service (FIRS) at
(800) 877–8339.
SUPPLEMENTARY INFORMATION: In the ICC
Termination Act of 1995, Public Law
104–88, 109 Stat. 803 (1995) (ICCTA),
Congress revised the process for filing
Offers of Financial Assistance (OFAs)
for continued rail service, codified at 49
U.S.C. 10904. Under the OFA process,
as implemented in the Board’s
regulations at 49 CFR 1152.27,
financially responsible parties may offer
to temporarily subsidize continued rail
service over a line on which a carrier
seeks to abandon or discontinue service,
or offer to purchase a line and provide
continued rail service on a line that a
carrier seeks to abandon.
Upon request, the abandoning or
discontinuing carrier must provide
certain information required under 49
U.S.C. 10904(b) and 49 CFR 1152.27(a)
to a party that is considering making an
OFA. A party that decides to make an
OFA (the offeror) must submit the OFA
to the Board, including the information
specified in 49 CFR 1152.27(c)(1)(ii). If
the Board determines that the OFA is
made by a ‘‘financially responsible’’
person, the abandonment or
discontinuance authority is postponed
to allow the parties to negotiate a sale
or subsidy arrangement. 49 U.S.C.
10904(d)(2); 49 CFR 1152.27(e). If the
parties cannot agree to the terms of a
sale or subsidy, they may request that
the Board set binding terms under 49
U.S.C. 10904(f)(1). After the Board has
set the terms, the offeror can accept the
terms or withdraw the OFA. When the
operation of a line is subsidized to
prevent abandonment or discontinuance
of service, it may only be subsidized for
up to one year, unless the parties
mutually agree otherwise. 49 U.S.C.
10904(f)(4)(b). When a line is purchased
pursuant to an OFA, the buyer must
SUMMARY:
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
30997
provide common carrier service over the
line for a minimum of two years and
may not resell the line (except to the
carrier from which the line was
purchased) for five years after the
purchase. 49 U.S.C. 10904(f)(4)(A); 49
CFR 1152.27(i)(2).
On May 26, 2015, Norfolk Southern
Railway Company (NSR) filed a petition
to institute a rulemaking proceeding to
address abuses of Board processes. In
particular, NSR sought to have the
Board establish new rules regarding the
OFA process. NSR proposed that the
Board establish new rules creating: A
pre-approval process for filings
submitted by parties deemed abusive
filers; financial responsibility
presumptions; and additional financial
responsibility certifications. In a
decision served on September 23, 2015,
the Board denied NSR’s petition, stating
that the Board would instead seek to
address the concerns raised in the
petition through increased enforcement
of existing rules and by instituting an
Advance Notice of Proposed
Rulemaking (ANPRM) to consider
possible changes to the OFA process.
Pet. of Norfolk S. Ry. to Institute a
Rulemaking Proceeding to Address
Abuses of Board Processes (NSR
Petition), EP 727, slip op. at 4 (STB
served Sept. 23, 2015).
The Board issued an ANPRM on
December 14, 2015. In that ANPRM, the
Board explained that its experiences
have shown that there are areas where
clarifications and revisions could
enhance the OFA process and protect it
against abuse. Accordingly, the Board
requested public comments on whether
and how to improve any aspect of the
OFA process, including enhancing its
transparency and ensuring that it is
invoked only to further its statutory
purpose of preserving lines for
continued rail service. The Board also
specifically requested comments on:
Ensuring offerors are financially
responsible; addressing issues related to
the continuation of rail service; and
clarifying the identities of potential
offerors.
On September 30, 2016, the Board
issued a Notice of Proposed Rulemaking
(NPRM), addressing the comments on
the ANPRM and proposing specific
amendments to its regulations at 49 CFR
1152.27 based on those comments. The
Board proposed four amendments
intended to clarify the requirement that
OFA offerors be financially responsible
and to require offerors to provide
additional evidence of financial
responsibility to the Board; one
amendment intended to require that
potential offerors demonstrate the
continued need for rail service over the
E:\FR\FM\05JYR1.SGM
05JYR1
]]>Agencies
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30993-30997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14099]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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.
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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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
https://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]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
[[Page 30997]]
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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
