[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Rules and Regulations]
[Pages 55970-55974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24585]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0614; FRL-9982-73]
Tin Oxide; 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 tin oxide (CAS Reg. No. 18282-10-5) when
used as an inert ingredient (seed treatment colorant) not to exceed 40%
by weight in pesticide formulations applied to growing crops. Exponent
on behalf of Aceto Corporation 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 tin oxide.
DATES: This regulation is effective November 9, 2018. Objections and
requests for hearings must be received on or before January 8, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0614, 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 L. 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.
[[Page 55971]]
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0614 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
January 8, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0614, 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 March 21, 2018 (83 FR 12311) (FRL-9974-
76), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11058) by
Exponent (1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036),
on behalf of Aceto Corporation (Aceto, 4 Tri Harbor Court, Port
Washington, NY 11050). The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of tin oxide (CAS Reg. No. 18282-10-5) when used
as an inert ingredient (seed treatment colorant) in pesticide
formulations applied to growing crops not to exceed 40% by weight. That
document referenced a summary of the petition prepared by Exponent on
behalf of Aceto Corporation, the petitioner, which is available in the
docket, http://www.regulations.gov. There were no timely 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 tin oxide including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with tin oxide 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. Specific information on the studies received and the nature
of the adverse effects caused by tin oxide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
Although limited data are available on tin oxide, tin oxide belongs
to the chemical class of water insoluble inorganic tins; therefore, the
Agency used data available on inorganic tins, specifically tin (II)
chloride (CAS Reg No. 21651-19-4) to fill data gaps.
The acute oral toxicity of tin oxide is very low. The lethal dose,
(LD)50>20,000 milligrams/kilograms (mg/kg) in rats
[[Page 55972]]
and mice. There is no eye irritation in Leghorn eggs nor in bovine
cornea.
The only repeated dose studies available with tin oxide are the 28-
day and 13-week oral toxicity studies in rats. No toxicity is observed
in either study up to 1,000 and 500 mg/kg/day, respectively of tin
oxide, the highest dose tested in both studies.
Although developmental and reproduction toxicity studies are not
available on tin oxide, evidence of potential developmental or
reproduction toxicity is not observed in the available studies with tin
oxide and no toxicity is seen up to 500 mg/kg/day, the highest dose
tested. Available reproduction and developmental studies with tin (II)
chloride that show no maternal, offspring or reproduction toxicity at
40 mg/kg/day, the highest dose tested, in rats, although these studies
are of limited value since the doses tested were not high enough to
assess developmental and reproduction effects. Nevertheless, there is
no concern for fetal susceptibility due to dietary exposure to tin
oxide because it is insoluble and is not expected to be absorbed or
cause systemic toxicity. Also, no toxicity is observed in reproduction
organs at 500 and 1,000 mg/kg/day, the highest doses tested in the 13-
and 4-week, respectively, oral toxicity studies in rats.
Carcinogenicity studies with tin (II) chloride in rats and mice
indicate that inorganic tins are not carcinogenic at 40 and 60 mg/kg/
day, respectively, the highest dose tested.
In an in vitro mutagenicity assay, tin oxide caused micronuclei and
karyorrhexis in lung macrophages. The toxicologic significance of this
finding is equivocal.
Neurotoxicity and immunotoxicity studies are not available for
review. However, no evidence of neurotoxicity and immunotoxicity is
observed in the submitted studies.
The absorption of inorganic tin compounds from the gastrointestinal
tract in humans and animals is very low with as much as 98% excreted
directly in the feces. Because of their limited absorption, inorganic
tin compounds have low systemic toxicity.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The 13-week oral toxicity study in rats is selected for the chronic
dietary exposure scenario. No toxicity is observed up to 500 mg/kg/day,
the highest dose tested. The lowest NOAEL in the database is found in
the developmental and reproduction toxicity studies in the rat. In
these studies, no treatment related adverse toxicity is observed at 800
ppm (40 mg tin/kg/day), the highest dose tested in both studies.
However, the developmental and reproduction toxicity studies are not
considered appropriate for risk assessment since tested doses are not
high enough to assess developmental and reproduction toxicity.
Therefore, the 13-week toxicity study in rats treated with tin oxide is
used for the chronic dietary exposure scenario. There is no concern for
the lack of developmental and reproduction toxicity studies because tin
oxide is an insoluble tin and is not expected to be absorbed or cause
systemic toxicity. Further supporting the lack of toxicity, no systemic
toxicity or adverse effects are observed up to 500 mg/kg/day, the
highest dose tested, in the 13-week toxicity study in rats. Based on
the weight of evidence, there is no concern for increased
susceptibility and no additional uncertainty factor is necessary. The
standard inter- and intra-species uncertainty factors of 10x are
applied. Dermal and inhalation endpoints were not selected as tin oxide
is not expected to be dermally absorbed because it is insoluble, and
not expected to be absorbed in the lungs due to its particle size.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tin oxide, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from tin oxide in food as follows:
Dietary exposure (food and drinking water) to tin oxide can occur
following ingestion of foods with residues from treated crops with
pesticide formulations containing tin oxide. In addition, dietary
exposure can occur from exposure to non-pesticidal sources of tin
oxide. FDA has approved the use of tin oxide as a colorant in food-
contact articles at a maximum level of 1.1% by weight in colorants
otherwise composed of mica and titanium dioxide, provided that the
maximum loading rate for the colorant in the food-contact material does
not exceed 3% by weight for polymers, 5% for paper and paperboard, 15%
for coatings, or 30% for ink formulations. See Food and Drug
Administration (FDA) threshold of regulation (TOR) exemption 98-004. It
may be used, in combination with silicon dioxide and titanium dioxide,
as a colorant for food-contact polymers, paper and paperboard,
coatings, and in printing inks applied to non-food-contact surfaces of
food-contact articles. The food contact substance will be used at a
level not to exceed 6% of the total colorant weight. See FDA, Food
Contact Notification (FCN) 000431. Tin oxide can also be used as a
pigment for all polyolefins for food contact applications as long as
the use level does not exceed 0.5% by weight of the polymer and is
subject to certain limitations. See FDA, Food Contact Notification
(FCN) 235.
Because no adverse effects attributable to a single exposure of tin
oxide are seen in the toxicity databases, an acute dietary risk
assessment is not necessary. For the chronic dietary risk assessment,
EPA used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCIDTM), Version 3.16, and
food consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for tin oxide. In the absence of specific
residue data, EPA utilized a highly conservative assumption that the
residues on all commodities are 47 ppm based on the effective
application rate of tin oxide when used as a colorant for seed
treatment pesticide products and the presumption that all applied tin
oxide
[[Page 55973]]
would be present in the edible portions of crops derived from treated
seed. A complete description of the general approach taken to assess
inert ingredient risks in the absence of residue data is contained in
the memorandum entitled ``Alkyl Amines Polyalkoxylates (Cluster 4):
Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure
and Risk Assessments for the Inerts,'' (D361707, S. Piper, 2/25/09) and
can be found at http://www.regulations.gov in docket ID number EPA-HQ-
OPP-2008-0738.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for tin oxide, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values were directly entered into the
dietary exposure model.
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).
Tin oxide is not expected to be used as an inert ingredient in
pesticide products that are registered for specific uses that may
result in residential exposure, as the requested use is for commercial
use only. However, tin oxide is present in cosmetics and personal care
products. The typical reported concentration for tin oxide in cosmetics
and personal care products ranges from 0.03 to 1.3%. Based on the 2013
Cosmetic Ingredient Review (CIR) document, tin oxide is used in dusting
powders (up to 0.03%), body and hand cosmetic sprays (up to 0.06%), and
other fragrance preparations (up to 0.08%).
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.''
EPA has not found tin oxide to share a common mechanism of toxicity
with any other substances, and tin oxide does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that tin oxide does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
The Agency has concluded that there is reliable data to determine
that infants and children will be safe if the FQPA SF of 10x is reduced
to 1X for the chronic dietary assessment for the following reasons.
First, the toxicity database for tin oxide contains subchronic,
carcinogenicity and mutagenicity studies. There is no indication of
immunotoxicity or neurotoxicity in the available studies; therefore,
there is no need to require an immunotoxicity or neurotoxicity study.
Although no developmental and reproduction toxicity studies with tin
oxide are available, there is no concern for fetal susceptibility
because tin oxide is insoluble and is not expected to be absorbed or
cause systemic toxicity. Further supporting the lack of toxicity, no
adverse effects or systemic toxicity are observed up to 500 mg/kg/day,
the highest dose tested, in the 13-week toxicity study in rats. Based
on the weight of evidence, there is no concern for increased
susceptibility and, the Agency has concluded that reducing the FQPA SF
to 1X is appropriate.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
tin oxide from food and water will utilize 38.3% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the available data, oral exposure to tin oxide
residues from non-pesticide uses is expected to be negligible compared
to the conservative estimates of exposure resulting from the proposed
use as a colorant for seed treatment pesticides, and not expected to
significantly impact dietary exposure.
3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level).
Tin oxide is not expected to be used as an inert ingredient in
pesticide products that could result in short- and intermediate-term
residential exposure as the request is strictly for commercial seed
treatment use only, although tin oxide is currently approved for use in
cosmetic, manufacturing applications.
Dermal exposure to residues of tin oxide is not expected to result
in systemic toxicity as tin oxide is insoluble and not absorbed through
the skin. Inhalation exposure is possible due to its use in cosmetics
and personal care products. However, as reported in the CIR 2013 on tin
oxide, inhalation exposure to tin oxide particles are not expected as
95-99% of the particles are >10 micrometers (um) and not expected to
enter the lungs. Because of the lack of adverse effects from dermal or
inhalation exposure, the Agency does not expect these residential
exposures to pose risks of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two rodent carcinogenicity studies, tin
oxide is not expected to pose a cancer risk to humans.
[[Page 55974]]
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to tin oxide residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation. The Agency ensures
compliance with the limitation in the tolerance exemption through the
registration of pesticides with formulations that satisfy the
limitation under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for residues of tin oxide (CAS Reg.
No. 18282-10-5) when used as an inert ingredient (colorant) in
pesticide seed treatment formulations applied to growing crops not to
exceed 40% by weight.
VII. Statutory and Executive Order Reviews
This action establishes an exemption to the requirement for 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), nor is it considered a regulatory action under
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: November 1, 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, add alphabetically the inert ingredient ``Tin
oxide (CAS Reg. No. 18282-10-5)'' to the table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Tin oxide (CAS Reg. No. Not to exceed 40% by Colorant.
18282-10-5). weight for use in
seed treatment
pesticide
formulations only.
* * * * * * *
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[FR Doc. 2018-24585 Filed 11-8-18; 8:45 am]
BILLING CODE 6560-50-P