83 FR 55970 - Tin Oxide; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 218 (November 9, 2018)

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.

[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Rules and Regulations]
[Pages 55970-55974]
From the Federal Register Online  [www.thefederalregister.org]
[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.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-24585 Filed 11-8-18; 8:45 am]
 BILLING CODE 6560-50-P