83 FR 42783 - Zinc Oxide; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 165 (August 24, 2018)

Page Range		42783-42787
FR Document		2018-18402

This regulation amends an exemption from the requirement of a tolerance for residues of zinc oxide (CAS Reg. No. 1314-13-2) when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest, to include use as a stabilizer, at a concentration not to exceed 15% by weight of the pesticide formulation. Nutrenare-AG, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an amended new use for an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of zinc oxide when used in accordance with the limitations of the exemption.

Federal Register, Volume 83 Issue 165 (Friday, August 24, 2018)

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Rules and Regulations]
[Pages 42783-42787]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-18402]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0574; FRL-9978-36]

Zinc Oxide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends an exemption from the requirement of a
tolerance for residues of zinc oxide (CAS Reg. No. 1314-13-2) when used
as an inert ingredient in pesticide formulations applied to growing
crops or raw agricultural commodities after harvest, to include use as
a stabilizer, at a concentration not to exceed 15% by weight of the
pesticide formulation. Nutrenare-AG, Inc. submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
establishment of an amended new use for an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of zinc oxide when
used in accordance with the limitations of the exemption.

DATES: This regulation is effective August 24, 2018. Objections and
requests for hearings must be received on or before October 23, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0574, 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:
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

[[Page 42784]]

determine whether this document applies to them. Potentially affected
entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0574 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 23, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0574, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11059) by Nutri Ag, Inc. (now d/b/a Nutrenare-AG, Inc.), 4740 N
Interstate 35 E, Waxahachie, TX 75165. The petition requested that the
exemption from the requirement of a tolerance for residues of zinc
oxide (CAS Reg. No. 1314-13-2) when used as an inert ingredient in
pesticide formulations applied to growing crops or raw agricultural
commodities after harvest under 40 CFR 180.910 be amended to include
use as a stabilizer, at a concentration not to exceed 15% by weight of
the pesticide formulation. That document referenced a summary of the
petition prepared by OMC Ag Consulting on behalf of Nutrenare-AG, Inc.,
the petitioner, which is available in the docket, http://www.regulations.gov. While comments were submitted to the docket, none
raised any issues related to the Agency's safety assessment of zinc
oxide.

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 zinc oxide including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with zinc 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

[[Page 42785]]

subgroups of consumers, including infants and children.
Zinc (typically in the form of zinc salts and zinc oxide) is
ubiquitous in the environment, is widely distributed in plants and
animals, and occurs in the earth's crust at an average concentration of
approximately 70 milligrams per kilogram (mg/kg). Zinc is also an
essential nutrient in the body and a normal part of metabolism in all
living organisms. Zinc is recommended for nutritional use and exists
naturally in food. The U.S. Food and Drug Administration considers zinc
oxide as generally recognized as safe for use as a nutrient in foods.
See 21 CFR 182.8991.
Zinc oxide is one of several zinc salts the Agency has evaluated in
reregistration and in registration review. The Agency's current risk
assessment for zinc oxide relies heavily on the Agency's previous
analysis, including the 2009 risk assessment, which is entitled
``Summary of Human Health Effects Data for Zinc, Zinc Salts, and
Zeolites Registration Review Decision Document'' and is included in the
zinc salts registration review docket at http://www.regulations.gov,
using document number EPA-HQ-OPP-2009-0011-0002.
The 2009 zinc salts risk assessment concluded that ``The Agency has
reviewed all toxicity studies submitted for the zinc salts and has
determined that the toxicological database is sufficient. The Agency
has not selected toxicological endpoints for zinc salts. The
toxicological database for the zinc salts case is currently comprised
of published and unpublished studies either submitted to the Agency or
obtained directly from published open literature.'' That risk
assessment also referenced the Agency's Reregistration Eligibility
Decision (RED) for Zinc Salts of August, 1992.
With regard to acute toxicity, the Agency's database includes
information indicating that zinc oxide presents low to no acute
toxicity. With regard to subchronic and chronic toxicity, the Agency
has reviewed the scientific literature about zinc, which has been
extensively researched as a natural component of the earth's crust and
being widely distributed in plants and animals, an essential nutrient
in the body and part of the metabolism of living things, and naturally
occurring in foods.
For toxicological concerns, there are adequate toxicology studies
in the zinc database to evaluate incidental oral exposures. As noted in
the 2009 risk assessment, at high levels, oral exposure to zinc in
animal studies may result in toxic effects such as pancreatic and renal
lesions as well as histological alterations in the pituitary and
adrenal glands. In general, the levels of zinc causing these
toxicological effects occur at much higher dose levels than the level
recommended for nutritional use and that is naturally available in
food. The 2009 risk assessment noted that zinc compounds have not been
classified as cancerous compounds.

B. Toxicological Points of Departure/Levels of Concern

As noted in the previous section, the 2009 risk assessment did not
identify any toxicological endpoints of concern because of the ubiquity
of zinc in the environment and presence in food, its role as an
essential element, and FDA's consideration of zinc as GRAS for use as a
nutrient in food. That assessment concluded that the toxicological
effects seen in the database indicated effects at much higher levels
than the level recommended for nutritional use and what is naturally
found in food. To supplement those conclusions, the Agency considered
the findings of the National Academy of Sciences' (NAS) Institute of
Medicine, Food and Nutrition Board; the European Food Safety
Authority's (EFSA) Panel on Dietetic Products, Nutrition and Allergies;
and the European Commission's Scientific Committee on Food (SCF).
The NAS, EFSA, and SCF have considered zinc in its role as an
essential nutrient. These organizations have established upper limit
intake levels for zinc. The NAS upper limit intake level for zinc is
referred to as the Tolerable Upper Intake Level (UL) and is defined as
the highest level of daily nutrient intake that is likely to pose no
risk of adverse health effects for almost all individuals. The NAS UL
for zinc is 40 mg/day for adults. The EFSA and SCF Tolerable Upper
Intake Level for zinc is 25 mg/day for adults. Both of these values are
based on adverse effects associated with chronic intake of supplemental
zinc, particularly those attributable to copper deficiency, with these
adverse effects observed at zinc exposure levels in humans above 60 mg/
day.
The NAS Recommended Dietary Allowance (RDA) for zinc is based upon
replacement of endogenous zinc loss in the body via normal metabolic
processes and is established at 8 mg/day for women and 11 mg/day for
men. (The EFSA Dietary Reference Values and the SCF Population
Reference Intake are consistent with the NAS RDA, ranging from 7 mg/day
to 12 mg/day for adults.) NAS also noted that the median intake of zinc
from food in the United States was approximately 9 mg/day for women and
14 mg/day for men. The estimated worst-case dietary exposures to zinc
from the use of zinc oxide as an inert ingredient in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest is 2 mg/day, a value significantly less than both the RDA
and UL for zinc.
Because the Agency does not anticipate aggregate exposures to zinc
oxide to approach the UL, it has not selected toxicological endpoints
for zinc oxide for use in a quantitative risk assessment.

C. Exposure Assessment

1. Dietary exposure. In evaluating dietary exposure to zinc oxide,
EPA considered exposure under the proposed exemption from the
requirement of a tolerance. EPA qualitatively assessed dietary
exposures from zinc oxide in food as follows:
Dietary exposure to zinc oxide can occur following ingestion of
foods with residues from treated crops, animals or food contact
surfaces. In addition, dietary exposure is expected from the presence
of zinc oxide naturally occurring in foods and from use as a nutrient.
Based on the insoluble nature of zinc oxide, use on food crops would
not be expected to result in residues of zinc oxide in drinking water,
although zinc may be present naturally in water at low concentrations.
2. 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).
Zinc oxide may be used in pesticide products and non-pesticide
products that may be used in and around the home. Based on the
discussion above, a quantitative residential exposure assessment for
zinc oxide was not conducted.
3. 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 zinc oxide to share a common mechanism of
toxicity with any other substances, and zinc oxide does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this

[[Page 42786]]

tolerance action, therefore, EPA has assumed that zinc 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 Food Quality Protection Act
Safety Factor (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.
As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

Exposures resulting from the use of zinc oxide as an inert
ingredient in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest and the dietary exposure
(expressed as median intake) of zinc from food, would be significantly
less than the Tolerable Upper Intake Levels for zinc. Therefore, EPA
concludes that aggregate exposure to residues of zinc oxide will not
pose a risk to the U.S. population, including infants and children, and
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to zinc 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. EPA is establishing
limitations on the amount of zinc oxide that may be used as a
stabilizer in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest. These limitations 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 formulation for use on
growing crops or raw agricultural commodities after harvest for sale or
distribution containing zinc oxide as a stabilizer that exceeds 15% by
weight of zinc oxide.

VI. Conclusions

Therefore, the exemption from the requirement of a tolerance for
residues of zinc oxide when used as an inert ingredient in pesticide
formulations applied to growing crops or raw agricultural commodities
after harvest under 40 CFR 180.910 is amended to include use as a
stabilizer, at a concentration not to exceed 15% by weight of the
pesticide formulation.

VII. Statutory and Executive Order Reviews

This action amends an exemption from the requirement of a tolerance
under FFDCA section 408(d) in response to a petition submitted to the
Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001); Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' ((82 FR 9339, February 3, 2017). This action does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: August 16, 2018.
Michael Goodis,
Director, Registration Division.

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:

[[Page 42787]]

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

0
2. In Sec. 180.910, revise the zinc oxide entry in the table to read
as follows:

Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------

* * * * * * *
Zinc oxide (CAS Reg. No. 1314-13-2).... Not more than 15% by Coating agent, stabilizer.
weight in pesticide
formulations when used as
stabilizer.

* * * * * * *
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[FR Doc. 2018-18402 Filed 8-23-18; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 42783

the Federal Government and Indian regulations, and policies. As such, to the Register. This rule is not a ‘‘major rule’’
tribes, or otherwise have any unique extent that information is publicly as defined by 5 U.S.C. 804(2).
impacts on local governments. Thus, the available or was submitted in comments List of Subjects in 40 CFR Part 180
Agency has determined that Executive to EPA, the Agency considered whether
Order 13132, entitled Federalism (64 FR groups or segments of the population, as Environmental protection,
43255, August 10, 1999) and Executive a result of their location, cultural Administrative practice and procedure,
Order 13175, entitled Consultation and practices, or other factors, may have Agricultural commodities, Pesticides
Coordination with Indian Tribal atypical or disproportionately high and and pests, Reporting and recordkeeping
Governments (65 FR 67249, November adverse human health impacts or requirements.
9, 2000) do not apply to this final rule. environmental effects from exposure to Dated: August 16, 2018.
In addition, this final rule does not the pesticide discussed in this Michael Goodis,
impose any enforceable duty or contain document, compared to the general
any unfunded mandate as described Director, Registration Division, Office of
population. Pesticide Programs.
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. XI. Congressional Review Act Therefore, 40 CFR chapter I is
104–4). amended as follows:
Although this action does not require The Congressional Review Act, 5
any special considerations under U.S.C. 801 et seq., generally provides PART 180—[AMENDED]
Executive Order 12898, entitled Federal that before a rule may take effect, the
Actions to Address Environmental agency promulgating the rule must ■ 1. The authority citation for part 180
Justice in Minority Populations and submit a rule report to each House of continues to read as follows:
Low-Income Populations (59 FR 7629, the Congress and to the Comptroller Authority: 21 U.S.C. 321(q), 346a and 371.
February 16, 1994), EPA seeks to General of the United States. EPA will ■ 2. In § 180.960, the table is amended
achieve environmental justice, the fair submit a report containing this rule and by adding alphabetically the following
treatment and meaningful involvement other required information to the U.S. polymers to read as follows:
of any group, including minority and/or Senate, the U.S. House of
low-income populations, in the Representatives, and the Comptroller § 180.960 Polymers; exemptions from the
development, implementation, and General of the United States prior to requirement of a tolerance.
enforcement of environmental laws, publication of this rule in the Federal * * * * *

Polymer CAS No.

* * * * * * *
Lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1), minimum number aver-
age molecular weight (in amu); 4,500 daltons ................................................................................................................................ 1905409–74–6

* * * * * * *

[FR Doc. 2018–18407 Filed 8–23–18; 8:45 am] and Cosmetic Act (FFDCA), requesting Monday through Friday, excluding legal
BILLING CODE 6560–50–P establishment of an amended new use holidays. The telephone number for the
for an exemption from the requirement Public Reading Room is (202) 566–1744,
of a tolerance. This regulation and the telephone number for the OPP
ENVIRONMENTAL PROTECTION eliminates the need to establish a Docket is (703) 305–5805. Please review
AGENCY maximum permissible level for residues the visitor instructions and additional
of zinc oxide when used in accordance information about the docket available
40 CFR Part 180 with the limitations of the exemption. at http://www.epa.gov/dockets.
[EPA–HQ–OPP–2017–0574; FRL–9978–36] DATES: This regulation is effective FOR FURTHER INFORMATION CONTACT:
August 24, 2018. Objections and Michael L. Goodis, Registration Division
Zinc Oxide; Exemption From the requests for hearings must be received (7505P), Office of Pesticide Programs,
Requirement of a Tolerance on or before October 23, 2018, and must Environmental Protection Agency, 1200
be filed in accordance with the Pennsylvania Ave. NW, Washington, DC
AGENCY: Environmental Protection 20460–0001; main telephone number:
instructions provided in 40 CFR part
Agency (EPA). (703) 305–7090; email address:
178 (see also Unit I.C. of the
ACTION: Final rule. SUPPLEMENTARY INFORMATION). RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY: This regulation amends an ADDRESSES: The docket for this action,
exemption from the requirement of a identified by docket identification (ID) I. General Information
tolerance for residues of zinc oxide number EPA–HQ–OPP–2017–0574, is
(CAS Reg. No. 1314–13–2) when used as available at http://www.regulations.gov A. Does this action apply to me?
an inert ingredient in pesticide or at the Office of Pesticide Programs You may be potentially affected by
sradovich on DSK3GMQ082PROD with RULES

formulations applied to growing crops Regulatory Public Docket (OPP Docket) this action if you are an agricultural
or raw agricultural commodities after in the Environmental Protection Agency producer, food manufacturer, or
harvest, to include use as a stabilizer, at Docket Center (EPA/DC), West William pesticide manufacturer. The following
a concentration not to exceed 15% by Jefferson Clinton Bldg., Rm. 3334, 1301 list of North American Industrial
weight of the pesticide formulation. Constitution Ave. NW, Washington, DC Classification System (NAICS) codes is
Nutrenare-AG, Inc. submitted a petition 20460–0001. The Public Reading Room not intended to be exhaustive, but rather
to EPA under the Federal Food, Drug, is open from 8:30 a.m. to 4:30 p.m., provides a guide to help readers

VerDate Sep<11>2014 00:53 Aug 24, 2018 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\24AUR1.SGM 24AUR1

42786 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations

tolerance action, therefore, EPA has applied to growing crops and raw Flexibility Act (RFA) (5 U.S.C. 601 et
assumed that zinc oxide does not have agricultural commodities after harvest. seq.), do not apply.
a common mechanism of toxicity with These limitations will be enforced This action directly regulates growers,
other substances. For information through the pesticide registration food processors, food handlers, and food
regarding EPA’s efforts to determine process under the Federal Insecticide, retailers, not States or tribes, nor does
which chemicals have a common Fungicide, and Rodenticide Act this action alter the relationships or
mechanism of toxicity and to evaluate (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA will distribution of power and
the cumulative effects of such not register any pesticide formulation responsibilities established by Congress
chemicals, see EPA’s website at http:// for use on growing crops or raw in the preemption provisions of FFDCA
www.epa.gov/pesticides/cumulative. agricultural commodities after harvest section 408(n)(4). As such, the Agency
for sale or distribution containing zinc has determined that this action will not
D. Safety Factor for Infants and oxide as a stabilizer that exceeds 15% have a substantial direct effect on States
Children by weight of zinc oxide. or tribal governments, on the
Section 408(b)(2)(C) of FFDCA relationship between the national
VI. Conclusions
provides that EPA shall apply an government and the States or tribal
additional tenfold (10X) margin of safety Therefore, the exemption from the governments, or on the distribution of
for infants and children in the case of requirement of a tolerance for residues power and responsibilities among the
threshold effects to account for prenatal of zinc oxide when used as an inert various levels of government or between
and postnatal toxicity and the ingredient in pesticide formulations the Federal Government and Indian
completeness of the database on toxicity applied to growing crops or raw tribes. Thus, the Agency has determined
and exposure unless EPA determines agricultural commodities after harvest that Executive Order 13132, entitled
based on reliable data that a different under 40 CFR 180.910 is amended to ‘‘Federalism’’ (64 FR 43255, August 10,
margin of safety will be safe for infants include use as a stabilizer, at a 1999) and Executive Order 13175,
and children. This additional margin of concentration not to exceed 15% by entitled ‘‘Consultation and Coordination
safety is commonly referred to as the weight of the pesticide formulation. with Indian Tribal Governments’’ (65 FR
Food Quality Protection Act Safety VII. Statutory and Executive Order 67249, November 9, 2000) do not apply
Factor (FQPA SF). In applying this Reviews to this action. In addition, this action
provision, EPA either retains the default does not impose any enforceable duty or
This action amends an exemption
value of 10X, or uses a different contain any unfunded mandate as
from the requirement of a tolerance
additional safety factor when reliable described under Title II of the Unfunded
under FFDCA section 408(d) in
data available to EPA support the choice response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C.
of a different factor. Agency. The Office of Management and 1501 et seq.).
As part of its qualitative assessment, Budget (OMB) has exempted these types This action does not involve any
the Agency did not use safety factors for of actions from review under Executive technical standards that would require
assessing risk, and no additional safety Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
factor is needed for assessing risk to Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
infants and children. October 4, 1993). Because this action 12(d) of the National Technology
E. Aggregate Risks and Determination of has been exempted from review under Transfer and Advancement Act
Safety Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
not subject to Executive Order 13211, VIII. Congressional Review Act
Exposures resulting from the use of
entitled ‘‘Actions Concerning
zinc oxide as an inert ingredient in Pursuant to the Congressional Review
Regulations That Significantly Affect
pesticide formulations applied to Act (5 U.S.C. 801 et seq.), EPA will
Energy Supply, Distribution, or Use’’ (66
growing crops and raw agricultural submit a report containing this rule and
FR 28355, May 22, 2001); Executive
commodities after harvest and the other required information to the U.S.
Order 13045, entitled ‘‘Protection of
dietary exposure (expressed as median Senate, the U.S. House of
Children from Environmental Health
intake) of zinc from food, would be Representatives, and the Comptroller
Risks and Safety Risks’’ (62 FR 19885,
significantly less than the Tolerable General of the United States prior to
April 23, 1997); or Executive Order
Upper Intake Levels for zinc. Therefore, publication of the rule in the Federal
13771, entitled ‘‘Reducing Regulations
EPA concludes that aggregate exposure Register. This action is not a ‘‘major
and Controlling Regulatory Costs’’ ((82
to residues of zinc oxide will not pose rule’’ as defined by 5 U.S.C. 804(2).
FR 9339, February 3, 2017). This action
a risk to the U.S. population, including
does not contain any information List of Subjects in 40 CFR Part 180
infants and children, and that there is a
collections subject to OMB approval Environmental protection,
reasonable certainty that no harm will
under the Paperwork Reduction Act Administrative practice and procedure,
result to the general population, or to
(PRA) (44 U.S.C. 3501 et seq.), nor does Agricultural commodities, Pesticides
infants and children from aggregate
it require any special considerations and pests, Reporting and recordkeeping
exposure to zinc oxide residues.
under Executive Order 12898, entitled requirements.
V. Other Considerations ‘‘Federal Actions to Address
Environmental Justice in Minority Dated: August 16, 2018.
A. Analytical Enforcement Methodology Michael Goodis,
Populations and Low-Income
An analytical method is not required Populations’’ (59 FR 7629, February 16, Director, Registration Division.
sradovich on DSK3GMQ082PROD with RULES

for enforcement purposes since the 1994). Therefore, 40 CFR chapter I is
Agency is establishing an exemption Since tolerances and exemptions that amended as follows:
from the requirement of a tolerance are established on the basis of a petition
without any numerical limitation. EPA under FFDCA section 408(d), such as PART 180—[AMENDED]
is establishing limitations on the the exemption in this final rule, do not
amount of zinc oxide that may be used require the issuance of a proposed rule, ■ 1. The authority citation for part 180
as a stabilizer in pesticide formulations the requirements of the Regulatory continues to read as follows:

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective August 24, 2018. Objections and requests for hearings must be received on or before October 23, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation		83 FR 42783
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements