Document ID: EPA-HQ-OPP-2017-0574-0006
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Zinc Oxide
Posted Date: 2018-08-24T04:00Z

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Rules and Regulations]
[Pages 42783-42787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[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

[[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.

* * * * *

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           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