Zinc Oxide; Exemption From the Requirement of a Tolerance, 42783-42787 [2018-18402]
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Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations
the Federal Government and Indian
tribes, or otherwise have any unique
impacts on local governments. 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 final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
Although this action does not 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), EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. As such, to the
extent that information is publicly
available or was submitted in comments
to EPA, the Agency considered whether
groups or segments of the population, as
a result of their location, cultural
practices, or other factors, may have
atypical or disproportionately high and
adverse human health impacts or
environmental effects from exposure to
the pesticide discussed in this
document, compared to the general
population.
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this rule in the Federal
Register. This rule 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, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, the table is amended
by adding alphabetically the following
polymers to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Polymer
CAS No.
*
*
*
*
*
*
Lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1), minimum number average molecular weight (in amu); 4,500 daltons ................................................................................................................................
*
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*
*
40 CFR Part 180
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.
[EPA–HQ–OPP–2017–0574; FRL–9978–36]
DATES:
[FR Doc. 2018–18407 Filed 8–23–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
Zinc Oxide; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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,
SUMMARY:
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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).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0574, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
ADDRESSES:
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1905409–74–6
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Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael 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
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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).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://www.ecfr.
gov/cgi-bin/text-idx?&c=ecfr&tpl=/
ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–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: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
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follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Petition for Exemption
In the Federal Register of 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, https://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
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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
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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 https://
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
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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
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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
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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 https://
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
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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
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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
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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]
1. The authority citation for part 180
continues to read as follows:
■
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, revise the zinc oxide
entry in the table to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
Inert ingredients
*
Zinc oxide (CAS Reg. No.
1314–13–2).
*
Uses
*
*
*
*
*
Not more than 15% by weight in pesticide formulations when used as stabilizer .......
*
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BILLING CODE 6560–50–P
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 231
[Docket DARS–2017–0013]
RIN 0750–AJ51
Defense Federal Acquisition
Regulation Supplement: Repeal of
Independent Research and
Development Technical Interchange
(DFARS Case 2017–D041)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
AGENCY:
DoD is issuing a final rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to remove a requirement for
major contractors to have a technical
interchange with the Government prior
to generating independent research and
development costs.
DATES: Effective August 24, 2018.
FOR FURTHER INFORMATION CONTACT: Ms.
Carrie Moore, telephone 571–372–6093.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
sradovich on DSK3GMQ082PROD with RULES
*
Limits
[FR Doc. 2018–18402 Filed 8–23–18; 8:45 am]
DoD is amending the DFARS to
remove the text at DFARS 231.205–
18(c)(iii)(C)(4), which requires major
contractors to engage in and document
a technical interchange with the
Government, prior to generating
independent research and development
(IR&D) costs for IR&D projects initiated
in fiscal year 2017 and later, in order for
those costs to be determined allowable.
The removal of this DFARS text
supports a recommendation from the
DoD Regulatory Reform Task Force. On
February 24, 2017, the President signed
Executive Order (E.O.) 13777,
VerDate Sep<11>2014
*
00:53 Aug 24, 2018
Jkt 244001
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*
‘‘Enforcing the Regulatory Reform
Agenda,’’ which established a Federal
policy ‘‘to alleviate unnecessary
regulatory burdens’’ on the American
people. In accordance with E.O. 13777,
DoD established a Regulatory Reform
Task Force to review and validate DoD
regulations, including the DFARS. A
public notice of the establishment of the
DFARS Subgroup to the DoD Regulatory
Reform Task Force, for the purpose of
reviewing DFARS provisions and
clauses, was published in the Federal
Register at 82 FR 35741 on August 1,
2017. No public comments were
received on this DFARS requirement in
response to the notice. Subsequently,
the DoD Task Force reviewed the
requirements of DFARS 231.205–
18(c)(iii)(C)(4) and determined that the
DFARS coverage was outmoded and
recommended removal, since requiring
a technical interchange between the
Government and major contractors is
unnecessary. The objective of the
interchange can be met through other
means.
II. Applicability to Contracts At or
Below the Simplified Acquisition
Threshold and for Commercial Items,
Including Commercially Available Offthe-Shelf Items
This rule only removes an unneeded
requirement in the DFARS that required
a technical interchange between the
Government and certain contractors.
Therefore, the rule does not impose any
new requirements on contracts at or
below the simplified acquisition
threshold and for commercial items,
including commercially available offthe-shelf items.
III. Expected Cost Savings
Effective November 4, 2016, DFARS
231.205–18(c)(iii)(C)(4) was revised to
require contractors to engage in a
technical interchange with the
Government, prior to the generation of
IR&D costs for IR&D projects initiated in
fiscal year 2017 and later, in order for
those costs to be allowable. This
requirement causes the contractor to
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
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Coating agent, stabilizer.
*
expend time preparing for a discussion,
contacting appropriate Government
personnel, and discussing the IR&D
project. Since contractors commonly
pool all of their IR&D project costs to
develop a single billing rate, this
requirement would necessitate
contractors having to discuss all of the
IR&D projects contained in their billing
rate. While some contractors may have
a single project, many have close to 100
or more, which could be significantly
burdensome.
This requirement applies to major
contractors seeking to include IR&D
costs as part of their reimbursable costs
under a contract. Major contractors are
defined as those whose covered
segments allocated a total of more than
$11 million in IR&D and bid and
proposal costs to covered contracts
during the preceding fiscal year;
therefore, small entities are not expected
to meet the definition of a major
contractor or to be impacted. IR&D costs
are most commonly included in
noncommercial, cost-type contracts that
are subject to certified cost and pricing
data and cost accounting standards.
This rule removes the requirement for
major contractors to have a technical
interchange with the Government prior
to generating IR&D costs. Removal of
this requirement will result in freeing
contractors to pursue IR&D projects
without including the Government in
those preliminary decisions.
DoD has performed a regulatory cost
analysis on this rule. The following is a
summary of the estimated public
annualized cost savings, calculated in
2016 dollars at a 7-percent discount rate
in perpetuity:
Annualized 7% ¥$1.7 million
Present Value 7% ¥$24.0 million
To access the full Regulatory Cost
Analysis for this rule, go to the Federal
eRulemaking Portal at
www.regulations.gov, search for
‘‘DFARS Case 2017–D041,’’ click ‘‘Open
Docket,’’ and view ‘‘Supporting
Documents.’’
E:\FR\FM\24AUR1.SGM
24AUR1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael 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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of 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, https://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 https://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 https://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
