Oxirane, 2-methyl, Polymer With Oxirane, Hydrogen Sulfate, Ammonium Salt and Potassium Salt; Tolerance Exemption, 30990-30993 [2017-14111]
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30990
Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations
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).
ENVIRONMENTAL PROTECTION
AGENCY
List of Subjects in 40 CFR Part 180
Oxirane, 2-methyl, Polymer With
Oxirane, Hydrogen Sulfate, Ammonium
Salt and Potassium Salt; Tolerance
Exemption
40 CFR Part 180
[EPA–HQ–OPP–2016–0780; FRL–9962–19]
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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Dated: May 19, 2017.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of oxirane, 2methyl, polymer with oxirane, hydrogen
sulfate, ammonium salt and oxirane, 2Therefore, 40 CFR chapter I is
methyl, polymer with oxirane, hydrogen
amended as follows:
sulfate, potassium salt; when used as an
PART 180—[AMENDED]
inert ingredient in a pesticide chemical
formulation. Clariant Corporation,
submitted a petition to EPA under the
■ 1. The authority citation for part 180
Federal Food, Drug, and Cosmetic Act
continues to read as follows:
(FFDCA), requesting an exemption from
Authority: 21 U.S.C. 321(q), 346a and 371.
the requirement of a tolerance. This
regulation eliminates the need to
■ 2. In § 180.638:
establish a maximum permissible level
■ a. Revise paragraph (a) introductory
for residues of oxirane, 2-methyl,
text; and
polymer with oxirane, hydrogen sulfate,
■ b. Add alphabetically the
ammonium salt and oxirane, 2-methyl,
commodities ‘‘teff, forage’’; ‘‘teff, grain’’; polymer with oxirane, hydrogen sulfate,
‘‘teff, hay’’; and ‘‘teff, straw’’; and
potassium salt on food or feed
footnote 1 to the table in paragraph (a).
commodities.
The revision and additoins read as
DATES: This regulation is effective July
follows:
5, 2017. Objections and requests for
hearings must be received on or before
§ 180.638 Pyroxsulam; tolerances for
September 5, 2017, and must be filed in
residues.
accordance with the instructions
(a) General. Tolerances are
provided in 40 CFR part 178 (see also
established for residues of pyroxsulam,
Unit I.C. of the SUPPLEMENTARY
including its metabolites and
INFORMATION).
degradates, in or on the commodities
ADDRESSES: The docket for this action,
listed in the table below. Compliance
identified by docket identification (ID)
with the tolerance levels specified
below is to be determined by measuring number EPA–HQ–OPP–2016–0780, is
available at https://www.regulations.gov
only pyroxsulam, N-(5,7-dimethoxy[l,
or at the Office of Pesticide Programs
2,4]triazolo[l, 5-a]pyrimidin-2-yl)-2Regulatory Public Docket (OPP Docket)
methoxy-4-(trifluoromethyl)-3in the Environmental Protection Agency
pyridinesulfonamide, in or on the
Docket Center (EPA/DC), West William
commodity.
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
Parts per
Commodity
20460–0001. The Public Reading Room
million
is open from 8:30 a.m. to 4:30 p.m.,
Teff, forage 1 ...............................
0.06 Monday through Friday, excluding legal
Teff, grain 1 .................................
0.01 holidays. The telephone number for the
Teff, hay 1 ....................................
0.01 Public Reading Room is (202) 566–1744,
Teff, straw 1 .................................
0.03 and the telephone number for the OPP
Docket is (703) 305–5805. Please review
*
*
*
*
*
the visitor instructions and additional
information about the docket available
1 There are no U.S. registrations on teff as
at https://www.epa.gov/dockets.
of May 8, 2017.
FOR FURTHER INFORMATION CONTACT:
*
*
*
*
*
Michael L. Goodis, Registration Division
[FR Doc. 2017–14091 Filed 7–3–17; 8:45 am]
(7505P), Office of Pesticide Programs,
BILLING CODE 6560–50–P
Environmental Protection Agency, 1200
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SUMMARY:
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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
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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. 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–2016–0780 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 September 5, 2017. 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
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sradovich on DSK3GMQ082PROD with RULES
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0780, 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. Background and Statutory Findings
In the Federal Register of April 10,
2017 (82 FR 17175) (FRL–9959–61),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11004) filed by Clariant
Corporation, 4000 Monroe Road,
Charlotte NC 28205. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt and oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
potassium salt; CAS Nos. 57608–14–7
and 1838191–48–2, respectively. That
document included a summary of the
petition prepared by the petitioner and
solicited comments on the petitioner’s
request. The Agency did not receive any
comments.
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 exemption is ‘‘safe.’’
Section 408(c)(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
use 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
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chemical residue in establishing an
exemption from the requirement of 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 . . .’’ and specifies
factors EPA is to consider in
establishing an exemption.
III. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown 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(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. In the
case of certain chemical substances that
are defined as polymers, the Agency has
established a set of criteria to identify
categories of polymers expected to
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). Oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt and potassium salt
conforms to the definition of a polymer
given in 40 CFR 723.250(b) and meets
the following criteria that are used to
identify low-risk polymers.
1. The polymers are not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymers do contain as an
integral part of its composition the
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atomic elements carbon, hydrogen, and
oxygen.
3. The polymers do not contain as an
integral part of their composition,
except as impurities, any element other
than those listed in 40 CFR
723.250(d)(2)(ii).
4. The polymers are neither designed
nor can it be reasonably anticipated to
substantially degrade, decompose, or
depolymerize.
5. The polymers are manufactured or
imported from monomers and/or
reactants that are already included on
the TSCA Chemical Substance
Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymers are not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 daltons.
7. The polymers do not contain
certain perfluoroalkyl moieties
consisting of a CF3- or longer chain
length as specified in 40 CFR
723.250(d)(6).
Additionally, the polymers also meet
as required the following exemption
criteria specified in 40 CFR 723.250(e).
8. The polymers’, oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt,
number average MW of 1800 and 2100,
respectively, are greater than 1,000 and
less than 10,000 daltons. The polymers
contain less than 10% oligomeric
material below MW 500 and less than
25% oligomeric material below MW
1,000, and the polymers do not contain
any reactive functional groups.
Thus, oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt and potassium salt meet
the criteria for a polymer to be
considered low risk under 40 CFR
723.250. Based on its conformance to
the criteria in this unit, no mammalian
toxicity is anticipated from dietary,
inhalation, or dermal exposure to
oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium
salt and potassium salt.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium
salt and potassium salt could be present
in all raw and processed agricultural
commodities and drinking water, and
that non-occupational non-dietary
exposure was possible. The number
average MW of oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt are
1800 and 2100 daltons, respectively.
Generally, a polymer of this size would
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be poorly absorbed through the intact
gastrointestinal tract or through intact
human skin. Since oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt
conform to the criteria that identify a
low-risk polymer, there are no concerns
for risks associated with any potential
exposure scenarios that are reasonably
foreseeable. The Agency has determined
that tolerances are not necessary to
protect the public health.
V. 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 oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt to
share a common mechanism of toxicity
with any other substances, and oxirane,
2-methyl, polymer with oxirane,
hydrogen sulfate, ammonium salt and
potassium salt do not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt do
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 Web site at https://
www.epa.gov/pesticides/cumulative.
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VI. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold 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 data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. Due to the expected low
toxicity of oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt and potassium salt, EPA
has not used a safety factor analysis to
assess the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
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VII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt and potassium salt.
VIII. Other Considerations
A. Existing Exemptions From a
Tolerance
There are no existing tolerances for
oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium
salt and potassium salt.
B. 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.
C. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium
salt and potassium salt.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of oxirane, 2methyl, polymer with oxirane, hydrogen
sulfate, ammonium salt and potassium
salt from the requirement of a tolerance
will be safe.
X. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
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Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). 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 tolerance 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
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consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
XI. 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: May 18, 2017.
Donna Davis,
Acting Associate Director, Registration
Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, add alphabetically the
polymers ‘‘Oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate,
ammonium salt; average molecular
weight (in amu), 1800’’ and ‘‘Oxirane, 2methyl, polymer with oxirane, hydrogen
sulfate, potassium salt; average
molecular weight (in amu), 2100’’ to the
table to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
PART 180—[AMENDED]
*
*
*
*
1. The authority citation for part 180
continues to read as follows:
■
Polymer
CAS No.
*
*
*
*
*
*
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, ammonium salt; average molecular weight (in amu), 1800 .................
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, potassium salt; average molecular weight (in amu), 2100 ..................
*
57608–14–7
1838191–48–2
*
*
*
*
*
[FR Doc. 2017–14111 Filed 7–3–17; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 6560–50–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0252, 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 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:
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0252; FRL–9961–82]
Titanium Dioxide; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of titanium
dioxide (CAS Reg. No. 13463–67–7) in
honey when used as an inert ingredient
(colorant) at a concentration of not more
than 0.1% by weight in pesticide
formulations intended for varroa mite
control around bee hives. Bayer
Healthcare, LLC submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of titanium dioxide
resulting from this use.
DATES: This regulation is effective July
5, 2017. Objections and requests for
hearings must be received on or before
September 5, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
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SUMMARY:
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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
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*
*
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&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–2016–0252 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
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Agencies
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30990-30993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14111]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0780; FRL-9962-19]
Oxirane, 2-methyl, Polymer With Oxirane, Hydrogen Sulfate,
Ammonium Salt and Potassium Salt; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, 2-methyl, polymer with oxirane,
hydrogen sulfate, ammonium salt and oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, potassium salt; when used as an inert
ingredient in a pesticide chemical formulation. Clariant Corporation,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium salt and oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate, potassium salt on food or feed
commodities.
DATES: This regulation is effective July 5, 2017. Objections and
requests for hearings must be received on or before September 5, 2017,
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-2016-0780, 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:
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 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. 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-2016-0780 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
September 5, 2017. 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
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objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2016-0780, 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. Background and Statutory Findings
In the Federal Register of April 10, 2017 (82 FR 17175) (FRL-9959-
61), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11004)
filed by Clariant Corporation, 4000 Monroe Road, Charlotte NC 28205.
The petition requested that 40 CFR 180.960 be amended by establishing
an exemption from the requirement of a tolerance for residues of
oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, ammonium
salt and oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate,
potassium salt; CAS Nos. 57608-14-7 and 1838191-48-2, respectively.
That document included a summary of the petition prepared by the
petitioner and solicited comments on the petitioner's request. The
Agency did not receive any comments.
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 exemption is ``safe.'' Section 408(c)(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 use 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 an exemption from the
requirement of 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 . . .'' and
specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown 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(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium salt and potassium salt conforms to
the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
1. The polymers are not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymers do contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
3. The polymers do not contain as an integral part of their
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymers are neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
5. The polymers are manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymers are not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
7. The polymers do not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as specified in 40 CFR
723.250(d)(6).
Additionally, the polymers also meet as required the following
exemption criteria specified in 40 CFR 723.250(e).
8. The polymers', oxirane, 2-methyl, polymer with oxirane, hydrogen
sulfate, ammonium salt and potassium salt, number average MW of 1800
and 2100, respectively, are greater than 1,000 and less than 10,000
daltons. The polymers contain less than 10% oligomeric material below
MW 500 and less than 25% oligomeric material below MW 1,000, and the
polymers do not contain any reactive functional groups.
Thus, oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate,
ammonium salt and potassium salt meet the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate, ammonium salt and potassium salt.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that oxirane, 2-methyl, polymer with oxirane,
hydrogen sulfate, ammonium salt and potassium salt could be present in
all raw and processed agricultural commodities and drinking water, and
that non-occupational non-dietary exposure was possible. The number
average MW of oxirane, 2-methyl, polymer with oxirane, hydrogen
sulfate, ammonium salt and potassium salt are 1800 and 2100 daltons,
respectively. Generally, a polymer of this size would
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be poorly absorbed through the intact gastrointestinal tract or through
intact human skin. Since oxirane, 2-methyl, polymer with oxirane,
hydrogen sulfate, ammonium salt and potassium salt conform to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that tolerances are
not necessary to protect the public health.
V. 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 oxirane, 2-methyl, polymer with oxirane, hydrogen
sulfate, ammonium salt and potassium salt to share a common mechanism
of toxicity with any other substances, and oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate, ammonium salt and potassium salt do not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, ammonium
salt and potassium salt do 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 Web site at https://www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold 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 data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of oxirane, 2-methyl,
polymer with oxirane, hydrogen sulfate, ammonium salt and potassium
salt, EPA has not used a safety factor analysis to assess the risk. For
the same reasons the additional tenfold safety factor is unnecessary.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, ammonium salt and potassium salt.
VIII. Other Considerations
A. Existing Exemptions From a Tolerance
There are no existing tolerances for oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate, ammonium salt and potassium salt.
B. 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.
C. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for oxirane, 2-methyl, polymer
with oxirane, hydrogen sulfate, ammonium salt and potassium salt.
IX. Conclusion
Accordingly, EPA finds that exempting residues of oxirane, 2-
methyl, polymer with oxirane, hydrogen sulfate, ammonium salt and
potassium salt from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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 tolerance 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
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consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
XI. 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: May 18, 2017.
Donna Davis,
Acting Associate Director, Registration Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.960, add alphabetically the polymers ``Oxirane, 2-
methyl, polymer with oxirane, hydrogen sulfate, ammonium salt; average
molecular weight (in amu), 1800'' and ``Oxirane, 2-methyl, polymer with
oxirane, hydrogen sulfate, potassium salt; average molecular weight (in
amu), 2100'' to the table to read as follows:
Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
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Polymer CAS No.
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* * * * * * *
Oxirane, 2-methyl, polymer with oxirane, hydrogen 57608-14-7
sulfate, ammonium salt; average molecular weight (in
amu), 1800.............................................
Oxirane, 2-methyl, polymer with oxirane, hydrogen 1838191-48-2
sulfate, potassium salt; average molecular weight (in
amu), 2100.............................................
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[FR Doc. 2017-14111 Filed 7-3-17; 8:45 am]
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