Pyroxsulam; Pesticide Tolerances, 31893-31895 [2018-14735]
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Federal Register / Vol. 83, No. 132 / Tuesday, July 10, 2018 / Rules and Regulations
888–REG–FAIR (1–888–734–3247). The
Coast Guard will not retaliate against
small entities that question or complain
about this rule or any policy or action
of the Coast Guard.
C. Collection of Information
This rule will not call for a new
collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, this rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section
above.
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E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Directive 023–01 and Commandant
Instruction M16475.1D, which guide the
Coast Guard in complying with the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
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individually or cumulatively have a
significant effect on the human
environment. This rule establishes a
temporary safety zone. It is categorically
excluded from further review under
paragraph L60(a) of Appendix A, Table
1 of DHS Instruction Manual 023–01–
001–01, Rev. 01. A Record of
Environmental Consideration
supporting this determination is
available in the docket where indicated
under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T09–0630 to read as
follows:
■
§ 165.T09–0630 Safety Zone; Hamburg
Beach Blast Fireworks Display; Lake Erie,
Hamburg, NY.
(a) Location. The safety zone will
encompass all waters of Lake Erie;
Hamburg, NY contained within a 280foot radius of: 42°45′59.21″ N,
078°52′41.51″ W.
(b) Enforcement period. This
regulation will be enforced from 9:45
p.m. until 10:45 p.m. on July 28, 2018.
(c) Regulations. (1) In accordance with
the general regulations in § 165.23, entry
into, transiting, or anchoring within this
safety zone is prohibited unless
authorized by the Captain of the Port
Buffalo or his designated on-scene
representative.
(2) This safety zone is closed to all
vessel traffic, except as may be
permitted by the Captain of the Port
Buffalo or his designated on-scene
representative.
(3) The ‘‘on-scene representative’’ of
the Captain of the Port Buffalo is any
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31893
Coast Guard commissioned, warrant or
petty officer who has been designated
by the Captain of the Port Buffalo to act
on his behalf.
(4) Vessel operators desiring to enter
or operate within the safety zone must
contact the Captain of the Port Buffalo
or his on-scene representative to obtain
permission to do so. The Captain of the
Port Buffalo or his on-scene
representative may be contacted via
VHF Channel 16. Vessel operators given
permission to enter or operate in the
safety zone must comply with all
directions given to them by the Captain
of the Port Buffalo, or his on-scene
representative.
Dated: July 5, 2018.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the
Port Buffalo.
[FR Doc. 2018–14740 Filed 7–9–18; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0227; FRL–9978–15]
Pyroxsulam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends
existing tolerances for residues of
pyroxsulam in or on teff forage, teff
grain, teff hay, and teff straw.
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective July
10, 2018. Objections and requests for
hearings must be received on or before
September 10, 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–2017–0227, 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,
SUMMARY:
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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:
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 EPA’s tolerance
regulations at 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.
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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–2017–0227 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 10, 2018. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
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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–
2017–0227, 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. Summary of Petitioned-For
Tolerance
In the Federal Register of October 23,
2017 (82 FR 49020) (FRL–9967–37),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7E8551) by IR–4,
Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of the herbicide pyroxsulam,
N-(5,7-dimethoxy[1,2,4]triazolo[1,5a]pyrimidin-2-yl)-2-methoxy-4(trifluoromethyl)-3-pyridinesulfonamide
in or on the raw agricultural
commodities teff, forage at 0.06 ppm;
teff, grain at 0.01 ppm; teff, straw at 0.03
ppm; and teff, hay at 0.01 ppm. That
document referenced a summary of the
petition prepared by Dow Agrosciences,
the registrant, which is available in the
docket, https://www.regulations.gov. A
comment was received on the notice of
filing but was related to the impact of
wind turbines on bats and therefore not
relevant to this action.
In between the submission of the
petition and the publication of this
document, tolerances were established
in the Federal Register of July 5, 2017
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(82 FR 30987) (FRL–9962–60) for
residues in teff forage, teff grain, teff
hay, and teff straw at the levels
requested in this petition to cover
residues of pyroxsulam in or on imports
of those commodities since there was no
domestic registration for that use at the
time.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish 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. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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 consistent with
FFDCA section 408(b)(2).
In the Federal Register of July 5, 2017
(82 FR 30987), EPA established
tolerances for residues of pyroxsulam in
or on teff forage, teff grain, teff hay, and
teff straw at the same levels as those
requested in this action. Because there
was no domestic use of pyroxsulam
registered on those commodities at the
time, the tolerances included a footnote
noting the lack of U.S. registrations for
use of pyroxsulam on teff. Due to
changes in the status of domestic
registrations for use of pyroxsulam in or
on teff, this footnote is no longer
accurate and needs to be removed.
The U.S. registration of teff on
pyroxsulam does not change the
Agency’s previous conclusions about
drinking water exposure or residential
exposure; therefore, the previous
aggregate risk assessment supports the
amendment of the teff tolerances. Based
on this assessment of potential exposure
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from use of pyroxsulam on teff and the
findings supporting the July 5, 2017
tolerances established for teff
commodities, EPA concludes that there
is a reasonable certainty that no harm
will result to the general population, or
to infants and children from aggregate
exposure to pyroxsulam residues.
For a detailed discussion of the
aggregate risk assessments and
determination of safety for the proposed
tolerances, please refer to the July 5,
2017 Federal Register document and its
supporting documents available at
https://www.regulations.gov in docket ID
numbers EPA–HQ–OPP–2006–0785 and
EPA–HQ–OPP–2017–0227.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement
methodology, Method GRM 04.17, a
liquid chromatography with tandem
mass spectrometry (LC/MS/MS)
method, is available to enforce the
tolerance expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
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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 pyroxsulam.
V. Conclusion
Therefore, the tolerances for teff
commodities in 40 CFR 180.638 are
amended by removing the footnote
stating ‘‘There are no U.S. registrations
on teff as of May 8, 2017’’.
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VI. Statutory and Executive Order
Reviews
This action modifies tolerances under
FFDCA section 408(d) in response to a
petition submitted to the Agency. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerances 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
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Frm 00055
Fmt 4700
Sfmt 9990
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).
VII. 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: June 15, 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 § 180.638, revise the table in
paragraph (a) to read as follows:
■
§ 180.638 Pyroxsulam; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
Teff, forage .................................
Teff, grain ...................................
Teff, hay ......................................
Teff, straw ...................................
Wheat, forage .............................
Wheat, grain ...............................
Wheat, hay .................................
Wheat, straw ...............................
*
*
*
*
*
[FR Doc. 2018–14735 Filed 7–9–18; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 83, Number 132 (Tuesday, July 10, 2018)]
[Rules and Regulations]
[Pages 31893-31895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14735]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0227; FRL-9978-15]
Pyroxsulam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends existing tolerances for residues of
pyroxsulam in or on teff forage, teff grain, teff hay, and teff straw.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 10, 2018. Objections and
requests for hearings must be received on or before September 10, 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-2017-0227, 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,
[[Page 31894]]
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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 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-2017-0227 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 10, 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-2017-0227, 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. Summary of Petitioned-For Tolerance
In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8551) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the herbicide pyroxsulam, N-(5,7-
dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide in or on the raw agricultural
commodities teff, forage at 0.06 ppm; teff, grain at 0.01 ppm; teff,
straw at 0.03 ppm; and teff, hay at 0.01 ppm. That document referenced
a summary of the petition prepared by Dow Agrosciences, the registrant,
which is available in the docket, https://www.regulations.gov. A comment
was received on the notice of filing but was related to the impact of
wind turbines on bats and therefore not relevant to this action.
In between the submission of the petition and the publication of
this document, tolerances were established in the Federal Register of
July 5, 2017 (82 FR 30987) (FRL-9962-60) for residues in teff forage,
teff grain, teff hay, and teff straw at the levels requested in this
petition to cover residues of pyroxsulam in or on imports of those
commodities since there was no domestic registration for that use at
the time.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 consistent with FFDCA section
408(b)(2).
In the Federal Register of July 5, 2017 (82 FR 30987), EPA
established tolerances for residues of pyroxsulam in or on teff forage,
teff grain, teff hay, and teff straw at the same levels as those
requested in this action. Because there was no domestic use of
pyroxsulam registered on those commodities at the time, the tolerances
included a footnote noting the lack of U.S. registrations for use of
pyroxsulam on teff. Due to changes in the status of domestic
registrations for use of pyroxsulam in or on teff, this footnote is no
longer accurate and needs to be removed.
The U.S. registration of teff on pyroxsulam does not change the
Agency's previous conclusions about drinking water exposure or
residential exposure; therefore, the previous aggregate risk assessment
supports the amendment of the teff tolerances. Based on this assessment
of potential exposure
[[Page 31895]]
from use of pyroxsulam on teff and the findings supporting the July 5,
2017 tolerances established for teff commodities, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population, or to infants and children from aggregate exposure to
pyroxsulam residues.
For a detailed discussion of the aggregate risk assessments and
determination of safety for the proposed tolerances, please refer to
the July 5, 2017 Federal Register document and its supporting documents
available at https://www.regulations.gov in docket ID numbers EPA-HQ-
OPP-2006-0785 and EPA-HQ-OPP-2017-0227.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology, Method GRM 04.17, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method, is
available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. 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 pyroxsulam.
V. Conclusion
Therefore, the tolerances for teff commodities in 40 CFR 180.638
are amended by removing the footnote stating ``There are no U.S.
registrations on teff as of May 8, 2017''.
VI. Statutory and Executive Order Reviews
This action modifies tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances 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).
VII. 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: June 15, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.638, revise the table in paragraph (a) to read as
follows:
Sec. 180.638 Pyroxsulam; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Teff, forage................................................ 0.06
Teff, grain................................................. 0.01
Teff, hay................................................... 0.01
Teff, straw................................................. 0.03
Wheat, forage............................................... 0.06
Wheat, grain................................................ 0.01
Wheat, hay.................................................. 0.01
Wheat, straw................................................ 0.03
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-14735 Filed 7-9-18; 8:45 am]
BILLING CODE 6560-50-P