Fluensulfone; Pesticide Tolerance for Emergency Exemption, 11121-11124 [2016-04757]
Download as PDF
Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Rules and Regulations
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
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. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by May 2, 2016.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this action for
the purposes of judicial review nor does
it extend the time within which a
petition for judicial review may be filed,
and shall not postpone the effectiveness
of such rule or action. This action may
not be challenged later in proceedings to
enforce its requirements (see section
307(b)(2)).
List of Subjects in 40 CFR Part 52
mstockstill on DSK4VPTVN1PROD with RULES
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Reporting
and recordkeeping requirements.
Dated: January 25, 2016.
Jared Blumenfeld,
Regional Administrator, Region IX.
Part 52, Chapter I, Title 40 of the Code
of Federal Regulations is amended as
follows:
VerDate Sep<11>2014
17:47 Mar 02, 2016
Jkt 238001
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
11121
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
■
Authority: 42 U.S.C. 7401 et seq.
Subpart D—Arizona
2. Section 52.120 is amended by
adding paragraph (c)(173) to read as
follows:
■
§ 52.120
Identification of plan.
*
*
*
*
*
(c) * * *
(173) The following plan was
submitted on April 2, 2013 by the
Governor’s designee.
(i) [RESERVED].
(ii) Additional materials.
(A) Arizona Department of
Environmental Quality.
(1) MAG 2013 Carbon Monoxide
Maintenance Plan for the Maricopa
County Area, adopted by the Maricopa
Association of Governments on March
27, 2013.
*
*
*
*
*
[FR Doc. 2016–04614 Filed 3–2–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0475, 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Susan T. Lewis, 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
40 CFR Part 180
[EPA–HQ–OPP–2015–0475; FRL–9942–10]
Fluensulfone; Pesticide Tolerance for
Emergency Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
time-limited tolerance for residues of
fluensulfone, measured as 3,4,4trifluoro-but-3-ene-1-sulfonic acid,
resulting from use of fluensulfone in or
on carrots in accordance with the terms
of an emergency exemption issued
under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). This action is in response
to the issuance of a crisis emergency
exemption under FIFRA section 18
authorizing use of the pesticide on
carrots. This regulation establishes a
maximum permissible level for residues
of fluensulfone in or on carrots. The
time-limited tolerance expires on
December 31, 2017.
DATES: This regulation is effective
March 3, 2016. Objections and requests
for hearings must be received on or
before May 2, 2016, and must be filed
SUMMARY:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\03MRR1.SGM
03MRR1
11122
Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Rules and Regulations
C. How can I file an objection or hearing
request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
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–2015–0475 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 May 2, 2016. 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–
2015–0475 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.
mstockstill on DSK4VPTVN1PROD with RULES
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6), 21 U.S.C. 346a(e) and
346a(1)(6), is establishing a time-limited
tolerance for residues of fluensulfone, to
be enforced by measuring only the
metabolite 3,4,4-trifluoro-but-3-ene-1sulfonic acid, in or on carrots at 2.0
parts per million (ppm). There are no
VerDate Sep<11>2014
17:47 Mar 02, 2016
Jkt 238001
Canadian or Codex MRLs for residues of
fluensulfone in or on carrot at this time.
International harmonization is not an
issue for this emergency exemption.
This time-limited tolerance expires on
December 31, 2017.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a time-limited
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 . . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Fluensulfone on Carrots and FFDCA
Tolerances
The Michigan Department of
Agriculture and Rural Development
asserted that an emergency condition
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
existed in accordance with the criteria
for approval of an emergency
exemption, and utilized a crisis
exemption under FIFRA section 18 to
allow the use of fluensulfone on carrots
to control plant-parasitic nematodes in
carrot fields in Michigan. The Michigan
Department of Agriculture and Rural
Development invoked the crisis
exemption provision on April 14, 2015.
After having reviewed the submission,
EPA concurred on the emergency action
in order to meet the needs of Michigan
carrot growers who faced significant
economic loss. The crisis exemption
program expired on June 15, 2015.
As part of its evaluation of the
Michigan crisis exemption, EPA
assessed the potential risks presented by
residues of fluensulfone in or on carrots.
In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2),
and EPA decided that the necessary
time-limited tolerance under FFDCA
section 408(l)(6) would be consistent
with the safety standard and with
FIFRA section 18. Consistent with the
need to move quickly on the emergency
exemption in order to address an urgent
non-routine situation and to ensure that
the resulting food is safe and lawful,
EPA is issuing this time-limited
tolerance without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although this time-limited tolerance
expires on December 31, 2017, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerance remaining in
or on carrots after that date will not be
unlawful, provided the pesticide was
applied in a manner that was lawful
under FIFRA, and the residues do not
exceed a level that was authorized by
this time-limited tolerance at the time of
that application. EPA will take action to
revoke this time-limited tolerance
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether fluensulfone
meets FIFRA’s registration requirements
for use on carrots or whether permanent
tolerances for this use would be
appropriate. Under these circumstances,
EPA does not believe that this timelimited tolerance decision serves as a
basis for registration of fluensulfone by
a State for special local needs under
FIFRA section 24(c). Nor does this timelimited tolerance by itself serve as the
authority for persons in any State other
than Michigan to use this pesticide on
the applicable crops under FIFRA
E:\FR\FM\03MRR1.SGM
03MRR1
Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Rules and Regulations
mstockstill on DSK4VPTVN1PROD with RULES
section 18 absent the issuance of an
emergency exemption applicable within
that State. For additional information
regarding the crisis exemption for
fluensulfone, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
IV. 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 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 expected as a result
of the crisis exemption and this timelimited tolerance for residues of
fluensulfone on carrots at 2.0 parts per
million (ppm), measured as 3,4,4trifluoro-but-3-ene-1-sulfonic acid.
EPA’s assessment of exposures and risks
associated with establishing a timelimited tolerance follows.
The Agency assessed the use of the
fluensulfone use on carrots based on a
0.50 ppm residue level of the parent
compound, which is the residue of
concern for purposes of risk assessment
on carrots (i.e., 100% crop treated) and
determined that there would be no
resulting change in the estimates from
the previous risk assessment for the
chemical. Since the publication of the
September 24, 2014 final rule, the
toxicity profile of fluensulfone has not
changed, and the risk assessments that
supported the establishment of those
tolerances published in the Federal
Register remain valid. The dietary risk
assessments for fluensulfone are based
VerDate Sep<11>2014
17:47 Mar 02, 2016
Jkt 238001
on residues of the parent compound
only. Therefore, EPA relies upon those
supporting risk assessments and the
findings made in the September 24,
2014 Federal Register document, as
well as an updated dietary exposure and
risk assessment on carrots. 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
fluensulfone residues.
A summary of the toxicological
endpoints for fluensulfone used for
human risk assessment were previously
described in a final rule published in
the Federal Register of September 24,
2014 (79 FR 56964) (FRL–9914–35).
Please refer to this Federal Register
document and its supporting
documents, available at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2012–0593 for a
detailed discussion of the aggregate risk
assessments and determination of safety
for the proposed time-limited tolerance
for residues of fluensulfone on carrots at
2.0 parts per million (ppm) when
measured as 3,4,4-trifluoro-but-3-ene-1sulfonic acid.
V. Analytical Enforcement Methodology
An analytic method suitable for
enforcement purposes has been
approved by the Agency. That same
method was used in the field trials for
carrot and was shown to be appropriate
for that crop. The method has an LOQ,
defined as the lower limit of method
validation, of 0.01 ppm of 3,4,4trifluoro-but-3-ene-1-sulfonic acid. For
carrot, the method has a calculated LOQ
of 0.005 ppm of 3,4,4-trifluoro-but-3ene-1-sulfonic acid. Adequate
enforcement methodology, a reversephase high performance liquid
chromatography with dual mass
spectrometry/mass spectrometry
(HPLC–MS/MS), 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.
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).
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
11123
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 fluensulfone or 3,4,4-trifluoro-but-3ene-1-sulfonic acid, in or on carrot.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of fluensulfone,
measured as 3,4,4-trifluoro-but-3-ene-1sulfonic acid, in or on carrots at 2.0
ppm. This tolerance expires on
December 31, 2017.
VII. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). 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 in accordance with
FFDCA sections 408(e) and 408(l)(6),
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
E:\FR\FM\03MRR1.SGM
03MRR1
11124
Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Rules and Regulations
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.
mstockstill on DSK4VPTVN1PROD with RULES
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the nematicide fluensulfone,
including its metabolites and
degradates, in or on the commodities in
the table below, resulting from use of
the pesticide pursuant to FIFRA section
18 emergency exemptions. Compliance
with the tolerance levels specified
below is to be determined by measuring
only 3,4,4-trifluoro-but-3-ene-1-sulfonic
acid. The tolerances expire on the date
specified in the table.
Parts per
million
Commodity
Carrot ..................
*
*
*
2.0
*
Expiration
date
12/31/17
*
[FR Doc. 2016–04757 Filed 3–2–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF THE INTERIOR
Office of the Secretary
43 CFR Part 2
[13XD4523WS DS10200000
DWSN00000.000000 WBS DP10202]
RIN 1093–AA19
Freedom of Information Act
Regulations
Office of the Secretary, Interior.
Final rule.
AGENCY:
ACTION:
This rule revises the
regulations that the Department of the
Interior (Department) follows in
processing records under the Freedom
of Information Act. The revisions clarify
and update procedures for requesting
information from the Department and
procedures that the Department follows
in responding to requests from the
public.
SUMMARY:
This rule is effective on April 4,
2016.
FOR FURTHER INFORMATION CONTACT:
Cindy Cafaro, Office of the Executive
Secretariat and Regulatory Affairs, 202–
208–5342.
SUPPLEMENTARY INFORMATION:
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
I. Why We’re Publishing This Rule and
What it Does
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.680, revise paragraph (b) to
read as follows:
■
17:47 Mar 02, 2016
*
DATES:
Dated: February 25, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
VerDate Sep<11>2014
§ 180.680 Fluensulfone; tolerances for
residues.
Jkt 238001
A. Introduction
In late 2012, the Department
published a final rule updating and
replacing the Department’s previous
Freedom of Information Act (FOIA)
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
regulations. Since that time, in order to
maintain the independence of the Office
of Inspector General (OIG), the
Department and the OIG have agreed to
authorize the OIG to process their own
FOIA appeals. Additionally, the
Department has recently migrated its
Web site to a new framework, leading to
updated links. Finally, the Department
has received feedback from its FOIA
practitioners and requesters and
identified areas where it is possible to
further update, clarify, and streamline
the language of some procedural
provisions. Therefore, the Department is
making the following changes:
• Section 2.1(e) is amended to
identify the regulations applicable to
Privacy Act requests.
• Section 2.5(d) is amended to
provide more guidance on what
happens when a request does not
reasonably describe the records sought.
• Portions of § 2.6 are amended to
make explicit that a fee waiver request
is a valid way of responding to a request
for additional fee information and that
requesters may inform bureaus why
they believe they are eligible for
discretionary fee waivers, and to
emphasize when fee issues must be
resolved before processing will begin.
• A sentence is added to § 2.8(a) to
require a bureau that cannot readily
reproduce the requested record in the
form or format requested to explain why
it cannot.
• Section 2.9(b) is amended to
remove a superfluous introductory
phrase.
• Section 2.10 is amended to
highlight the requirements a requester
seeking expedited processing must meet
and the consequences of not meeting
those requirements.
• Section 2.11 is amended to reduce
the suggested contact information
provided by requesters.
• Section 2.12(c) is amended to
emphasize that reasonable efforts must
be made to search for requested records
and to clarify when searching for
requested records in electronic form or
format will not occur.
• A sentence is added to § 2.15(e) to
require bureaus to provide more
information to requesters when placing
them in a different processing track than
requested.
• Section 2.16(a) is amended to
clarify and streamline discussion of
when the time period for responding to
a request begins and ends.
• The introductory language of
§ 2.19(a) is amended to clarify when
bureaus may extend the basic time limit.
• Portions of § 2.20 are amended to
make explicit that expedited processing
requests are only appropriate before the
E:\FR\FM\03MRR1.SGM
03MRR1
Agencies
[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Rules and Regulations]
[Pages 11121-11124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04757]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0475; FRL-9942-10]
Fluensulfone; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-
sulfonic acid, resulting from use of fluensulfone in or on carrots in
accordance with the terms of an emergency exemption issued under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). This action is in response to the issuance of a crisis
emergency exemption under FIFRA section 18 authorizing use of the
pesticide on carrots. This regulation establishes a maximum permissible
level for residues of fluensulfone in or on carrots. The time-limited
tolerance expires on December 31, 2017.
DATES: This regulation is effective March 3, 2016. Objections and
requests for hearings must be received on or before May 2, 2016, 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-2015-0475, 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: Susan T. Lewis, 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:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]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.
[[Page 11122]]
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2015-0475 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 May 2, 2016. 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-2015-0475 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
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
a time-limited tolerance for residues of fluensulfone, to be enforced
by measuring only the metabolite 3,4,4-trifluoro-but-3-ene-1-sulfonic
acid, in or on carrots at 2.0 parts per million (ppm). There are no
Canadian or Codex MRLs for residues of fluensulfone in or on carrot at
this time. International harmonization is not an issue for this
emergency exemption. This time-limited tolerance expires on December
31, 2017.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-
limited 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 . .
. .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Fluensulfone on Carrots and FFDCA
Tolerances
The Michigan Department of Agriculture and Rural Development
asserted that an emergency condition existed in accordance with the
criteria for approval of an emergency exemption, and utilized a crisis
exemption under FIFRA section 18 to allow the use of fluensulfone on
carrots to control plant-parasitic nematodes in carrot fields in
Michigan. The Michigan Department of Agriculture and Rural Development
invoked the crisis exemption provision on April 14, 2015. After having
reviewed the submission, EPA concurred on the emergency action in order
to meet the needs of Michigan carrot growers who faced significant
economic loss. The crisis exemption program expired on June 15, 2015.
As part of its evaluation of the Michigan crisis exemption, EPA
assessed the potential risks presented by residues of fluensulfone in
or on carrots. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary time-limited
tolerance under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this time-limited tolerance without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although this time-limited tolerance expires on December 31, 2017,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on carrots
after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this time-limited tolerance
at the time of that application. EPA will take action to revoke this
time-limited tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
fluensulfone meets FIFRA's registration requirements for use on carrots
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of fluensulfone
by a State for special local needs under FIFRA section 24(c). Nor does
this time-limited tolerance by itself serve as the authority for
persons in any State other than Michigan to use this pesticide on the
applicable crops under FIFRA
[[Page 11123]]
section 18 absent the issuance of an emergency exemption applicable
within that State. For additional information regarding the crisis
exemption for fluensulfone, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result of the crisis exemption and this time-
limited tolerance for residues of fluensulfone on carrots at 2.0 parts
per million (ppm), measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic
acid. EPA's assessment of exposures and risks associated with
establishing a time-limited tolerance follows.
The Agency assessed the use of the fluensulfone use on carrots
based on a 0.50 ppm residue level of the parent compound, which is the
residue of concern for purposes of risk assessment on carrots (i.e.,
100% crop treated) and determined that there would be no resulting
change in the estimates from the previous risk assessment for the
chemical. Since the publication of the September 24, 2014 final rule,
the toxicity profile of fluensulfone has not changed, and the risk
assessments that supported the establishment of those tolerances
published in the Federal Register remain valid. The dietary risk
assessments for fluensulfone are based on residues of the parent
compound only. Therefore, EPA relies upon those supporting risk
assessments and the findings made in the September 24, 2014 Federal
Register document, as well as an updated dietary exposure and risk
assessment on carrots. 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 fluensulfone residues.
A summary of the toxicological endpoints for fluensulfone used for
human risk assessment were previously described in a final rule
published in the Federal Register of September 24, 2014 (79 FR 56964)
(FRL-9914-35). Please refer to this Federal Register document and its
supporting documents, available at https://www.regulations.gov in docket
ID number EPA-HQ-OPP-2012-0593 for a detailed discussion of the
aggregate risk assessments and determination of safety for the proposed
time-limited tolerance for residues of fluensulfone on carrots at 2.0
parts per million (ppm) when measured as 3,4,4-trifluoro-but-3-ene-1-
sulfonic acid.
V. Analytical Enforcement Methodology
An analytic method suitable for enforcement purposes has been
approved by the Agency. That same method was used in the field trials
for carrot and was shown to be appropriate for that crop. The method
has an LOQ, defined as the lower limit of method validation, of 0.01
ppm of 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. For carrot, the
method has a calculated LOQ of 0.005 ppm of 3,4,4-trifluoro-but-3-ene-
1-sulfonic acid. Adequate enforcement methodology, a reverse-phase high
performance liquid chromatography with dual mass spectrometry/mass
spectrometry (HPLC-MS/MS), 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.
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 fluensulfone or 3,4,4-
trifluoro-but-3-ene-1-sulfonic acid, in or on carrot.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in
or on carrots at 2.0 ppm. This tolerance expires on December 31, 2017.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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
[[Page 11124]]
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: February 25, 2016.
Susan Lewis,
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. 180.680, revise paragraph (b) to read as follows:
Sec. 180.680 Fluensulfone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
nematicide fluensulfone, including its metabolites and degradates, in
or on the commodities in the table below, resulting from use of the
pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance
with the tolerance levels specified below is to be determined by
measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. The
tolerances expire on the date specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Carrot......................................... 2.0 12/31/17
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-04757 Filed 3-2-16; 8:45 am]
BILLING CODE 6560-50-P