Dinotefuran; Pesticide Tolerances for Emergency Exemptions, 67282-67285 [2012-27403]
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67282
Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations
Dated: November 2, 2012.
Adam J. Szubin,
Director, Office of Foreign Assets Control.
Approved: November 2, 2012.
David S. Cohen,
Under Secretary, Office of Terrorism and
Financial Intelligence, Department of the
Treasury.
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:
Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9356; email address:
conrath.andrea@epa.gov.
[FR Doc. 2012–27352 Filed 11–8–12; 8:45 am]
BILLING CODE 4810–AL–P
ENVIRONMENTAL PROTECTION
AGENCY
SUPPLEMENTARY INFORMATION:
I. General Information
40 CFR Part 180
A. Does this action apply to me?
[EPA–HQ–OPP–2012–0755; FRL–9366–3]
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).
Dinotefuran; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
dinotefuran in or on pome fruits and
stone fruits. This action is in response
to EPA’s granting of emergency
exemptions under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the
pesticide on pome fruits and stone
fruits. This regulation establishes a
maximum permissible level for residues
of dinotefuran in or on these
commodities. The time-limited
tolerances expire on December 31, 2015.
This regulation also makes the
systematic chemical name for
dinotefuran consistent within the
section and with EPA’s policy on
chemical nomenclature.
DATES: This regulation is effective
November 9, 2012. Objections and
requests for hearings must be received
on or before January 8, 2013, 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–2012–0755, 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), EPA West
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
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SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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–2012–0755 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 January 8, 2013. 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–
2012–0755, 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.htm.
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 time-limited
tolerances for combined residues of
dinotefuran, (RS)-1-methyl-2-nitro-3((tetrahydro-3furanyl)methyl)guanidine, including its
metabolites and degradates, in or on
pome fruits and stone fruits at 1.0 part
per million (ppm). These time-limited
tolerances expire on December 31, 2015.
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
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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations
received any petition from an outside
party.
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.
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III. Emergency Exemptions for
Dinotefuran on Pome Fruits and Stone
Fruits and FFDCA Tolerances
Several States requested emergency
exemptions claiming that the abrupt
increase and spread of damaging
populations of the Brown Marmorated
Stink Bug (BMSB) resulted in an urgent
and non-routine pest control situation.
The available insecticides for BMSB
control are either ineffective, adversely
impact integrated pest management
programs, and/or have use limitations
that make them unsuitable for seasonlong control of BMSB. The States
asserted that without the use of
dinotefuran as an additional pest
management tool for pome and stone
fruit orchards, uncontrolled infestations
of BMSB are likely to result in economic
losses in excess of 20%. After having
reviewed the submissions, EPA
determined that an emergency condition
exists for these States, and that the
criteria for approval of the emergency
exemptions were met. EPA authorized
specific exemptions under FIFRA
section 18 for the use of dinotefuran on
pome fruits and stone fruits for control
of the BMSB in Delaware, Maryland,
New Jersey, North Carolina,
Pennsylvania, Virginia, and West
Virginia.
Consistent with the need to move
quickly on the emergency exemptions in
order to address an urgent non-routine
situation and to ensure that the resulting
food is safe and lawful, EPA is issuing
these tolerances without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although these time-limited tolerances
expire on December 31, 2015, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerances remaining in
or on pome fruits and stone fruits 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 these time-limited
tolerances at the time of that
application. EPA will take action to
revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
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on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether dinotefuran
meets FIFRA’s registration requirements
for use on pome fruits and stone fruits
or whether permanent tolerances for
this use would be appropriate. Under
these circumstances, EPA does not
believe that these time-limited tolerance
decisions serve as a basis for registration
of dinotefuran by a State for special
local needs under FIFRA section 24(c).
Nor do these tolerances by themselves
serve as the authority for persons in any
State other than Delaware, Maryland,
New Jersey, North Carolina,
Pennsylvania Virginia, and West
Virginia to use this pesticide on the
applicable crops under FIFRA section
18 absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
emergency exemptions for dinotefuran,
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 * * *.’’
As part of its evaluation of the
emergency exemption applications, EPA
assessed the potential risks presented by
residues of dinotefuran in or on pome
fruits and stone fruits. In doing so, EPA
considered the safety standard in
FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances
under FFDCA section 408(l)(6) would be
consistent with the safety standard and
with FIFRA section 18.
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EPA has evaluated the use of
dinotefuran on pome fruits and stone
fruits, as well as various other crops,
and recently established tolerances for
similar use patterns, in the Federal
Register issue of September 12, 2012 (77
FR 56133) (FRL–9359–6) in association
with requests for tolerances to support
registrations of dinotefuran under
section 3 of FIFRA.
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 for dinotefuran
including exposure resulting from the
tolerances established by this action.
In the September 12, 2012 Federal
Register issue, EPA published a final
rule establishing tolerances for residues
of dinotefuran in 40 CFR 180.603(a) in
or on berry, low growing, except
strawberry, subgroup 13–07H; fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F; onion, bulb,
subgroup 3–07A; onion, green, subgroup
3–07B; peach; tea, dried; vegetable,
tuberous and corm, subgroup 1C; and
watercress. A summary of the
toxicological endpoints for dinotefuran
used for human risk assessment is
discussed in Units III.A. and B. of the
September 12, 2012 final rule.
The human health risk assessment
used to support the September 12, 2012
final rule (‘‘Dinotefuran: Human Health
Risk Assessment for Proposed Section 3
Uses on Tuberous and Corm Vegetables
Subgroup 1C, Onion Subgroup 3–07A,
Onion Subgroup 3–07B, Small Fruit
Subgroup 13–07F, Berry Subgroup 13–
07H, Peach, and Watercress, And a
Tolerance on Imported Tea’’), took into
account the assumption that dinotefuran
would be used on pome fruits and stone
fruits pursuant to emergency
exemptions.
Therefore the aggregate risks for
dinotefuran for this action are not
changed from those discussed in the
September 12, 2012 final rule.
In its aggregate assessment of
exposures and risks associated with
dinotefuran, EPA concluded the
following: That the acute dietary
exposure from food and water to
dinotefuran will occupy 5.8% of the
acute population adjusted dose (aPAD)
for children 1–2 years old, the
population group receiving the greatest
exposure; that chronic exposure to
dinotefuran from food and water will
utilize 2.6% of the chronic population
adjusted dose (cPAD) for children 1–2
years old, the population group
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receiving the greatest exposure; and that
the combined short-term risk from food,
water, and residential exposures result
in an aggregate margin of exposure
(MOE) of 3,000 for children 1–2 years
old from hand to mouth exposure from
treated turf, the scenario with the
highest exposure. Because EPA’s level
of concern for dinotefuran is a MOE of
100 or below, the MOEs are not of
concern. Based on the lack of evidence
of carcinogenicity in two adequate
rodent carcinogenicity studies,
dinotefuran is not expected to pose a
cancer risk to humans.
Therefore, EPA concluded that there
is a reasonable certainty that no harm
will result to the general population and
to infants and children from aggregate
exposure to dinotefuran residues. Refer
to the September 12, 2012 final rule,
available at https://www.regulations.gov,
for a summary of the aggregate risk
assessments and determination of
safety. A more detailed discussion of the
aggregate risk assessments and
determination of safety may be found at
https://www.regulations.gov in the
document titled ‘‘Revised: Dinotefuran:
Human Health Risk Assessment for
Proposed Section 3 Uses on Tuberous
and Corm Vegetables Subgroup 1C,
Onion Subgroup 3–07A, Onion
Subgroup 3–07B, Small Fruit Subgroup
13–07F, Berry Subgroup 13–07H, Peach,
and Watercress, And a Tolerance on
Imported Tea’’ in docket ID number
EPA–HQ–OPP–2011–0433.
EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
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V. Other Considerations
A. Analytical Enforcement Methodology
There are several analytical methods
available for determination of residues
of dinotefuran and its metabolites. For
determination of dinotefuran and its
metabolites, DN, 1-methyl-3-(tetrahydro3-furylmethyl)guanidine, and UF, 1methyl-3-(tetrahydro-3furylmethyl)urea, a high performance
liquid chromatography/tandem mass
spectrometry (HPLC/MS/MS) method is
available. For the determination of
residues of dinotefuran only, an HPLC/
ultraviolet (UV) detection method is
available. For the determination of only
the metabolites (DN and UF), HPLC/MS
and HPLC/MS/MS methods are
available. These methods are adequate
to enforce the tolerance expression.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
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email address: residuemethods@epa.
gov.
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.
There are currently no Codex,
Canadian or Mexican MRLs established
for dinotefuran.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of dinotefuran,
(RS)-1-methyl-2-nitro-3-((tetrahydro-3furanyl)methyl)guanidine, including its
metabolites and degradates, in or on
fruit, pome, group 11 and fruit, stone,
group 12 at 1.0 ppm. These tolerances
expire on December 31, 2015.
EPA is also revising 40 CFR
180.603(b) to use the same systematic
chemical name for dinotefuran as is
presently used in 40 CFR 180.603(a), for
purposes of consistency within the
section and with EPA’s policy regarding
chemical nomenclature.
VII. Statutory and Executive Order
Reviews
This final rule 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 final rule
has been exempted from review under
Executive Order 12866, this final rule 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 final rule does not
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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 final rule 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 final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (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 of 1995
(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).
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List of Subjects in 40 CFR Part 180
PART 180—[AMENDED]
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
■
Dated: November 1, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.603, revise paragraph (b) to
read as follows:
■
§ 180.603 Dinotefuran; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances are established
for residues of dinotefuran, (RS)-1methyl-2-nitro-3-((tetrahydro-3furanyl)methyl)guanidine, including its
Therefore, 40 CFR chapter I is
amended as follows:
metabolites and degradates, in or on the
commodities in the following table,
resulting from use of the pesticide
pursuant to FIFRA section 18
emergency exemptions. Compliance
with the tolerance levels specified in the
table is to be determined by measuring
only the sum of dinotefuran and its
metabolites DN, 1-methyl-3-(tetrahydro3-furylmethyl)guanidine, and UF, 1methyl-3-(tetrahydro-3furylmethyl)urea, calculated as the
stoichiometric equivalent of
dinotefuran, in or on the commodities
listed in the table. The tolerances expire
and are revoked on the dates specified
in the table.
Parts per
million
Commodity
Fruit, pome, group 11 ..............................................................................................................................................
Fruit, stone, group 12 ..............................................................................................................................................
Rice, grain ................................................................................................................................................................
*
*
*
*
*
[FR Doc. 2012–27403 Filed 11–8–12; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 206
[Docket ID FEMA–2012–0004]
RIN 1660–AA75
Debris Removal: Eligibility of Force
Account Labor Straight-Time Costs
Under the Public Assistance Program
for Hurricane Sandy
Federal Emergency
Management Agency, DHS.
ACTION: Interim final rule.
AGENCY:
The Fiscal Year 2007
Department of Homeland Security
Appropriations Act authorized a Public
Assistance Pilot Program intended to
reduce the costs to the Federal
government of providing assistance to
States and local governments; increase
flexibility in the administration of
assistance; and expedite the provision of
assistance under the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act. Due to the current
pressing need for efficient and timely
recovery from a catastrophic disaster
event, Hurricane Sandy, which has cast
widespread debris over a major portion
of the eastern seaboard of the United
States, this rule implements one of the
debris-related Public Assistance Pilot
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procedures: it allows for the
reimbursement of the straight- or regular
time salaries and benefits of the
employees of Public Assistance
applicants who perform disaster-related
debris and wreckage removal work for
any major disaster or emergency
declared by the President on or after
October 27, 2012, in response to
Hurricane Sandy.
DATES: This interim final rule is
effective November 9, 2012, and
applicable October 27, 2012. Comments
must be submitted by January 8, 2013.
ADDRESSES: You may submit comments,
identified by Docket ID FEMA–2012–
0004, by one of the following methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail/Hand Delivery/Courier:
Regulatory Affairs Division, Office of
Chief Counsel, Federal Emergency
Management Agency, Room 835, 500 C
Street, SW., Washington, DC 20472.
FOR FURTHER INFORMATION CONTACT:
William Roche, Director, Public
Assistance Division, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472–3100, (phone)
202–212–2340; or (email)
William.Roche@dhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Public Assistance Program
1. General
Each year, the United States is struck
by natural disasters, which may include
events such as storms, earthquakes,
volcanic eruptions, and landslides, as
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1.0
1.0
2.8
Expiration/revocation date
12/31/15
12/31/15
12/31/12
well as events that occur from various
other causes, such as fires, floods, and
explosions. When a locality is, or will
be, overwhelmed by the magnitude of
the damage from any such event, the
community turns to the State for help.
If it is evident that the situation is or
will be beyond the combined
capabilities of local and State resources,
the Governor may request that the
President declare that an emergency or
major disaster exists in the State, under
the authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act (Stafford Act), 42 U.S.C.
5121–5207.
If the President declares an emergency
or major disaster and authorizes Public
Assistance, FEMA may award Public
Assistance grants to assist State and
local governments (including Indian
Tribal governments) and certain private
nonprofit (PNP) organizations as
defined in subpart H of 44 CFR part 206
(collectively referred to as ‘‘applicants,’’
‘‘grantees,’’ or ‘‘subgrantees’’). Public
Assistance grants assist State, Tribal,
and local governments with the
response to and recovery from the
declared event. Specifically, the Public
Assistance program provides assistance
for debris removal, emergency
protective measures, and permanent
restoration of public infrastructure.
FEMA refers to debris removal and
emergency protective measures as
‘‘emergency work.’’ FEMA also
categorizes these types of work as
Category A (debris removal) and
Category B (emergency protective
measures). Category B includes debris
removal costs that are incurred as
emergency protective measures, such as
E:\FR\FM\09NOR1.SGM
09NOR1
]]>Agencies
[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Rules and Regulations]
[Pages 67282-67285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27403]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0755; FRL-9366-3]
Dinotefuran; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of dinotefuran in or on pome fruits and stone fruits. This
action is in response to EPA's granting of emergency exemptions under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on pome fruits and stone fruits. This
regulation establishes a maximum permissible level for residues of
dinotefuran in or on these commodities. The time-limited tolerances
expire on December 31, 2015.
This regulation also makes the systematic chemical name for
dinotefuran consistent within the section and with EPA's policy on
chemical nomenclature.
DATES: This regulation is effective November 9, 2012. Objections and
requests for hearings must be received on or before January 8, 2013,
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-2012-0755, 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), EPA West 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: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; email address: conrath.andrea@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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-
2012-0755 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 January 8, 2013. 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-2012-0755, 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.htm.
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
time-limited tolerances for combined residues of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, including its
metabolites and degradates, in or on pome fruits and stone fruits at
1.0 part per million (ppm). These time-limited tolerances expire on
December 31, 2015.
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
[[Page 67283]]
received any petition from an outside party.
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 Exemptions for Dinotefuran on Pome Fruits and Stone
Fruits and FFDCA Tolerances
Several States requested emergency exemptions claiming that the
abrupt increase and spread of damaging populations of the Brown
Marmorated Stink Bug (BMSB) resulted in an urgent and non-routine pest
control situation. The available insecticides for BMSB control are
either ineffective, adversely impact integrated pest management
programs, and/or have use limitations that make them unsuitable for
season-long control of BMSB. The States asserted that without the use
of dinotefuran as an additional pest management tool for pome and stone
fruit orchards, uncontrolled infestations of BMSB are likely to result
in economic losses in excess of 20%. After having reviewed the
submissions, EPA determined that an emergency condition exists for
these States, and that the criteria for approval of the emergency
exemptions were met. EPA authorized specific exemptions under FIFRA
section 18 for the use of dinotefuran on pome fruits and stone fruits
for control of the BMSB in Delaware, Maryland, New Jersey, North
Carolina, Pennsylvania, Virginia, and West Virginia.
Consistent with the need to move quickly on the emergency
exemptions in order to address an urgent non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing these
tolerances without notice and opportunity for public comment as
provided in FFDCA section 408(l)(6). Although these time-limited
tolerances expire on December 31, 2015, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on pome fruits and stone fruits 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 these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
dinotefuran meets FIFRA's registration requirements for use on pome
fruits and stone fruits or whether permanent tolerances for this use
would be appropriate. Under these circumstances, EPA does not believe
that these time-limited tolerance decisions serve as a basis for
registration of dinotefuran by a State for special local needs under
FIFRA section 24(c). Nor do these tolerances by themselves serve as the
authority for persons in any State other than Delaware, Maryland, New
Jersey, North Carolina, Pennsylvania Virginia, and West Virginia to use
this pesticide on the applicable crops under FIFRA section 18 absent
the issuance of an emergency exemption applicable within that State.
For additional information regarding the emergency exemptions for
dinotefuran, 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 * *
*.''
As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of dinotefuran
in or on pome fruits and stone fruits. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18.
EPA has evaluated the use of dinotefuran on pome fruits and stone
fruits, as well as various other crops, and recently established
tolerances for similar use patterns, in the Federal Register issue of
September 12, 2012 (77 FR 56133) (FRL-9359-6) in association with
requests for tolerances to support registrations of dinotefuran under
section 3 of FIFRA.
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 for dinotefuran including exposure
resulting from the tolerances established by this action.
In the September 12, 2012 Federal Register issue, EPA published a
final rule establishing tolerances for residues of dinotefuran in 40
CFR 180.603(a) in or on berry, low growing, except strawberry, subgroup
13-07H; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F; onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B;
peach; tea, dried; vegetable, tuberous and corm, subgroup 1C; and
watercress. A summary of the toxicological endpoints for dinotefuran
used for human risk assessment is discussed in Units III.A. and B. of
the September 12, 2012 final rule.
The human health risk assessment used to support the September 12,
2012 final rule (``Dinotefuran: Human Health Risk Assessment for
Proposed Section 3 Uses on Tuberous and Corm Vegetables Subgroup 1C,
Onion Subgroup 3-07A, Onion Subgroup 3-07B, Small Fruit Subgroup 13-
07F, Berry Subgroup 13-07H, Peach, and Watercress, And a Tolerance on
Imported Tea''), took into account the assumption that dinotefuran
would be used on pome fruits and stone fruits pursuant to emergency
exemptions.
Therefore the aggregate risks for dinotefuran for this action are
not changed from those discussed in the September 12, 2012 final rule.
In its aggregate assessment of exposures and risks associated with
dinotefuran, EPA concluded the following: That the acute dietary
exposure from food and water to dinotefuran will occupy 5.8% of the
acute population adjusted dose (aPAD) for children 1-2 years old, the
population group receiving the greatest exposure; that chronic exposure
to dinotefuran from food and water will utilize 2.6% of the chronic
population adjusted dose (cPAD) for children 1-2 years old, the
population group
[[Page 67284]]
receiving the greatest exposure; and that the combined short-term risk
from food, water, and residential exposures result in an aggregate
margin of exposure (MOE) of 3,000 for children 1-2 years old from hand
to mouth exposure from treated turf, the scenario with the highest
exposure. Because EPA's level of concern for dinotefuran is a MOE of
100 or below, the MOEs are not of concern. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, dinotefuran is not expected to pose a cancer risk to humans.
Therefore, EPA concluded that there is a reasonable certainty that
no harm will result to the general population and to infants and
children from aggregate exposure to dinotefuran residues. Refer to the
September 12, 2012 final rule, available at https://www.regulations.gov,
for a summary of the aggregate risk assessments and determination of
safety. A more detailed discussion of the aggregate risk assessments
and determination of safety may be found at https://www.regulations.gov
in the document titled ``Revised: Dinotefuran: Human Health Risk
Assessment for Proposed Section 3 Uses on Tuberous and Corm Vegetables
Subgroup 1C, Onion Subgroup 3-07A, Onion Subgroup 3-07B, Small Fruit
Subgroup 13-07F, Berry Subgroup 13-07H, Peach, and Watercress, And a
Tolerance on Imported Tea'' in docket ID number EPA-HQ-OPP-2011-0433.
EPA relies upon those risk assessments and the findings made in the
Federal Register document in support of this action.
V. Other Considerations
A. Analytical Enforcement Methodology
There are several analytical methods available for determination of
residues of dinotefuran and its metabolites. For determination of
dinotefuran and its metabolites, DN, 1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, a high performance liquid chromatography/tandem mass
spectrometry (HPLC/MS/MS) method is available. For the determination of
residues of dinotefuran only, an HPLC/ultraviolet (UV) detection method
is available. For the determination of only the metabolites (DN and
UF), HPLC/MS and HPLC/MS/MS methods are available. These methods are
adequate to enforce the tolerance expression.
The methods 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
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.
There are currently no Codex, Canadian or Mexican MRLs established
for dinotefuran.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine, including its metabolites and degradates, in
or on fruit, pome, group 11 and fruit, stone, group 12 at 1.0 ppm.
These tolerances expire on December 31, 2015.
EPA is also revising 40 CFR 180.603(b) to use the same systematic
chemical name for dinotefuran as is presently used in 40 CFR
180.603(a), for purposes of consistency within the section and with
EPA's policy regarding chemical nomenclature.
VII. Statutory and Executive Order Reviews
This final rule 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 final rule has been exempted from review under
Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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 of 1995 (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).
[[Page 67285]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 1, 2012.
Lois Rossi,
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. 180.603, revise paragraph (b) to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and
degradates, in or on the commodities in the following table, resulting
from use of the pesticide pursuant to FIFRA section 18 emergency
exemptions. Compliance with the tolerance levels specified in the table
is to be determined by measuring only the sum of dinotefuran and its
metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF,
1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the
stoichiometric equivalent of dinotefuran, in or on the commodities
listed in the table. The tolerances expire and are revoked on the dates
specified in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Fruit, pome, group 11................... 1.0 12/31/15
Fruit, stone, group 12.................. 1.0 12/31/15
Rice, grain............................. 2.8 12/31/12
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-27403 Filed 11-8-12; 8:45 am]
BILLING CODE 6560-50-P
