Spiromesifen; Pesticide Tolerances, 8490-8492 [E9-4058]
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Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Rules and Regulations
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Neva R. Watson,
Attorney, Legislative.
[FR Doc. E9–3962 Filed 2–24–09; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
3.40
4.40
5.40
6.40
7.40
$5,000 max .......................................................................
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Jennifer Gaines, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number
(703) 305–5967; e-mail address:
gaines.jennifer@epa.gov.
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2008–0262; FRL–8398–8]
I. General Information
Spiromesifen; Pesticide Tolerances
A. Does this Action Apply to Me?
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
rwilkins on PROD1PC63 with RULES
40 CFR Part 180
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
SUMMARY: This regulation establishes a
tolerance for combined residues of
spiromesifen in or on tomato, paste.
Bayer CropScience requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 25, 2009. Objections and
requests for hearings must be received
on or before April 27, 2009, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0262. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
VerDate Nov<24>2008
16:26 Feb 24, 2009
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
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Fee
$52.40
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of 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–2008–0262 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before April 27, 2009.
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 that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0262, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
E:\FR\FM\25FER1.SGM
25FER1
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Rules and Regulations
Docket Facility telephone number is
(703) 305–5805.
rwilkins on PROD1PC63 with RULES
II. Petition for Tolerance
In the Federal Register of December 3,
2008 (73 FR 73643) (FRL–8390–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8F7444) by Bayer
CropScience, Box 12014, 2 T.W.,
Alexander Dr, Research, Triangle Park,
NC 27709. The petition requested that
40 CFR 180.607 be amended by
increasing the tolerance for combined
residues of the insecticide spiromesifen,
2-oxo-3-(2,4,6-trimethylphenyl)-1oxaspiro[4.4]non-3-en-4-yl 3,3dimethylbutanoate, and its enol
metabolite, 4-hydroxy-3-(2,4,6trimethylphenyl)-1-oxaspiro[4.4]non-3en-2-one, in or on tomato, paste to 0.80
parts per million (ppm). That notice
referenced a summary of the petition
prepared by Bayer CropScience, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
This petition is related to Bayer
CropScience’s application to amend its
registration under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), for spiromesifen to
decrease the preharvest interval (PHI)
on tomato from 7 days to 1 day. Crop
field residue data for that revised PHI
indicated that the existing tolerance
applicable to spiromesifen on tomato is
adequate but the tolerance on tomato,
paste, needed to be raised from 0.60
ppm to 0.80 ppm.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
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aggregate exposure to the pesticide
chemical residue....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for combined residue of
spiromesifen on tomato, paste at 0.80
ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances follows.
On September 10, 2008 the Agency
published a Final Rule (73 FR 52603,
FRL–8379–8) establishing tolerances for
combined residues of spiromesifen in or
on corn, field, at 5.0 ppm for forage and
8.0 ppm for stover. When the Agency
conducted the risk assessments in
support of the September, 2008
tolerance action, it also assessed the risk
resulting from the increased residues in
tomato, paste which would occur from
the proposed decreased PHI for
spiromesifen on tomato. Specifically, in
that risk assessment, EPA assumed that
spiromesifen would be present in
tomato, paste at 0.80 ppm. EPA relies
upon those risk assessments and the
findings made in the Federal Register
document in support of this action.
Refer to the September 10, 2008 Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessments and determination of
safety.
Based on the risk assessments
discussed in the final rule published in
the Federal Register of September 10,
2008 (73 FR 52603, FRL–8379–8), EPA
concludes that there is a reasonable
certainty that no harm will result to the
general population, and to infants and
children from aggregate exposure to
spiromesifen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology—
high-performance liquid
chromatography (HPLC)/triple stage
quadruple mass spectrometry (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; e-mail address:
residuemethods@epa.gov.
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8491
B. International Residue Limits
There are no CODEX MRLs
(maximum residue limits) established
for spiromesifen on tomato, paste
commodities.
V. Conclusion
Therefore, tolerances are established
for combined residues of spiromesifen,
2-oxo-3-(2,4,6-trimethylphenyl)-1oxaspiro[4.4]non-3-en-4-yl 3,3dimethylbutanoate, and its enol
metabolite, 4-hydroxy-3-(2,4,6trimethylphenyl)-1-oxaspiro[4.4]non-3en-2-one, in or on tomato, paste at 0.80
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this 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 on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This 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 section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
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Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Rules and Regulations
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) (Public Law 104–4).
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), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 9, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
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■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.607 is amended by
revising the entry for the commodity
■
VerDate Nov<24>2008
16:26 Feb 24, 2009
Jkt 217001
‘‘tomato, paste’’ in the table in
paragraph (a)(1) to read as follows:
§ 180.607 Spiromesifen; tolerances for
residues.
(a) * * *
(1) * * *
Commodity
Parts per million
*
*
*
Tomato, paste .................
*
*
*
*
*
*
*
*
*
0.80
*
*
*
[FR Doc. E9–4058 Filed 2–24–09; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 09100091344–9056–02]
RIN 0648–XM99
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod by NonAmerican Fisheries Act Crab Vessels
Catching Pacific Cod for Processing
by the Inshore Component in the
Western Regulatory Area of the Gulf of
Alaska
AGENCY: National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
SUMMARY: NMFS is prohibiting directed
fishing for the A season allowance of the
2009 Pacific cod sideboard limits
apportioned to non–American Fisheries
Act (AFA) crab vessels catching Pacific
cod for processing by the inshore
component in the Western Regulatory
Area of the Gulf of Alaska (GOA). This
action is necessary to prevent exceeding
the A season allowance of the 2009
Pacific cod sideboard limits apportioned
to non–AFA crab vessels catching
Pacific cod for processing by the inshore
component in the Western Regulatory
Area of the GOA.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), February 22, 2009, until
1200 hrs, A.l.t., September 1, 2009.
FOR FURTHER INFORMATION CONTACT: Josh
Keaton, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
GOA exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Gulf of
Alaska (FMP) prepared by the North
Pacific Fishery Management Council
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under authority of the Magnuson–
Stevens Fishery Conservation and
Management Act. Regulations governing
fishing by U.S. vessels in accordance
with the FMP appear at subpart H of 50
CFR part 600 and 50 CFR part 679.
Regulations governing sideboard
protections for GOA groundfish
fisheries appear at subpart B of 50 CFR
part 680.
The A season allowance of 2009
Pacific cod sideboard limits apportioned
to non–AFA crab vessels catching
Pacific cod for processing by the inshore
component in the Western Regulatory
Area of the GOA is 788 metric tons (mt)
for the GOA, as established by the final
2009 and 2010 harvest specifications for
groundfish of the GOA (74 FR 7333,
February 17, 2009).
In accordance with § 680.22(e)(2)(i),
the Administrator, Alaska Region,
NMFS (Regional Administrator), has
determined that the A season allowance
of the 2009 Pacific cod sideboard limits
apportioned to non–AFA crab vessels
catching Pacific cod for processing by
the inshore component in the Western
Regulatory Area of the GOA will soon
be reached. Therefore, the Regional
Administrator is establishing a
sideboard directed fishing allowance for
Pacific cod as 781 mt in the Gulf of
Alaska. The remaining 7 mt in the Gulf
of Alaska will be set aside as bycatch to
support other anticipated groundfish
fisheries. In accordance with
§ 680.22(e)(3), the Regional
Administrator finds that this sideboard
directed fishing allowance has been
reached. Consequently, NMFS is
prohibiting directed fishing for Pacific
cod by non–AFA crab vessels catching
Pacific cod for processing by the inshore
component in the Western Regulatory
Area of the GOA.
After the effective date of this closure
the maximum retainable amounts at
§ 679.20(e) and (f) apply at any time
during a trip.
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA
(AA), finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such requirement is
impracticable and contrary to the public
interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
responding to the most recent fisheries
data in a timely fashion and would
delay the sideboard directed fishing
closure of Pacific cod apportioned to
E:\FR\FM\25FER1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Rules and Regulations]
[Pages 8490-8492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4058]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0262; FRL-8398-8]
Spiromesifen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of spiromesifen in or on tomato, paste. Bayer CropScience requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective February 25, 2009. Objections and
requests for hearings must be received on or before April 27, 2009, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0262. All documents in the
docket are listed in the docket index available at https://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Jennifer Gaines, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number (703) 305-5967; e-mail address: gaines.jennifer@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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of 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-2008-0262 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before April 27, 2009.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0262, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The
[[Page 8491]]
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73643) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7444) by Bayer CropScience, Box 12014, 2 T.W., Alexander Dr,
Research, Triangle Park, NC 27709. The petition requested that 40 CFR
180.607 be amended by increasing the tolerance for combined residues of
the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, and its enol
metabolite, 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one, in or on tomato, paste to 0.80 parts per million (ppm). That
notice referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available to the public in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
This petition is related to Bayer CropScience's application to
amend its registration under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), for spiromesifen to decrease the preharvest
interval (PHI) on tomato from 7 days to 1 day. Crop field residue data
for that revised PHI indicated that the existing tolerance applicable
to spiromesifen on tomato is adequate but the tolerance on tomato,
paste, needed to be raised from 0.60 ppm to 0.80 ppm.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for combined residue of spiromesifen on tomato, paste at
0.80 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follows.
On September 10, 2008 the Agency published a Final Rule (73 FR
52603, FRL-8379-8) establishing tolerances for combined residues of
spiromesifen in or on corn, field, at 5.0 ppm for forage and 8.0 ppm
for stover. When the Agency conducted the risk assessments in support
of the September, 2008 tolerance action, it also assessed the risk
resulting from the increased residues in tomato, paste which would
occur from the proposed decreased PHI for spiromesifen on tomato.
Specifically, in that risk assessment, EPA assumed that spiromesifen
would be present in tomato, paste at 0.80 ppm. EPA relies upon those
risk assessments and the findings made in the Federal Register document
in support of this action. Refer to the September 10, 2008 Federal
Register document, available at https://www.regulations.gov, for a
detailed discussion of the aggregate risk assessments and determination
of safety.
Based on the risk assessments discussed in the final rule published
in the Federal Register of September 10, 2008 (73 FR 52603, FRL-8379-
8), EPA concludes that there is a reasonable certainty that no harm
will result to the general population, and to infants and children from
aggregate exposure to spiromesifen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology--high-performance liquid
chromatography (HPLC)/triple stage quadruple mass spectrometry (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; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX MRLs (maximum residue limits) established for
spiromesifen on tomato, paste commodities.
V. Conclusion
Therefore, tolerances are established for combined residues of
spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate, and its enol metabolite, 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, in or on tomato,
paste at 0.80 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this 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 on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments,
[[Page 8492]]
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) (Public Law 104-4).
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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 9, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.607 is amended by revising the entry for the commodity
``tomato, paste'' in the table in paragraph (a)(1) to read as follows:
Sec. 180.607 Spiromesifen; tolerances for residues.
(a) * * *
(1) * * *
Commodity Parts per million
* * * * *
Tomato, paste........................................ 0.80
* * * * *
* * * * *
[FR Doc. E9-4058 Filed 2-24-09; 8:45 am]
BILLING CODE 6560-50-S
