Spirodiclofen; Pesticide Tolerances, 73937-73940 [2012-29902]
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Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, the
EPA seeks to harmonize U.S. tolerances
with international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. The 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. The
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 Bacillus subtilis strain QST 713
variant soil.
VIII. Conclusions
The EPA concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of Bacillus subtilis
strain QST 713 variant soil. Therefore,
the EPA is amending the tolerance
exemption for Bacillus subtilis strain
QST 713 to include residues of Bacillus
subtilis strain QST 713 variant soil in or
on all food commodities when used in
accordance with good agricultural
practices.
emcdonald on DSK67QTVN1PROD with
IX. References
1. U.S. EPA. 2010. Bacillus subtilis
Final Registration Review Decision.
Case 6012. March 2010.
2. U.S. EPA. 1997. Bacillus subtilis
Final Risk Assessment.
3. U.S. EPA. July 11, 2012.
Memorandum from Dr. Ibrahim S.
Barsoum and Dr. John L. Kough to
Michael Glikes: Review of Product
Chemistry and Acute Toxicity Studies
for Section 3 Registration of a new
TGAI, Bacillus subtilis strain QST
variant soil, and a new EP, Serenade soil
DPZ (EPA Reg. No. 69592–EI).
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X. Statutory and Executive Order
Reviews
This final rule amends an exiting
tolerance under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Because
this 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 FFDCA section 408(d), such as
the exemption from 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 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
PO 00000
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73937
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).
XI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the 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: November 26, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1209 to read as
follows:
■
§ 180.1209 Bacillus subtilisstrain QST 713
and strain QST 713 variant soil; exemption
from the requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the microbial pesticides Bacillus
subtilis strain QST 713 and strain QST
713 variant soil when used in or on all
food commodities.
[FR Doc. 2012–29903 Filed 12–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0326; FRL–9371–5]
Spirodiclofen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations
This regulation modifies
currently established tolerances for
residues of spirodiclofen, 3-(2,4dichlorophenyl)-2-oxo-1oxaspiro[4.5]dec-3-en-4-yl 2,2dimethylbutanoate in or on apple, wet
pomace and grape, raisin to 2.4 and 6.0
parts per million (ppm) respectively,
and deletes the tolerance for grape juice.
Bayer CropScience requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 12, 2012. Objections and
requests for hearings must be received
on or before February 11, 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–2012–0326, 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: Rita
Kumar, Registration Division, Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (703) 308–8291;
email address: kumar.rita@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. General Information
emcdonald on DSK67QTVN1PROD with
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).
VerDate Mar<15>2010
15:22 Dec 11, 2012
Jkt 229001
• Pesticide manufacturing (NAICS
code 32532).
dockets generally, is available at
https://www.epa.gov/dockets.
B. How can I get electronic access to
other related information?
II. Summary of Petitioned-For
Tolerance
In the Federal Register of July 25,
2012 (77 FR 43562) (FRL–9353–6), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 1F7952) by Bayer
CropScience, 2 T.W. Alexander Drive,
P.O. Box 12014, Research Triangle Park,
NC 27709. The petition requested that
40 CFR 180.608 be amended by
modifying tolerances for residues of the
insecticide spirodiclofen, 3-(2,4dichlorophenyl)-2-oxo-1oxaspiro[4.5]dec-3-en-4-yl 2,2dimethylbutanoate, in or on apple, wet
pomace and grape, raisin from 2.0 and
4.0 parts per million (ppm) respectively,
to 2.4 and 6.0 ppm respectively, and by
deleting the tolerance for grape juice.
That document referenced a summary of
the petition prepared by Bayer
CropScience, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://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 FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2012–0326, 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 February 11, 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–
2012–0326, 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
Confidential Business Information (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
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue * * * .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for spirodiclofen
including exposure resulting from the
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Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with spirodiclofen follows.
In 2005, EPA assessed the use of
spirodiclofen on citrus fruit, grape,
pome fruit, stone fruit, and tree nut
crops and reviewed the residue
chemistry data submitted in support of
these uses. Apple and grape processing
studies were required as conditional to
these registrations. These processing
studies were subsequently submitted by
Bayer CropScience, and reviewed by the
Agency in a memo dated October 25,
2007, posted to docket EPA–HQ–OPP–
2012–0326. In this memo, EPA
concluded that the tolerances for wet
apple pomace and raisin grape need to
be revised as indicated above, and the
tolerance for grape juice is no longer
necessary.
In the most recent spirodiclofen
tolerance rulemaking published in the
Federal Register of May 5, 2010 (75 FR
24428) (FRL–8820–4), EPA assessed risk
from aggregate exposure to spirodiclofen
assuming that exposure occurred in wet
apple pomace and raisins at the levels
of the revised wet apple pomace and
raisin grape tolerances. In that action,
EPA determined that aggregate risk from
exposure to spirodiclofen was safe.
Based upon the 2010 spirodiclofen
rulemaking and the other information
discussed above, 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 spirodiclofen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
a liquid chromatography/mass
spectrometry (LC/MS/MS) method, is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email address:
residuemethods@epa.gov.
emcdonald on DSK67QTVN1PROD with
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
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Jkt 229001
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 spirodiclofen.
V. Conclusion
Therefore, the established tolerances
for residues of spirodiclofen, 3-(2,4dichlorophenyl)-2-oxo-1oxaspiro[4.5]dec-3-en-4-yl 2,2dimethylbutanoate, in or on apple, wet
pomace and grape, raisin are amended
from 2.0 and 4.0 ppm to 2.4 and 6.0
ppm respectively, and the tolerance for
grape juice is deleted.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this 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 FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
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73939
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).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 30, 2012.
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:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.608 revise paragraph (a)(1)
introductory text; in the table in
paragraph (a)(1) remove the entry for
‘‘Grape juice,’’ and revise the entries for
■
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Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
§ 180.608 Spirodiclofen; tolerances for
NW., Washington, DC 20460–0001. The
residues.
Public Reading Room is open from 8:30
(a) General. (1) Tolerances are
a.m. to 4:30 p.m., Monday through
established for residues of spirodiclofen, Friday, excluding legal holidays. The
including its metabolites and
telephone number for the Public
degradates, in or on the commodities
Reading Room is (202) 566–1744, and
listed below. Compliance with the
the telephone number for the OPP
following tolerance levels is to be
Docket is (703) 305–5805. Please review
determined by measuring only
the visitor instructions and additional
spirodiclofen, 3-(2,4-dichlorophenyl)-2- information about the docket available
oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2at https://www.epa.gov/dockets.
dimethylbutanoate.
FOR FURTHER INFORMATION CONTACT:
Carmen Rodia, Registration Division
Parts per
Commodity
(7505P), Office of Pesticide Programs,
million
Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington,
*
*
*
*
*
DC 20460–0001; telephone number:
Apple, wet pomace ...................
2.4 (703) 306–0327; fax number: (703) 308–
0029; email address:
*
*
*
*
*
rodia.carmen@epa.gov.
Grape, raisin .............................
6.0
SUPPLEMENTARY INFORMATION:
‘‘Apple, wet pomace’’ and ‘‘Grape,
raisin’’ to read as follows:
*
*
*
*
*
*
*
*
*
I. General Information
*
[FR Doc. 2012–29902 Filed 12–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0099; FRL–9373–3]
Flubendiamide; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation modifies
tolerances for residues of flubendiamide
in or on multiple food commodities
which are identified, and discussed in
detail later in this document. Bayer
CropScience LP in c/o Nichino America,
Inc. (U.S. subsidiary of Nihon Nohyaku
Co., Ltd.) requested these tolerances,
and revisions to tolerances under the
Federal Food, Drug and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
December 12, 2012. Objections and
requests for hearings must be received
on or before February 11, 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–2007–0099, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
emcdonald on DSK67QTVN1PROD with
DATES:
VerDate Mar<15>2010
15:22 Dec 11, 2012
Jkt 229001
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://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 FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
OPP–2007–0099 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 February 11, 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–
2007–0099, 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. Summary of Petitioned-For
Tolerance
In the Federal Register of May 23,
2012 (77 FR 30481) (FRL–9347–8), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 2F7981) by Bayer
CropScience LP in c/o Nichino America,
Inc. (U.S. subsidiary of Nihon Nohyaku
Co., Ltd.), P.O. Box 12014, Research
Triangle Park, NC 27709–2014. The
petition requested that the established
tolerances listed in 40 CFR 180.639 for
residues of the insecticide
flubendiamide, N2-[1, 1-dimethyl-2(methylsulfonyl)ethyl]-3-iodo-N1-[2methyl-4-[l, 2,2,2-tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide, in or on Apple,
wet pomace be increased from 2.0 parts
per million (ppm) to 5.0 ppm; and Fruit,
pome, group 11 be increased from 0.70
ppm to 1.5 ppm. That document
E:\FR\FM\12DER1.SGM
12DER1
Agencies
[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73937-73940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29902]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0326; FRL-9371-5]
Spirodiclofen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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[[Page 73938]]
SUMMARY: This regulation modifies currently established tolerances for
residues of spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate in or on apple, wet
pomace and grape, raisin to 2.4 and 6.0 parts per million (ppm)
respectively, and deletes the tolerance for grape juice. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 12, 2012. Objections and
requests for hearings must be received on or before February 11, 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-2012-0326, 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: Rita Kumar, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-8291; email address: kumar.rita@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://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 FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0326, 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
February 11, 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-2012-0326, 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 Confidential Business
Information (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. Summary of Petitioned-For Tolerance
In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7952) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.608 be amended by modifying tolerances for residues of the
insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on apple, wet
pomace and grape, raisin from 2.0 and 4.0 parts per million (ppm)
respectively, to 2.4 and 6.0 ppm respectively, and by deleting the
tolerance for grape juice. That document referenced a summary of the
petition prepared by Bayer CropScience, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
* .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for spirodiclofen including
exposure resulting from the
[[Page 73939]]
tolerances established by this action. EPA's assessment of exposures
and risks associated with spirodiclofen follows.
In 2005, EPA assessed the use of spirodiclofen on citrus fruit,
grape, pome fruit, stone fruit, and tree nut crops and reviewed the
residue chemistry data submitted in support of these uses. Apple and
grape processing studies were required as conditional to these
registrations. These processing studies were subsequently submitted by
Bayer CropScience, and reviewed by the Agency in a memo dated October
25, 2007, posted to docket EPA-HQ-OPP-2012-0326. In this memo, EPA
concluded that the tolerances for wet apple pomace and raisin grape
need to be revised as indicated above, and the tolerance for grape
juice is no longer necessary.
In the most recent spirodiclofen tolerance rulemaking published in
the Federal Register of May 5, 2010 (75 FR 24428) (FRL-8820-4), EPA
assessed risk from aggregate exposure to spirodiclofen assuming that
exposure occurred in wet apple pomace and raisins at the levels of the
revised wet apple pomace and raisin grape tolerances. In that action,
EPA determined that aggregate risk from exposure to spirodiclofen was
safe. Based upon the 2010 spirodiclofen rulemaking and the other
information discussed above, 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 spirodiclofen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a liquid chromatography/mass
spectrometry (LC/MS/MS) method, is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
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 spirodiclofen.
V. Conclusion
Therefore, the established tolerances for residues of
spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-
yl 2,2-dimethylbutanoate, in or on apple, wet pomace and grape, raisin
are amended from 2.0 and 4.0 ppm to 2.4 and 6.0 ppm respectively, and
the tolerance for grape juice is deleted.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 30, 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. 180.608 revise paragraph (a)(1) introductory text; in the
table in paragraph (a)(1) remove the entry for ``Grape juice,'' and
revise the entries for
[[Page 73940]]
``Apple, wet pomace'' and ``Grape, raisin'' to read as follows:
Sec. 180.608 Spirodiclofen; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below. Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Apple, wet pomace.......................................... 2.4
* * * * *
Grape, raisin.............................................. 6.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-29902 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P