Acetamiprid; Pesticide Tolerance, 2809-2812 [E8-683]
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 522.970, revise paragraph (b)(2)
and add paragraph (b)(4) to read as
follows:
I
§ 522.970
Flunixin.
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(b) * * *
(2) See Nos. 057561, 059130, and
061623 for use as in paragraphs (e)(1),
(e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of
this section.
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(4) See No. 055529 for use as in
paragraphs (e)(1) and (e)(2) of this
section.
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Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E8–699 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0733; FRL–8348–1]
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
Acetamiprid; Pesticide Tolerance
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
ebenthall on PRODPC61 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of acetamiprid in
or on bushberry subgroup 13–07B;
caneberry subgroup 13–07A; low
growing berry subgroup 13–07G; onion,
bulb, subgroup 3–07A; and onion,
green, subgroup 3–07B. Nippon Soda
Co., Ltd. requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17, 2008, 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–2006–0733. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
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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 an electronic
copy of this Federal Register document
through the electronic docket 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 pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2006–0733 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 March 17, 2008.
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–2006–0733, 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.
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
• 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’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
Docket Facility telephone number is
(703) 305–5805.
ebenthall on PRODPC61 with RULES
II. Petition for Tolerance
In the Federal Register of September
22, 2006 (71 FR 55468) (FRL–8091–9),
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 6F7051) by
Nippon Soda Co., Ltd., c/o Nisso
America Inc., 45 Broadway, Suite 2120,
New York, NY, 10006. The petition
requested that 40 CFR 180.578 be
amended by establishing tolerances for
residues of the insecticide acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2cyano-N1-methylacetamidine, in or on
bulb vegetables crop group 3 at 3 ppm;
edible podded legume vegetables, crop
subgroup 6a at 0.5 ppm; succulent
shelled peas and beans, crop subgroup
6b, at 0.5 ppm; and berries, crop group
13 at 1 ppm. That notice referenced a
summary of the petition prepared by
Nippon Soda Co., Ltd., the registrant,
which is available to the public in the
docket ID Number EPA–HQ–OPP–2006–
0733, https://www.regulations.gov. There
were no comments received in response
to the notice of filing.
In the Federal Register of April 2,
2007 (72 FR 16352) (FRL–8119–2), 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 6E7163) by
Interregional Research Project Number 4
(IR-4), 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.578 be
amended by establishing tolerances for
residues of the insecticide acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2cyano-N1-methylacetamidine, in or on
strawberry, bearberry, bilberry, lowbush
blueberry, cloudberry, cranberry,
lingonberry, muntries and
partridgeberry at 0.60 parts per million
(ppm). That notice referenced a
summary of the petition prepared by
Nippon Soda Co., Ltd., the registrant,
which is available to the public in the
docket ID Number EPA–HQ–OPP–2007–
0105, https://www.regulations.gov. There
were no comments received in response
to the notice of filing.
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In the Federal Register of November
28, 2007 (72 FR 67256) (FRL–8340–6),
EPA issued a final rule establishing
tolerances for residues of acetamiprid
in/on edible-podded legume vegetables
and succulent shelled peas and beans
but deferred to a later date the decision
on the petitioned-for tolerances on the
bulb vegetable and berry commodities
requested in these petitions. EPA is
establishing the bulb vegetable and
berry tolerances at this time but has
modified the commodity terms and
most of the proposed tolerance levels.
The reasons for these changes are
explained in Unit V.
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. . . .’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
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 the petitioned-for
tolerance for residues of acetamiprid on
bushberry subgroup 13–07B at 1.6 ppm;
caneberry subgroup 13–07A at 1.6 ppm;
low growing berry subgroup 13–07G at
0.60 ppm; onion, bulb, subgroup 3–07A
at 0.02 ppm; and onion, green, subgroup
3–07B at 4.5 ppm. EPA’s assessment of
exposures and risks associated with
establishing the tolerance follows.
As noted above, on November 28,
2007, EPA issued a final rule in the
Federal Register establishing tolerances
for residues of acetamiprid in/on ediblepodded legume vegetables and
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succulent shelled peas and beans. When
the Agency conducted the risk
assessments in support of this tolerance
action it assumed that acetamiprid
residues would be present on bulb
vegetables and commodities in the
aforementioned berry subgroups as well
as on all foods covered by the proposed
and established tolerances. Therefore,
establishing the bulb vegetable and
berry tolerances will not change the
most recent estimated aggregate risks
resulting from use of acetamiprid, as
discussed in the November 28, 2007
Federal Register. Refer to the November
28, 2007 Federal Register document (72
FR 67256) (FRL–8340–6), available at
https://www.regulations.gov, for a
detailed discussion of the aggregate risk
assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
Based on the risk assessments
discussed in the final rule published in
the Federal Register of November 28,
2007 (72 FR 67256) (FRL–8340–6), 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
acetamiprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate residue analytical methods
gas chromatography/electron-capture
detection (GC/ECD) and highperformance liquid chromatography/
ultraviolet detector (HPLC/UV)) are
available for the enforcement of
established and new tolerances for plant
and animal commodities. These
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
There are no Codex, Canadian or
Mexican MRLs established for
acetamiprid on the commodities
associated with these petitions.
V. Conclusion
The registrant, Nippon Soda Co., Ltd.,
petitioned for tolerances on bulb
vegetables group 3 and berries group 13
as those crop groups were defined at the
time of the petition. IR-4 also petitioned
for individual tolerances on strawberry,
bearberry, bilberry, lowbush blueberry,
cloudberry, cranberry, lingonberry,
muntries and partridgeberry (PP
6E7163). In the Federal Register of
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
December 7, 2007 (72 FR 69150) (FRL–
8340–6), EPA issued a final rule that
revised the crop grouping regulations.
As part of this action, EPA expanded
and revised bulb vegetables group 3 and
berries group 13. Changes to crop group
3 (bulb vegetables) included adding new
commodities, creating subgroups for
bulb and green onions, and changing the
name of one of the representative
commodities from ‘‘onion, dry bulb’’ to
‘‘onion, bulb’’. Changes to crop group 13
(berries) included adding new
commodities, revising existing
subgroups and creating new subgroups
(including a low growing berry
subgroup consisting of the commodities
requested in PP 6E7163 and cultivars,
varieties, and/or hybrids of these).
EPA indicated in the December 7,
2007 final rule as well as the earlier May
23, 2007 proposed rule (72 FR 28920)
(FRL–8126–1) that, for existing petitions
for which a notice of filing had been
published, the Agency would attempt to
conform these petitions to the rule.
Therefore, consistent with this rule,
EPA is establishing tolerances on
bushberry subgroup 13–07B; caneberry
subgroup 13–07A; low growing berry
subgroup 13–07G; onion, bulb,
subgroup 3–07A; and onion, green,
subgroup 3–07B. The low growing berry
subgroup 13–07G consists of the berries
for which tolerances were requested in
PP 6E7163. The other subgroups include
the remaining berries and bulb
vegetables for which tolerances were
requested in PP 6F7051.
EPA concludes it is reasonable to
revise the petitioned-for tolerances so
that they agree with the recent crop
grouping revisions because (1) although
the new crop groups/subgroups include
several new commodities, the added
commodities are closely related minor
crops which contribute little to overall
dietary or aggregate exposure and risk;
and acetamiprid exposure from these
added commodities was considered
when EPA conducted the dietary and
aggregate risk assessments supporting
this action; and (2) the representative
commodities for the revised crop
groups/subgroups have not changed.
Based upon review of the data
supporting PP 6F7051, EPA has also
revised the tolerance levels for
bushberry subgroup 13–07B and
caneberry subgroup 13–07A to 1.6 ppm;
onion, bulb, subgroup 3–07A to 0.02
ppm; and onion, green, subgroup 3–07B
to 4.5 ppm. EPA revised these tolerance
levels based on analyses of the residue
field trial data using the Agency’s
Tolerance Spreadsheet in accordance
with the Agency’s Guidance for Setting
Pesticide Tolerances Based on Field
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Trial Data Standard Operating
Procedure (SOP).
Therefore, tolerances are established
for residues of acetamiprid, N1-[(6chloro-3-pyridyl)methyl]-N2-cyano-N1methylacetamidine, in or on bushberry
subgroup 13–07B at 1.6 ppm; caneberry
subgroup 13–07A at 1.6 ppm; low
growing berry subgroup 13–07G at 0.60
ppm; onion, bulb, subgroup 3–07A at
0.02 ppm; and onion, green, subgroup
3–07B at 4.5 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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 rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
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,
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
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2811
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 6, 2000) do not apply
to this rule. In addition, This 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 8, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.578 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a)(1) to read as follows:
I
180.578 Acetamiprid; tolerances for
residues.
(a) * * * (1) * * *
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Commodity
Parts per million
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Berry, low growing subgroups 13–07G ...............................................................................................................................
Bushberry subgroup 13–07B ...............................................................................................................................................
Caneberry subgroup 13–07A ..............................................................................................................................................
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*
Onion, bulb, subgroup 3–07A ..............................................................................................................................................
Onion, green, subgroup 3–07B ...........................................................................................................................................
*
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[FR Doc. E8–683 Filed 1–15–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0461; FRL–8346–6]
Mandipropamid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of
mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide in or
on Brassica, head and stem, subgroup
5A; Brassica, leafy greens, subgroup 5B;
vegetable, cucurbit, group 9; vegetable,
fruiting, group 8; okra; vegetable, leafy
except brassica, group 4; vegetable,
tuberous and corm, subgroup 1C; grape;
grape, raisin; onion, dry bulb; onion,
green; and potato, wet peel. Syngenta
Crop Protection Inc. requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17, 2008, 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–2007–0461. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
ebenthall on PRODPC61 with RULES
SUMMARY:
VerDate Aug<31>2005
15:01 Jan 15, 2008
Jkt 214001
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: Rose
Mary Kearns, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305-5611; e-mail address:
kearns.rosemary@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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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0.60
1.6
1.6
0.02
4.5
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 an electronic
copy of this Federal Register document
through the electronic docket 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 pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2007–0461 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 March 17, 2008.
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
E:\FR\FM\16JAR1.SGM
16JAR1
Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Rules and Regulations]
[Pages 2809-2812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-683]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0733; FRL-8348-1]
Acetamiprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
acetamiprid in or on bushberry subgroup 13-07B; caneberry subgroup 13-
07A; low growing berry subgroup 13-07G; onion, bulb, subgroup 3-07A;
and onion, green, subgroup 3-07B. Nippon Soda Co., Ltd. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 16, 2008. Objections and
requests for hearings must be received on or before March 17, 2008, 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-2006-0733. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2006-0733 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 March 17, 2008.
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-2006-0733, 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.
[[Page 2810]]
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'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
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of September 22, 2006 (71 FR 55468) (FRL-
8091-9), 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
6F7051) by Nippon Soda Co., Ltd., c/o Nisso America Inc., 45 Broadway,
Suite 2120, New York, NY, 10006. The petition requested that 40 CFR
180.578 be amended by establishing tolerances for residues of the
insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine, in or on bulb vegetables crop group 3 at 3 ppm;
edible podded legume vegetables, crop subgroup 6a at 0.5 ppm; succulent
shelled peas and beans, crop subgroup 6b, at 0.5 ppm; and berries, crop
group 13 at 1 ppm. That notice referenced a summary of the petition
prepared by Nippon Soda Co., Ltd., the registrant, which is available
to the public in the docket ID Number EPA-HQ-OPP-2006-0733, https://
www.regulations.gov. There were no comments received in response to the
notice of filing.
In the Federal Register of April 2, 2007 (72 FR 16352) (FRL-8119-
2), 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
6E7163) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.578 be amended by establishing tolerances for residues
of the insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-
cyano-N1-methylacetamidine, in or on strawberry, bearberry, bilberry,
lowbush blueberry, cloudberry, cranberry, lingonberry, muntries and
partridgeberry at 0.60 parts per million (ppm). That notice referenced
a summary of the petition prepared by Nippon Soda Co., Ltd., the
registrant, which is available to the public in the docket ID Number
EPA-HQ-OPP-2007-0105, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
In the Federal Register of November 28, 2007 (72 FR 67256) (FRL-
8340-6), EPA issued a final rule establishing tolerances for residues
of acetamiprid in/on edible-podded legume vegetables and succulent
shelled peas and beans but deferred to a later date the decision on the
petitioned-for tolerances on the bulb vegetable and berry commodities
requested in these petitions. EPA is establishing the bulb vegetable
and berry tolerances at this time but has modified the commodity terms
and most of the proposed tolerance levels. The reasons for these
changes are explained in Unit V.
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. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
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 the petitioned-for tolerance
for residues of acetamiprid on bushberry subgroup 13-07B at 1.6 ppm;
caneberry subgroup 13-07A at 1.6 ppm; low growing berry subgroup 13-07G
at 0.60 ppm; onion, bulb, subgroup 3-07A at 0.02 ppm; and onion, green,
subgroup 3-07B at 4.5 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
As noted above, on November 28, 2007, EPA issued a final rule in
the Federal Register establishing tolerances for residues of
acetamiprid in/on edible-podded legume vegetables and succulent shelled
peas and beans. When the Agency conducted the risk assessments in
support of this tolerance action it assumed that acetamiprid residues
would be present on bulb vegetables and commodities in the
aforementioned berry subgroups as well as on all foods covered by the
proposed and established tolerances. Therefore, establishing the bulb
vegetable and berry tolerances will not change the most recent
estimated aggregate risks resulting from use of acetamiprid, as
discussed in the November 28, 2007 Federal Register. Refer to the
November 28, 2007 Federal Register document (72 FR 67256) (FRL-8340-6),
available at https://www.regulations.gov, for a detailed discussion of
the aggregate risk assessments and determination of safety. EPA relies
upon those risk assessments and the findings made in the Federal
Register document in support of this action.
Based on the risk assessments discussed in the final rule published
in the Federal Register of November 28, 2007 (72 FR 67256) (FRL-8340-
6), 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 acetamiprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate residue analytical methods gas chromatography/electron-
capture detection (GC/ECD) and high-performance liquid chromatography/
ultraviolet detector (HPLC/UV)) are available for the enforcement of
established and new tolerances for plant and animal commodities. These
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; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or Mexican MRLs established for
acetamiprid on the commodities associated with these petitions.
V. Conclusion
The registrant, Nippon Soda Co., Ltd., petitioned for tolerances on
bulb vegetables group 3 and berries group 13 as those crop groups were
defined at the time of the petition. IR-4 also petitioned for
individual tolerances on strawberry, bearberry, bilberry, lowbush
blueberry, cloudberry, cranberry, lingonberry, muntries and
partridgeberry (PP 6E7163). In the Federal Register of
[[Page 2811]]
December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a final rule
that revised the crop grouping regulations. As part of this action, EPA
expanded and revised bulb vegetables group 3 and berries group 13.
Changes to crop group 3 (bulb vegetables) included adding new
commodities, creating subgroups for bulb and green onions, and changing
the name of one of the representative commodities from ``onion, dry
bulb'' to ``onion, bulb''. Changes to crop group 13 (berries) included
adding new commodities, revising existing subgroups and creating new
subgroups (including a low growing berry subgroup consisting of the
commodities requested in PP 6E7163 and cultivars, varieties, and/or
hybrids of these).
EPA indicated in the December 7, 2007 final rule as well as the
earlier May 23, 2007 proposed rule (72 FR 28920) (FRL-8126-1) that, for
existing petitions for which a notice of filing had been published, the
Agency would attempt to conform these petitions to the rule. Therefore,
consistent with this rule, EPA is establishing tolerances on bushberry
subgroup 13-07B; caneberry subgroup 13-07A; low growing berry subgroup
13-07G; onion, bulb, subgroup 3-07A; and onion, green, subgroup 3-07B.
The low growing berry subgroup 13-07G consists of the berries for which
tolerances were requested in PP 6E7163. The other subgroups include the
remaining berries and bulb vegetables for which tolerances were
requested in PP 6F7051.
EPA concludes it is reasonable to revise the petitioned-for
tolerances so that they agree with the recent crop grouping revisions
because (1) although the new crop groups/subgroups include several new
commodities, the added commodities are closely related minor crops
which contribute little to overall dietary or aggregate exposure and
risk; and acetamiprid exposure from these added commodities was
considered when EPA conducted the dietary and aggregate risk
assessments supporting this action; and (2) the representative
commodities for the revised crop groups/subgroups have not changed.
Based upon review of the data supporting PP 6F7051, EPA has also
revised the tolerance levels for bushberry subgroup 13-07B and
caneberry subgroup 13-07A to 1.6 ppm; onion, bulb, subgroup 3-07A to
0.02 ppm; and onion, green, subgroup 3-07B to 4.5 ppm. EPA revised
these tolerance levels based on analyses of the residue field trial
data using the Agency's Tolerance Spreadsheet in accordance with the
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial
Data Standard Operating Procedure (SOP).
Therefore, tolerances are established for residues of acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on
bushberry subgroup 13-07B at 1.6 ppm; caneberry subgroup 13-07A at 1.6
ppm; low growing berry subgroup 13-07G at 0.60 ppm; onion, bulb,
subgroup 3-07A at 0.02 ppm; and onion, green, subgroup 3-07B at 4.5
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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, 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 6, 2000) do not apply to this rule. In addition, This
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 8, 2008.
Donald R. Stubbs,
Acting 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 180.578 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:
180.578 Acetamiprid; tolerances for residues.
(a) * * * (1) * * *
[[Page 2812]]
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Berry, low growing subgroups 13-07G............ 0.60
Bushberry subgroup 13-07B...................... 1.6
Caneberry subgroup 13-07A...................... 1.6
* * * * *
Onion, bulb, subgroup 3-07A.................... 0.02
Onion, green, subgroup 3-07B................... 4.5
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-683 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S