[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Rules and Regulations]
[Page 2809-2812]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-9]
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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 http://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 http://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 http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://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 http://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: http://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, http://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, http://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 http://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]]
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Commodity Parts per million
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* * * * *
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
* * * * *
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[FR Doc. E8-683 Filed 1-15-08; 8:45 am]
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