Document ID: EPA-HQ-OPP-2006-0733-0004
Agency: epa
Document Type: Rule
Title: Acetamiprid; Pesticide Tolerance
Posted Date: 2008-01-16T05:00Z

[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]                         

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]]

------------------------------------------------------------------------
                   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