[Federal Register Volume 71, Number 55 (Wednesday, March 22, 2006)]
[Rules and Regulations]
[Pages 14406-14409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2712]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0053; FRL-7766-8]


Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of imidacloprid in or on oats and rye. Bayer CropScience requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 22, 2006. Objections and 
requests for hearings must be received on or before May 22, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2006-0053. All documents in the 
docket are listed in the EDOCKET index at http://www.epa.gov/edocket. 
Although listed in the index, some information is not publicly 
available, i.e., 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 either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Daniel Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7546; e-mail address: [email protected].

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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 provides 
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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. EDOCKET, EPA's electronic public docket and comment system 
was replaced on November 25, 2005, by an enchanced Federal-wide 
electronic docket management and comment system located at http://www.regulations.gov/ Follow the on-line instructions. A frequently 
updated electronic version of 40 CFR part 180 is available at E-CFR 
Beta Site Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS 
Harmonized Guidelines referenced in this document, go directly to the 
guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of January 27, 2006 (71 FR 4580) (FRL-7759-
1), 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 
5F7020) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.472 be amended 
by establishing a tolerance for combined residues of the insecticide 
imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on oats, grain at 0.5 parts per million (ppm); 
oats, forage at 2.0 ppm; oats, hay at 6.0 ppm; oats, straw at 3.0 ppm; 
rye, grain at 0.5 ppm; rye, forage at 2.0 ppm; rye, hay at 6.0 ppm; and 
rye, straw at 3.0 ppm. In order to correct a typographical error in the 
original petition, the proposed tolerance levels for oats, grain and 
rye, grain were subsequently revised to 0.05 ppm. That notice included 
a summary of the petition prepared by Bayer CropScience, the 
registrant. There were no comments received in response to the notice 
of filing.
    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. * * 
*''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

[[Page 14407]]

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
imidacloprid on oats, grain at 0.05 ppm; oats, forage at 2.0 ppm; oats, 
hay at 6.0 ppm; oats, straw at 3.0 ppm; rye, grain at 0.05 ppm; rye, 
forage at 2.0 ppm; rye, hay at 6.0 ppm; and rye, straw at 3.0 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.
    The proposed use for imidacloprid on oats and rye involves the 
registration of imidacloprid as a seed treatment. Imidacloprid is 
already registered as a seed treatment on barley, corn, sorghum, and 
wheat. Permanent tolerances for imidacloprid are established for 
barley, corn, sorghum, and wheat, and seed treatment residue data are 
available for these crops. These crops are considered to be 
representative commodities for the cereal grain crop group, which also 
includes oats and rye. After consideration of the existing data used to 
support the tolerances discussed above, and provided that the proposed 
oat and rye seed treatment application rates are similar to the 
application rates used in the barley, corn, sorghum, and wheat residue 
studies, EPA concluded that the translation of this data to support 
tolerances on oats and rye is acceptable and that the highest residues 
be used for estimation of residues in/on oat and rye.
    On June 13, 2003 the Agency published a Final Rule (68 FR 35303, 
FRL-7310-8) establishing tolerances for residues of imidacloprid in or 
on acerola; artichoke, globe; avocado; banana (import); canistel; corn, 
pop, grain; corn, pop, stover; cranberry; currant; elderberry; feijoa; 
fruit, stone, group 12; gooseberry; huckleberry; guava; jaboticaba; 
juneberry; lingonberry; longan; lychee; mango; mustard, seed; okra; 
papaya; passionfruit; persimmon; pulasan; rambutan; salal; sapodilla; 
sapote, black; sapote, mamey; Spanish lime; star apple; starfruit; 
strawberry; vegetable, leaves of root and tuber, group 2; vegetable, 
legume, group 6, except soybean; vegetable, root and tuber, group 1, 
except sugar beet; watercress; wax jambu. When the Agency conducted the 
risk assessments in support of this tolerance action, it assumed that 
imidacloprid residues would be present on oats and rye (including 
grain, forage, hay, and straw) as well as on all foods covered by the 
proposed and established tolerances. Residues on oats and rye were 
included because there were previously established indirect or 
inadvertent tolerances for imidacloprid in or on cereal grains, 
including oats and rye. In assuming the dietary risk from the 
consumption of treated oats and rye, the most conservative assumptions 
were used (i.e., 100% of oats and rye crops were treated and residues 
on the treated commodities were at tolerance levels). Therefore, 
establishing permanent tolerances in or on oat and rye commodities will 
not change the most recent estimated aggregate risks resulting from use 
of imidacloprid, as discussed in the June 13, 2003 Federal Register. 
Refer to the June 13, 2003 Federal Register document 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 June 13, 2003, 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 
imidacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Bayer Gas Chromatography/Mass 
Spectrometry (GC/MS) Method 00200 in plant commodities, and Bayer GC/MS 
Method 00191 in livestock commodities) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no established Codex maximum residue limits for 
imidacloprid in or on oats or rye.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on oats, grain at 0.05 ppm; oats, forage at 
2.0 ppm; oats, hay at 6.0 ppm; oats, straw at 3.0 ppm; rye, grain at 
0.05 ppm; rye, forage at 2.0 ppm; rye, hay at 6.0 ppm; and rye, straw 
at 3.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2006-0053 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 on or before May 22, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked

[[Page 14408]]

confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2006-0053, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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 due to its lack of 
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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.


[[Page 14409]]


    Dated: March 13, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.472 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.472  Imidacloprid; tolerances for residues.

    (a)* * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Oats, forage...............................................         a2.0
Oats, grain................................................         0.05
Oats, hay..................................................          6.0
Oats, straw................................................          3.0
                                * * * * *
Rye, forage................................................          2.0
Rye, grain.................................................         0.05
Rye, hay...................................................          6.0
Rye, straw.................................................          3.0
------------------------------------------------------------------------

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[FR Doc. 06-2712 Filed 3-21-06; 8:45 am]
BILLING CODE 6560-50-S