[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)]
[Rules and Regulations]
[Pages 11243-11246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5047]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300980; FRL-6493-2]
RIN 2070-AB78


Imidacloprid; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for the 
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety in or on corn, field fodder, forage, and grain. 
Gustafson, Incorporated requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act (FQPA) of 1996. The tolerance will expire on December 
31, 2000.

DATES: This regulation is effective March 2, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300980, 
must be received by EPA on or before May 1, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300980 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Peg Perreault, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5417; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                        Examples of
             Categories                  NAICS     potentially affected
                                         codes           entities
------------------------------------------------------------------------
Industry............................         111  Crop production
                                             112  Animal production
                                             311  Food manufacturing
                                           32532  Pesticide
                                                   manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and hen look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300980. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 25, 1997 (62 FR 34269) (FRL-5719-
6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a as amended by the FQPA of 1996 (Public Law 104-170) announcing the 
filing of a pesticide petition (PP) for tolerance by Gustafson, 
Incorporated, P.O. Box 660065, Dallas, TX 75255-0065. This notice 
included a summary of the petition prepared by Gustafson, Incorporated, 
the registrant. There were no comments received in response to the 
notice of filing.
    The petition requested that 40 CFR 180.472(a) be amended by 
establishing tolerances 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 corn, field fodder at 0.2 parts per 
million (ppm), corn, field forage at 0.1 ppm, and corn, field grain at 
0.05 ppm. The tolerances will expire on December 31, 2000. Time-limited 
tolerances are being established based on EPA's initial review of the 
crop field trial data for seed-treatment of field corn, which indicates 
that the data support the proposed tolerances for combined residues of 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety. The time-limited tolerances for field corn are being 
established until a full review of

[[Page 11244]]

the residue data is completed and permanent tolerances are established.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2), for tolerances for combined residues of imidacloprid on 
corn, field fodder, forage, and grain at 0.2, 0.1, and 0.05 ppm, 
respectively. EPA's assessment of the exposures and risks associated 
with establishing the tolerance was included in the preamble to two 
separate final rules on imidacloprid pesticide tolerances, published in 
the Federal Register on September 18, 1998 (63 FR 49837) (FRL-6027-1) 
and August 2, 1999 (64 FR 41804) (FRL-6090-2). The risk assessment 
supporting the tolerance actions in the August 2, 1999 Federal Register 
Notice also, assumed that tolerances would be established on corn, 
field fodder, forage, and grain at 0.2, 0.1, and 0.05 ppm, 
respectively. Accordingly, the analysis and findings in the August 2, 
1999 preamble apply equally to the tolerances for corn, field fodder, 
forage, and grain being established by this final rule and EPA 
reaffirms those findings in promulgating this rule.

IV. Other Considerations

A. Metabolism in Plants and Animals

    Data concerning the metabolism of imidacloprid in apples, potatoes, 
tomatoes, eggplant, cottonseed, field corn, ruminants and poultry have 
previously been submitted. The nature of imidacloprid residues in 
plants and animals is adequately understood. The residue of concern is 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as parent, as specified in 40 CFR 180.472.

B. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of the 
regulated imidacloprid residue in plant (Bayer GC/MS Method 00200 and 
Bayer HPLC-UV Confirmatory Method 00357) and animal (Bayer GC/MS Method 
00191) commodities. These methods have successfully completed EPA 
Tolerance Method Validation, and are awaiting publication in the 
Pesticide Analytical Manual II (PAM II). In the interim, these methods 
are available from: Calvin Furlow, PRRIB, IRSD (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].
    Bayer Corporation has previously submitted adequate multiresidue 
method (MRM) recovery data for imidacloprid and its olefin, hydroxy, 
guanidine, and 6-chloronicotininc acid metabolites through FDA's 
Protocols A through E. Imidacloprid and its metabolites were not 
recoverable by these methods. These data have been forwarded to FDA and 
we expect them to be published in PAM, Vol I, Appendix I in a future 
update. Additional MRM recovery data are not required.

C. Magnitude of Residues

    An initial review of the crop field trial data for seed-treatment 
of field corn support the proposed tolerances for combined residues of 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety. Time-limited tolerances for field corn are being established 
until a full review of the residue data is completed and permanent 
tolerances are established.

D. International Residue Limits

    There are no established CODEX, Canadian or Mexican residue limits 
for imidacloprid in/on field corn fodder, forage, and grain. Thus, 
harmonization of the proposed tolerances with CODEX, Canada and Mexico 
is not an issue for these petitions.

E. Rotational Crop Restrictions

    Data concerning the metabolism of imidacloprid in confined 
rotational crops was previously submitted. The nature of the residue in 
rotational crops is adequately understood and is nearly identical to 
that identified in the primary crops. The residue of concern in 
rotational crops is imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent. Treated areas may be 
replanted with any crop specified on an imidacloprid label, or any crop 
for which a tolerance exists for imidacloprid, as soon as practical 
following the last application, with the exception of cereals, legumes, 
and safflower, which have a 30-day plant-back restriction. A 12-month 
plant-back restriction must be observed for crops not listed on an 
imidacloprid label and for crops for which no tolerances for 
imidacloprid have been established.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety, in or on corn, field fodder at 0.2 ppm, corn, field forage at 
0.1 ppm, and corn, field grain at 0.05 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

[[Page 11245]]

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 control number OPP-300980 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 1, 
2000.
    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 issues(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 confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. You may also deliver your request to 
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., 
SW., Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. 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 Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300980, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
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 file 
format 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 issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. 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

[[Page 11246]]

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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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 United States Senate, the United States 
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: February 15, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


Sec. 180.472  Imidacloprid; tolerances for residues.

    (a)  *    *    *

 
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                        Commodity                             Parts per million      Expiration/Revocation date
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                                      *        *        *        *        *
Corn, field fodder.......................................                     0.20                      12/31/00
Corn, field forage.......................................                     0.10                      12/31/00
Corn, field grain........................................                     0.05                      12/31/00
 
                                      *        *        *        *        *
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[FR Doc. 00-5047 Filed 3-1-00; 8:45 am]
BILLING CODE 6560-50-F