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Imidacloprid - Time-Limited Pesticide Tolerance 2/00

[Federal Register: March 2, 2000 (Volume 65, Number 42)]
[Rules and Regulations]
[Page 11243-11246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02mr00-11]
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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: Perreault.Peg@epa.gov.

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: furlow.calvin@epa.gov.
    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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov.
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
----------------------------------------------------------------------------------------------------------------

                                      *        *        *        *        *
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