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Imidacloprid - Pesticide Tolerance and Feed Additive Regulation 8/95

[Federal Register: August 30, 1995 (Volume 60, Number 168)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 4F4337 and FAP 4H5700/R2167; FRL-4976-2]
RIN 2070-AB78
Imidacloprid (NTN); Pesticide Tolerances and a Feed Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: These regulations establish time-limited tolerances and a feed
additive regulation for residues of the insecticide 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine (also known as
imidacloprid) and its metabolites in or on wheat and sugarbeets with an
expiration date 3 years after its effective date. Gustafson, Inc.,
submitted petitions under the Federal Food, Drug and Cosmetics Act
(FFDCA) that requested these regulations to establish these maximum
permissible levels for residues of the insecticide.

EFFECTIVE DATES: These regulations became effective on August 24, 1995.

ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4337 and FAP 4H5700/R2167], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency,
Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying
objections shall be labeled "Tolerance Petition Fees" and forwarded
to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance
Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections
and hearing requests filed with the Hearing Clerk should be identified
by the document control number and submitted to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202.
    A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
4F4337 and FAP 4H5700/R2167]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic copies of
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 207, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6386; e-mail:
edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register
of November 2, 1994 (59 FR 54907), which announced that Gustafson,
Inc., P.O. Box 660065, Dallas, TX 75266-0065, had submitted a petition
to amend 40 CFR part 180 by establishing under sections 408 and 409 of
the Federal Food Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a and
348, a regulation to permit residues of the insecticide (1-[6-chloro-3-
pyridinyl) methyl]-N-nitro-2-imidazolidinime, in or on the raw
agricultural commodities wheat, forage at 7.0 ppm, wheat, straw at 0.3
ppm, wheat, grain at 0.1 ppm; barley, forage at 1.2 ppm, barley, straw
at 0.2 ppm, and barley, grain at 0.1 ppm, sorghum, forage at 0.2 ppm,
sorghum, straw at 0.1 ppm, sorghum, grain at 0.1 ppm, beet, sugar,
(roots) at 0.1 pm, and beets sugar (tops) at 0.1 ppm. Gustafson, Inc.,
later withdrew the proposed sorghum tolerance and resubmitted it as
separate petition. Gustafson also amended the petition to request a
feed additive tolerance of 0.5 ppm on sugarbeet molasses and revised
the tolerance proposed for wheat grain to 0.05 ppm and sugarbeet roots
to 0.05 ppm (see the Federal Register of June 15, 1995 (60 FR 31467)).
The Agency has since decided that the appropriate sugarbeet molasses
tolerance should be 0.3 ppm.
    On August 14, 1995, Gustafson, submitted a revised Section F
deleting barley from this petition. It will be resubmitted as a
separate petition.
    These tolerances and feed additive regulation are being established
with a 3-year time limit to enable Gustafson to complete additional
residue trials and present a final report. On June 2, 1994, the Agency
issued a guidance document on crop residue trials. Among other things,
this document provided guidance on the number and location of domestic
crop field trials for establishment of pesticide residue trials. Based
on this guidance document, the Agency determined that additional field
trials are needed for wheat and sugarbeets. However, the Agency does
not believe that these data will significantly change its risk
assessment.
    All relevant materials have been evaluated. The toxicology data
considered in support of the tolerances include:
    1. A three-generation rat reproduction study with a no-observed-
effect level (NOEL) of 100 ppm (8 mg/kg/day); rat and rabbit teratology
studies which were negative at doses up to 30 mg/kg/day and 24 mg/kg/
day, respectively.
    2. A 2-year rat feeding/carcinogenicity study that was negative for
carcinogenic
effects under the conditions of the study and had a NOEL of 100 ppm
(5.7 mg/kg/day, male and 7.6 mg/kg/day, female) for noncarcinogenic
effects that included decreased body weight gain in females at 300 ppm
and increased thyroid lesions in males at 300 ppm and females at 900
ppm.
    3. A 1-year dog-feeding study with a NOEL of 1,250 ppm (41 mg/kg/
day).
    4. A 2-year mouse carcinogenicity study that was negative for
carcinogenic effects under conditions of the study and that had a NOEL
of 1,000 ppm (208 mg/kg/day).
    There is no cancer risk associated with exposure to this chemical.
Imidacloprid has been classified under "Group E" (no evidence of
carcinogenicity) by EPA's OPP/HED's Reference Dose (RFD) Committee.
    The reference dose (RfD), based on the 2-year rat feeding/
carcinogenic study with a NOEL of 5.7 mg/kg/bwt and 100-fold
uncertainity factor, is calculated to be 0.057 mg/kg/bwt. The
theoretical maximum residue contribution (TMRC) from published uses is
0.008088 mg/kg/bwt/day. This represents 14.189% of the RfD for overall
U.S. population. The proposed tolerance will increase the TMRC, .000091
mg/kg/day representing an increase in the ADI of 0.158%. Thus the TMRC
will be .0008179 mg/kg/day utilizing 14.377% of the RFD. For exposure
of the most highly exposured subgroups in the population, children ages
1 to 6 years, the TMRC for the published and proposed tolerances is is
0.016934 mg/kg/day. This is equal to 29.709% of the RfD. Dietary
exposure from the existing uses and proposed use will not exceed the
reference dose for any subpopulation (including infants and children)
based on the information available from EPA's Dietary Risk Evaluation
System.
    The nature of the imidacloprid residue in plants and livestock is
adequately understood. The residues of concern are combined residues of
imidacloprid and it metabolites containing the 6-chloropyridinyl
moiety, all calculated as imidacloprid. The analytical method is a
common moiety method for imidacloprid and its metabolites containing
the 6-chloropyridiyl moiety using a permanganate oxidation, silyl
derivatization, and capillary GC-MS selective ion monitoring.
Imidacloprid and its metabolites are stable in the commodities when
frozen for at least 24 months. There are adequate amounts of
geographically representative crop field trial data to show that
combined residues of imidacloprid and it metabolites, all calculated as
imidacloprid, will not exceed the proposed tolerances when use as
directed.
    There are currently no actions pending against the continued
registration of this chemical.
    This pesticide is considered useful for the purposes for which the
tolerance is sought and capable of achieving the intended physical or
technical effect. Based on the information and data considered, the
Agency has determined that the tolerances established by amending 40
CFR part 180 will protect the public health and that use of the
pesticide in accordance with the regulation established by amending 40
CFR part 186 will be safe. Therefore, these tolerances are established
as set forth below.
    Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). 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). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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).
     A record has been established for this rulemaking under docket
number [PP 4F4337 and FAP 4H5700/R2167] (including objections and
hearing requests submitted electronically as described below). A public
version of this record, including printed, paper versions of electronic
comments, which does not include any information claimed as CBI, is
available for inspection from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The public record is located in Room
1132 of the Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document
control number [PP 4F4337 and FAP 4H5700/R2167], may be submitted to
the Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708,
401 M St., SW., Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
    A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
    The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all objections and hearing requests submitted directly in
writing. The official rulemaking record is the paper record maintained
at the address in "ADDRESSES" at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is "significant"
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
"significant" as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also known as
"economically significant"); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not "significant" and is therefore not subject to
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Parts 180 and 186

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Pesticides and pests,
Reporting and recordkeeping requirements.

    Dated: August 24, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR parts 180 and 186 are amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.

    b. In Sec. 180.472, by adding new paragraph (e), to read as
follows:

Sec. 180.472   1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.

*        *        *        *        *
    (e) Time-limited tolerances are established for residues of the
insecticide 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 the following raw agricultural commodities

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                                                 Parts per    Expiration
                   Commodity                      million        date
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Beets, sugar (roots)..........................    0.05   August 24, 1998
Beets, sugar (tops)...........................    0.1
Wheat, forage.................................    7.0            Do.
Wheat, straw..................................    0.3            Do.
Wheat, grain..................................    0.05           Do.

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PART 186--[AMENDED]

    2. In part 186:
    a. The authority citation for part 186 continues to read as
follows:

    Authority: 21 U.S.C. 348.

    b. In Sec. 186.900, by revising the section heading and adding new
paragraph (d), to read as follows:

Sec. 186.900   1-[(6-Chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine.

*      *      *      *      *
    (d) A time-limited feed additive tolerance is established for
residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine and it metabolites containing 6-chloropyridinyl
moiety in or on processed feed when present therein as a result of
application to sugarbeets.

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                                                 Parts per    Expiration
                   Commodity                      million        date
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Beets, sugar, molasses........................     0.3   August 24, 1998
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Residues in this commodity not in excess of the established tolerances
resulting from the use described in this paragraph remaining after
expiration of the time-limited tolerance will not be considered to be
actionable if the insecticide is applied during the term of and in
accordance with the provisions of the above regulation.