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Imidacloprid - Time-Limited Tolerance on Forage—Final Rule 12/95

[Federal Register: December 13, 1995 (Volume 60, Number 239)]
[Rules and Regulations]
[Page 63958-63960]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4584/R2190; FRL-4988-4]
RIN 2070-AB78
Imidacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes time-limited tolerances 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 barley forage, straw, and grain with an expiration date of 3
years after its effective date. Gustafson, Inc., submitted a petition
under the Federal Food, Drug and Cosmetic Act (FFDCA) that requested
this regulation to establish these maximum permissible levels for
residues of the insecticide.

EFFECTIVE DATES: This effective date of this regulation is November 28, 1995.

ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 5F4584/R2190], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. 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. 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.
    Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [PP 5F4584/R2190]. No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic
comments on this proposed 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 pesticide
petition (PP 4F4337) to amend 40 CFR part 180 by establishing a
regulation to permit residues of the insecticide 1-[6-chloro-3-
pyridinyl) methyl]-N-nitro-2-imidazolidinimine 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, and sorghum, grain at 0.1 ppm; and beet,
sugar (roots) at 0.1 pm and beets, sugar (tops) at 0.1 ppm. Gustafson,
Inc., later withdrew the proposed sorghum tolerances and resubmitted
them in a separate petition. On June 15, 1995, Gustafson amended this
petition to request a feed additive tolerance of 0.5 ppm on sugarbeets
and molasses. (See the Federal Register of June 15, 1995 (60 FR 31467)).
    On August 14, 1995, Gustafson submitted a revised Section F
deleting barley from this petition and stating it would be resubmitted
in a separate petition. EPA issued a notice in the Federal Register of
October 25, 1995 (60 FR 54691), which announced that Gustasfson, Inc.,
P.O. Box 660065, Dallas, TX 75266-0065, had submitted a tolerance
petition for premitting residues of insecticide imidacloprid in or the
raw agriculture commodites barley, forage at 1.5 ppm, barley, straw at
0.2 ppm, and barley, grain at 0.05 ppm.
    These tolerances are being established as 3-year time-limited
tolerances 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 barley. However, the Agency does not believe that
this data will significantly change its risk assessment.
    All relevant materials have been evaluated. The toxicology data
considered in support of the tolerance include:
    1. A three-generation rat reproduction study with a no-observed-
effect level (NOEL) of 100 ppm (8 mg/kg/bwt); rat and rabbit teratology
studies were negative at doses up to 30 mg/kg/ bwt and 24 mg/kg/bwt,
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/bwt in males and 7.6 mg/kg/bwt in females) 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/
bwt).
    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
.000817 mg/kg/bwt/day utilizing 14.377% of the RFD. The proposed
tolerance will not significantly increase the TMRC. 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
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 its 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 its metabolites, all calculated
as imidacloprid, will not exceed the proposed tolerance when use as
directed.
    There are currently no actions pending against the continued
registration of this chemical.
    The 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. Therefore, the 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 5F4584/R2190] (including comments and data 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.
    Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
    Electronic comments 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 all comments 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 comments
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 Part 180

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

    Dated: November 28, 1995.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.472, paragraph (e) is amended by redesignating the
existing text as paragraph (e)(1), by revising the table therein, and
by adding paragraph (e)(2) to read as follows:

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

* * * * *
    (e) *  *  *

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                                                 Parts per    Expiration
                   Commodity                      million        date
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Barley, forage................................      1.5    Nov. 28, 1998
Barley, grain.................................      0.05          Do.
Barley, straw.................................      0.2           Do.
Beets, sugar (roots)..........................      0.05   August 24, 1998
Beets, sugar (tops)...........................      0.1           Do.
Wheat, forage.................................      7.0           Do.
Wheat, grain..................................      0.05          Do.
Wheat, straw..................................      0.3           Do.
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    (2) Residues in the commodities listed in paragraph (e)(1) of this
section not in excess of the established tolerances resulting from the
uses described in this paragraph (e) remaining after expiration of the
time-limited tolerances 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 in this paragraph (e).