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Imidacloprid - Pesticide Tolerance on Canola Seed—Final Rule 2/96

[Federal Register: February 14, 1996 (Volume 61, Number 31)]
[Page 5769-5770]
40 CFR Part 180
[PP PP 5F4534/R2199; FRL-4995-2]
RIN 2070-AC18
Imidacloprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

SUMMARY: This rule establishes a tolerance for residues of the
insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) (proposed common name "imidacloprid") and its
metabolites in or on canola seed. Gustafson, Inc. requested this
regulation to establish maximum permissible levels for residues of the

EFFECTIVE DATE: This regulation became effective February 7, 1996.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [PP 5F4534/R2199], may be submitted to: Hearing
Clerk (A-110), 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
docket 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.
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.
    An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP by sending electronic mail
    Copies of electronic objections and hearing requests must be
submitted as an ASCII file avoiding 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 5.1 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket number [PP 5F4534/R2199]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic 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

Product Manager (PM 19), Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 207, CM #2 1921 Jefferson Davis Highway, Arlington, VA,
(703) 305-6386; e-mail:

SUPPLEMENTARY INFORMATION: EPA issued a notice published in the Federal
Register of August 17, 1995 (60 FR 42884), which announced that
Gustafson, Inc., P.O. Box 660065, Dallas, TX 75266-0065, had submitted
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-imidazolidinime, in or on the raw agricultural commodity canola seed
at 0.05 parts per million (ppm).
    The Agency is currently issuing a 2-year conditional registration
for use of "imidacloprid" on canola seed. Additional residue trials
are needed. 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 domestice crop field trials for
establishment of pesticide residue trials. Based on this guidance
document, the Agency determined that additional field trials are needed
for canola. However, the Agency does not believe that this data will
significantly change its risk assessment.
    The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerance include:
    1. A three-generation rat reproduction study with no-observed-
effect level (NOEL) of 100 ppm (8 mg/kg/bwt); rat and rabbit
developmental toxicity studies were negative at doses up to 30 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 male and 7.6 mg/kg/bwt female) for
noncarcinogenic effects that included decrease 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 carcinoginicity 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) for published uses is
0.008189 mg/kg/bwt/day utilizing 14.4% of the RFD. The proposed
tolerance will increase the TMRC by .000077 mg/kg/day representing an
increase in the ADI of 1.5%. The TMRC will be .008266 mg/kg/day
utilizing 15.9% of the RFD. For exposure of subgroups in the
population, children (1-6), the TMRC for the published and proposed
tolerances is 0.016934 mg/kg/day. This is equal to 29.7% 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-chloropyridinyl 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 used as
directed. Canola meal is a livestock feedstuff ruminant, and poultry
feeding studies show transfer of imidacloprid from feedstuff to meat,
milk, poultry, and eggs. The secondary tolerances in meat, milk,
poutry, eggs are adequate to cover the additional use on canola.
    There are presently 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 tolerance established by amending 40 CFR
part 180 will protect the public health. Therefore, the tolerance is
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 5F4535/R2199] (including any comments and data submitted
electronically). 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 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.
    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 copies of 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 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. 9-354, 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: February 7, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:


    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, by amending paragraph (a) in the table therein
by adding and alphabetically inserting the following commodity to read
as follows:

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

    (a) *  *  *

                  Commodities                       Parts per million

              *        *        *        *        *
Canola.........................................          0.05

              *        *        *        *        *

Residues in these commodities not in excess of the established
tolerances resulting from the use described in this paragraph remaining
after expiration of the conditional registration 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.
    *    *    *    *    *