[Federal Register Volume 59, Number 230 (Thursday, December 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X94-11201]


[[Page Unknown]]

[Federal Register: December 1, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4F4415, 4F4337/R2089; FRL-4922-7]
RIN 2070-AB78

 

Pesticide Tolerances for Imidacloprid

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes time limited-tolerances for residues of 
the insectiicide imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine) and its metabolites in or on the raw 
agricultural commodity sorghum forage and straw at 0.1 part per million 
(ppm) and grain at 0.05 ppm, with an expiration date of 3 years after 
its effective date. Gustafson, Inc., requested this regulation to 
establish these maximum permissible levels for residues of the 
insecticide.

EFFECTIVE DATE: November 17, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4F4415, 4F4337/R2089], 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.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, 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)-305-3686.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published 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 pesticide petition 4F4337 to EPA requesting that the 
Administrator, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend 40 CFR part 180 to 
establish tolerances for residues of the insecticide (1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidacloprid in or on the raw agricultural 
commodities wheat forage at 7 ppm, wheat straw at 0.3 ppm, and 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, straw, and grain at 0.1 
ppm; and sugar beet roots and tops at 0.1 ppm. A feed additive 
tolerance was proposed for sugar beet molasses at 0.2 ppm.
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing.
    Because of the data base supporting the proposed sorghum tolerance 
was relatively complete and would support establishment of a sorghum 
tolerance, petition 4F4337 was amended by withdrawing the proposed 
sorghum tolerance and resubmitting it as a new petition. A new petition 
was submitted for sorghum forage and straw, and grain at 0.05 ppm. EPA 
issued a notice, published in the Federal Register of September 28, 
1994 (59 FR 49397), which anounced that Gustafson, Inc., P.O. Box 
660065, Dallas, TX 75266-0065, had submitted a petition (4F4415) 
proposing to amend 40 CFR part 180 by establishing a regulation to 
permit residues of imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine, and its metabolites containing the 6-
chlorpyridinyl moiety in or on sorghum forage, straw, and grain at 0.05 
ppm. No comments were received in response to the notice of filing.
    EPA has corrected the notice of the petition (PP 4F4415) to state 
that the actual proposed tolerances in the petition are for sorghum 
grain at 0.05 ppm and sorghum forage and fodder at 0.1 ppm.
    The database for imidacloprid is relatively complete. The most 
significant data gap is the need for additional magnitude of the 
residue data and analytical method validation data, and this is the 
reason for making the tolerance a 3-year time-limited tolerance. 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 tolerances. Based on this guidance document, three 
additional residue trials are needed to fully support the sorghum 
tolerance. However, the Agency does not believe 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 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 male and 7.6 mg/kg/bwt 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/
bwt).
    4. A 2-year mouse carcinogenicity study that was negative for 
carcinogenic effects under conditions of the study and that 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 for humans) of EPA's cancer Assement Guidlines OPP by 
the 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 
.001734 mg/kg/bwt/day. This represents 3.0% of the RfD. The proposed 
tolerance contributes 0.000001188 mg/kg/bwt/day. This represents 0.002% 
of the RfD. Dietary exposure from the existing uses and proposed uses 
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.
    Although some additional confirmatory analytical method validation 
data for sorghum is needed, the method has been validated.
    The analytical methods are common moiety methods 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 18 months. The 
geographically representative magnitude of the residue crop field trial 
data presented at this time for imidacloprid on sorghum forage, fodder, 
and grain indicate that residues of total imidacloprid will not exceed 
the proposed tolerance when the formulation is used as directed. A 
sorghum processing study was not conducted as the Agency is not now 
requiring data on sorghum flour. Based on the results of the 
imidacloprid bovine and poultry feeding studies, finite residues will 
occur in meat, milk, poultry, and eggs from feeding of imidacloprid-
treated feed items when the formulations are used as directed. 
Appropriate secondary tolerances have been proposed.
    There are currently no actions pending against the continued 
registration of this chemical.
    This pesticide is considered useful for the purposes for which the 
tolerances are 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).
    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 17, 1994.

Daniel M. Barolo,
Director, 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, by adding new paragraph (c), to read as 
follows:


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

* * * * *
    (c) Time-limited tolerances, to expire November 17, 1997, are 
established permitting the combined 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:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Sorghum, forage............................................          0.1
Sorghum, straw.............................................          0.1
Sorghum, grain.............................................         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 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.

BILLING CODE 6560-50-F