[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Rules and Regulations]
[Pages 18547-18549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8733]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186

[PP 3F4231 and FAP 3H5675/R2122; FRL-4947-4]
RIN 2070-AB78


Imidacloprid; Pesticide Tolerance and Food/Feed Additive 
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes a tolerance and food/feed additive 
regulations for residues of the insecticide (1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine) (proposed comon name 
``imidacloprid'') and its metabolites in or on various commodities. 
Miles, Inc., requested these regulations to establish these maximum 
permissible levels for residues of the insecticide and to establish the 
food and feed additive regulations.

EFFECTIVE DATE: This regulation becomes effective March 31, 1995.
ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 3F4231 and FAP 3H5675/R2122], 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; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
[[Page 18548]] Federal Register of October 21, 1993 (58 FR 54354), 
which announced that Miles, Inc., 8400 Hawthorn Rd., P.O. Box 4913, 
Kansas City, MO 64120-0013, had submitted pesticide petition 3F4231 and 
a food/feed additive petition (FAP 3H5675) to EPA requesting that 
Administrator, pursuant to sections 408(d) and 409(b) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348(b), 
establish tolerances for residues of the insecticide imidacloprid, 1-
[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, and it's 
metabolites in or on fruiting vegetables (including tomato, eggplant, 
and pepper) at 1.0 part per million (ppm); brassica (cole) leafy 
vegetables (including broccoli, caulifower, brussels sprouts, and 
cabbage) at 3.5 ppm; lettuce (head and leaf) at 3.5 ppm; grape, fruit 
at 1.0 ppm; milk at 0.1 ppm; and meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, and sheep at 0.3 ppm. FAP 3H5675 proposed 
establishing a food or feed additive to permit residues of imidacloprid 
and its and it metabolites in or on tomato puree at 2.0 ppm; grape, 
raisin and grape, juice at 1.5 ppm; tomato pomace, wet at 2.0 ppm; 
tomato pomace, dry at 6.0 ppm; grape pomace, wet at 2.5 ppm; grape 
pomace, dry at 5.0 ppm; and grape raisin waste at 15.0 ppm. There were 
no comments or requests for referral to an advisory committee received 
in response to the notice of filing.
    EPA issued a later notice, published Federal Register of February 
8, 1995 (60 FR 7543), which announced that Miles, Inc., Agricultural 
Division, was amending pesticide petition FAP 3H5675. The revised 
petiton proposed that 40 CFR parts 185 (food additive) and 186 (feed 
additive) be amended to establish tolerances for combined residues of 
imidacloprid and its metabolites in the following food additive 
commodities: Tomato, puree at 3.0 ppm; tomato, paste at 6.0 ppm; and 
grape, raisin and grape, juice at 1.5 ppm; and in or on the following 
feed additive commodities: Tomato, pomace (wet or dried) at 4.0 ppm; 
grape pomace (wet or dried) at 5.0 ppm: and grape, raisin waste at 15.0 
ppm.
    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 
developmental toxicity 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 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 
.002594 mg/kg/day. This represents 4.5% of the RfD. The proposed 
tolerance contributes .005494 mg/kg/bwt/day. This represents 10% 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-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 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. 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).
    Under Executive Order 12866 (58 FR 51735, Oct. 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) 
[[Page 18549]] 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, 185, and 186

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

Dated: March 31, 1995.

Susan Lewis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, chapter I of title 40 of the Code of Federal Regulations 
is 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 amending paragraph (a) in the table therein 
by adding and alphabetically inserting the following commodities, to 
read as follows:


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

    (a) *  *  *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Brassica vegetables crop group.............................          3.5
                  *        *        *        *        *                 
Fruiting vegetables crop group.............................          1.0
                  *        *        *        *        *                 
Grapes.....................................................          1.0
                  *        *        *        *        *                 
Lettuce, head and leaf.....................................          3.5
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

    b. In Sec. 185.900, by designating the existing text as paragraph 
(a) and adding new paragraph (b), to read as follows:


Sec. 185.900   1-[(6-Chloro-3-pryridinyl) methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.

*        *        *        *        *
    (b) A food additive regulation is established premitting residues 
of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidimine in or on the following food commodities:

------------------------------------------------------------------------
                                                               Part per 
                            Food                               million  
------------------------------------------------------------------------
                                                                        
Grape, juice...............................................          1.5
Grape, raisin..............................................          1.5
Tomato, paste..............................................          6.0
Tomato, puree..............................................          3.0
------------------------------------------------------------------------

PART 186--[AMENDED]

    3. 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 adding new paragraph (c), to read as 
follows:


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

*        *        *        *        *
    (c) A feed additive regulation is established premitting residues 
of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-2-
imidazolidinimine in or on the following feed commodities resulting 
from application of the insecticide to tomato and grapes:

------------------------------------------------------------------------
                                                               Part per 
                            Feed                               million  
------------------------------------------------------------------------
                                                                        
Grape, pomace (wet or dried)...............................          5.0
Grape, raisin waste........................................         15.0
Tomato, pomace (wet or dried)..............................          4.0
                                                                        
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[FR Doc. 95-8733 Filed 4-11-95; 8:45 am]
BILLING CODE 6560-50-F