[Federal Register Volume 59, Number 229 (Wednesday, November 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29501]
[[Page Unknown]]
[Federal Register: November 30, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186
[PP 3F4169 and FAP 3H5655/R2090; FRL-4922-8]
RIN 2070-AB78
Pesticide Tolerance for Imidacloprid
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes certain permanent and time-limited
pesticide tolerances and food and feed additive regulations for the
insecticide imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) 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: November 17, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 3F4169 and FAP 3H5655/R2090], 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 notices, published in the Federal
Register of October 21, 1993 (58 FR 54353) and amended in the Federal
Register of September 28, 1994 (59 FR 49397), which announced that
Miles, Inc., Agricultural Division, P.O. Box 491, Kansas City, MO
64120, had submtted a pesticide petition (PP 3F4169) and a food/feed
additive petition (FAP 3H5655) to EPA requesting that the
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 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine in or on the raw
agricultural commodities apples at 0.5 part per million (ppm), potatoes
at 0.3 ppm, and cottonseed at 6.0 ppm. FAP 3H5655 proposed establishing
a food or feed additive regulation for cottonseed meal at 9 ppm and for
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as imidacloprid, on apple pomace
(wet or dried) at 3 ppm, on potato chip at 0.4 ppm, and on potato waste
at 0.9 ppm. A time limitation was requested on the cottonseed tolerance
and the cottonseed meal food additive tolerance. There were no comments
or request for referral to an advisory committee received in response
to the notices of filling.
The database for imidacloprid is relatively complete. The most
significant data gap is the need to complete additional cotton crop
field trials and present a final report, and this is the reason for the
2-year time limitation on the tolerances. 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, additional residue trials are needed
to fully support the cotton tolerance. Given the relatively low risk
presented by imidacloprid, EPA does not believe that the missing data
will significantly change EPA's 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 noobserved-
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 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 for humans) under EPA's cancer Assement Guidlines by
the Office of Pesticide Programs (OPP) 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
uncertainty 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% of the RfD. The proposed
tolerances contribute .0008957 mg/kg/bwt/day. This represents a 1.56%
increase in 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 residue in plants and livestock is adequately
understood. The residues of concern are imidacloprid and its
metabolites that contain the 6-chloropyridinyl moiety, all calculated
as imidacloprid. The analytical methods are common moiety methods for
imidacloprid and its metabolites containing the 6-chloropyridiyl moiety
using a permanganate oxidation, silyl derivatization, and capillary GC-
MS selective ion monitoring. Adequate geographically representative
magnitude of the residue crop field trial data for imidacloprid on
apples, potatoes, and cotton indicate that residues of total
imidacloprid will not exceed the proposed tolerances when the
formulation is used as directed. Cotton, potato, and apple processing
studies were conducted using the raw agricultural commodities bearing
detectable imidacloprid residues. These studies followed commercial
processing practices. Imidacloprid was found to concentrate in apple
pomace, cottonseed meal, potato chips, and potato waste. Appropriate
imidacloprid food additive tolerances have been requested. Based on the
results of the imidacloprid bovine and poultry feeding studies finite
imidacloprid residues will occur in meat, milk, poultry, and eggs from
feeding of imidacloprid-treated feed items, or their processed feed
items, when the formulations are used as directed. Appropriate
secondary tolerances have been requested. Although additional cotton
field trial are needed, EPA does not believe the additional data will
change its risk assessment.
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 regulations established by
amending 40 CFR part 180 will protect the public health and that use of
the pesticide in accordance with the terms of the requested food/feed
additive tolerances will be safe. 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 Parts 180, 185, and 186
Environmental protection, Administrative practice and procedures,
Agricultural commodities, Feed additives, Food additives, Pesticides
and pests, Reporting and recordkeeping requirements.
Dated: November 17, 1994.
Daniel M. Barolo,
Director, 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. By revising Sec. 180.472, to read as follows:
Sec. 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.
(a) Tolerances 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
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Apples..................................................... 0.5
Cattle, fat................................................ 0.3
Cattle, meat............................................... 0.3
Cattle, mbyp............................................... 0.3
Eggs....................................................... 0.02
Goats, fat................................................. 0.3
Goats, meat................................................ 0.3
Goats, mbyp................................................ 0.3
Hogs, fat.................................................. 0.3
Hogs, mbyp................................................. 0.3
Hogs, meat................................................. 0.3
Hops, dried................................................ 3.0
Horses, fat................................................ 0.3
Horses, mbyp............................................... 0.3
Horses, meat............................................... 0.3
Milk....................................................... 0.1
Potatoes................................................... 0.3
Poultry, fat............................................... 0.05
Poultry, mbyp.............................................. 0.05
Poultry, meat.............................................. 0.05
Sheep, fat................................................. 0.3
Sheep, mbyp................................................ 0.3
Sheep, meat................................................ 0.3
------------------------------------------------------------------------
(b) A time-limited tolerance, to expire November 17, 1994, is
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 commodity:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cotton seed................................................ 6
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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. By adding new Sec. 185.900, to read as follows.
Sec. 185.900 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.
A food additive regulation is established permitting residues of
the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine in or on the following food resulting from
application of the insecticide to potatoes:
------------------------------------------------------------------------
Parts per
Food million
------------------------------------------------------------------------
Potato, chip............................................... 0.4
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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. By adding new Sec. 186.900, to read as follows.
Sec. 186.900 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.
(a) A feed additive regulation is established permitting residues
of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine in or on the following feeds resulting from
application of the insecticide to apples and potatoes:
------------------------------------------------------------------------
Parts per
Feed million
------------------------------------------------------------------------
Apples, pomace (wet)....................................... 3.0
Potato, waste.............................................. 0.9
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(b) A time-limited tolerance, to expire November 17, 1996, is
established permitting residues of the insecticide 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine in or on the following
feed resulting from application of the insecticide to cotton:
------------------------------------------------------------------------
Parts per
Feed million
------------------------------------------------------------------------
Cottonseed meal............................................ 9.0
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[FR Doc. 94-29501 Filed 11-29-94; 8:45 am]
BILLING CODE 6560-50-F
