Imidacloprid - Pesticide Tolerance on Pome Fruits—Final Rule 4/96
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4600/5H5733/R2233; FRL-5364-5]
Imidacloprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule establishes a tolerance for residues of the
imidazolidinimine) and its metabolites in or on pome fruits. Bayer
Corporation (formerly Miles, Inc.) requested this regulation to
establish these maximum permissible levels for residues of the
EFFECTIVE DATES: This regulation became effective April 19, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [PP 5F4600/5H5733/R2233], 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
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. An electronic copy of objections and hearing requests filed
with Hearing Clerk may be submitted to OPP by sending electronic mail
(e-mail) to: email@example.com.
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, telephone number, and e-mail
address: Rm. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA,
(703) 305-6386; e-mail: firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register
of November 15, 1995 (60 FR 57423), which announced that Bayer
Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-
0013, had submitted pesticide petition 5F4600/5H5733 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), establish tolerances
for residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine in or on pome fruit (fresh fruit) including
apple, pear, crabapple, loquat, mayhaw, pear
(oriental) and quince, at 0.6 ppm and a Food Additive Tolerance (FAT)
5H5733 in or on apples, pomace (wet or dried) at 4.0 ppm. There were no
comments or request for referral to an advisory committee received in
response to this notice of filing. Subsequent to the notice of filing
Bayer submitted a revised Section F deleting the 4 ppm apple pomace
tolerance that was proposed in the pome fruit petition. The reason
apple pomace was deleted is because dried apple pomace is no longer
considered a significant livestock feedstuff in the Agency's September
1995 revised Table II and there is no significant concentration from
apples to wet apple pomace.
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/
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
0.008187 mg/kg/bwt/day utilizing 14.4% of the RfD. The tolerance will
increase the TMRC by .000154 mg/kg/day representing an increase in the
ADI of 0.3%. Thus the TMRC will be .008340 mg/kg/day utilizing 14.6% of
the RfD. For exposure of the most highly exposured subgroups in the
population, children (ages 1-6), the TMRC for the tolerances is
0.016570 mg/kg/day. This is equal to 29.1% 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-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 used as
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 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, 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
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
Dated: April 19, 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
Authority: 21 U.S.C. 346a and 371.
2. Section 180.472(a) is amended in the table therein by adding in
alphabetical order the following commodity to read as follows:
Sec. 180.472 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.
(a) * * *
Commodity Parts per million
* * * * *
Pome fruits crop group 0.6
* * * * *
* * * * *
[FR Doc. 96-10915 Filed 5-02-96; 8:45 am]
BILLING CODE 6560-50-F