[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Proposed Rules]
[Pages 45113-45115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21516]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4383/P627; FRL-4970-9]
RIN 2070-AC18
Norflurazon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for combined residues of
the herbicide norflurazon and its desmethyl metabolite in or on the raw
agricultural commodity caneberries. The Interregional Research Project
No. 4 (IR-4) submitted a petition requesting the proposed regulation to
establish a maximum permissible level for residues of norflurazon.
DATES: Comments, identified by the document control number [PP 4E4383/
P627], must be received on or before September 29, 1995.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202. Comments and data may
also be submitted to OPP by sending electronic mail (e-mail) to:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [PP 4E4383/P627]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions
[[Page 45114]]
can be found in the ``SUPPLEMENTARY INFORMATION'' section of this
document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information.'' CBI should not be submitted
through e-mail. Information marked as CBI will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice. All written comments will be
available for public inspection in Rm. 1132 at the address given above,
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783; e-mail:
jamerson.hoyt@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP 4E4383) to EPA on behalf of the IR-4 Agricultural
Experiment Stations of Virginia and Washington. This petition requests
that the Administrator, pursuant to section 408(e) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.356
by establishing a tolerance for residues of the herbicide norflurazon
(4-chloro-5-(methylamino)-2-(alpha, alpha, alpha-trifluro-m-tolyl)-3-
(2H) pyridazinone) and its desmethyl metabolite ((4-chloro-5-(amino)-2-
alpha, alpha, alpha-trifluro-m-tolyl)-3(2H)-pyridazinone) in or on the
raw agricultural commodity caneberries at 0.2 part per million (ppm).
Caneberries are defined for tolerance purposes to include blackberries,
loganberry, raspberries, and varieties and/or hybrids of these.
Tolerances are already established for the combined residues of
norflurazon and its desmethyl metabolite in or on blackberries at 0.1
ppm and raspberries at 0.2 ppm.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance include:
1. Acute oral and dermal toxicity studies were performed, placing
technical norflurazon in toxicity Category IV and Category III for
primary eye irritation.
2. A 6-month feeding study with dogs fed diets containing 0, 50,
150, or 450 ppm (equivalent to 0, 1.53, 5.02, or 14.27 milligrams (mg)/
kilogram (kg)/day for males; 0, 1.58, 4.77, or 17.75 mg/kg/day for
females) with a no-observed-effect level (NOEL) of 50 ppm, based on
increased absolute and relative liver weight and increased cholesterol
in both sexes at the 150-ppm dose level.
3. A developmental toxicity study in rats given oral gavage doses
of 0, 100, 200, or 400 mg/kg/day with a NOEL for maternal toxicity of
less than 100 mg/kg/day based on decreased body weight gain. The NOEL
for developmental toxicity was established at 400 mg/kg/day.
Developmental toxicity was suggested at the 400-mg/kg/day dose level in
the form of an increase in bipartite thoracic vertebrae and an increase
in rudimentary 14th ribs. These effects are believed to be secondary to
the maternal effects observed at the 400-mg/kg/day dose level.
4. A developmental toxicity study in rabbits given oral gavage
doses of 0, 10, 30, or 60 mg/kg/day with a NOEL for maternal toxicity
of 30 mg/kg/day based on clinical toxicity and reduced body weight gain
at the 60-mg/kg/day dose level. The NOEL for developmental toxicity was
established at 30 mg/kg/day based on a statistical increase in skeletal
variations at the 60-mg/kg/day dose level.
5. A three-generation reproduction study in rats fed diets
containing 0, 125, 375, or 1,025 ppm (equivalent to 0, 6.25, 18.75. or
51.25 mg/kg/day) with a NOEL for reproductive toxicity of 1,025 ppm.
There were no apparent effects on reproductive performance in this
study.
6. A carcinogenicity study in rats fed diets containing 0, 125,
375, or 1,025 ppm (equivalent to 0, 6.25, 18.75, or 51.25 mg/kg/day)
with a NOEL of 375 ppm and a lowest-effect-level (LEL) of 1,025 ppm
based on increased kidney weight and accompanying microscopic
pathologic changes, as well as an increase in liver weight in male and
female rats, and an increase in thyroid weight in males. There were no
carcinogenic effects attributable to norflurazon observed under the
conditions of the study.
7. A carcinogenicity study in mice fed diets containing 0, 85, 340,
or 1,360 ppm (equivalent to 0, 12.8, 58.7, or 218.8 mg/kg/day) with a
NOEL for systemic effects of 85 ppm for male mice and 340 ppm for
female mice. The LEL is established at 340 ppm for male mice based on
the increased incidence of enlarged spleen, increased absolute and
relative liver weight, and increased incidence of nephritis. The LEL
for female mice is established at 1,360 ppm based on the increased
incidence of enlarged liver and cystic ovaries, the increased absolute
and relative liver weight, and the increased incidence of
pyelonephritis, a significant positive trend in hepatocellular adenomas
and in combined hepatocellular adenomas and/or carcinomas. A
significant pairwise increase in hepatocellular adenomas and
hepatocellular adenomas/carcinomas combined was observed at the 204 mg/
kg/day dose level in males. There were no statistically significant
increases in tumor incidence with incremental doses of norflurazon in
females.
8. Mutagenicity assays including an in-vitro cytogenetic assay in
Chinese hamster ovary cells for chromosome aberrations, negative; and
an unscheduled DNA synthesis test in primary rat hepatocytes for DNA
repair, negative for potential mutagenic activity.
9. In a rat metabolism study norflurazon was rapidly absorbed from
the gastrointestinal tract and extensively metabolized.
Based on a weight-of-the evidence determination, EPA has classified
norflurazon as a possible human carcinogen (Group C). This
classification is based on the presence of benign tumors in only one
sex of one species at one dose level, adequate but negative
mutagenicity studies, and no finding of carcinogenicity in structurally
related compounds. EPA has determined that for purposes of risk
characterization the reference dose (RfD) should be used to quantify
dietary risk.
Dietary risk assessments for norflurazon indicate that there is
minimal risk from established tolerances and the proposed tolerance for
caneberries. Dietary risk assessments for the herbicide were conducted
using the Reference Dose (RfD) to assess chronic exposure and risk and
the Margin of Exposure (MOE) for acute toxicity.
The RfD is calculated at 0.02 mg/kg/of body weight/day based on a
NOEL of 1.53 mg/kg/day from the 6-month dog feeding study and an
uncertainty factor of 100. The theoretical maximum residue contribution
(TMRC) from existing tolerances and the proposed tolerance for
caneberries utilize 10 percent of the RfD for the general population
and 47 percent of the RfD for
[[Page 45115]]
nonnursing infants less than 1-year in age.
The MOE is a measure of how closely the high-end acute dietary
exposure comes to the no-observed-effect (NOEL) level from the toxicity
endpoint of concern. For norflurazon the MOE was calculated as a ratio
of the NOEL (30 mg/kg/day) from the rabbit developmental toxicity study
to dietary exposure, as estimated for the population subgroup at
greatest risk (females of child-bearing age). The MOE for this subgroup
is estimated at 5,000 for high-end exposure. Acute dietary margins of
exposure of less than 100 are generally of concern to EPA. A MOE of
5,000 poses minimal risk.
The nature of the residues in caneberries is adequately understood
for the purposes of the proposed tolerance. An adequate analytical
method is available for enforcement purposes. Because of the long lead
time from establishing these tolerances to publication of the
enforcement method in the Pesticide Analytical Manual, Volume II, the
analytical method is being made available to anyone with an interest in
pesticide enforcement when requested from: Calvin Furlow, Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protections
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703)-305-5937.
No secondary residues are expected in meat, milk, poultry, or eggs
since caneberries are not considered a livestock feed commodity.
There are currently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
A record has been established for this rulemaking under docket
number [PP 4E4383/P627] (including comments and data submitted
electronically as described below). 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 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Rm. 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.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
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 all comments 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, 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)
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: August 11, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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.
Sec. 180.356 [Amended]
2. In Sec. 180.356 Norflurazon; tolerances for residues by amending
the table therein by adding and alphabetically inserting an entry for
caneberries at 0.2 part per million (ppm) and by removing the entries
for blackberries and raspberries.
[FR Doc. 95-21516 Filed 8-29-95; 8:45 am]
BILLING CODE 6560-50-F
