[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Proposed Rules]
[Pages 49816-49818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24005]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[PP 5E4429/P631; FRL-4973-9]
RIN 2070-AC18
Oxyfluorfen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
herbicide oxyfluorfen in or on the raw agricultural commodities
blackberry and raspberry. The proposed regulation to establish maximum
permissible levels for residues of the herbicide was requested in a
petition submitted by the Interregional Research Project No. 4 (IR-4)
pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA). EPA also
proposes deleting the metabolites of oxyfluorfen containing the
diphenyl ether linkage from certain tolerance expressions.
DATES: Comments, identified by the document control number [PP 5E4429/
P631], must be received on or before October 27, 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 5E4429/P631]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions 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) 5E4429 to EPA on behalf of the Agricultural Experiment
Stations of Oregon, New York, 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 180.381 by establishing a tolerance for residues of the
herbicide oxyfluorfen [2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene] in or on the raw agricultural commodities
blackberry and raspberry at 0.05 part per million (ppm). The petitioner
proposed that use of oxyfluorfen on blackberry and raspberry be
geographically limited to Oregon and Washington based on the
geographical representation of the residue data submitted. Additional
residue data will be required to expand the area of usage. Persons
seeking geographically broader registration should contact the Agency's
Registration Division at the address provided above.
EPA also proposes to amend established tolerances for oxyfluorfen
by deleting the diphenyl ether linkage metabolites from the tolerance
expressions under 40 CFR 180.381 and 185.4600. Tolerances are currently
established for residues of oxyfluorfen and its metabolites containing
the diphenyl ether linkage in or on certain raw agricultural
commodities under 40 CFR 180.381 and certain processed foods under
185.4600. EPA has determined that it is no longer necessary to regulate
these metabolites in raw agricultural and processed commodities.
Metabolism studies with oxyfluorfen show no detectable residues of the
diphenyl ether linkage metabolites in plants. Oxyfluorfen per se is the
major residue found in meat, meat byproducts, fat, milk, and eggs.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. A 2-year feeding study in dogs fed diets containing 0, 100, 600,
or 2,000 ppm with a no-observed-effect level (NOEL) of 100 ppm
(equivalent to 2.5 milligrams (mg)/kilogram (kg)/day). Effects observed
in dogs fed diets containing 600 ppm (equivalent to 15 mg/kg/day) were
increased liver weight,
[[Page 49817]]
increases in alkaline phosphatase, renal tubule vacuolization, and
thyroid C-cell hyperplasia.
2. A developmental toxicity study in rats given gavage doses of 0,
18, 183, or 848 mg/kg/day with NOEL's for maternal and developmental
toxicity of 18 mg/kg/day. Developmental effects consisting of decreased
fetal body weight, increased resorptions, and an increase in the
incidence of left carotid artery from the innominate, bent bones of the
forelimbs, and other ossification irregularities were observed at the
183-mg/kg/day dose level. These effects were confined to the mid-dose
level, since there was 100 percent litter loss in the high-dose groups
as a result of maternal mortality and resorptions. The lowest-observed-
effect level (LOEL) for maternal toxicity was established at 183 mg/kg/
day based on decreased weight gain and food consumption, increased
incidences of soft or scant feces, and increased alkaline phosphatase.
3. A developmental toxicity study in rabbits given gavage doses of
0, 10, 30, or 90 mg/kg/day with NOEL's for maternal and developmental
toxicity of 10 mg/kg/day. Developmental toxicity (fused sternebrae) and
maternal toxicity (anorexia and decreased body weight gain) were
observed at the 30-mg/kg/day dose level.
4. A two generation reproduction study in rats fed diets containing
0, 100, 400, or 1,600 ppm with NOEL's for reproductive and systemic
effects of 400 ppm (equivalent to 20 mg/kg/day). Reproductive effects
observed at the 1,600-ppm dose level were decreased pup body weight
during lactation in both the F1a and F2a litters and a
decreased litter size at birth in F1a and F2a litters.
Systemic effects observed at the 1,600-ppm dose level include pelvic
mineralization and pelvic papillary hyperplasia of P1 and P2
males and P2 females and dilation of kidney collecting ductules in
both P2 sexes.
5. Mutagenicity studies including Salmonella assays, positive with
and without activation in strains TA98, TA100, and TA1537; Salmonella
assays, negative with and without activation in strains TA98, TA100,
TA1535, and TA1537; in vivo cytogenetic assay in rats, negative for
cytogenetic chromosomal aberrations both with and without metabolic
activation; and mouse lymphoma forward mutation assay, positive in the
presence of an activation system.
6. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing 0, 2, 40, or 800/1,600 ppm (the 800-ppm dosage level was
raised to 1,600 ppm at week 57 of the study) with a NOEL of 40 ppm
(equivalent to 2.0 mg/kg/day) based on minimal hypertrophy of liver
cells. There were no carcinogenic effects observed under the conditions
of the study at any dose level tested.
7. A 20-month carcinogenicity study in CD-1 mice fed diets
containing 0, 2, 20, or 200 ppm with a NOEL of 2 ppm (equivalent to 0.3
mg/kg/day) for systemic effects. Oxyfluorfen was associated with
significant positive dose-related trends for liver adenoma, carcinoma,
and combined adenoma and/or carcinoma in male mice when compared with
historical control data from CD-1 mouse studies of 20 to 22 months
duration. There was no apparent effect on the latency period for tumor
occurrence, and no compound-related increase in tumors were observed in
female mice.
Based on a weight-of-the-evidence determination, EPA has classified
oxyfluorfen as a possible human carcinogen (Group C) with quantified
risk. The qualitative categorization of carcinogenicity is based on the
Agency's Guidelines for Carcinogenic Risk Assessment, published in the
Federal Register of September 24, 1986 (51 FR 33992).
Although there was no compound-related increase in tumors observed
in female mice or in male or female rats, and no evidence for a
reduction in latency period for the time-to-liver tumor appearance in
male mice, quantification of carcinogenic risk for oxyfluorfen is
considered appropriate. The decision supporting a Category C
classification with quantified risk is based on the significant
positive dose-related trends in liver adenomas, carcinomas, and
combined adenomas and/or carcinomas in male CD-1 mice. Supporting
evidence includes a strong association of oxyfluorfen with diphenyl
ether herbicides (a class of herbicides associated with evidence of
carcinogenicity) and evidence of mutagenicity in the Salmonella and the
mouse lymphoma assays.
A carcinogenic risk assessment for oxyfluorfen has been completed
based on the available information. The potential carcinogenic risk
from dietary exposure resulting from existing uses of oxyfluorfen is
calculated at 1.8 X 10-6. The dietary risk assessment is based on
a potency estimator (Q1*) of 0.13 (mg/kg/day)-1. Dietary
exposure is calculated at 0.000014 mg/kg/day based on theoretical
maximum residue contribution (TMRC) estimates for some uses and
anticipated residue contribution (ARC) estimates for other uses. TMRC
values assume that 100 percent of the crops are treated and that the
resulting residues are at tolerance levels. ARC values estimate
expected dietary exposure based on actual residue levels that are
anticipated on the treated commodities and/or the estimated percent of
the crop treated. The potential carcinogenic risk from residues of
oxyfluorfen in the diet is expected to be less than calculated since
data were not available to estimate the percent of crop treated for
several commodities which theoretically contribute significant residues
to the diet. In the absence of these data, the Agency has assumed that
100 percent of the crop was treated.
Dietary exposure resulting from tolerance level residues in or on
blackberry and raspberry is estimated at 0.000001 mg/kg/day. The
potential carcinogenic risk to the proposed tolerance level residues
for blackberry and raspberry is calculated at 6 X 10-8, a
negligible increase.
The Reference Dose (RfD) for oxyfluorfen is calculated at 0.003 mg/
kg/day, based on a NOEL of 0.30 mg/kg of body weight/day from the 20-
month feeding study in mice and an uncertainty factor of 100. Dietary
exposure from existing tolerances and the proposed tolerances for
blackberry and raspberry utilizes less than 1 percent of the RfD for
the general population and for children, aged 1 to 6 years (the
subgroup population most highly exposed.)
An adequate analytical method is available for enforcement
purposes. The metabolism of oxyfluorfen in plants is adequately
understood. An analytical method for enforcing these tolerances has
been published in the Pesticide Analytical Manual, Vol. II (PAM II). No
secondary residues are expected in meat, milk, poultry, or eggs since
blackberry and raspberry are not considered livestock feed commodities.
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 tolerances established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerances 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 document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
[[Page 49818]]
A record has been established for this rulemaking under docket
number [PP 5E4429/P631] (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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: September 18, 1995.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that parts 180 and 185 be 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. 180.381, by amending paragraph (a) by revising the
introductory text therein and revising paragraph (b), to read as
follows:
Sec. 180.381 Oxyfluorfen; tolerances for residues.
(a) Tolerances are established for residues of the herbicide
oxyfluorfen [2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene] in or on the following raw agricultural
commodities:
* * * * *
(b) Tolerances with regional registration are established for
residues of the herbicide oxyfluorfen [2-chloro-1-(3-ethoxy-
4nitrophenoxy)-4-(trifluoromethyl)benzene] in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Blackberry................................................. 0.05
Garbanzo beans............................................. 0.05
Guava...................................................... 0.05
Papaya..................................................... 0.05
Taro (corms and leaves).................................... 0.05
Raspberry.................................................. 0.05
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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 amending Sec. 185.4600 by revising the introductory text to
read as follows:
Sec. 185.4600 Oxyfluorfen.
A regulation is established permitting residues of the herbicide
oxyfluorfen [2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene] in or on the following processed food when
present therein as a result of application of the herbicide to growing
crops:
* * * * *
[FR Doc. 95-24005 Filed 9-26-95; 8:45 am]
BILLING CODE 6560-50-F
