[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Proposed Rules]
[Pages 30200-30202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15041]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4573/P662; FRL-5375-1]
RIN 2070-AC18
Fenarimol; Pesticide Tolerance For Residues in or on Filberts
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for residues of the
fungicide fenarimol in or on the raw agricultural commodity filberts.
The proposed regulation to establish a maximum permissible level for
residues of the fungicide was requested in a petition submitted by the
Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the docket number [PP 5E4573/P662], must
be received on or before July 15, 1996.
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 Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: [email protected]. 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 5E4573/P662]. 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). 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
Virginia 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 Highway, Arlington, VA 22202, (703) 308-8783; e-
mail: [email protected].
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) 5E4573 to EPA on behalf of the Oregon Filbert Commission.
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 180.421 by establishing a tolerance for residues
of the fungicide fenarimol [alpha-(2-chlorophenyl)-alpha-(4-
chlorophenyl)-5-pyrimidine methanol] in or on the raw agricultural
commodity filberts at 0.02 parts per million (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. A 1-year feeding study with dogs fed diets containing 0, 1.25,
12.5, or 125 milligrams/kilogram (mg/kg)/day. The no-observed-effects
level (NOEL) for this study is established at 12.5 mg/kg/day. The high
dose level (125 mg/kg/day) caused increased serum alkaline phosphatase,
increased liver weights, an increase in p-nitroanisole o-demethylase
activity, and mild hepatic bile stasis.
2. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing concentrations of 0, 50, 130, or 350 ppm (equivalent to 0,
2.5, 6.5, or 17.5 mg/kg/day) with a systemic NOEL of 130 ppm
(equivalent to 6.5 mg/kg/day). An increase in fatty liver changes was
observed in rats fed diets containing 350 ppm. There were no
carcinogenic effects observed under the conditions of the study.
3. A second 2-year chronic feeding/carcinogenicity study in rats
fed diets containing 0, 12.5, 25, or 50 ppm (equivalent to 0, 0.63,
1.25, or 2.5 mg/kg/day) with no systemic or carcinogenic effects
observed under the conditions of the study.
4. A 2-year carcinogenicity study in mice fed diets containing
concentrations of 0, 50, 170, or 600 ppm (equivalent to 0, 7, 24.3, or
85.7 mg/kg/day) with a NOEL for systemic effects at 170 ppm. An
increase in fatty liver changes was observed in mice at the 600 ppm
dose level. There were no carcinogenic efects observed under the
conditions of the study.
5. A developmental toxicity study with rabbits given oral doses of
0, 5, 10, or 35 mg/kg/day with no developmental toxicity observed under
the conditions of the study.
6. A developmental toxicity study with rats given oral doses of 0,
5, 13, or 35 mg/kg/day demonstrated hydronephrosis at 35 mg/kg/day. The
NOEL for developmental toxicity in this study is established at 13 mg/
kg/day.
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7. A second developmental toxicity study in rats (with a postpartum
evaluation) again demonstrated hydronephrosis at 35 mg/kg/day. Maternal
toxicity (decreased body weight gain) was also observed at the 35 mg/
kg/day. The NOEL's for developmental and maternal toxicity in this
study are established at 13 mg/kg/day.
8. A 3-generation reproduction study in rats fed diets containing
0, 12.5, 25, or 50 ppm (equivalent to 0.625, 1.25, or 2.5 mg/kg/day)
demonstrated decreased mating in males at the 25 ppm and delayed
parturition and dystocia in females at 25 ppm and 50 ppm. The NOEL for
reproductive effects in this study is established at 12.5 ppm. The
infertility effect in male rats is considered to be a species-specific
effect mediated by the inhibition of testosterone aromatase which
catalyzes the conversion of testosterone to estradiol in the
hypothalamus. Estradiol plays an essential role in the development and
maintenance of sexual behavior of rats but not in man.
9. Multi-generation reproduction studies that were negative for
reproductive effects at 35 mg/kg/day (highest dose tested) in guinea
pigs and 20 mg/kg/day (highest doses tested) in mice.
10. An aromatase inhibition study in rats that showed fenarimol to
be a moderately weak inhibitor of aromatase activity.
The adverse reproductive effects observed in the rat multi-
generation reproduction study are considered to be a species-specific
effect caused by aromatase inhibition. The aromatose enzyme promotes
normal sexual behavior in rats and mice, but not in guinea pigs, or
primates (including humans). A NOEL of 35 mg/kg/day for reproductive
effects relevant to humans was established based on the NOEL from the
multi-generation reproduction study in guinea pigs.
11. Fenarimol tested negative in several assay systems for gene
mutation, structural chromosome aberration and other genotoxic effects.
In a micronucleus test in the mouse, fenarimol did produce a
significant increase in the percent of polychromatic erythrocytes with
micronucleus at 24 hours, but not at 48 hours or 72 hours. The
significance of this finding is not known, but the negative results of
the other assays demonstrate that the mutagenic potential of fenarimol
is very low.
12. Metabolism studies in rats show that fenarimol is rapidly
metabolized and excreted. Major metabolic pathways were oxidation of
the carbinol-carbon atom, the phenyl rings and the pyrimidine ring.
Based on the above findings, the Agency concluded that fenarimol
was not carcinogenic in long-term studies in rats and mice under the
test conditions in which the highest dose tested for both species
approached a maximum-tolerated dose as evidenced by increased fatty
changes in the liver.
The Reference Dose (RfD) is calculated at 0.065 mg/kg bwt/day. The
RfD is based on a NOEL of 6.5 mg/kg/bwt/day from the 2-year rat chronic
feeding study and an uncertainty factor of 100. The theoretical maximum
residue contribution (TMRC) from previously established tolerances and
the proposed tolerance for filberts utilizes less than 1 percent of the
RfD for the general population and less than 2 percent of the RfD for
children 1 to 6 years of age (the population subgroup most highly
exposed to dietary residues of fenarimol). EPA generally has no concern
for exposures below 100 percent of the RfD.
The metabolism of fenarimol in plants is adequately understood for
the purposes of the proposed tolerance. The residue of concern is
fenarimol per se. An adequate analytical method, is available for
enforcement purposes. The analytical method is published in the
Pesticide Analytical Manual, Volume II (PAM II).
There is no reasonable expectation that secondary residues of
fenarimol will occur in milk, egg, or meat, fat, and meat byproducts of
livestock or poultry as a result of this action; there are no livestock
feed commodities associated with filberts.
There are presently 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.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number [PP 5E4573/P662].
A record has been established for this rulemaking under docket
number [PP 5E4573/P662] (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 Room 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.
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 t his 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.
This action does not impose any enforceable duty, or contain any
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``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this
determination 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: June 3, 1996.
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.
2. In Sec. 180.421, the table in paragraph (a) is amended by adding
alphabetically the entry for filberts, to read as follows:
Sec. 180.421 Fenarimol; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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* * * * *
Filberts................................................... 0.02
* * * * *
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[FR Doc. 96-15041 Filed 6-13-96; 8:45 am]
BILLING CODE 6560-50-F