[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.

[[Page 30201]]

    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

[[Page 30202]]

``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) *  *  *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Filberts...................................................         0.02
                                                                        
                  *        *        *        *        *                 
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* * * * *

[FR Doc. 96-15041 Filed 6-13-96; 8:45 am]
BILLING CODE 6560-50-F