[Federal Register Volume 60, Number 100 (Wednesday, May 24, 1995)]
[Rules and Regulations]
[Pages 27419-27421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12743]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2F4154/R2136; FRL-4955-3]
RIN 2070-AB78
Fenbuconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of the fungicide fenbuconazole, alpha-[2-(4-
chlorophenyl)ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile, and its metabolites cis-5-(4-chlorophenyl)dihydro-3-
phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone and trans-5-(4-
chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanone, expressed as fenbuconazole, in or on the raw agricultural
commodity bananas (whole fruit) at 0.3 ppm of which not more than 0.05
ppm is contained in the banana pulp. Rohm & Haas Co. submitted
petitions for this regulation to establish a maximum permissible level
for residues of the fungicide.
EFFECTIVE DATE: This regulation becomes effective May 24, 1995..
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 2F4154/R2136], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251. A copy of any objections and hearing request
filed with the Hearing Clerk should be identified by the document
control number and submitted to: Public Response and Program Resources
Branch, Field Operations Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20450. In person, bring copy of objections and hearing request to:
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
2F4154/R2136]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: James M. Stone, Acting
Product Manager (PM) 22, Registration Division, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 229, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)- 305-5540; e-mail:
stone.james@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of December 30, 1992 (57 FR 62334), which announced
that Rohm & Haas, Agricultural Chemicals, Independence Mall West,
Philadelphia, PA 19105, had submitted a pesticide petition (PP) 2F4154,
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),
amend 40 CFR part 180 by establishing a regulation to permit residues
of fenbuconazole, alpha-[2-(4-chlorophenyl)ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites [5-(4-
chlorophenyl)-dihydro-3-phenyl-3-(methyl-1H-1,2,4-triazole-1-yl)-2-3H-
furanone] in or on bananas (pulp) at 0.05 part per million (ppm) and
bananas (peel) at 0.3 ppm. Subsequently, on June 29, 1994 (59 FR
33503), EPA announced that Rohm & Haas had amended the petition to
propose amending 40 CFR part 180 by establishing a regulation to permit
residues of fenbuconazole, alpha-(2-(4-chlorophenyl)ethyl)-alpha-
phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile, and its metabolites cis-
5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-4-ylmethyl)-
2-3H-furanone and trans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone in or on bananas (whole fruit) at
0.3 ppm of which not more than 0.05 ppm is contained in banana pulp.
There were no comments or requests for referral to an advisory
committee received in response to these notices of filing.
The scientific data submitted in the petitions and all other
relevant material have been evaluated. The toxicology data considered
in support of the tolerances include:
1. A rat acute oral study with an LD50 greater than 2 grams
(g)/kilogram (kg).
2. A 13-week rat feeding study with a no-observed-effect level
(NOEL) of 20 ppm (1.3 milligrams(mg)/kg/day males and 1.5 mg/kg/day
females) and a lowest-observed-effect level (LOEL) of 80 ppm (5.1 mg/
kg/day males and 6.3 mg/kg/day females) based on hepatotoxicity.
3. A 3-month mouse feeding study with a NOEL of 20 ppm (3.8 mg/kg/
day males and 5.7 mg/kg/day females) and a LOEL of 60 ppm (11.1 mg/kg/
day males and 17.6 mg/kg/day females) based on hepatotoxicity.
4. A 3-month dog feeding study with a NOEL of 100 ppm (3.3 mg/kg/
day males and 3.5 mg/kg/day females) and LOEL of 400 ppm (13.3 mg/kg/
day males and 14.0 mg/kg/day females), based hepatocellular
hypertrophy.
5. A 21-day rat dermal study with a NOEL greater than 1,000 mg/kg/
day (limit dose).
6. A 78-week dietary carcinogenicity study in mice with a NOEL of
1.43 mg/kg/day and a LOEL of 28.6 mg/kg/day (males) and 92.9 mg/kg/day
(females) based on hepatocellular enlargement and a greater incidence
and severity of hepatocellular vacuolation. There was evidence of
carcinogenicity based on the occurrence of increased trend for
malignant liver tumors in males and an increase in benign and malignant
liver tumors in females. The carcinogenic effects observed are
discussed below.
7. A 24-month rat chronic feeding/carcinogenicity study with a NOEL
of 80 ppm (3.03 mg/kg/day for males and 4.02 mg/kg/day for females) for
systemic effects and an LEL of 800 ppm (30.62 mg/kg/day for males and
43.07 mg/kg/day for females) based on decreased in body weights in
females, and increased liver weighs in females and males along with
hepatocellular enlargement and [[Page 27420]] vacuolization. There was
also an increase in thyroid weights with slight increases in thyroid
focal cystic hyperplasia and follicular cell neoplasia in both sexes. A
LOEL was not established for males. There was evidence of
carcinogenicity based on the increased occurrence of thyroid follicular
cell benign and malignant tumors in males. The carcinogenic effects
observed are discussed further below.
8. A 24-month male rat chronic feeding/carcinogenicity study with a
NOEL of less than 800 ppm (30.41 mg/kg/day) and a LOEL is 800 ppm
(30.41 mg/kg/day) based on increased liver with centrilobular to
midzonal hepatocellular enlargement and vacuolization, decreased body
weight gain, and increased thyroid weights. There was evidence of
carcinogenicity based on the increased occurrence of thyroid follicular
cell benign and malignant tumors. The carcinogenic effects observed are
discussed further below.
9. A 1-year dog chronic feeding study with a NOEL of 150 ppm (3.75
mg/kg/day) and the LOEL, based on decreases in body weight gain and
increased liver weight, of 1,200 ppm (30 mg/kg/day).
10. A two generation reproduction study in rats with a parental
NOEL of 4 mg/kg/day (80 ppm) and a LOEL of 40 mg/kg/day (800 ppm),
based on decreased body weight, decreased food consumption, increased
number of dams not delivering viable or delivering nonviable offspring,
and increases in adrenal and thyroid weights. The reproductive NOEL is
greater than 40 mg/kg/day (800 ppm) [(highest dose tested (HDT)].
11. A developmental toxicity study in rabbits with a maternal NOEL
of 10 mg/kg/day, and a developmental NOEL of 30 mg/kg/day, and a
maternal LOEL of 30 mg/kg/day due to only 1/19 (5%) of the pregnant
does producing a viable fetus, and no developmental LOEL (greater than
30 mg/kg/day).
12. A developmental toxicity study in rats with a maternal NOEL and
developmental NOEL of 30 mg/kg/day and a LEL of 75 mg/kg/day due to
decrease in maternal body weight compared to controls and increase in
early and late resorption with a decrease in number of live fetuses per
dam.
13. No evidence of gene mutation was observed in a test for
induction of gene mutation at the HGPRT locus in Chinese hamster ovary
cells. No increase in the number of cells with aberrations or
observations per cell were noted in an in vivo cytogenetics assay using
bone marrow from treated rats. No increase in unscheduled DNA synthesis
in rat primary hepatocyte study was observed.
14. A rat metabolism study showed that radiolabeled fenbuconazole
is rapidly absorbed, distributed, and excreted following oral
administration in rats. Biliary excretion data indicated that systemic
absorption of fenbuconazole was high for all dosing groups. The feces
was the major route of excretion. Tissue distribution and
bioaccumulation of fenbuconazole appeared to be minimal.
The Health Effects Division Carcinogenicity Peer Review Committee
has concluded that the available data provide limited evidence of the
carcinogenicity of fenbuconazole in mice and rats and has classified
fenbuconazole as a Group C (possible human carcinogen with limited
evidence of carcinogenicity in animals) in accordance with Agency
guidelines, published in the Federal Register in 1986 (51 FR 33992;
Sept. 24, 1986) and recommended that for the purpose of risk
characterization a low-dose extrapolation model should be applied to
the experimental animal tumor data for quantification for human risk
(Q1*). This decision was based on the induction of thyroid
follicular cell adenomas and/or combined adenomas-carcinomas in male
rats in two studies, both by pairwise comparison with controls and by
trend analysis. The studies were combined for the purpose of deriving
the Q1*. The Q1* for fenbuconazole based on a recalculation
with a 3/4's power safety factor is 1.06 X 10-2 (mg/kg/day)-1
in human equivalents.
Based on (1) the established pecan and stone fruit group (except
plums and prunes) tolerances, (2) the limitation of production of the
only fenbuconazole product registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for use on stone fruit to 28,500
pounds of active ingredient per year (calculated to be equivalent to
treating 12.8% of the total U.S acreage of apricots, cherries,
nectarines, and peaches per year), and (3) the proposed banana
tolerances, the upper-bound limit of the dietary carcinogenic risk is
calculated in the range of 1 incidence in 1 million (9 X 10-7).
Processing studies for bananas are not required. Therefore, food/
feed additive tolerances are not needed in conjunction with these uses.
Using the NOEL of 3.0 mg/kg/day from the most sensitive species in
the rat chronic feeding study with a 100-fold safety factor, the
Reference Dose (RfD) for systemic effects is 0.03 mg/kg/day. The
theoretical maximum residue contribution (TMRC) from the established
and proposed tolerances is 0.000616 mg/kg/day and utilizes 2 percent of
the RfD for the overall U.S. population. For exposure of the most
highly exposed subgroups in the population, non-nursing infants (less
than 1-year old), the TMRC is 0.00522 mg/kg/day and utilizes 17 percent
of the RfD.
The metabolism of fenbuconazole in plants is adequately understood.
Due to the following chemistry data gap, magnitude of the residue: Crop
field trials with unbagged bananas (two in Hawaii and two in Puerto
Rico) [GLN 171-4], EPA believes it is inappropriate to establish
permanent tolerances for the uses of fenbuconazole at this time.
However, based on trials with bagged bananas and one side-by-side trial
with bagged and unbagged bananas, EPA believes that the existing data
support time-limited tolerances to December 31, 1998.
The nature of the residue in plants is adequately understood for
the purposes of these time-limited tolerances. An analytical method,
gas-liquid chromatography with a thermionic-specific detector with
nitrogen selectivity, is available for enforcement purposes. The
enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II). Because of the long lead time for publication of the
method in PAM II, the analytical methodology is being made available in
the interim to anyone interested in pesticide enforcement when
requested from: Calvin Furlow, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection 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)-305-5232.
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat of livestock and poultry since there are
no livestock feed items associated with this action. The pesticide is
considered useful for the purpose for which the tolerance is sought.
Based on the information and data considered, the Agency has determined
that the time-limited tolerance established by amending 40 CFR part 180
will protect the public health. Therefore, the 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 and/or request a hearing with the
[[Page 27421]] 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 fees provided 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, and the requestor's contentions on each such issue, and a
summary of the evidence relied upon by the objection (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 a 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).
A record has been established for this rulemaking under docket
number [PP 2F4154/R2136] (including objections and hearing requests
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, 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.
Written objections and hearing requests, identified by the document
control number [PP 2F4154/R2136], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the
Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests 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, 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
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: May 10, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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.
b. In Sec. 180.480, by amending paragraph (a) in the table therein
by adding and alphabetically inserting the raw agricultural commodity
bananas, to read as follows:
Sec. 180.480 Fenbuconazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Bananas (whole fruit).............. 0.3 (of which not more than 0.05
ppm is contained in the banana
pulp).
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 95-12743 Filed 5-23-95; 8:45 am]
BILLING CODE 6560-50-F
