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Tebuconazole - Pesticide Tolerance 7/94

40 CFR Part 180
[PP 9F3724 /R2073; FRL-4904-2]
RIN 2070-AB78
Pesticide Tolerance for Tebuconazole
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for residues of the
fungicide tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl]-alpha-
(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol) in or on the
raw agricultural commodities peanuts and peanut hulls. Miles,
Inc., petitioned EPA for this regulation to establish a maximum
permissible level for residues of the fungicide.

EFFECTIVE DATE: This regulation becomes effective July 15, 1994.

ADDRESSES: Written objections and hearing requests, identified
by the document control number, [PP 9F3724/R2073], may be submitted
to: Hearing Clerk (1900), Environmental Protection Agency, rm.
M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections
and hearing requests 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 (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In
person, bring copy of objections and hearing requests to rm.
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Fees accompanying objections shall be labeled "Tolerance Petition
Fees" and forwarded to: EPA Headquarters Accounting Operations
Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins, Acting
Product Manager (PM) 21, Registration Division (7505C), Office
of Pesticide Programs, Environmental Protection Agency, 401
M St., SW., Washington, DC 20460. Office location and telephone
number: rm. 227, CM #2, 1921 Jefferson Davis Hwy., Arlington,
VA 22202, (703) 305-6900.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in
the Federal Register of March 23, 1989 (54 FR 12009), which
announced that Miles, Inc., Agricultural Division (formerly
Mobay Corp., Agricultural Chemicals Division), P.O. Box 4913,
Kansas City, MO 64120-0013, had submitted pesticide petition
(PP) 9F3724 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), propose to amend 40 CFR part 180
by establishing tolerances for residues of the fungicide tebuconazole
(alpha-[2-(4-chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-
1H-1,2,4-triazole-1-ethanol) in or on the raw agricultural commodities
barley grain at 2.0 parts per million (ppm), barley grain forage
at 5.0 ppm, barley straw at 5.0 ppm, grapes at 2.0 ppm, grass
seed cleanings (including hulls) at 25.0 ppm, grass seed straw
(including chaff) at 30.0 ppm, peanuts at 0.05 ppm, peanut hulls
at 3.5 ppm, peanut hay at 50.0 ppm, raisins at 3.0 ppm, wheat
grain at 0.40 ppm, wheat grain forage at 4.5 ppm and wheat straw
at 19.0 ppm.

Miles, Inc., has amended the petition to propose amending
40 CFR part 180 by establishing a regulation to permit the residues
of the fungicide tebuconazole in or on peanuts at 0.1 ppm and
peanut hulls at 4.0 ppm. This was announced as a notice in the
Federal Register of June 6, 1994 (59 FR 29291).

In previous amendments to the cited pesticide petition, requested
by Miles, Inc., all commodities other than peanuts and peanut
hulls (peanut hay, barley grain, barley grain forage, barley
straw, grapes, grass seed cleanings including hulls, grass seed
straw including chaff, raisins, wheat grain, wheat grain forage,
and wheat straw) were withdrawn.

Comments on the Amended Notice of Filing

Comments have been received in reponse to the June 6, 1994
notice of filing.

Comments were received asserting that tebuconazole concentrates
in peanut oil, based on the previously proposed food additive
petition (FAP) for tebuconazole in peanut oil and the assumption
that tebuconazole therefore concentrates during processing in
peanut oil. The commenter asked how EPA could proceed to grant
the section 408 tolerances for peanuts without also addressing
the section 409 food additive regulation for peanut oil.
EPA's response. Tebuconazole does in fact concentrate in
peanut crude oil. However, EPA does not regulate peanut crude
oil; instead, EPA regulates the peanut refined oil used in commerce
and consumed by humans. Initial tebuconazole peanut processing
studies and the resulting proposed food additive regulation
in/on peanut oil indicated concentration of tebuconazole in
both peanut crude and refined oil, but those studies did not
represent commercial peanut oil refining procedures since they
did not include oil bleaching and deodorization.

A subsequent peanut processing study did include oil bleaching
and deodorization and these additional refining operations,
which are used in commercial peanut oil refining, resulted in
a 93-percent reduction in tebuconazole residues. Therefore,
a section 409 food additive regulation for tebuconazole in/on
peanut oil is not required.

Tebuconazole has been shown to concentrate in peanut soapstock.
Based upon recently acquired information, EPA has found that
peanut soapstock is no longer used as an animal feed. Therefore,
an FAP for tebuconazole in peanut soapstock is not required.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered
in support of the tolerance include:

1. A 90-day rat feeding study with a no-observed-effect level
(NOEL) of 34.8 milligrams per kilogram of body weight per day
(mg/kg bw/day) (400 ppm) and a lowest effect level (LEL) of
171.7 mg/kg bw/day (1600 ppm) in males, based on decreased body
weight gains and histological changes in the adrenals. For females,
the NOEL was 10.8 mg/kg bw/day (100 ppm) and the LEL was 46.5
mg/kg bw/day (400 ppm) based on decreased body weights, decreased
body weight gains, and histological changes in the adrenals.

2. A 90-day dog feeding study with a NOEL of 200 ppm (73.7
mg/kg bw/day in males and 73.4 mg/kg bw/day in females) and
a LEL of 1000 ppm (368.3 mg/kg bw/day in males and 351.8 mg/kg
bw/day in females). The LEL was based on decreases in mean body
weights, body weight gains, and food consumption, and an increase
in liver N-demethylase activity.

3. A 1-year dog feeding study with a NOEL of 1 mg/kg bw/day
(40 ppm) and a LEL of 5 mg/kg bw/day (200 ppm), based on lenticular
and corneal opacity and hepatic toxicity in either sex (the
current Reference Dose was determined based on this study).
A subsequent 1-year dog feeding study, using lower doses to
further define the NOEL for tebuconazole, defines a systemic
LOEL of 150 ppm (based on adrenal effects in both sexes) and
a systemic NOEL of 100 ppm.

4. A 2-year rat chronic feeding study defined, a NOEL of
7.4 mg/kg bw/day (100 ppm) and a LEL of 22.8 mg/kg bw/day (300
ppm) based on body weight depression, decreased hemoglobin,
hematocrit, MCV and MCHC, and increased liver microsomal enzymes
in females. Tebuconazole was not oncogenic at the dose levels
tested (0, 100, 300, 1000 ppm).

5. A rat oral developmental toxicity study with a maternal
NOEL of 30 mg/kg bw/day and a LEL of 60 mg/kg bw/day based on
elevation of absolute and relative liver weights. For developmental
toxicity, a NOEL of 30 mg/kg bw/day and a LEL of 60 mg/kg bw/day
was determined, based on delayed ossification of thoracic, cervical
and sacral vertebrae, sternum, fore and hind limbs and increase
in supernumerary ribs.

6. A rabbit oral developmental toxicity study with a maternal
NOEL of 30 mg/kg bw/day and a LEL of 100 mg/kg bw/day based
on depression of body weight gains and food consumption. A developmental
NOEL of 30 mg/kg bw/day and a LEL of 100 mg/kg bw/day were based
on increased post-implantation losses, from both early and late
resorptions.

7. A mouse oral developmental toxicity study with a maternal
NOEL of 10 mg/kg bw/day and a LEL of 20 mg/kg bw/day based on
a supplementary study indicating reduction in hematocrit and
histological changes in liver. A developmental NOEL of 10 mg/kg
bw/day and a LEL of 30 mg/kg bw/day based on dose-dependent
increases in runts/dam at 30 and 100 mg/kg bw/day.

8. A mouse dermal developmental toxicity study with a maternal
NOEL of 30 mg/kg bw/day and a LEL of 60 mg/kg bw/day based on
a supplementary study indicating increased liver microsomal
enzymes and histological changes in liver. The NOEL for developmental
toxicity in the dermal study in the mouse is 1000 mg/kg bw/day,
the highest dose tested (HDT).

9. A two-generation rat reproduction study with a dietary
maternal NOEL of 15 mg/kg bw/day (300 ppm) and a LEL of 50 mg/kg
bw/day (1000 ppm) based on depressed body weights, increased
spleen hemosiderosis and decreased liver and kidney weights.
A reproductive NOEL of 15 mg/kg bw/day (300 ppm) and a LEL of
50 mg/kg bw/day (1000 ppm) were based on neonatal birth weight
depression.

10. An Ames mutagenesis study in Salmonella that showed no
mutagenicity with or without metabolic activation.

11. A micronucleus mutagenesis assay study in mice that showed
no genotoxicity.

12. A sister chromatid exchange mutagenesis study using CHO
cells that was negative at dose levels 4 to 30 MUg/ml without
activation or 15 to 120 MUg/ml with activation.

13. An unscheduled DNA synthesis (UDS) study that was negative
for UDS in rat hepatocytes.

Additionally, a mouse oncogenicity study at dietary levels
of 0, 20, 60, and 80 ppm for 21 months did not reveal any oncogenic
effect for tebuconazole at any dose tested. Because the Maximum
Tolerated Dose (MTD) was not reached in this study, the study
was classified as supplementary. A followup mouse study at higher
doses (0, 500, 1500 ppm in the diet), with an MTD at 500 ppm,
revealed statistically significant incidences of hepatocellular
adenomas and carcinomas in males and carcinomas in females.
The initial and follow-up studies, together with supplementary
data submitted by Miles, Inc., were classified as core minimum.
The Office of Pesticide Programs' Health Effects Division's
Carcinogenicity Peer Review Committee (CPRC) has classified
tebuconazole as a Group C carcinogen (possible human carcinogen).
This classification is based on the Agency's "Guidelines for
Carcinogen Risk Assessment" published in the Federal Register
of September 24, 1986 (51 FR 33992). The Agency has chosen to
use the reference dose calculations to estimate human dietary
risk from tebuconazole residues. EPA believes any cancer risk
to humans from consumption of tebuconazole residues to be negligible.
The Reference Dose (RfD) is established at 0.01 mg/kg of
body weight (bwt)/day, based on a lower NOEL of 1 mg/kg bwt/day
from the first of two 52-week feeding studies in dogs, and an
uncertainty factor of 100. The Theoretical Maximum Residue Contribution
(TMRC) from the current action is estimated at 0.000007 mg/kg
bwt/day and utilizes 0.07 percent of the RfD for the general
population of the 48 States. The TMRCs for the most highly exposed
subgroups, children (1 to 6 years old) and children (7 to 12
years old) are 0.000024 mg/kg bwt/day (0.24% of the RfD) and
0.000017 mg/kg bwt/day (0.17 percent of the RfD), respectively.
The nature of the residue in peanuts is adequately understood.
An adequate analytical method, high-pressure liquid chromatography,
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 Highway, Arlington, VA 22202 (703) 305-5232.

Miles has withdrawn proposed tebuconazole tolerances in animal
tissues, milk and eggs. The Agency has determined that, with
the label restriction against feeding peanut hay, there is no
reasonable expectation that secondary residues will occur in
milk, eggs or meat of livestock or poultry as a result of the
proposed use on peanuts.

The pesticide is considered useful for the purpose for which
the tolerances are sought.

Based on the information and data considered, the Agency
has determined that the tolerances 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 to the regulation and may also request
a hearing on those objections. Objections and hearing requests
must be filed with the 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 fee prescribed 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, the
requestor's contentions on such issues, and a summary of any
evidence relied upon by the objector (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 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).

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: July 15, 1994.
Penelope A. Fenner-Crisp,
Acting Deputy Director, 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.

2. By adding new sec 180.474, to read as follows:
sec 180.474 Tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl]-alpha-
(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol); tolerances
for residues.

Tolerances are established for residues of the fungicide
tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-
1H-1,2,4-triazole-1-ethanol) in or on the following raw agricultural
commodities:
------------------------------------------------------------
Commodity Parts per
million
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Peanuts........................................0.1
Peanut, hulls................................. 4.0
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[FR Doc. 94-18758 Filed 8-2-94; 8:45 am]