[Federal Register Volume 59, Number 148 (Wednesday, August 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18758]
[[Page Unknown]]
[Federal Register: August 3, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
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 g/ml without
activation or 15 to 120 g/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:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Peanuts.................................................... 0.1
Peanut, hulls.............................................. 4.0
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[FR Doc. 94-18758 Filed 8-2-94; 8:45 am]
BILLING CODE 6560-50-F
