[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 
------------------------------------------------------------------------


[FR Doc. 94-18758 Filed 8-2-94; 8:45 am]
BILLING CODE 6560-50-F