Pesticide Tolerance for Tebuconazole

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

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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]

BILLING CODE 6560-50-F