96-15479. Triadimefon; Revocation of Pesticide Tolerances and a Food Additive Regulation

[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Proposed Rules]
[Pages 31081-31083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15479]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185

[OPP-300431; FRL-5379-7]
RIN 2070-AC18


Triadimefon; Revocation of Pesticide Tolerances and a Food 
Additive Regulation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke the pesticide tolerances for 
triadimefon on barley grain, green forage and straw and the food 
additive regulation for triadimefon on milled fractions of barley 
(except flour) because there are no longer registered uses of 
triadimefon on barley. EPA is proposing that the revocation of the 
tolerance become effective as of May 23, 1997.

DATES: Written comments, identified by the docket number OPP-300431, 
must be received on or before July 19, 1996. This revocation is 
proposed to become effective on May 23, 1997.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA. Information submitted and any 
comment(s) concerning this notice may be claimed confidential by 
marking any part or all of that information as ``Confidential Business 
Information'' (CBI). Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment(s) that does not contain CBI must be submitted for inclusion in 
the public record. Information not marked confidential may be disclosed 
publicly by EPA without prior notice to the submitter. Information on 
the proposed action and any written comments will be available for 
public inspection in Rm. 1132 at the Virginia address given above, from 
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [e-mail]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [OPP-300431]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic comments on this 
proposed 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, Lisa Nisenson, Special Review 
Branch (7508W), Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: 3rd floor, Crystal Station, 2800 Crystal Drive, 
Arlington, VA 22202, [phone]; e-mail: 
[e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Statutory Background

    The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et 
seq., authorizes the establishment by regulation of maximum permissible 
levels of pesticides in foods. Such regulations are commonly referred 
to as ``tolerances.'' Without such a tolerance or an exemption from the 
requirement of a tolerance, a food containing a pesticide residue is 
``adulterated'' under section 402 of the FFDCA and may not be legally 
moved in interstate commerce. 21 U.S.C. 331, 342.
    The FFDCA has separate provisions for tolerances for pesticide 
residues on raw agricultural commodities (RACs) and tolerances on 
processed food. For pesticide residues in or on RACs, EPA establishes 
tolerances, or exemptions from tolerances when appropriate, under 
section 408. 21 U.S.C. 346a. EPA regulates pesticide residues in 
processed foods under section 409, which pertains to ``food 
additives.'' 21 U.S.C. 348. Maximum residue

[[Page 31082]]

regulations established under section 409 are commonly referred to as 
food additive regulations (hereafter referred to as ``FARs'').
    If a food additive regulation must be established, section 409 of 
the FFDCA requires that the use of the pesticide will be ``safe'' (21 
U.S.C. 348(c)(3)). Relevant factors in this safety determination 
include (1) the probable consumption of the pesticide or its 
metabolites; (2) the cumulative effect of the pesticide in the diet of 
man or animals, taking into account any related substances in the diet; 
and (3) appropriate safety factors to relate the animal data to the 
human risk evaluation. Section 409 also contains the Delaney clause, 
which specifically provides that ``no additive shall be deemed safe if 
it has been found, after tests which are appropriate for the evaluation 
of the safety of food additives, to induce cancer when ingested by man 
or animal.''

B. Regulatory Background

    Following a series of petitions related to EPA's interpretation of 
the Delaney clause, the U.S. Court of Appeals, Ninth Circuit on July 8, 
1992, ruled that the Delaney clause barred the establishment of a FAR 
for pesticides which ``induce cancer'' even though the associated 
cancer risk may be small (Les v. Reilly, 968 F.2d 985 (9th Cir.), cert. 
denied, 113 S.Ct. 1361 (1993)). Shortly thereafter, the sole registrant 
of triadimefon, Miles Inc., requested voluntary cancellation of the 
triadimefon use on barley, which EPA granted on August 25, 1993 (58 FR 
44823). The effective date of the cancellation of the use of 
triadimefon on barley was November 23, 1993 and the registrant was 
allowed to sell stocks labeled with the barley use up to 18 months 
after the effective date.
    On January 18, 1995 (59 FR 3602)(FRL-4910-8), EPA proposed to 
revoke, among other things, the FAR for triadimefon on milled fractions 
of barley (except flour) based on the Agency's determination that 
triadimefon induces cancer in man or animals and that the FAR at issue 
violates the Delaney clause. This notice supplements the proposed 
revocation published in the January 18, 1995 proposal with respect to 
triadimefon, and announces an alternative proposal to revoke the 
triadimefon FAR and associated tolerances on the basis that the 
tolerance is not needed because the use was cancelled in 1993. EPA may 
finalize the revocation on either of the grounds proposed. Readers are 
therefore encouraged to consult OPP Docket 300360 to obtain copies of 
the comments received in EPA's earlier proposal.

II. Proposed Revocation

    EPA is proposing to revoke the food additive regulation for 
triadimefon (1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-
yl)-2-butanone) and its metabolite beta-(4-chlorophenoxy)-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol set to cover residues in or 
on milled fractions of barley (except flour). This FAR, which is 
codified at 40 CFR 185.800 is set at 4 ppm. EPA is also proposing to 
revoke the tolerances for 1-(4-chlorophenoxy)-3,3-dimethyl-1(1H-1,2,4-
triazol-1-yl)-2-butanone and its metabolite containing chlorophenoxy 
and triazole moieties (expressed as the fungicide) in or on barley 
grain, green forage and straw. These tolerances are codified at 40 CFR 
180.410 at 1 ppm.
    EPA is proposing to revoke the above-stated tolerance and FAR since 
the use of triadimefon on barley is no longer registered. As a matter 
of policy, where a use is no longer registered, EPA revokes the 
tolerance(s) and/or FAR's for any residues related to the deleted 
use(s). Although EPA had proposed revocation of the FAR for triadimefon 
on barley in a previous notice based on Delaney clause grounds, EPA has 
noted that where there are gounds for revocation of a FAR unconnected 
to safety, EPA generally would, as a policy matter, rely on those 
grounds to revoke the FAR prior to revoking finally under the Delaney 
clause (61 FR 11994, March 22, 1996) (FRL-5357-7) However, EPA has also 
noted that the Agency is under no legal obligation to subordinate the 
Delaney clause to other grounds in a revocation proceeding (61 FR 2377, 
January 25, 1996)(FRL-4991-9).
    In the case of triadimefon on barley, the registrant requested, and 
EPA granted, voluntary cancellation. In the August 25, 1993 notice, the 
registrant was given 18 months, or until May 23, 1995, to sell existing 
stocks labelled with the use on barley. With voluntary cancellations, 
EPA generally allows 2 years for legally-treated commodities to clear 
channels of trade, thus EPA is proposing that the tolerance and FAR on 
barley be revoked as of May 23, 1997.

III. Consideration of Comments

    Any interested person may submit comments on this proposed action 
on or before July 19, 1996 at the address given in the section above 
entitled ``ADDRESSES.'' Before issuing a final revocation, EPA will 
consider all relevant comments, including those on the proposed 
effective date. Comments should be limited only to the tolerances and 
food additive regulation subject to this proposed notice. After 
consideration of comments, EPA will issue a final order determining 
whether revocation of the tolerances and food additive regulation is 
appropriate. Such order will be subject to objections pursuant to 
section 409(f)(21 U.S.C. 348(f)). Failure to file an objection within 
the appointed period will constitute waiver of the right to raise 
issues presented in the order in future proceedings.
     A record has been established for this rulemaking under docket 
number [OPP-300431] (including comments and data 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 Room 1132 of the 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.
    Electronic comments can be sent directly to EPA at:
    [e-mail]


    Electronic comments 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 all comments 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 comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the Virginia address in ``ADDRESSES'' at the 
beginning of this document.

IV. Regulatory Requirements

A. Executive Order 12866

    EPA submitted this action to the Office of Management and Budget 
(OMB) for review and any changes made during that review have been 
documented in the public record. EPA does not expect any adverse 
economic impacts from this proposed action since the use on barley was 
cancelled in 1993 at the request of the registrant.

[[Page 31083]]

B. Regulatory Flexibility Act

    EPA has reviewed this proposed rule under the Regulatory 
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et 
seq.], and has determined that it will not have a significant economic 
impact on any small businesses, governments or organizations.
    Accordingly, I certify that this proposed rule does not require a 
separate Regulatory Flexibility Analysis under the Regulatory 
Flexibility Act.

C. Paperwork Reduction Act

    This order does not contain any information collection requirements 
subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

D. Unfunded Mandates Reform Act and Executive Order 12875

    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).

List of Subjects

40 CFR Part 180

    Administrative practice and procedure, Agricultural commodities, 
Pesticides and pests, Reporting and recordkeeping requirements

40 CFR Part 185

    Food additives, Pesticides and pests

    Dated: June 11, 1996.

Lois Rossi,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR parts 180 and 185 are proposed to be amended as 
follows:
    1. In part 180:

PART 180--[AMENDED]

    a. The authority citation for part 180 continues to read as 
follows:
    Authority: 2l U.S.C. 346a and 371.


Sec. 180.410 [Amended]

    b. By removing from the table in Sec. 180.410 the entries for 
``Barley; grain,'' ``Barley, green forage,'' and ``Barley, straw.''
    2. In part 185:

PART 185--[AMENDED]

    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 2l U.S.C. 346a and 348.


Sec. 185.800 [Amended]

    b. By removing from the table in Sec. 185.800; the entry for 
``Barley, milled fractions of barley (except flour).''

[FR Doc. 96-15479 Filed 6-18-96; 8:45 am]
BILLING CODE 6560-50-F