[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Rules and Regulations]
[Pages 4585-4586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2212]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300604; FRL-5766-5]
RIN 2070-AB78


Carboxin; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends a time-limited tolerance for residues of the 
fungicide carboxin and its metabolites in or on onion seed at 0.2 parts 
per million (ppm) for an additional 1-year period, to January 31, 1999. 
This action is in response to EPA's granting of an emergency exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on onion seed. 
Additionally, this rule changes the commodity expression for the 
tolerance from ``onion seed'' to ``onions, dry bulb.'' Section 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires 
EPA to establish a time-limited tolerance or exemption from the 
requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under section 18 of FIFRA.

DATES: This regulation becomes effective January 30, 1998. Objections 
and requests for hearings must be received by EPA, on or before March 
31, 1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300604], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300604], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Follow the instructions in 
Unit II. of this preamble. No Confidential Business Information (CBI) 
should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 267, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9362; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of February 3, 1997 (62 FR 4911) (FRL-5584-5), which 
announced that on its own initiative and under section 408(e) of the 
FFDCA, 21 U.S.C. 346a(e) and (l)(6), it established a time-limited 
tolerance for the residues of carboxin and its metabolites in or on 
onion seed at 0.2 ppm, with an expiration date of January 17, 1998. EPA 
established the tolerance because section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under section 18 of FIFRA. Such tolerances can 
be established without providing notice or period for public comment.
    EPA received a request to extend the use of carboxin on onion seed 
for this year's growing season due to the urgent and non-routine 
situation resulting from a lack of effective registered pesticides or 
alternative practices to control onion smut in northern onion producing 
States. After having reviewed the submission, EPA concurs that 
emergency conditions exist for these States. EPA has authorized under 
FIFRA section 18 the use of carboxin on onion seed for control of onion 
smut in onions, dry bulb.
    EPA assessed the potential risks presented by residues of carboxin 
in or on onions, dry bulb. In doing so, EPA considered the new safety 
standard in FFDCA section 408(b)(2), and decided that the necessary 
tolerance under FFDCA section 408(l)(6) would be consistent with the 
new safety standard and with FIFRA section 18. The data and other 
relevant material have been evaluated and discussed in the final rule 
of February 3, 1997 (62 FR 4911). Based on that data and information 
considered, the Agency reaffirms that extension of the time-limited 
tolerance will continue to meet the requirements of section 408(l)(6). 
Therefore, the time-limited tolerance is extended for an additional 1-
year period. Although this tolerance will expire and is revoked on 
January 31, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on onions, dry bulb after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA and the application occurred prior to the revocation of the 
tolerance. EPA will take action to revoke this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.

I. Objections and Hearing Requests

     The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by March 31, 1998, file written objections to any 
aspect of this 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

[[Page 4586]]

requested, the objections must include a statement of the factual 
issues on which a hearing is requested, the requestor's contentions on 
such issues, and a summary of any evidence relied upon by the requestor 
(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 issues in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information 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.

II. Public Record and Electronic Submissions

     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 any copies of objections and hearing requests 
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
    Electronic comments may be sent directly to EPA at:
[email protected].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will also be accepted on 
disks in WordPerfect 51/6.1 or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified 
by the docket control number [OPP-300604]. No CBI should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

III. Regulatory Assessment Requirements

    This final rule extends a time-limited tolerancethat was previously 
extended by EPA under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). In addition, this final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    Since this extension of an existing time-limited tolerance does not 
require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
Nevertheless, the Agency has previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

IV. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
General Accounting Office prior to publication of this rule in today's 
Federal Register. This is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 14, 1998.

James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I 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. Section 180.301 is amended by adding a heading to paragraph (a); 
by revising paragraph (b); and by adding and reserving paragraphs (c) 
and (d) with headings to read as follows:


Sec. 180.301  Carboxin; tolerances for residues.

    (a) General. *      *      *      
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the combined residues (free and bound) of 
the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its sulfoxide metabolite (5,6-dihydro-3-
carboxanilide-2-methyl-1,4-oxathiin-4-oxide), each expressed as the 
parent compund in connection with use of the pesticide under section 18 
emergency exemption granted by EPA. The tolerance will expire and is 
revoked on the date specified in the following table:

                                                                        
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                                           Parts per      Expiration/   
                Commodity                   million     revocation date 
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Onions, dry bulb........................          0.2            1/31/99
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    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 98-2212 Filed 1-29-98; 8:45 am]
BILLING CODE 6560-50-F