[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Rules and Regulations]
[Pages 11789-11792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5960]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300796; FRL-6064-1]
RIN 2070-AB78


Maleic hydrazide; Extension of Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation extends time-limited tolerances for combined 
residues of the herbicide maleic hydrazide and its metabolites in or on 
rice, grain at 105 parts per million (ppm); rice, straw at 75 ppm; 
rice, hulls at 240 ppm; and rice, bran at 180 ppm. In addition, this 
rule extends time-limited tolerances for secondary residues in milk at 
1.0 ppm; at 2.5 ppm in meat, 7 ppm in liver, 32 ppm in kidney, and 3 
ppm in fat of cattle, goats, hogs, horses and sheep; at 0.5 ppm in 
meat, liver, and fat of poultry; 1.4 ppm in poultry meat byproducts; 
and 0.5 ppm in eggs. All of these time-limited tolerances are extended 
for an additional 1-year period. These tolerances will expire and are 
revoked on September 30, 2000. This action is in response to EPA's 
granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on rice. Section 408(l)(6) of the Federal Food, Drug, and 
Cosmetic Act 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 FIFRA section 18.

DATES: This regulation becomes effective March 10, 1999. Objections and 
requests for hearings must be received by EPA, on or before May 10, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300796], 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-300796], 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 (CM #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]. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of

[[Page 11790]]

electronic objections and hearing requests must be identified by the 
docket control number [OPP-300796]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Copies of 
electronic objections and hearing requests on this rule may be filed 
online at many Federal Depository Libraries.

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. 271, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9362, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of December 5, 1997 (62 FR 64287) (FRL-5754-5), which 
announced that on its own initiative under section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a and (l)(6), as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) it established time-limited tolerances for the combined residues 
of maleic hydrazide and its metabolites in or on rice, grain at 105 
ppm; rice, straw at 75 ppm; rice, hulls at 240 ppm; and rice, bran at 
180 ppm. In addition, this rule extends time-limited tolerances for 
secondary residues in milk at 1.0 ppm; at 2.5 ppm in meat, 7 ppm in 
liver, 32 ppm in kidney, and 3 ppm in fat of cattle, goats, hogs, 
horses and sheep; at 0.5 ppm in meat, liver, and fat of poultry; 1.4 
ppm in poultry meat byproducts; and 0.5 ppm in eggs, with an expiration 
date of September 30, 1998. EPA extended the expiration date of these 
tolerances to September 30, 1999 in a Federal Register notice published 
October 7, 1998 (63 FR 53815) (FRL-6034-8). EPA established the 
tolerances 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 FIFRA section 18. Such tolerances can be established 
without providing notice or period for public comment.
    EPA received a request to extend the use of maleic hydrazide on 
rice for this year growing season due to the continued emergency 
situation facing rice growers in Louisiana, Mississippi and Texas. 
After having reviewed the submissions, EPA concurs that emergency 
conditions exist. EPA has authorized under FIFRA section 18 the use of 
maleic hydrazide on rice for control of red rice in rice.
    EPA assessed the potential risks presented by residues of maleic 
hydrazide in or on rice and secondary residues in meat, milk, poultry 
and eggs. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. The data and other relevant material have 
been evaluated and discussed in the final rule of December 5, 1997 (62 
FR 64287) (FRL-5754-5). Based on that data and information considered, 
the Agency reaffirms that extension of the time-limited tolerances will 
continue to meet the requirements of section 408(l)(6). Therefore, the 
time-limited tolerances are extended for an additional 1-year period. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerances from the Code of Federal Regulations (CFR). Although 
these tolerances will expire and are revoked on September 30, 2000, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerances remaining in or on rice 
commodities, meat, milk, poultry and eggs 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 
tolerances. EPA will take action to revoke these tolerances 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 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 May 10, 1999, 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 under the ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, 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. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703) 305-5697, [email protected]. Requests for waiver of tolerance 
objection fees should be sent to James Hollins, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    If a hearing is 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.

[[Page 11791]]

II. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300796] (including any comments and data submitted 
electronically). 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 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].


    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit 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 record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

III. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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). 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 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).
    In addition, since tolerances and exemptions that are established 
under section 408(l)(6) of FFDCA, such as the tolerance/exemption in 
this final rule, do 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 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule 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.


[[Page 11792]]


    Dated: February 26, 1999.

Peter Caulkins,
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. 321(q), 346a and 371.

Sec. 180.175  [Amended]

    2. In Sec. 180.175, by amending the table in paragraph (b) for all 
of the commodities by changing the date ``9/30/99'' to read ``9/30/
00''.

[FR Doc. 99-5960 Filed 3-9-99; 8:45 am]
BILLING CODE 6560-50-F