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Metolachlor; Extension of Tolerance for Emergency Exemptions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 2, 1998 (Volume 63, Number 231)]
[Rules and Regulations]
[Page 66435-66437]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de98-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300746; FRL-6038-4]
RIN 2070-AB78
Metolachlor; 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
herbicide metolachlor and its metabolites in or on spinach at 0.3 parts
per million (ppm) for an additional 18-month period, to May 15, 2000.
This action is in response to EPA's granting of an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of the pesticide on spinach. 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 December 2, 1998. Objections
and requests for hearings must be received by EPA, on or before
February 1, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300746], 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-300746], 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
[[Page 66436]]
may also be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. 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: Andrew Ertman, 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. 272, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9367; e-
mail: ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of November 29, 1996 (61 FR 60617-60622) (FRL-5574-7),
which announced that on its own initiative 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 metolachlor and its metabolites in or on
spinach at 0.3 ppm, with an expiration date of November 15, 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 metolachlor on spinach
for this year growing season due to the loss of the product Antor 4E
(diethatyl ethyl), an herbicide used on spinach. Antor is no longer
manufactured, and the remaining stocks of Antor have been exhausted
since 1993.
Spinach growers produce spinach on highly drained organic muck
soils. Presently there is no pre-emergence herbicide registered to
control annual grasses and certain broadleaf weeds in spinach. Without
a pre-emergence herbicide, it is doubtful that germinating spinach seed
will be able to compete with weeds for space, light, nutrients, and
water, thus making it economically unfeasible to produce and process
spinach. Alternative control practices consisting of field selection
and hand hoeing will not solve weed control problems that exist in
spinach due to the loss of Antor. Applicants claim that without the use
of metolachlor growers will suffer significant economic losses. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this state. EPA has authorized under FIFRA section 18 the use
of metolachlor on spinach for control of broadleaf weeds.
EPA assessed the potential risks presented by residues of
metolachlor in or on spinach. In doing so, EPA considered the 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
safety standard and with FIFRA section 18. The data and other relevant
material have been evaluated and discussed in the final rule of
November 29, 1996. 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 18-month period.
Although this tolerance will expire and is revoked on May 15, 2000,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on spinach
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 February 1, 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 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 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:
opp-docket@epamail.epa.gov.
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 5.1/6.1 or ASCII file
[[Page 66437]]
format. All copies of objections and hearing requests in electronic
form must be identified by the docket control number [OPP- 300746]. 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
A. Certain Acts and Executive Orders
This final rule extends a time-limited tolerance that was
previously established by EPA under FFDCA section 408 (l)(6). 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.
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 to 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 to 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.
Dated: October 15, 1998.
James Jones,
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.
Sec. 180.368 [Amended]
2. Section 180.368, by amending paragraph (b), by revising the date
for the commodity ``spinach'' from ``11/15/98'' to read ``5/15/00.''
[FR Doc. 98-32002 Filed 12-01-98; 8:45 am]
BILLING CODE 6560-50-F