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Glyphosate; 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: June 10, 1998 (Volume 63, Number 111)]
[Rules and Regulations]
[Page 31631-31633]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn98-25]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300652; FRL 5788-4]
RIN 2070-AB78
Glyphosate; 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
Roundup Ultra and Roundup Ultra RT (Glyphosate [N-
(Phosphonomethyl)glycine) and its metabolites in or on dry peas,
lentils, and chickpeas at 5 part per million (ppm) for an additional 18
month, to February 29, 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 dry peas, lentils, and chickpeas. 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 June 10, 1998. Objections and
requests for hearings must be received by EPA, on or before August 10,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300652], must be submitted to: Hearing
Clerk (1900), Environmental Protection
[[Page 31632]]
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-300652], 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: 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: Jackie Gwaltney, 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. 274, CM#2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-6792; e-mail:
gwaltney.jackie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of August 11, 1997 (62 FR 42921) (FRL 5732-7), 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 Roundup Ultra and Roundup Ultra RT
(Glyphosate [N-(Phosphonomethyl)glycine) and its metabolites in or on
dry peas, lentils, and chickpeas at 5 ppm, with an expiration date of
February 29, 2000. 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.
In the final rule published on August 11, 1997 (62 FR 42921), EPA
stated that an emergency exemption had been granted to Idaho, Oregon
and Washington for use of glyphosate on dry peas, garbanzo beans
(chickpeas) and lentils. The final rule was intended to establish
tolerances for residues of glyphosate and its metabolites in or on all
of these commodities. All of the commodities, including chickpeas, were
included in EPA's assessment of the aggregate risk from exposure to
glyphosate and in the Agency's determination that there is a reasonable
certainty that no harm would result from such exposure. However, the
commodity garbanzo beans (chickpeas) and its tolerance of 5 ppm was
inadvertently omitted from the regulatory text. Therefore, in this
final rule EPA is also adding a tolerance of 5 ppm for chickpeas with
an expiration date of February 29, 2000 to the table at 40 CFR
180.346(b).
EPA received a request to extend the use of Roundup Ultra and
Roundup Ultra RT (Glyphosate [N-(Phosphonomethyl)glycine) on dry peas,
lentils, and chickpeas for this year growing season due to a
combination of weather and environmental conditions that encouraged the
excessive spread of Canada thistle. Canada thistle is a severe threat
to Eastern Washington dry peas, lentils, and chickpeas cropland. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this state. EPA has authorized under FIFRA section 18 the use
of Roundup Ultra and Roundup Ultra RT (Glyphosate [N-
(Phosphonomethyl)glycine) on dry peas, lentils, and chickpeas for
control of Canada thistle in dry peas, lentils, and chickpeas.
EPA assessed the potential risks presented by residues of Roundup
Ultra and Roundup Ultra RT (Glyphosate [N-(Phosphonomethyl)glycine) in
or on dry peas, lentils, and chickpeas. 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 August 11, 1997 (62 FR 42921) [(FRL 5732-7)]. 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 months. Although this tolerance will expire and is
revoked on August 30, 1998, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on dry peas, lentils, and chickpeas 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 August 10, 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 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
[[Page 31633]]
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 format. All copies of
objections and hearing requests in electronic form must be identified
by the docket control number [OPP-300652]. 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 tolerance that 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 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 reportcontaining 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 this 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: May 21, 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.
2. In Sec. 180.364, by revising paragraph (b) to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide glyphosate, per se
in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerances will expire and are revoked
on the dates specified in the following table.
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Expiration/
Commodity Parts per revocation
million date
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Cattle, kidney................................ 4 2/29/00
Chickpeas..................................... 5 2/29/00
Goats, kidney................................. 4 2/29/00
Horses, kidney................................ 4 2/29/00
Lentils....................................... 5 2/29/00
Pea, hay...................................... 200 2/29/00
Pea, vines.................................... 60 2/29/00
Peas, dry..................................... 5 2/29/00
Sheep, kidney................................. 4 2/29/00
Silage, hay................................... 90 2/29/00
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[FR Doc. 98-15327 Filed 6-9-98; 8:45 am]
BILLING CODE 6560-50-F