[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Rules and Regulations]
[Pages 45885-45888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21830]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300907; FRL-6096-3]
RIN 2070-AB78
Buprofezin; Extension of Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation extends a time-limited tolerance for residues
of the insecticide buprofezin and its metabolites in or on tomatoes at
0.7 part per million (ppm) and tomato paste at 1.0 ppm for an
additional 2-year period, and citrus fruit at 2.0 ppm; dried citrus
pulp at 10 ppm; cotton seed at 1.0 ppm; cotton gin byproducts at 20
ppm; milk at 0.03 ppm; and cattle, sheep, hogs, goats, and horse meat
and fat at 0.02 ppm; and meat byproducts at 0.5 ppm for an additional
29-month period. These tolerances will expire and are revoked on
December 31, 2001. 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 tomatoes, citrus, and cotton. 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 August 23, 1999. Objections
and requests for hearings must be received by EPA, on or before October
22, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300907], 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-300907], 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@epa.gov. 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 electronic objections and hearing
requests must be identified by the docket control number [OPP-300907].
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: 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. 280, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367,
ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of August 5, 1998 (63 FR 41720)(FRL-6018-5), which
announced that on its own initiative under section 408(l)(6) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) it established a time-limited tolerance for the residues of
buprofezin and its metabolites in or on tomatoes at 0.7 ppm and tomato
paste at 1.0 ppm, with an expiration date of December 31, 1999. 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 FIFRA section 18. Such tolerances can be
established without providing notice or period for public comment.
EPA issued a final rule, published in the Federal Register of July
30, 1997 (63 FR 40735)(FRL-5732-1), which announced that on its own
initiative under section 408(1)(6), as amended by FQPA (Public Law 104-
170) it established time-limited tolerances for the residues of
buprofezin and its metabolites in or on citrus fruit at 2.0 ppm; dried
citrus pulp at 10 ppm; cotton seed at 1.0 ppm; cotton gin byproducts at
20 ppm; milk at 0.03 ppm; and cattle, sheep, hogs, goats, and horse
meat and fat at 0.02 ppm; and meat byproducts at 0.5 ppm; with an
expiration date of July 31, 1998. EPA subsequently published a final
rule in the Federal Register of June 19, 1998 (63 FR 33583) (FRL-5794-
7), extending these tolerances to expire on July 31, 1999. 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 buprofezin on tomatoes
for this year's growing season due to the continuation of the emergency
condition with silverleaf whiteflies. Silverleaf whitefly is a key pest
on tomatoes from the seedling stage through harvest in Florida year-
round in all production regions. High populations feeding on plants
cause irregular ripening, reducing fruit value. Whiteflies may also
transmit tomato mottle geminivirus (TMV) and tomato yellow leaf curl
virus (TYLCV) during feeding. TYLCV was discovered in tomatoes in
Florida in the summer of 1997 and is, therefore, a new pest-related
problem. Because whitefly is such a good vector of the virus and the
virus is so prevalent, only minimal infestations of whitefly are
required to transmit TYLCV to tomato plants. After having reviewed the
submission, EPA concurs that emergency conditions
[[Page 45886]]
exist. EPA has authorized under FIFRA section 18 the use of buprofezin
on tomatoes for control of silverleaf whiteflies in Florida.
EPA received a request to extend the use of buprofezin on citrus
for this year's growing season to control red scale, which has
developed resistance to available controls in some areas of California,
and has caused significant losses for affected growers; this situation
remains unchanged from that of last year. EPA also received requests
from California and Arizona to extend the use of buprofezin on cotton
for this year's growing season since the situation has remained the
same as last year; a recently-introduced new strain or species of
whitefly has caused significant losses to cotton growers and has
demonstrated resistance to available controls. After having reviewed
the submission, EPA concurs that emergency conditions exist for these
states. EPA has authorized under FIFRA section 18 the use of buprofezin
on citrus for control of red scale and on cotton for control of
whiteflies.
EPA assessed the potential risks presented by residues of
buprofezin in or on tomatoes, citrus and cotton. 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 rules of July 30, 1997 (62 FR 40735) and August 5, 1998 (63 FR
41720). Based on the 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
tolerances on tomatoes and tomato paste are extended for an additional
2-year period and the tolerances for citrus fruit, dried citrus pulp,
cotton seed, cotton gin byproducts, milk, and cattle, sheep, hogs,
goats, and horse meat, fat, and meat byproducts are extended for an
additional 29-month 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 December 31, 2001, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on tomatoes, tomato paste, citrus fruit,
dried citrus pulp, cotton seed, cotton gin byproducts, milk, and
cattle, sheep, hogs, goats, and horse meat, fat, and meat byproducts
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 October 22, 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, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. 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.
II. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300907] (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 Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
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
[[Page 45887]]
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) (Public Law 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 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.
Dated: August 11, 1999.
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. 321q, 346a and 371.
2. In Sec. 180.511, by revising the table in paragraph (b) to read
as follows:
Sec. 180.511 Buprofezin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Cattle, fat...................................... 0.02 12/31/01
Cattle, MBYP..................................... 0.5 12/31/01
Cattle, meat..................................... 0.02 12/31/01
Citrus fruit..................................... 2.0 12/31/01
Citrus, pulp, dried.............................. 10 12/31/01
Cotton seed...................................... 1.0 12/31/01
Cotton, gin byproducts........................... 20 12/31/01
Curcurbits....................................... 0.5 12/31/99
Goats, fat....................................... 0.02 12/31/01
Goats, MBYP...................................... 0.5 12/31/01
Goats, meat...................................... 0.02 12/31/01
Hogs, fat........................................ 0.02 12/31/01
Hogs, MBYP....................................... 0.5 12/31/01
[[Page 45888]]
Hogs, meat....................................... 0.02 12/31/01
Horses, fat...................................... 0.02 12/31/01
Horses, MBYP..................................... 0.5 12/31/01
Horses, meat..................................... 0.02 12/31/01
Milk............................................. 0.03 12/31/01
Sheep, fat....................................... 0.02 12/31/01
Sheep, MBYP...................................... 0.5 12/31/01
Sheep, meat...................................... 0.02 12/31/01
Tomatoes......................................... 0.7 12/31/01
Tomato paste..................................... 1.0 12/31/01
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[FR Doc. 99-21830 Filed 8-20-99; 8:45 am]
BILLING CODE 6560-50-F
