[Federal Register Volume 66, Number 101 (Thursday, May 24, 2001)]
[Rules and Regulations]
[Pages 28668-28672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12901]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301124; FRL-6782-1]
RIN 2070-AB78
Extension of Tolerances for Emergency Exemptions (Multiple
Chemicals)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation extends time-limited tolerances for the
pesticides listed in Unit II. of the SUPPLEMENTARY INFORMATION. These
actions are in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of these pesticides. 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.
DATES: This regulation is effective May 24, 2001. Objections and
requests for hearings, identified by docket control number OPP-301125,
must be received by EPA on or before June 25, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit III. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301125 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: See the listing below for the name of
a specific contact person. The following mailing address and telephone
number apply to all contact persons: Emergency Response Team,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-9366.
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Pesticide CFR cite Contact person E-mail
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Diuron 40 CFR 180.106 Shaja R. Brothers [email protected]
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Terbacil 40 CFR 180.209 Beth Edwards [email protected]
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Hydramethylnon 40 CFR 180.395 Libby Pemberton [email protected]
Clopyralid 40 CFR 180.431
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Imidacloprid 40 CFR 180.472 Andrew Ertman [email protected]
Spinosad 40 CFR 180.495
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[[Page 28669]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories
------------------------------------------------------------------------
Examples of
Categories NAICS codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180 _00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301125. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA published final rules in the Federal Register for each
chemical/commodity listed below. The initial issuance of these final
rules announced that EPA, on its own initiative, under section 408 of
the FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection
Act of 1996 (FQPA) (Public Law 104-170) was establishing time-limited
tolerances.
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 section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be
established without providing notice or time for public comment.
EPA received requests to extend the use of these chemicals for this
year's growing season. After having reviewed these submissions, EPA
concurs that emergency conditions exist. EPA assessed the potential
risks presented by residues for each chemical/commodity. 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 originally published to support these uses.
Based on that data and information considered, the Agency reaffirms
that extension of these time-limited tolerances will continue to meet
the requirements of section 408(l)(6). Therefore, the time-limited
tolerances are extended until the date listed below. 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 the date listed, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on the commodity after that
date will not be unlawful, provided the residue is present as a result
of an application or use of a pesticide at a time and in a manner that
was lawful under FIFRA, the tolerance was in place at the time of the
application, and the residue does not exceed the level that was
authorized by the tolerance. 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.
Tolerances for the use of the following pesticide chemicals on
specific commodities are being extended:
1. Diuron. EPA has authorized under FIFRA section 18 the use of
diuron, in catfish ponds for control of blue green algae in Arkansas
and Mississippi. This regulation extends a time-limited tolerance for
combined residues of the herbicide, diuron (3-(3,4-dichlorophenyl)-1,1-
dimethylurea) and its metabolites convertible to 3,4-dichloroaniline in
or on catfish fillets at 2.0 ppm for an additional 2-year period. This
tolerance will expire and is revoked on June 30, 2003. A time-limited
tolerance was originally published in the Federal Registeron July 30,
1999 (64 FR 41297) (FRL-6087-2).
2. Terbacil. EPA has authorized under FIFRA section 18 the use of
terbacil on watermelon for control of weeds in Delaware, Maryland, and
Virginia. This regulation extends a time-limited tolerance for residues
of the herbicide terbacil (3-tert-butyl-5-chloro-6-methyluracil) and
its metabolites 3-tert-
[[Page 28670]]
butyl-5-chloro-6-hydroxymethyluracil, 6-chloro-2,3-dihydro-7-
hydroxymethy 3,3-dimethyl-5H oxazolo (3,2-a) pirimidin-5-one, and - 6-
chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one),
calculated as terbacil in or on watermelon at 0.4 ppm for an additional
2-year, 1-month period. This tolerance will expire and is revoked on
June 30, 2003. A time-limited tolerance was originally published in the
Federal Register on June 20, 1997 (62 FR 33557) (FRL-6080-5).
3. Hydramethylnon. EPA has authorized under FIFRA section 18 the
use of hydramethynon on pineapple for control of big-headed and
Argentine ants in Hawaii. This regulation extends a time-limited
tolerance for residues of the insecticide hydramethylnon; tetrahydro-
5,5-dimethyl-2-(1H)-pyrimidinoine (3-(4-trifluoromethyl)phenyl)-1-[2-
[4(trifluoromethyl)phenyl]ethenyl)-2-propenylidene) hydrazone in or on
pineapple at 0.05 ppm for an additional 2-year, 1-month period. This
tolerance will expire and is revoked on June 30, 2003. A time-limited
tolerance was originally published in the Federal Register on March 4,
1998 (63 FR 10537) (FRL-5767-1).
4. Clopyralid. EPA has authorized under FIFRA section 18 the use of
clopyralid on canola for control of Canada thistle and perennial
sowthistle in Minnesota, Montana, and North Dakota. This regulation
extends a time-limited tolerance for residues of the herbicide
clopyralid in or on canola at 3 ppm for an additional 1-year, 11-month
period. This tolerance will expire and is revoked on June 30, 2003. A
time-limited tolerance was originally published in the Federal Register
on May 16, 1997 (62 FR 26949) (FRL-5718-2).
5. Imidacloprid--Blueberries. EPA has authorized under FIFRA
section 18 the use of imidacloprid on blueberries for control of
oriental beetles and blueberry aphids in New Jersey. This regulation
extends a time-limited tolerance for combined residues of the
insecticide imidacloprid; (1-6-chloro-3-pyridinyl)methyl-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent in or on blueberries at 1.0 ppm for an
additional 2-year, 1-month period. This tolerance will expire and is
revoked on June 30, 2003. A time-limited tolerance was originally
published in the Federal Register on July 21, 1999 (64 FR 39041) (FRL-
6088-3).
6. Spinosad. EPA has authorized under FIFRA section 18 the use of
spinosad on cranberries for control of sparganothis fruitworm in
Massachusetts. This regulation extends a time-limited tolerance for
residues of the insecticide spinosad; Spinosyn A (Factor A; CAS
#131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl--L-
manno-pyranosyl)oxy-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2, 3, 3a, 5a, 5b, 6, 9, 10, 11, 12, 13, 14,
16a, 16b- tetradecahydro-14-methyl-1H-as-indaceno[3,2-doxacyclododecin-
7,15-dione; and Spinosyn D (Factor D; CAS #131929-63-0) or 2-(6-deoxy-
2,3,4-tri-O-methyl--L-manno-pyranosyl)oxy-13[[-5-
(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2, 3,
3a, 5a, 5b, 6, 9, 10, 11, 12, 13, 14, 16a, 16b-tetradecahydro 4,14-
methyl-1H-as-indaceno[3,2]-doxacyclododecin-7, 15-dione in or on
cranberries at 0.02 ppm for an additional 2-year, 1-month period. This
tolerance will expire and is revoked on June 30, 2003. A time-limited
tolerance was originally published in the Federal Register on July 21,
1999 (64 FR 39053) (FRL-6086-7).
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301125 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before June 25,
2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
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 the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental
[[Page 28671]]
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit III.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301125, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IV. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under FFDCA
section 408. 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 under 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 or
any other Agency action under Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established under FFDCA section 408(l)(6) in
response to an exemption under FIFRA section 18, such as the tolerances
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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
V. 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 this final rule in the Federal Register. This final
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 2, 2001.
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. 321(q), 346(a) and 371.
Sec. 180.106 [AMENDED]
2. In Sec. 180.106(b), amend the table entry for catfish fillets by
revising the
[[Page 28672]]
expiration date ``6/30/01'' to read ``6/30/03''.
Sec. 180.209 [AMENDED]
3. In Sec. 180.209(b), amend the table entry for watermelon by
revising the expiration date ``5/30/01'' to read ``6/30/03''.
Sec. 180.395 [AMENDED]
4. In Sec. 180.395(b), amend the table entry for pineapple by
revising the expiration date ``5/30/01'' to read ``6/30/03''.
Sec. 180.431 [AMENDED]
5. In Sec. 180.431(b), amend the table entry for canola by revising
the expiration date ``7/31/01'' to read ``6/30/03.''
Sec. 180.472 [AMENDED]
6. In Sec. 180.472(b), amend the table entry for cranberries by
revising the expiration date ``06/01/01'' to read ``6/30/03.''
Sec. 180.495 [AMENDED]
7. In Sec. 180.495(b), amend the table entry for cranberries by
revising the expiration date ``06/01/01'' to read ``6/30/03.''
[FR Doc. 01-12901 Filed 5-23-01; 8:45 am]
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