Propiconazole; Extension of Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: August 16, 2000 (Volume 65, Number 159)]
[Rules and Regulations]
[Page 49924-49927]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au00-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301036; FRL-6737-1]
RIN 2070-AB78


Propiconazole; Extension of Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for combined
residues of the fungicide propiconazole and its metabolites in or on
sorghum, grain, grain at 0.2 part per million (ppm); sorghum, grain,
stover at 1.5 ppm; sorghum, aspirated grain fractions at 20 ppm; dry
beans at 0.5 ppm; dry bean, forage at 8 ppm; dry bean, hay at 8 ppm;
and blueberries, cranberries and raspberries at 1.0 ppm. The sorghum
and cranberry tolerances are extended for an additional 17-month
period; the dry bean, raspberry, and blueberry tolerances are extended
for an additional 1-year period. All of 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 authorizing uses of the
pesticide on sorghum, dry beans, blueberries, cranberries, and
raspberries. 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 section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act.

DATES: This regulation is effective August 16, 2000. Objections and
requests for hearings, identified by docket control number OPP-301036,
must be received by EPA on or before October 16, 2000.

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-301036 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703-308-9362; and e-mail
address: schaible.stephen@epa.gov.

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 and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       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://

[[Page 49925]]

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/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301036. 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 issued a final rule, published in the Federal Register of
August 13, 1997 (62 FR 43284) (FRL-5735-2), which announced that on its
own initiative under section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-
limited tolerances for the combined residues of propiconazole and its
metabolites in or on sorghum, grain, grain at 0.2 ppm; sorghum, grain,
stover at 1.5 ppm; and sorghum, aspirated grain fractions at 20 ppm,
with an expiration date of July 31, 1998.
    EPA also issued a final rule, published in the Federal Register of
April 11, 1997 (62 FR 17710) (FRL-5600-5), which announced that on its
own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as
amended by the FQPA (Public Law 104-170) it established a time-limited
tolerance for the combined residues of propiconazole and its
metabolites in or on cranberries at 41.0 ppm, with an expiration date
of July 31, 1998. The tolerance level was corrected to be 1.0 ppm in
the Federal Register of May 2, 1997 (62 FR 24045) (FRL-5783-5).
    EPA additionally issued a final rule, published in the Federal
Register of June 13, 1997 (62 FR 32224) (FRL-5718-8), which announced
that on its own initiative under section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Public Law 104-170) it established time-
limited tolerances for the combined residues of propiconazole and its
metabolites in or on dry beans at 0.5 ppm; dry bean forage at 8 ppm and
dry bean hay at 8 ppm, with an expiration date of December 31, 1998.
    EPA also issued a final rule, published in the Federal Register of
January 20, 1999 (64 FR 2995) (FRL-6049-8), which announced that on its
own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as
amended by the FQPA (Public Law 104-170) it established time-limited
tolerances for the combined residues of propiconazole and its
metabolites in or on blueberries and raspberries at 1.0 ppm, with an
expiration date of December 31, 1999.
    EPA established these 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 FIFRA. Such tolerances
can be established without providing notice or period for public
comment.
    EPA received requests to extend the use of propiconazole on
blueberries and cranberries for this year's growing season due to the
continued emergency situation facing blueberry and cranberry growers
due to the cancellation of the fungicide triforine, which was the only
product registered to control cottonball disease in cranberries or
mummy berry disease in blueberries. Raspberry growers in Oregon and
Washington requested the use of propiconazole be extended due to wet
and mild weather conditions in the Pacific Northwest which result in
severe disease pressure from yellow rust. Disease pressure from sorghum
ergot and rust led the sorghum and dry bean growers, respectively, to
request the use of propiconazole on these crops. After having reviewed
these submissions, EPA concurs that emergency conditions exist for
these growers. EPA has authorized under FIFRA section 18 the use of
propiconazole on sorghum for control of sorghum ergot in Kansas,
Nebraska, New Mexico, Oklahoma and Texas; the use on dry beans for
control of rust in Kansas, Minnesota, and North Dakota; the use on
blueberries for control of mummy berry disease in Connecticut, Maine,
Massachusetts, New Hampshire, Rhode Island, and Washington; the use on
cranberries for control of cottonball disease in Washington and
Wisconsin; and the use of propiconazole on raspberries for control of
yellow rust in Oregon and Washington.
    EPA assessed the potential risks presented by residues of
propiconazole in or on the above commodities. 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 rules of April 17, 1997 (62 FR 17710) (FRL-5600-5), June 13, 1997
(62 FR 32224) (FRL-5718-8), August 13, 1997 (62 FR 43284) (FRL-5735-2),
and January 20, 1999 (64 FR 2995) (FRL-6049- 8). 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 for sorghum
and cranberries are extended for an additional 17-month period; the
time-limited tolerances for dry beans, blueberries and raspberries 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 December 31, 2001, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on blueberries; cranberries; raspberries;
dry beans; dry bean forage; dry bean hay; sorghum grain, sorghum grain,
grain; sorghum grain, stover; and sorghum aspirated grain fractions
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.

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

[[Page 49926]]

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-301036 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 October
16, 2000.
    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 tompkins.jim@epa.gov,
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 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-301036, 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: opp-docket@epa.gov. 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 extends 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 prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); 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 or any 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 on the basis of a FIFRA
section 18 petition under FFDCA section 408, 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

[[Page 49927]]

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).

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: August 4, 2000.
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), (346a) and 371.

Sec. 180.434  [Amended]

    2. In Sec. 180.434, amend the table in paragraph (b), by revising
the revocation/expiration date for ``Cranberries,'' ``Sorghum,
aspirated grain fractions,'' ``Sorghum, grain, grain,'' and ``Sorghum,
grain, stover'' from ``7/31/00'' to read ``12/31/01'' and by revising
the revocation/expiration date for ``Blueberries,'' ``Dry bean
forage,'' ``Dry bean hay,'' ``Dry beans,'' and ``Raspberries'' from
``12/31/00'' to read ``12/31/01''.
[FR Doc. 00-20733 Filed 8-15-00; 8:45 am]
BILLING CODE 6560-50-S
Propiconazole; Extension of Tolerances for Emergency Exemptions

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