[Federal Register Volume 65, Number 139 (Wednesday, July 19, 2000)]
[Rules and Regulations]
[Pages 44696-44699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18096]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301012; FRL-6594-1]
RIN 2070-AB78


Azoxystrobin or Methyl (E)-2-[2-[6-(-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances forcombined 
residues of the fungicide azoxystrobin or methyl (E)-2-[2-[6-(-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3- and its metabolites in or on 
strawberries at 10.0 parts per million (ppm), soybean forage at 0.2 
ppm, soybean hay at 1.0 ppm, soybean hulls at 2.0 ppm, soybean meal at 
0.3 ppm, soybean oil at 2.0 ppm, soybean seed at 0.1 ppm, soybean 
silage at 2.0 ppm, and sugar beet roots at 0.05 ppm, sugar beet, 
molasses at 0.70 ppm, and sugar beet, pulp, dried at 1.0 ppm, and sugar 
beet refined sugar at 0.70 ppm for an additional 18 month period. These 
tolerances will expire and are revoked on December 30, 2001. 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 strawberries, soybeans, and sugar 
beets. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act 
requires EPA to establish a time-limited tolerance or exemptionfrom 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 July 19, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301012, 
must be received by EPA on or before September 18, 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-301012 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jackie Mosby-Gwaltney, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6792; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 44697]]

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
           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'' 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-301012. 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 
ofJanuary 29, 1999 (64 FR 4572) (FRL-6050-6), 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 a 
time-limited tolerance for the combined residues of azoxystrobin or 
methyl (E)-2-[2-[6-(-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3- and its 
metabolites inor on strawberries at 10.0 ppm, soybean forage at 0.2 
ppm, soybean hay at1.0 ppm, soybean hulls at 2.0 ppm, soybean meal at 
0.3 ppm, soybean oil at 2.0 ppm, soybean seed at 0.1 ppm, soybean 
silage at 2.0 ppm, and sugar beet roots at 0.05 ppm, sugar beet, 
molasses at 0.70 ppm, and sugar beet, pulp, dried at 1.0 ppm, and sugar 
beet refined sugar at 0.70 ppm with an expiration date of December 30, 
2001. 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 
infood 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 period for public comment.
    EPA received a request to extend the use of azoxystrobin or methyl 
(E)-2-[2-[6-(-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3- on strawberries 
for this year's growing season because the Florida Department of 
Agriculture and Consumer Services requested an emergency exemption on 
September 28, 1998, for the control of anthracnose on strawberries. 
Anthracnose adversely affect the plants in a variety of ways. It can 
cause plant losses (crown rot, root rot, anthracnose of the stolon and 
petiole, but rot, and leaf spots) and fruit losses (anthracnose fruit 
rot and flower blight). There are several fungicides currently labeled 
for use on Florida grown strawberries. These include:Ridomil, Rovral, 
Captan, Sulfur, Aliette, Copper, Benlate, and Topsin. Of all these 
products, only two have demonstrated efficacy toward anthracnose: 
Benlalte and Captan. An experiment conducted by the University of 
Florida demonstrates the lack of efficacy of both products last season. 
Thus, both products have only limited utility against anthracnose.
    The two factors that have brought about this emergency condition 
include variety shift and lack of efficacy of previously effective 
fungicides. No single variety has all the desirable characteristics. 
Among these desirable characteristics important to Florida growers are: 
season-long production, early and late production, disease resistance, 
insect and mite resistance, etc. After having reviewed the submission, 
EPA concurs that emergency conditions exist. EPA has authorized under 
FIFRA section 18 the use of azoxystrobin or methyl (E)-2-[2-[6-(-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3- on strawberries for control 
of anthracnose disease in strawberries.
    EPA also received requests to extend the use of azoxystrobin or 
methyl (E)-2-[2-[6-(-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3- on 
soybean, and sugar beets for this year's growing season because the 
Minnesota Department of Agriculture requested an emergency exemption in 
April of 1998, for the control of cercospora leafspots on sugar beets. 
The registered alternative fungicides benomyl, thiabendazole 
thiophanate methyl, triphenyltin hydroxide, EBDCs (Mancozeb and Meneb), 
and copper hydroxide for controlling cercospora leaf spots do not 
control the disease effectively because of resistance and/ortolerance 
in the pathogen. Moderately resistant cultivars of sugar beet are 
available, but their yield potentials are lower than the susceptible. 
Cultural practices are not very effective in managing the disease. 
During 1998, the disease severity is expected to be higher and yield 
losses significant due to mild winter temperature (El Nino effects).
    Minnesota also claims that triphenyl tin hydroxide (TPTH) is still 
used in controlling the disease, but it is significantly less effective 
than in the past.
    In August 1998, the Arkansas Department of Agriculture also 
requested anemergency exemption for the control of aerial blight on 
soybeans. The disease is particularly aggressive in years of above-
normal night temperatures, high humidity, and

[[Page 44698]]

frequent rainfall. Conditions in 1998, have been near perfect for 
development of sheath blight of rice, with night temperatures in the 
78-82 range and oppressively high relative humidity within crop 
canopies. Rainfall in northeast Arkansas has also contributed to 
theproblem. Soybean has just entered the most susceptible flowering and 
early pod formation stages and aerial blight has become exceptionally 
aggressive as weather conditions continue to favor its development. 
Damage to soybean yield is through destruction of foliage, and to a 
greater extent-flowers, pods and seeds. Yield losses in some Arkansas 
field in the past have been estimated as high as 50%, however, this is 
a very rare occurrence most years.
    EPA assessed the potential risks presented by residues of 
azoxystrobin ormethyl (E)-2-[2-[6-(-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3- in or on strawberries,soybeans, and sugar beets. 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 January 29, 1999 (64 FR 4572) for 
strawberries, and November 25, 1998 (63 FR 65078) (FRL-6045-4) for 
soybeans, and sugar beets. 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. EPA will publish a document in the Federal Register to 
remove the revoked tolerance from the Code of Federal Regulations 
(CFR). Although this tolerance will expire and is revoked on December 
30, 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 
strawberries, soybeans, and sugar beets 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.

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-301012 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 September 
18, 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 [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 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-301012, 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.

[[Page 44699]]

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 a time-limited exemption from the 
tolerance requirement 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 exemption 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).

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: June 29, 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), 346(a) and 371.

Sec. 180.507  [Amended]

    2. In Sec. 180.507, by amending the table in paragraph (b), by 
revising the expiration/revocation date for the following commodities: 
``Strawberries'' from ``7/30/00'' to read ``12/30/01'' and ``Soybean 
forage,'' ``Soybean hay,'' ``Soybean hulls,'' ``Soybean meal,'' 
``Soybean oil,'' ``Soybean seed,'' ``Soybean silage,'' ``Sugar beet 
roots,'' ``Sugar beet tops,'' ``Sugar beets molasses'', ``Sugar beet, 
pulp, dried'' and ``Sugar beet, refined sugar'' from     ``6/30/00'' to 
read ``12/30/01''.

[FR Doc. 00-18096 Filed 7-18-00; 8:45 am]
BILLING CODE 6560-50-F