[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Rules and Regulations]
[Pages 49924-49927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20733]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].

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 [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-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: [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 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