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Sulfentrazone. December 10, 2004. Extension of Tolerances for Emergency Exemptions. FINAL RULE. Federal Register.

Docket ID number OPP-2004-0392.

Note from FAN:

There were 8 pesticides included in this Final Rule. We have excerpted information for Sulfentrazone only, which is:

Sulfentrazone. EPA has authorized under FIFRA section 18 the use of
sulfentrazone on lima beans and cowpeas for control of hophornbeam
copperleaf in Tennessee. This regulation extends a time-limited
tolerance for combined residues of the herbicide sulfentrazone and the
metabolites 3-hydroxymethyl sulfentrazone and 3-desmethyl sulfentrazone
in or on succulent bean seed without pod at 0.1 ppm for an additional
3-year period. This tolerance will expire and is revoked on December
31, 2007. A time-limited tolerance was originally published in the
Federal Register of September 21, 1999 (64 FR 51060) (FRL-6097-8).

Note: This FR of Sept 21, 1999, titled "Sulfentrazone; Pesticide Tolerances for Emergency Exemptions" stated:
-- Developmental toxicity studies - Rats: In EPA's oral developmental study in rats, the maternal (systemic) NOAEL was 25 mg/ kg/day, based on increased relative spleen weights and splenic extramedullary hematopoiesis at the LOAEL of 50 mg/kg/day. The developmental (fetal) NOAEL was 10 mg/kg/day, based on decreased mean fetal weight and retardation in skeletal development as evidenced by increased numbers of litters with any variation and by decreased numbers of caudal vertebral and metacarpal ossification sites at the LOEL of 25 mg/kg/day.
-- The developmental (fetal) NOAEL was 100 mg/kg/day, based on decreased fetal weight and increased fetal variations (hypoplastic or wavy ribs, incompletely ossified lumbar vertebral arches, incompletely ossified ischia or pubes, and reduced numbers of thoracic vertebral and rib ossification sites) at the LOAEL of 250 mg/kg/day.
-- Reproductive toxicity study -- Rats. In the 2-generation reproductive toxicity study in rats- The reproductive NOAEL was 14/16 mg/kg/day, based on: (a) Increased duration of gestation in both F1 and F2 dams; (b) decreased fertility in F1 generation (males); and/or (c) atrophy of the germinal epithelium of the testes, oligospermia and intratubular degeneration of the seminal product in the epididymis at the LOAEL of 33/40 mg/kg/day.
-- Chronic risk. RfD = 0.14 mg/kg/day. For chronic dietary risk assessment the Agency recommended use of the NOAEL of 14 mg/kg/day with an uncertainty factor of 100, based on:
(a) Decreased maternal body weight and/or body weight gain during gestation in both P and F1 generations;
(b) reduced premating body weight gains in the second generation (F1 adults);
(c) increased duration of gestation in both F1 and F2 dams;
(d) reduced prenatal viability (fetal and litter);
(e) reduced litter size;
(f) increased number of stillborn pups;
(g) reduced pup and litter postnatal survival;
(h) decreased pup body weights throughout lactation;
(i) decreased fertility in F1 generation males; and
(j) atrophy of the germinal epithelium of the testes, oligospermia and intratubular degeneration of the seminal product in the epididymis at the LOAEL of 33/44 mg/kg/day for males and females, respectively, from a 2-generation reproductive toxicity study in rats.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/December/Day-10/p27031.htm

[Federal Register: December 10, 2004 (Volume 69, Number 237)]
[Rules and Regulations]
[Page 71714-71717]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de04-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0392; FRL-7688-6]

Multiple Chemicals; Extension of Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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
(FIFRA) 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 December 10, 2004. Objections and
requests for hearings must be received on or before February 8, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit III. of the SUPPLEMENTARY

INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0392. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket . Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 South Bell St.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: See the table in this unit for the
name of a specific contact person. The following information applies to
all contact persons: Emergency Response Team, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
------------------------------------------------------------------------
Pesticide/CFR cite Contact person
------------------------------------------------------------------------
Azoxystrobin; 40 CFR 180.507; Libby Pemberton
Sec -18- Mailbox
(703) 308-9364
Cypermethrin; 40 CFR 180.418;
Desmedipham; 180.353;
Diuron; 40 CFR 180.106;
Propiconazole; 40 CFR 180.434;
Sodium chlorate 40 CFR 180.1020
-------------------------------------------
Sec -18- Mailbox
(703) 305-6463
-------------------------------------------
Sec -18- Mailbox
(703) 308-9367
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)

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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

II. Background and Statutory Findings

EPA published final rules in the Federal Register for each
chemical/commodity listed. 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 FIFRA section 18 . 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 section 408(b)(2) of the

[[Page 71715]]

FFDCA, and decided that the necessary tolerance under section 408(l)(6)
of the FFDCA 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) of the FFDCA. Therefore, the
time-limited tolerances are extended until the date listed. 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
section 408(l)(5) of the FFDCA, 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:

...

[[Page 71716]]

Sulfentrazone. EPA has authorized under FIFRA section 18 the use of
sulfentrazone on lima beans and cowpeas for control of hophornbeam
copperleaf in Tennessee. This regulation extends a time-limited
tolerance for combined residues of the herbicide sulfentrazone and the
metabolites 3-hydroxymethyl sulfentrazone and 3-desmethyl sulfentrazone
in or on succulent bean seed without pod at 0.1 ppm for an additional
3-year period. This tolerance will expire and is revoked on December
31, 2007. A time-limited tolerance was originally published in the
Federal Register of September 21, 1999 (64 FR 51060) (FRL-6097-8).

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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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 ID number OPP-2004-0392 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 January
10, 2005.

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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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) 564-6255.

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 20460-0001.
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 20460-0001.

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 ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0392, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211,

[[Page 71717]]

Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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 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 under section 408(l)(6)
of the FFDCA 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 section 408(n)(4) of the
FFDCA. 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 (59 FR 22951, 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. Congressional Review Act
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).

Dated: November 30, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

• 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. 180.106 [Amended] [Diuron]
• 2. In Sec. 180.106, in the table to paragraph (b), amend the entry for
``catfish fillets'' by revising the expiration date ``6/30/05'' to read
``6/30/08.''

Sec. 180.353 [Amended] [Desmedipham]
• 3. In Sec. 180.353, in the table to paragraph (b), amend the entry for
``red beet roots'' and ``red beet tops'' by revising the expiration
``6/30/05'' to read ``6/30/08.''

Sec. 180.418 [Amended] [Cypermethrin]
• 4. In Sec. 180.418, in the table to paragraph (b), amend the entries
for ``flax, meal'' and ``flax, seed'' by revising the expiration date
``6/30/2005'' to read ``6/30/2008.''

Sec. 180.434 [Amended] [Propiconazole]
• 5. In Sec. 180.434, in the table to paragraph (b), amend the entries
for ``grain, aspirated fractions;'' ``sorghum, grain, grain;'' and
``sorghum, grain, stover'' by revising the expiration date ``6/30/05'';
to read ``6/30/08.''

Sec. 180.443 [Amended] [Myclobutanil]
• 6. In Sec. 180.443, in the table to paragraph (b), amend the entry for
``beet, sugar, tops'' by revising the expiration date ``12/31/04'' to
read ``12/31/07''.

Sec. 180.498 [Amended] [SULFENTRAZONE]
• 7. In Sec. 180.498, in the table to paragraph (b), amend the entry for
``bean, succulent seed without pod (lima beans, cowpeas)'' by revising
the expiration date ``12/31/04'' to read ``12/31/07.''

Sec. 180.507 [Amended] [Azoxystrobin]
• 8. In Sec. 180.507. in the table to paragraph (b), amend the entry for
``safflower, seed'' by revising the expiration date ``6/30/05'' to read
``6/30/08.''

Sec. 180.1020 [Amended] [Sodium chlorate]
• 9. In subpart D, in Sec. 180.1020, in the table to paragraph (b),
amend the entry for ``wheat'' by revising the expiration date ``12/31/
04'' to read ``12/31/06.''

[FR Doc. 04-27031 Filed 12-9-04; 8:45 am]
BILLING CODE 6560-50-S