2-amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one (PP796); Exemption from the Requirement of a Tolerance, 46428-46431 [05-15837]
Download as PDF
46428
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
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
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 (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VIII. Congressional Review Act
Dated: July 27, 2005.
James Jones,
Director, Office of Pesticide Programs.
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 05–15523 Filed 8–9–05; 8:45 am]
I
Therefore, 40 CFR chapter I is
amended as follows:
BILLING CODE 6560–50–S
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.610 is added to subpart
C to read as follows:
I
§ 180.610 Aminopyralid; tolerances for
residues.
(a ) General. (1) Tolerances are
established for free and conjugated
residues of the herbicide, aminopyralid
(2-pyridine carboxylic acid, 4-amino3,6-dichloro-) calculated as
aminopyralid in or on:
Commodity
Parts per million
Grass, forage ........
Grass, hay ............
Wheat, bran ..........
Wheat, forage .......
Wheat, grain .........
Wheat, hay ...........
Wheat, straw .........
Aspirated grain
fractions .............
25
50
0.1
2.0
0.04
4.0
0.25
0.2
(2) Tolerances are established for
residues of the herbicide aminopyralid
in or on:
Commodity
Parts per million
List of Subjects in 40 CFR Part 180
Cattle, fat ..............
Cattle, meat ..........
Cattle, meat byproducts, excluding kidney ..........
Cattle, kidney ........
Goat, fat ................
Goat, meat ............
Goat, meat byproducts, excluding
kidney ................
Goat, kidney .........
Horse, fat ..............
Horse, meat ..........
Horse, meat byproducts, excluding kidney ..........
Horse, kidney ........
Milk .......................
Sheep, fat .............
Sheep, meat .........
Sheep, meat byproducts, excluding kidney ..........
Sheep, kidney .......
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
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).
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[OPP–2005–0141; FRL–7728–1]
2-amino-4,5-dihydro-6-methyl-4-propyls-triazolo(1,5-alpha)pyrimidin-5-one
(PP796); Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation amends the
established exemption from the
requirement of a tolerance under 40 CFR
180.1065 for 2-amino-4,5-dihydro-6methyl-4-propyl-s-triazolo(1,5alpha)pyrimidin-5-one, which is also
known as ‘‘PP796’’, by increasing the
amount that can be used to not more
than 0.3 percent in formulation of
paraquat dichloride. Syngenta Crop
Protection submitted a pesticide
petition ((PP) 5E6929) requesting this
amendment.
This regulation is effective
August 10, 2005. Objections and
requests for hearings must be received
on or before October 11, 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
identification (ID) number OPP–2005–
0141. 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., Confidential
Business Information (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 S. 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.
DATES:
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Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0404; e-mail address:
angulo.karen@epa.gov.
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 code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 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
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of June 30,
2005 (70 FR 37847) (FRL–7719–4), EPA
issued a notice pursuant to section
408(d)(3) of the Federal Food Drug and
Cosmetic Act (FFDCA), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 5E6929)
by Syngenta Crop Protection, P.O Box
18300, Greensboro, NC 27419–8300 for
2-amino-4,5-dihydro-6-methyl-4-propyls-triazolo(1,5-alpha)pyrimidin-5-one,
which is also known as ‘‘PP796’’. This
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Jkt 205001
notice included a summary of the
petition prepared by the petitioner. The
petition requested that the established
exemption from the requirement of a
tolerance under 40 CFR 180.1065 be
amended by increasing the amount of
PP796 that can be used to not more than
0.3 percent in formulation of paraquat
dichloride. No substantive comments
were received in response to the notice
of filing.
Section 408(c)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of the FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take into account the factors set
forth in section 408(b)(2)(C), which
require EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
residue in establishing a tolerance and
to ‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue. . . .’’ Additionally, section
408(b)(2)(D) of the FFDCA requires that
the Agency consider ‘‘available
information concerning the cumulative
effects of a particular pesticide’s
residues’’ and ‘‘other substances that
have a common mechanism of toxicity.’’
The existing tolerance exemption
under 40 CFR 180.1065 allows for the
use of PP796 as an emetic at not more
than 0.1 percent in formulation of
paraquat dichloride. In the Federal
Register Notice (November 12, 1981; 46
FR 55725) that established this
exemption, EPA stated the following in
its Basis for Approval: ‘‘This exemption
is justified because the severe health
hazard associated with oral ingestion of
paraquat allows for efforts to advance
any opportunity to reduce retention of
accidentally ingested paraquat
formulations. Also, any possible adverse
effect of PP796 (the inert emetic) is
minimal in comparison to the
irreversible severe consequences of
paraquat ingestion. Based on the above
information, and review of its use, it has
been found that, when used in
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46429
accordance with good agricultural
practices, this ingredient is useful and
does not pose a hazard to humans or to
the environment.’’
According to EPA’s Reregistration
Eligibility Decision (RED; 1997) for
paraquat dichloride, since 1988 the
manufacturer of paraquat dichloride has
added the emetic PP796 (a substance
that induces vomiting), a stenching
agent, and blue dye in an effort to
prevent accidental and intentional
ingestions from occurring. The RED
stated that ‘‘U.S. Poison Control Center
data show a decline of almost 50
percent when comparing the proportion
of all pesticide exposures due to
paraquat ingestion for the four years
pre- and post 1988.’’
According to the RED, paraquat
dichloride is a restricted use herbicide
currently registered to control weeds
and grasses in many agricultural and
non-agricultural areas. The RED states
there are no residential or other nonoccupational uses of paraquat
dichloride, and exposure to paraquat
dichloride in drinking water is not
expected. Therefore, exposure to PP796
from applications of paraquat dichloride
are not expected from residential/nonoccupational and drinking water
sources. A substantial increase in
dietary risk is not anticipated from this
small raise of the allowable percentage
of the emetic PP796 from 0.1 to 0.3 in
formulation of paraquat dichloride.
Therefore, the Agency has determined
that there is a reasonable certainty that
no harm to any population subgroup
will result from aggregate exposure
when considering dietary exposure and
all other non-occupational sources of
pesticide exposure for which there is
reliable information. Also, the health
benefits of including an emetic in
paraquat dichloride formulations as
stated in the 1981 Federal Register
Notice (46 FR 55725) are reaffirmed
here. In addition, the RED states
paraquat dichloride does not pose a
hazard to the environment. This small
increase in the allowable amount of
PP796 is also not expected to pose a
hazard to the environment.
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as
amended by the Food Quality Protection
Act of 1996 (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
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Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
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 ID number
OPP–2005–0141 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 11, 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 issue(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 14th 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. 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
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13:34 Aug 09, 2005
Jkt 205001
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0141, 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 ADDRESSES. You
may also send an electronic copy of
your request via e-mail to: oppdocket@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 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
issue(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 an
exemption from the tolerance
requirement under FFDCA section
408(d) in response to a petition
submitted to the Agency. 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, 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
PO 00000
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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 on the basis of a petition
under FFDCA section 408(d), 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. The Agency hereby
certifies that this rule will not have
significant negative economic impact on
a substantial number of small entities.
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,
entitledFederalism(64 FR 43255, August
10, 1999). Executive Order 13132
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by State and local officials
in the development of regulatory
policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’ This
final rule directly regulates growers,
food processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has
determined that this rule does not have
any ‘‘tribal implications’’ as described
in Executive Order 13175, entitled
Consultation and Coordination with
E:\FR\FM\10AUR1.SGM
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Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
V. 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).
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 1, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1065 is revised to read
as follows:
I
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13:34 Aug 09, 2005
Jkt 205001
§ 180.1065 2-Amino-4,5-dihydro-6-methyl4-propyl-s-triazolo(1,5-alpha)pyrimidin-5one; exemption from the requirement of a
tolerance.
The inert ingredient, 2-amino-4,5dihydro-6-methyl-4-propyl-striazolo(1,5-alpha)pyrimidin-5-one is
exempted from the requirement of a
tolerance when used as an emetic at not
more than 0.3 percent in formulations of
paraquat dichloride. Further restrictions
on this exemption are that this
ingredient may not be advertised as an
emetic and the paraquat product may
not be promoted in any way because of
the inclusion of this inert ingredient.
[FR Doc. 05–15837 Filed 8–9–05; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Parts 571 and 586
[Docket No. NHTSA–2005–21330]
RIN 2127–AJ64
Federal Motor Vehicle Safety
Standards; Fuel System Integrity
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation.
ACTION: Final rule; response to petitions
for reconsideration.
AGENCY:
This document responds to a
petition for reconsideration from
DaimlerChrysler Corporation of a final
rule relating to the agency’s upgrade of
rear and side impact tests in Federal
Motor Vehicle Safety Standard No. 301,
Fuel System Integrity. Among other
matters, that final rule provided
manufacturers of vehicles with a gross
vehicle weight rating greater than 2,722
kilograms (6,000 pounds) an additional
year of lead time to certify their vehicles
to the amended side impact
requirements, but did not provide for a
phase-in of those requirements for those
vehicles. On reconsideration, NHTSA is
providing manufacturers of those
vehicles a two year phase-in for the side
impact requirements. Ninety percent of
the vehicles manufactured on or after
September 1, 2005 must meet the
upgraded side impact requirements,
with 100 percent of the vehicles
manufactured on or after September 1,
2006 meeting the requirements.
DATES: Effective date: The amendments
made in this rule are effective August
10, 2005. Petitions for reconsideration
must be received by September 26,
2005, and should refer to this docket
SUMMARY:
PO 00000
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46431
and the notice number of this
document.
ADDRESSES: Petitions for reconsideration
must be sent to: Administrator, National
Highway Traffic Safety Administration,
400 Seventh St., SW., Washington, DC
20590.
FOR FURTHER INFORMATION CONTACT: For
non-legal issues, you may contact Mr.
Tewabe Asebe, Office of
Crashworthiness Standards, by
telephone at (202) 366–2365, or by fax
at (202) 366–7002. For legal issues, you
may contact Ms. Deirdre Fujita, Office of
Chief Counsel, at (202) 366–2992
(telephone), or at (202) 366–3820 (fax).
You may send mail to these officials at
the National Highway Traffic Safety
Administration, 400 Seventh St., SW.,
Washington, DC 20590.
SUPPLEMENTARY INFORMATION:
Background
To provide occupant protection from
exposure to fire that result from fuel
spillage during and after crashes,
Federal Motor Vehicle Safety Standard
(FMVSS) No. 301 (49 CFR 571.301)
specifies performance requirements for
the fuel systems of vehicles with a gross
vehicle weight rating (GVWR) of 4,536
kilograms (kg) or less (10,000 pounds
(lb) or less). The standard limits the
amount of fuel spillage from vehicles
during and after frontal, rear, and side
impact tests.
a. December 2003 Final Rule
In December 2003, NHTSA upgraded
both the rear impact and lateral (side)
impact test requirements in FMVSS No.
301 to increase safety and provide for
more realistic testing of fuel systems (68
FR 67068, December 1, 2003, Docket
16523). The December 2003 upgrade
established an offset rear impact test
procedure that specifies striking the rear
of the test vehicle at 50 miles per hour
(mph) (80 ± 1 kilometers per hour (km/
h)) with a 1,368 kg (3,015 lb) deformable
barrier at a 70 percent overlap with the
test vehicle. The rear impact test
replaced a 30 mph (48 km/h) crash test
that had used a 1,814 kg (4,000 lb) rigid
moving barrier. The upgrade of the
standard’s side impact test requirements
replaced a lateral 20 mph (32 km/h)
crash test with the side impact crash test
specified in FMVSS No. 214, ‘‘Side
impact protection.’’ FMVSS No. 214’s
test specifies that the test vehicle is
impacted at 33 ± 0.6 mph (53 ± 1 km/
h) with a 1,368 kg (3,015 lb) deformable
barrier.
The final rule provided manufacturers
three years of lead time to meet the
upgraded rear impact test, followed by
a three year phase-in beginning
E:\FR\FM\10AUR1.SGM
10AUR1
Agencies
[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46428-46431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15837]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0141; FRL-7728-1]
2-amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-
alpha)pyrimidin-5-one (PP796); Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the established exemption from the
requirement of a tolerance under 40 CFR 180.1065 for 2-amino-4,5-
dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one, which
is also known as ``PP796'', by increasing the amount that can be used
to not more than 0.3 percent in formulation of paraquat dichloride.
Syngenta Crop Protection submitted a pesticide petition ((PP) 5E6929)
requesting this amendment.
DATES: This regulation is effective August 10, 2005. Objections and
requests for hearings must be received on or before October 11, 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
identification (ID) number OPP-2005-0141. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
Confidential Business Information (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 S. 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.
[[Page 46429]]
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.
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 code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 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 (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of June 30, 2005 (70 FR 37847) (FRL-7719-
4), EPA issued a notice pursuant to section 408(d)(3) of the Federal
Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing
the filing of a pesticide tolerance petition (PP 5E6929) by Syngenta
Crop Protection, P.O Box 18300, Greensboro, NC 27419-8300 for 2-amino-
4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one,
which is also known as ``PP796''. This notice included a summary of the
petition prepared by the petitioner. The petition requested that the
established exemption from the requirement of a tolerance under 40 CFR
180.1065 be amended by increasing the amount of PP796 that can be used
to not more than 0.3 percent in formulation of paraquat dichloride. No
substantive comments were received in response to the notice of filing.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
The existing tolerance exemption under 40 CFR 180.1065 allows for
the use of PP796 as an emetic at not more than 0.1 percent in
formulation of paraquat dichloride. In the Federal Register Notice
(November 12, 1981; 46 FR 55725) that established this exemption, EPA
stated the following in its Basis for Approval: ``This exemption is
justified because the severe health hazard associated with oral
ingestion of paraquat allows for efforts to advance any opportunity to
reduce retention of accidentally ingested paraquat formulations. Also,
any possible adverse effect of PP796 (the inert emetic) is minimal in
comparison to the irreversible severe consequences of paraquat
ingestion. Based on the above information, and review of its use, it
has been found that, when used in accordance with good agricultural
practices, this ingredient is useful and does not pose a hazard to
humans or to the environment.''
According to EPA's Reregistration Eligibility Decision (RED; 1997)
for paraquat dichloride, since 1988 the manufacturer of paraquat
dichloride has added the emetic PP796 (a substance that induces
vomiting), a stenching agent, and blue dye in an effort to prevent
accidental and intentional ingestions from occurring. The RED stated
that ``U.S. Poison Control Center data show a decline of almost 50
percent when comparing the proportion of all pesticide exposures due to
paraquat ingestion for the four years pre- and post 1988.''
According to the RED, paraquat dichloride is a restricted use
herbicide currently registered to control weeds and grasses in many
agricultural and non-agricultural areas. The RED states there are no
residential or other non-occupational uses of paraquat dichloride, and
exposure to paraquat dichloride in drinking water is not expected.
Therefore, exposure to PP796 from applications of paraquat dichloride
are not expected from residential/non-occupational and drinking water
sources. A substantial increase in dietary risk is not anticipated from
this small raise of the allowable percentage of the emetic PP796 from
0.1 to 0.3 in formulation of paraquat dichloride. Therefore, the Agency
has determined that there is a reasonable certainty that no harm to any
population subgroup will result from aggregate exposure when
considering dietary exposure and all other non-occupational sources of
pesticide exposure for which there is reliable information. Also, the
health benefits of including an emetic in paraquat dichloride
formulations as stated in the 1981 Federal Register Notice (46 FR
55725) are reaffirmed here. In addition, the RED states paraquat
dichloride does not pose a hazard to the environment. This small
increase in the allowable amount of PP796 is also not expected to pose
a hazard to the environment.
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the Food Quality
Protection Act of 1996 (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
[[Page 46430]]
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 ID number OPP-2005-0141 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
11, 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 issue(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 14th 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. 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-2005-0141, 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 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 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 issue(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 an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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, 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 on the basis of a
petition under FFDCA section 408(d), 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. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. 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,
entitledFederalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with
[[Page 46431]]
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive Order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This rule will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
V. 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).
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 1, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1065 is revised to read as follows:
Sec. 180.1065 2-Amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-
alpha)pyrimidin-5-one; exemption from the requirement of a tolerance.
The inert ingredient, 2-amino-4,5-dihydro-6-methyl-4-propyl-s-
triazolo(1,5-alpha)pyrimidin-5-one is exempted from the requirement of
a tolerance when used as an emetic at not more than 0.3 percent in
formulations of paraquat dichloride. Further restrictions on this
exemption are that this ingredient may not be advertised as an emetic
and the paraquat product may not be promoted in any way because of the
inclusion of this inert ingredient.
[FR Doc. 05-15837 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-S