Isoxaflutole; Pesticide Tolerances, 75605-75609 [E8-29467]
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Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
methylpropyl 3-phenoxybenzoate, in or
on rice, grain at 0.01 ppm and rice,
straw at 0.06 ppm. Although EPA has
included the metabolite 2-(4ethyoxyphenyl)-2-methylpropyl 3phenoxybenzoate in its assessment of
exposure and risk for etofenprox, EPA
has decided to exclude the metabolite
from the tolerance expression because
the metabolism and residue studies
show that the parent compound will
serve as a better indicator of potential
misuse. Limiting the tolerance
expression to the parent only also
allows for harmonization with the
proposed Codex MRLs. EPA has
determined that rice, straw is not a
significant feedstuff; therefore, a
tolerance for residues of etofenprox per
se in/on rice straw is not needed. The
tolerance has been revised to reflect the
correct commodity definition, ‘‘rice,
grain’’ and the proposed tolerance
expression has been revised to residues
of etofenprox per se in or on rice, grain
of 0.01 ppm.
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V. Conclusion
Therefore, a tolerance is established
for residues of etofenprox, (2-(4ethoxyphenyl)-2-methylpropyl 3phenoxybenzyl ether), in or on rice,
grain at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA 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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
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the tolerance 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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75605
Dated: December 4, 2008.
Debra Edwards,
Director, 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.
2. Section 180.620 is amended by
revising pargraph (a) to read as follows:
■
§ 180.620 Etofenprox; tolerance for
residues.
(a) General. A tolerance is established
for residues of the insecticide
etofenprox [2-(4-ethoxyphenyl)-2methylpropyl 3-phenoxybenzyl ether] in
or on the following raw agricultural
commodity:
Commodity
Parts per million
Rice, grain ......................
*
*
*
*
0.01
*
[FR Doc. E8–29346 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0217; FRL–8393–1]
Isoxaflutole; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the
pesticide tolerance for isoxaflutole by
removing isoxaflutole’s benzoic acid
metabolite (RPA 203328) from the
established tolerance expression and
revising downward tolerance levels for
isoxaflutole in or on field corn. Bayer
CropScience requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 12, 2008. Objections and
requests for hearings must be received
on or before February 10, 2009, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0217. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
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information is not publicly available,
e.g., 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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Joanne Miller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6224; e-mail address:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
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 those engaged in the
following activities:
• 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 to provide 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.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–217 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
as required by 40 CFR part 178 on or
before February 10, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–217, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
II. Petition for Tolerance
In the Federal Register of April 16,
2008 (73 FR 20632) (FRL–8359–1), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
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I. General Information
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pesticide petition (PP 8F7328) by Bayer
CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The
petition requested that the tolerance for
isoxaflutole at 40 CFR 180.537 be
amended by removing the benzoic acid
metabolite (RPA 203328) from the
established tolerance expression and
revising downward the tolerance levels
for the following raw agricultural
commodities: Corn, field, grain; corn,
field, forage; and corn, field, stover. The
proposed level for each of these
tolerances is 0.02 parts per million
(ppm). Bayer CropScience requested
that the tolerance for isoxaflutole be
amended based on the results of several
toxicology studies submitted for the
benzoic acid metabolite, demonstrating
RPA 203328 is not of toxicological
concern. That notice referenced a
summary of the petition prepared by
Bayer CropScience the registrant, which
is available to the public in the docket,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the proposed tolerance level for the
combined residues of isoxaflutole and
its metabolite RPA 202248, calculated as
the parent compound, in or on corn,
field, forage from 0.02 ppm to 0.04 ppm.
Adequate crop field trial data with
isoxaflutole showed quantifiable
residues of isoxaflutole and RPA 202248
in field corn forage. These residues were
found only in samples from a single trial
and no residues were found in field
corn grain or stover in any of the trials.
Because the combined residues of
isoxaflutole and RPA 202248 in that
forage sample were at 0.029 ppm, a
tolerance of 0.04 ppm is necessary for
forage. Additionally, in light of the
revised, and significantly lower,
tolerances for isoxaflutole on field corn
commodities, EPA reassessed the
necessity for tolerances for isoxaflutole
on meat, milk, poultry, and egg
commodities. Meat, milk, poultry, and
egg tolerances are necessary for a
pesticide if pesticide residues in such
commodities are likely following
consumption by livestock of feed
commodities bearing pesticide residues.
Using the new tolerances and existing
animal feeding studies with
isoxaflutole, EPA determined that there
was no reasonable expectation of finite
isoxaflutole residues in livestock as the
maximum residues expected are well
below the limit of detection of the
analytical enforcement method.
Accordingly, EPA is revoking the
existing isoxaflutole meat, milk, and egg
tolerances as unnecessary.
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III. Aggregate Risk Assessment and
Determination of Safety
risk assessment are isoxaflutole and
RPA 202248.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of 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. Section
408(b)(2)(C) of FFDCA requires 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. . . .’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for the combined residues of
isoxaflutole and its metabolite RPA
202248, calculated as the parent
compound, in or on corn, field, forage
at 0.04 ppm; corn, field, grain at 0.02
ppm; and corn, field, stover at 0.02
ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances follows.
B. Safety of Isoxaflutole Tolerances
EPA’s last tolerance rulemaking with
regard to isoxaflutole occurred on
September 23, 1998. (63 FR 50773)
(FRL–6029–3). In that action,
isoxaflutole tolerances were established
for combined residues of isoxaflutole
and its metabolites RPA 202248 and
RPA 203328, calculated as the parent
compound, in or on the following raw
agricultural commodities: Corn, field,
forage at 1.0 ppm; corn, field, grain at
0.20 ppm; and corn, field, stover at 0.50
ppm. Tolerances were established for
the combined residues of isoxaflutole
and its metabolite RPA 202248,
calculated as the parent compound, in
or on the following raw agricultural
commodities: Cattle, fat at 0.20 ppm;
cattle, liver at 0.50 ppm; cattle, meat at
0.20 ppm; cattle, meat byproducts,
except liver at 0.10 ppm; egg at 0.01
ppm; goat, fat at 0.20 ppm; goat, liver at
0.50 ppm; goat, meat at 0.20 ppm; goat,
meat byproducts, except liver at 0.10
ppm; hog, fat at 0.20 ppm; hog, liver at
0.50 ppm; hog, meat at 0.20 ppm; hog,
meat byproducts, except liver at 0.10
ppm; horse, fat at 0.20 ppm; horse, liver
at 0.50 ppm; horse, meat at 0.20 ppm;
horse, meat byproducts, except liver at
0.10 ppm; milk at 0.02 ppm; poultry, fat
at 0.20 ppm; poultry, liver at 0.30 ppm;
poultry, meat at 0.20 ppm; sheep, fat at
0.20 ppm; sheep, liver at 0.50 ppm;
sheep, meat at 0.20 ppm; and sheep,
meat byproducts, except liver at 0.10
ppm.
In the 1998 tolerance action, EPA
assumed that the residues of concern in
field corn were isoxaflutole and its
metabolites RPA 202248 and RPA
203328. As explained in this unit,
however, EPA has now determined that
only the parent isoxaflutole and the
RPA 202248 metabolite pose a risk of
concern. Thus, the risk assessment done
in conjunction with the 1998
rulemaking, which showed isoxaflutole
exposure to be safe, greatly overstates
isoxaflutole exposure in comparison to
the revised tolerances. First, as to
exposure through human foods
produced from field corn (e.g., corn
meal, corn oil), the levels of isoxaflutole
residues of concern in such foods are an
order of magnitude lower than
previously assumed. Second, as to meat,
milk, poultry, and eggs from livestock
consuming isoxaflutole-treated field
corn, EPA has concluded that there is
no reasonable expectation of combined
residues of isoxaflutole and RPA 202248
in such commodities. Accordingly,
there is essentially no human exposure
to isoxaflutole residues in meat, milk,
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A. Removal of the Benzoic Acid
Metabolite RPA 203328
The previous risk assessment
concluded that RPA 203328 could not
be excluded from the risk assessment
and tolerance expression based on a
developmental endpoint of parent
isoxaflutole until an acceptable rat
developmental toxicity study was
submitted to the EPA. Additional
toxicity studies have been performed on
the metabolite RPA 203328 since the
last risk assessment, including an
acceptable developmental toxicity study
on RPA 203328. No evidence of
teratogenicity was observed in this
study and based on this data EPA
concluded that the developmental
toxicity observed with isoxaflutole is
not due to RPA 203328. EPA thus
determined that the residues of concern
for both the tolerance expression and
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poultry, and eggs from use of
isoxaflutole on field corn. For these
reasons, the 1998 risk assessment is a
very conservative assessment of the
potential risk from use of isoxaflutole on
field corn. Refer to the Federal Register
of September 23, 1998 (63 FR 50773)
(FRL–6029–3), available at https://
www.regulations.gov, for a detailed
discussion of the 1998 isoxaflutole
aggregate risk assessments and
determination of safety.
Since the 1998 rulemaking, EPA has
received a developmental neurotoxicity
study with isoxaflutole. Although EPA
has required that the study to be redone
due to a lack of morphometric analyses
of the brain, the maternal and offspring
no observed adverse effect levels
(NOAELs) in the study were otherwise
identified as 25 milligram/kiligram/day
(mg/kg/day). This value is above the
Point of Departure (POD) used in
assessing acute and chronic risk in the
1998 risk assessment. There, EPA used
a lowest observed adverse effect level
(LOAEL) of 5 mg/kg/day as the POD for
acute risks and a NOAEL of 2 mg/kg/day
as the POD for chronic risks. Thus, these
new data do not suggest that
isoxaflutole is more toxic than was
assumed in the 1998 assessment.
Further, it should be noted that in
assessing isoxaflutole risk, EPA applied
an additional safety factor of 30X for the
protection of infants and children in
addressing acute risks and an additional
safety factor of 10X for the protection of
infants and children in addressing
chronic risks. These additional safety
factors were used to address the absence
of a developmental neurotoxicity study
and reliance on a LOAEL. In another
development occurring since the 1998
rulemaking, EPA has noted, in tolerance
rulemakings for several other pesticides
that pesticides such as isoxaflutole
which inhibit the liver enzyme 4hydroxyphenylpyruvate dioxygenase
(HPPD) may operate through a common
mechanism of toxicity. To address this
issue, EPA has conducted a cumulative
screening assessment for these
pesticides and concluded that, even if
there is common mechanism for HPPDinhibition, cumulative exposure from
these pesticides does not raise a risk
concern. Refer to the Federal Register of
February 20, 2008 (73 FR 9221) (FRL–
8344–7). Further cumulative analysis is
unnecessary for this action because of
EPA’s conclusion that the revised
isoxaflutole tolerances result in
substantially lower isoxaflutole
exposure than previously assumed.
Accordingly, taking into account the
prior risk assessment for isoxaflutole,
EPA’s revised analysis of the level of
human exposure from use of
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isoxaflutole on field corn, the
developmental neurotoxicity study, and
EPA’s screening analysis of HPPDinhibiting pesticides, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children,
from aggregate exposure to isoxaflutole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A practical analytical method has
been developed for detecting and
quantifying levels of isoxaflutole and
RPA 202248 in or on raw agricultural
commodities obtained from field corn.
This method allows monitoring of these
commodities with residues at or above
the levels proposed. Quantification of
analytes as individual components is
performed by daughter-ion detection
using liquid chromatography/mass
spectroscopy (LC/MS/MS). The limit of
quantification (LOQ) for all analytes is
0.01 ppm. The proposed analytical
enforcement method to determine
isoxaflutole-derived residues in plants
has been validated by an independent
laboratory.
Adequate enforcement methodology
LC/MS/MS is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or
Mexican maximum residue limits
(MRLs) established for residues of
isoxaflutole in crop or livestock
commodities.
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V. Conclusion
Therefore, EPA has revised tolerances
for the combined residues of
isoxaflutole and its metabolites RPA
202248 and RPA 203328, calculated as
the parent compound, in or on corn,
field, forage at 0.04 ppm; corn, field,
grain at 0.02 ppm; and corn, field, stover
at 0.02 ppm; and has removed the
benzoic acid metabolite (RPA 203328)
from the established tolerance
expression. EPA has removed the
established tolerances for the combined
residues of isoxaflutole and its
metabolite RPA 202248, calculated as
the parent compound, in or on cattle, fat
at 0.20 ppm; cattle, liver at 0.50 ppm;
cattle, meat at 0.20 ppm; cattle, meat
byproducts, except liver at 0.10 ppm;
egg at 0.01 ppm; goat, fat at 0.20 ppm;
goat, liver at 0.50 ppm; goat, meat at
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0.20 ppm; goat, meat byproducts, except
liver at 0.10 ppm; hog, fat at 0.20 ppm;
hog, liver at 0.50 ppm; hog, meat at 0.20
ppm; hog, meat byproducts, except liver
at 0.10 ppm; horse, fat at 0.20 ppm;
horse, liver at 0.50 ppm; horse, meat at
0.20 ppm; horse, meat byproducts,
except liver at 0.10 ppm; milk at 0.02
ppm; poultry, fat at 0.20 ppm; poultry,
liver at 0.30 ppm; poultry, meat at 0.20
ppm; sheep, fat at 0.20 ppm; sheep, liver
at 0.50 ppm; sheep, meat at 0.20 ppm;
and sheep, meat byproducts, except
liver at 0.10 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA 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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
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power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: December 3, 2008.
Donald R. Stubbs,
Acting 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.
2. In § 180.537, paragraph (a) is
revised to read as follows:
■
§ 180.537
residues
Isoxaflutole; tolerances for
(a) General. Tolerances are
established for the combined residues of
E:\FR\FM\12DER1.SGM
12DER1
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
isoxaflutole 5-cyclopropyl-4-(2methylsulfonyl-4trifluoromethylbenzoyl) isoxazole and
its metabolite 1-(2-methylsulfonyl-4trifluoromethylphenyl)-2-cyano-3cyclopropyl propan-1,3-dione (RPA
75609
202248), calculated as the parent
compound, in or on the following raw
agricultural commodities:
Commodity
Parts per million
Corn, field, forage ............................................................................................................................................
Corn, field, grain ..............................................................................................................................................
Corn, field, stover ............................................................................................................................................
*
*
*
*
*
[FR Doc. E8–29467 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket No. FEMA–8053]
Suspension of Community Eligibility
mstockstill on PROD1PC62 with RULES
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
SUMMARY: This rule identifies
communities, where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP), that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: Effective Date: The effective date
of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact David Stearrett,
Mitigation Directorate, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–2953.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
flood insurance which is generally not
otherwise available. In return,
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
communities agree to adopt and
administer local floodplain management
aimed at protecting lives and new
construction from future flooding.
Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance
coverage as authorized under the NFIP,
42 U.S.C. 4001 et seq.; unless an
appropriate public body adopts
adequate floodplain management
measures with effective enforcement
measures. The communities listed in
this document no longer meet that
statutory requirement for compliance
with program regulations, 44 CFR part
59. Accordingly, the communities will
be suspended on the effective date in
the third column. As of that date, flood
insurance will no longer be available in
the community. However, some of these
communities may adopt and submit the
required documentation of legally
enforceable floodplain management
measures after this rule is published but
prior to the actual suspension date.
These communities will not be
suspended and will continue their
eligibility for the sale of insurance. A
notice withdrawing the suspension of
the communities will be published in
the Federal Register.
In addition, FEMA has identified the
Special Flood Hazard Areas (SFHAs) in
these communities by publishing a
Flood Insurance Rate Map (FIRM). The
date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may legally be provided for
construction or acquisition of buildings
in identified SFHAs for communities
not participating in the NFIP and
identified for more than a year, on
FEMA’s initial flood insurance map of
the community as having flood-prone
areas (section 202(a) of the Flood
Disaster Protection Act of 1973, 42
U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
PO 00000
Frm 00073
Fmt 4700
Sfmt 4700
0.04
0.02
0.02
public comment under 5 U.S.C. 553(b)
are impracticable and unnecessary
because communities listed in this final
rule have been adequately notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
This rule is categorically excluded from
the requirements of 44 CFR part 10,
Environmental Considerations. No
environmental impact assessment has
been prepared.
Regulatory Flexibility Act. The
Administrator has determined that this
rule is exempt from the requirements of
the Regulatory Flexibility Act because
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits flood insurance coverage
unless an appropriate public body
adopts adequate floodplain management
measures with effective enforcement
measures. The communities listed no
longer comply with the statutory
requirements, and after the effective
date, flood insurance will no longer be
available in the communities unless
remedial action takes place.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This rule involves no policies that have
federalism implications under Executive
Order 13132.
Executive Order 12988, Civil Justice
Reform. This rule meets the applicable
standards of Executive Order 12988.
Paperwork Reduction Act. This rule
does not involve any collection of
information for purposes of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
E:\FR\FM\12DER1.SGM
12DER1
]]>Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Rules and Regulations]
[Pages 75605-75609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29467]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0217; FRL-8393-1]
Isoxaflutole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the pesticide tolerance for
isoxaflutole by removing isoxaflutole's benzoic acid metabolite (RPA
203328) from the established tolerance expression and revising downward
tolerance levels for isoxaflutole in or on field corn. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 12, 2008. Objections and
requests for hearings must be received on or before February 10, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0217. All documents in the
docket are listed in the docket index available at https://
www.regulations.gov. Although listed in the index, some
[[Page 75606]]
information is not publicly available, e.g., 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 in the
electronic docket at https://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Joanne Miller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6224; e-mail address: miller.joanne@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 those
engaged in the following activities:
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 to
provide 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?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-217 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 as required by 40 CFR part 178
on or before February 10, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-217, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 16, 2008 (73 FR 20632) (FRL-8359-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7328) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that the tolerance for
isoxaflutole at 40 CFR 180.537 be amended by removing the benzoic acid
metabolite (RPA 203328) from the established tolerance expression and
revising downward the tolerance levels for the following raw
agricultural commodities: Corn, field, grain; corn, field, forage; and
corn, field, stover. The proposed level for each of these tolerances is
0.02 parts per million (ppm). Bayer CropScience requested that the
tolerance for isoxaflutole be amended based on the results of several
toxicology studies submitted for the benzoic acid metabolite,
demonstrating RPA 203328 is not of toxicological concern. That notice
referenced a summary of the petition prepared by Bayer CropScience the
registrant, which is available to the public in the docket, https://
www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance level for the combined residues of
isoxaflutole and its metabolite RPA 202248, calculated as the parent
compound, in or on corn, field, forage from 0.02 ppm to 0.04 ppm.
Adequate crop field trial data with isoxaflutole showed quantifiable
residues of isoxaflutole and RPA 202248 in field corn forage. These
residues were found only in samples from a single trial and no residues
were found in field corn grain or stover in any of the trials. Because
the combined residues of isoxaflutole and RPA 202248 in that forage
sample were at 0.029 ppm, a tolerance of 0.04 ppm is necessary for
forage. Additionally, in light of the revised, and significantly lower,
tolerances for isoxaflutole on field corn commodities, EPA reassessed
the necessity for tolerances for isoxaflutole on meat, milk, poultry,
and egg commodities. Meat, milk, poultry, and egg tolerances are
necessary for a pesticide if pesticide residues in such commodities are
likely following consumption by livestock of feed commodities bearing
pesticide residues. Using the new tolerances and existing animal
feeding studies with isoxaflutole, EPA determined that there was no
reasonable expectation of finite isoxaflutole residues in livestock as
the maximum residues expected are well below the limit of detection of
the analytical enforcement method. Accordingly, EPA is revoking the
existing isoxaflutole meat, milk, and egg tolerances as unnecessary.
[[Page 75607]]
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of 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.
Section 408(b)(2)(C) of FFDCA requires 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. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for the combined residues of isoxaflutole and its metabolite
RPA 202248, calculated as the parent compound, in or on corn, field,
forage at 0.04 ppm; corn, field, grain at 0.02 ppm; and corn, field,
stover at 0.02 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances follows.
A. Removal of the Benzoic Acid Metabolite RPA 203328
The previous risk assessment concluded that RPA 203328 could not be
excluded from the risk assessment and tolerance expression based on a
developmental endpoint of parent isoxaflutole until an acceptable rat
developmental toxicity study was submitted to the EPA. Additional
toxicity studies have been performed on the metabolite RPA 203328 since
the last risk assessment, including an acceptable developmental
toxicity study on RPA 203328. No evidence of teratogenicity was
observed in this study and based on this data EPA concluded that the
developmental toxicity observed with isoxaflutole is not due to RPA
203328. EPA thus determined that the residues of concern for both the
tolerance expression and risk assessment are isoxaflutole and RPA
202248.
B. Safety of Isoxaflutole Tolerances
EPA's last tolerance rulemaking with regard to isoxaflutole
occurred on September 23, 1998. (63 FR 50773) (FRL-6029-3). In that
action, isoxaflutole tolerances were established for combined residues
of isoxaflutole and its metabolites RPA 202248 and RPA 203328,
calculated as the parent compound, in or on the following raw
agricultural commodities: Corn, field, forage at 1.0 ppm; corn, field,
grain at 0.20 ppm; and corn, field, stover at 0.50 ppm. Tolerances were
established for the combined residues of isoxaflutole and its
metabolite RPA 202248, calculated as the parent compound, in or on the
following raw agricultural commodities: Cattle, fat at 0.20 ppm;
cattle, liver at 0.50 ppm; cattle, meat at 0.20 ppm; cattle, meat
byproducts, except liver at 0.10 ppm; egg at 0.01 ppm; goat, fat at
0.20 ppm; goat, liver at 0.50 ppm; goat, meat at 0.20 ppm; goat, meat
byproducts, except liver at 0.10 ppm; hog, fat at 0.20 ppm; hog, liver
at 0.50 ppm; hog, meat at 0.20 ppm; hog, meat byproducts, except liver
at 0.10 ppm; horse, fat at 0.20 ppm; horse, liver at 0.50 ppm; horse,
meat at 0.20 ppm; horse, meat byproducts, except liver at 0.10 ppm;
milk at 0.02 ppm; poultry, fat at 0.20 ppm; poultry, liver at 0.30 ppm;
poultry, meat at 0.20 ppm; sheep, fat at 0.20 ppm; sheep, liver at 0.50
ppm; sheep, meat at 0.20 ppm; and sheep, meat byproducts, except liver
at 0.10 ppm.
In the 1998 tolerance action, EPA assumed that the residues of
concern in field corn were isoxaflutole and its metabolites RPA 202248
and RPA 203328. As explained in this unit, however, EPA has now
determined that only the parent isoxaflutole and the RPA 202248
metabolite pose a risk of concern. Thus, the risk assessment done in
conjunction with the 1998 rulemaking, which showed isoxaflutole
exposure to be safe, greatly overstates isoxaflutole exposure in
comparison to the revised tolerances. First, as to exposure through
human foods produced from field corn (e.g., corn meal, corn oil), the
levels of isoxaflutole residues of concern in such foods are an order
of magnitude lower than previously assumed. Second, as to meat, milk,
poultry, and eggs from livestock consuming isoxaflutole-treated field
corn, EPA has concluded that there is no reasonable expectation of
combined residues of isoxaflutole and RPA 202248 in such commodities.
Accordingly, there is essentially no human exposure to isoxaflutole
residues in meat, milk, poultry, and eggs from use of isoxaflutole on
field corn. For these reasons, the 1998 risk assessment is a very
conservative assessment of the potential risk from use of isoxaflutole
on field corn. Refer to the Federal Register of September 23, 1998 (63
FR 50773) (FRL-6029-3), available at https://www.regulations.gov, for a
detailed discussion of the 1998 isoxaflutole aggregate risk assessments
and determination of safety.
Since the 1998 rulemaking, EPA has received a developmental
neurotoxicity study with isoxaflutole. Although EPA has required that
the study to be redone due to a lack of morphometric analyses of the
brain, the maternal and offspring no observed adverse effect levels
(NOAELs) in the study were otherwise identified as 25 milligram/
kiligram/day (mg/kg/day). This value is above the Point of Departure
(POD) used in assessing acute and chronic risk in the 1998 risk
assessment. There, EPA used a lowest observed adverse effect level
(LOAEL) of 5 mg/kg/day as the POD for acute risks and a NOAEL of 2 mg/
kg/day as the POD for chronic risks. Thus, these new data do not
suggest that isoxaflutole is more toxic than was assumed in the 1998
assessment. Further, it should be noted that in assessing isoxaflutole
risk, EPA applied an additional safety factor of 30X for the protection
of infants and children in addressing acute risks and an additional
safety factor of 10X for the protection of infants and children in
addressing chronic risks. These additional safety factors were used to
address the absence of a developmental neurotoxicity study and reliance
on a LOAEL. In another development occurring since the 1998 rulemaking,
EPA has noted, in tolerance rulemakings for several other pesticides
that pesticides such as isoxaflutole which inhibit the liver enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD) may operate through a common
mechanism of toxicity. To address this issue, EPA has conducted a
cumulative screening assessment for these pesticides and concluded
that, even if there is common mechanism for HPPD-inhibition, cumulative
exposure from these pesticides does not raise a risk concern. Refer to
the Federal Register of February 20, 2008 (73 FR 9221) (FRL-8344-7).
Further cumulative analysis is unnecessary for this action because of
EPA's conclusion that the revised isoxaflutole tolerances result in
substantially lower isoxaflutole exposure than previously assumed.
Accordingly, taking into account the prior risk assessment for
isoxaflutole, EPA's revised analysis of the level of human exposure
from use of
[[Page 75608]]
isoxaflutole on field corn, the developmental neurotoxicity study, and
EPA's screening analysis of HPPD-inhibiting pesticides, EPA concludes
that there is a reasonable certainty that no harm will result to the
general population, and to infants and children, from aggregate
exposure to isoxaflutole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A practical analytical method has been developed for detecting and
quantifying levels of isoxaflutole and RPA 202248 in or on raw
agricultural commodities obtained from field corn. This method allows
monitoring of these commodities with residues at or above the levels
proposed. Quantification of analytes as individual components is
performed by daughter-ion detection using liquid chromatography/mass
spectroscopy (LC/MS/MS). The limit of quantification (LOQ) for all
analytes is 0.01 ppm. The proposed analytical enforcement method to
determine isoxaflutole-derived residues in plants has been validated by
an independent laboratory.
Adequate enforcement methodology LC/MS/MS is available to enforce
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for residues of isoxaflutole in crop or livestock
commodities.
V. Conclusion
Therefore, EPA has revised tolerances for the combined residues of
isoxaflutole and its metabolites RPA 202248 and RPA 203328, calculated
as the parent compound, in or on corn, field, forage at 0.04 ppm; corn,
field, grain at 0.02 ppm; and corn, field, stover at 0.02 ppm; and has
removed the benzoic acid metabolite (RPA 203328) from the established
tolerance expression. EPA has removed the established tolerances for
the combined residues of isoxaflutole and its metabolite RPA 202248,
calculated as the parent compound, in or on cattle, fat at 0.20 ppm;
cattle, liver at 0.50 ppm; cattle, meat at 0.20 ppm; cattle, meat
byproducts, except liver at 0.10 ppm; egg at 0.01 ppm; goat, fat at
0.20 ppm; goat, liver at 0.50 ppm; goat, meat at 0.20 ppm; goat, meat
byproducts, except liver at 0.10 ppm; hog, fat at 0.20 ppm; hog, liver
at 0.50 ppm; hog, meat at 0.20 ppm; hog, meat byproducts, except liver
at 0.10 ppm; horse, fat at 0.20 ppm; horse, liver at 0.50 ppm; horse,
meat at 0.20 ppm; horse, meat byproducts, except liver at 0.10 ppm;
milk at 0.02 ppm; poultry, fat at 0.20 ppm; poultry, liver at 0.30 ppm;
poultry, meat at 0.20 ppm; sheep, fat at 0.20 ppm; sheep, liver at 0.50
ppm; sheep, meat at 0.20 ppm; and sheep, meat byproducts, except liver
at 0.10 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: December 3, 2008.
Donald R. Stubbs,
Acting 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. In Sec. 180.537, paragraph (a) is revised to read as follows:
Sec. 180.537 Isoxaflutole; tolerances for residues
(a) General. Tolerances are established for the combined residues
of
[[Page 75609]]
isoxaflutole 5-cyclopropyl-4-(2-methylsulfonyl-4-
trifluoromethylbenzoyl) isoxazole and its metabolite 1-(2-
methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propan-
1,3-dione (RPA 202248), calculated as the parent compound, in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Corn, field, forage................. 0.04
Corn, field, grain.................. 0.02
Corn, field, stover................. 0.02
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-29467 Filed 12-11-08; 8:45 am]
BILLING CODE 6560-50-S
