Chlorantraniliprole; Time-Limited Pesticide Tolerances, 27452-27456 [E7-9206]
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27452
Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This 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).
X. 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: May 4, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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 180.1275 is added to
subpart D to read as follows:
I
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§ 180.1275 Pythium; Exception from the
requirement of a tolerance.
An exemption from the requirement
of tolerance is established on all food/
feed commodities, for residues of
pythium oligandrum DV 74 when the
pesticide is used on food crops.
[FR Doc. E7–9298 Filed 5–15–07; 8:45 am]
BILLING CODE 6560–50–S
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0800; FRL–8128–2]
Chlorantraniliprole; Time-Limited
Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
chlorantraniliprole in or on apple and
apple, wet pomace, celery, cucumber,
head and leaf lettuce, pear, pepper,
spinach, squash, tomato and
watermelon commodities. DuPont Crop
Protection requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA). The tolerances will expire on
May 1, 2010.
DATES: This regulation is effective May
16, 2007. Objections and requests for
hearings must be received on or before
July 16, 2007, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0800. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some 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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the OPP
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 telephone number
is (703) 305-5805.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number: 703
306-0415; e-mail address:
kable.davis@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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions
discussed above. 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 an electronic
copy of this Federal Register document
through the electronic docket 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 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 the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
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procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2006–0800 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 July 16, 2007.
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 your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0800, 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’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 telephone number is (703) 3055805.
II. Background and Statutory Findings
In the Federal Register of October 13,
2006 (71 FR 198) (FRL–8096–2), EPA
issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6G7089) by E I.
DuPont de Nemours and Company,
DuPont Crop Protection, 1090 Elkton
Road, Newark, Delaware 19711. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the insecticide
chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide, in or on apple at 0.3 parts
per million (ppm), apple, celery at 7.0
ppm, cucumber at 0.09 ppm, lettuce,
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head at 4.0 ppm, lettuce, leaf at 7.5
ppm, pear at 0.30 ppm, pepper at 0.50
ppm, spinach at 13.0 ppm, squash at
0.25 ppm, tomato at 0.30 ppm and
watermelon at 0.20 ppm. This notice
referenced a summary of the petition
prepared by E.I. DuPont de Nemours
and Company, DuPont Crop Protection,
the registrant, which has been included
in the public docket. Several comments
were received from a private citizen on
objecting to pesticide body load, IR-4
profiteering, animal testing, and other
related matters. The Agency has
received these same comments from this
commenter on numerous previous
occasions. Refer to the Federal Register
of June 30, 2005 (70 FR 37686) (FRL–
7718–3), January 7, 2005 (70 FR 1354)
(FRL–7691–4), and October 29, 2004 69
FR 63096 for the Agency’s response to
these objections.
These temporary tolerances will
permit the marketing of the above raw
agricultural commodities when treated
in accordance with the provisions of the
experimental use permits 352-EUP-170,
and 353-EUP-171, which are being
issued under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), as amended (7 U.S.C. 136).
The scientific data reported and other
relevant material were evaluated, and it
was determined that establishment of
these temporary tolerances will protect
the public health. Therefore, these
temporary tolerances have been
established on the condition that the
pesticide be used in accordance with
the experimental use permits. The
tolerances will expire on May 1, 2010.
Section 408(b)(2)(A)(i) of the 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 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. Section
408(b)(2)(C) of the 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. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
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further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of the 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,
consistent with section 408(b)(2) of the
FFDCA , for tolerances for residues of
chlorantraniliprole on apple at 0.25
ppm, apple, wet pomace at 0.60 ppm,
celery at 7.0 ppm, cucumber at 0.10
ppm, lettuce, head at 4.0 ppm, lettuce,
leaf at 8.0 ppm, pear at 0.30 ppm,
pepper at 0.50 ppm, spinach at 13.0
ppm, squash at 0.40 ppm, tomato at 0.30
ppm and watermelon at 0.20 ppm.
EPA’s assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
chlorantraniliprole as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at www.regulations.gov in
Docket ID EPA–HQ–OPP–2006–0800.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which NOAEL from the
toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the LOAEL
of concern are identified is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
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The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for chlorantraniliprole used
for human risk assessment can be found
at www.regulations.gov in Docket ID
EPA–HQ–OPP–2006–0800.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Chlorantraniliprole is a new
active ingredient and tolerances have
not been established. A risk assessment
was conducted by EPA to assess dietary
exposures from chlorantraniliprole in
food (from crops treated under the
experimental permits) as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide if
a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one day or
single exposure. Acute dietary (food and
drinking water) exposure assessments
were conducted for chlorantraniliprole
using the Dietary Exposure Evaluation
Model (DEEM-FCID), and reflect the
proposed uses on apple, celery,
cucumber, head and leaf lettuce, pear,
pepper, spinach, squash, tomato and
watermelon crops. The modeled
exposure estimates are based on
tolerance level residues (calculated
using the maximum residue level
calculator) assuming 100% of crops are
treated and surface water estimated
drinking water concentrations (EDWCs)
(because surface water EDWCs were
higher than ground water EDWCs).
ii. Chronic exposure. Chronic dietary
(food and drinking water) exposure
assessments were conducted for
chlorantraniliprole using the DEEMFCID), and reflect the proposed uses on
apple, celery, cucumber, head and leaf
lettuce, pear, pepper, spinach, squash,
tomato and watermelon crops. The
modeled exposure estimates are based
on tolerance level residues (calculated
using the maximum residue level
calculator) assuming 100% of crops are
treated and surface water estimated
drinking water concentrations (EDWCs)
(because surface water EDWCs were
higher than ground water EDWCs).
iii. Cancer. Long-term exposure is not
expected to result from use under these
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Experimental Use Permits (EUPs). The
submitted subchronic studies in mice,
dog and rats, and the in vivo and in
vitro genotoxicity studies, identified no
tumors or preneoplastic foci, nor did
they identify mutagenic concern.
Therefore, the expected short/
intermediate-term exposure resulting
from the EUPs does not indicate a
concern for carcinogenicity.
2. Dietary exposure from drinking
water. Clorantraniliprole is an
unregistered chemical, thus, the Agency
lacks sufficient monitoring data to
complete a comprehensive dietary
exposure analysis and risk assessment
for chlorantraniliprole in drinking
water. Because the Agency does not
have comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
chlorantraniliprole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the EPA’s pesticide root
zone model/exposure analysis modeling
system (PRZM/EXAMS) and screening
concentration in groundwater (SCIGROW) models, the estimated
environmental concentrations (EECs) of
chlorantraniliprole for acute exposures
are estimated to be 14 ppb for surface
water and 0.38 ppb for ground water.
The EECs for chronic exposures are
estimated to be 2.3 ppb for surface water
and 0.38 for ground water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Chlorantraniliprole is not registered
for use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
chlorantraniliprole and any other
substances and chlorantraniliprole does
not appear to produce a toxic metabolite
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produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
chlorantraniliprole has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of the
FFDCA provides that EPA shall apply
an additional tenfold margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines that a different margin of
safety will be safe for infants and
children. Margins of safety are
incorporated into EPA risk assessments
either directly through use of a margin
of exposure (MOE) analysis or through
using uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans.
2. Prenatal and postnatal sensitivity.
There were no effects on fetal growth or
development up to the limit dose of
1,000 milligrams killogram day (mg/kg/
day) in rats or rabbits. There were no
treatment related effects on the numbers
of litters, fetuses (live or dead),
resorptions, sex ratio, or postimplantation loss. There were no effects
on fetal body weights, skeletal
ossification, and external, visceral, or
skeletal malformations or variations.
3. Conclusion. Due to the following,
the FQPA Safety Factor does not need
to be retained at this time:
The toxicology database is complete
for the characterization of potential
prenatal and postnatal risks to infants
and children. No susceptibility was
identified in the toxicological data base,
and there are no residual uncertainties
re: prenatal and/or postnatal exposure
(i.e., the developmental and
reproduction studies report no adverse
effects related to treatment ≥ 1,000 mg/
kg/day limit dose). Therefore, a degree
of concern analysis for prenatal and/or
postnatal susceptibility is not necessary.
Highly conservative dietary (food and
water) exposure estimates are at least
60,000 times lower than the highest
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dose tested in the mammalian toxicity
studies (at which no adverse observed
effects were seen).
E. Aggregate Risks and Determination of
Safety
1. Acute/chronic risk. Aggregating
routes and/or pathways of exposure is
not relevant, since no hazard was
identified via any route of exposure in
the EUP toxicology data base.
2. Short/Intermediate-term risk.
Chlorantraniliprole is not registered for
use on any sites that would result in
short and intermediate residential
exposure and therefore no risk
assessment was conducted for this
scenario.
3. Aggregate cancer risk for U.S.
population. Long-term exposure is not
expected to result from use under these
EUPs. The submitted subchronic studies
in mice, dog and rats, and the in vivo
and in vitro genotoxicity studies,
identified no tumors or preneoplastic
foci, nor did they identify mutagenic
concern.
4. Determination of safety. Based on
these risk assessments, 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
chlorantraniliprole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
LC/MS/MS methods are available for
measuring chlorantraniliprole in plants
and livestock. The registrant submitted
an LC/MS/MS method for the
determination of chlorantraniliprole in
plants, and an LC/MS/MS method for
the determination of chlorantraniliprole
and its metabolites in livestock.
Adequate method and concurrent
recovery data were provided for the
plant LC/MS/MS method, and the
fortification levels used in the method
and concurrent validation are adequate
to bracket the residue levels determined
in the proposed crops. An analytical
method for enforcing tolerances in
livestock commodities is not germane to
this EUP as tolerances in meat, milk,
poultry and eggs are not required.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican MRLs for
chlorantraniliprole.
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C. Conditions
None.
V. Conclusion
Therefore, time-limited tolerances are
established for residues of
chlorantraniliprole, 3-bromo-N-[4-
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chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide, in or on apple at 0.25
ppm, apple, wet pomace at 0.60 ppm,
celery at 7.0 ppm, cucumber at 0.10
ppm, lettuce, head at 4.0 ppm, lettuce,
leaf at 8.0 ppm, pear at 0.30 ppm,
pepper at 0.50 ppm, spinach at 13.0
ppm, squash at 0.40 ppm, tomato at 0.30
ppm and watermelon at 0.20 ppm.
These tolerances will expire on May 1,
2010.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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 rule has
been exempted from review under
Executive Order 12866, 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) 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
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27455
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 6, 2000) do not apply
to this rule. In addition, This 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: May 2, 2007.
Debra Edwards,
Director, 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 180.628 is added to read as
follows:
I
§180.628 Chlorantraniliprole; tolerances
for residues.
(a) Tolerances are established for
residues of the pesticide
chlorantraniliprole (3-bromo-N-[4chloro-2-methyl-6-
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27456
Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations
[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following raw
agricultural commodities:
Commodity
Expiration/revocation
date
Parts per million
Apple
0.25
05/01/2010
Apple, wet pomace
0.60
05/01/2010
7.0
05/01/2010
0.10
05/01/2010
Lettuce, head
4.0
05/01/2010
Lettuce, leaf
8.0
05/01/2010
Pear
0.30
05/01/2010
Pepper
0.50
05/01/2010
Spinach
13.0
05/01/2010
Squash
0.40
05/01/2010
Tomato
0.30
05/01/2010
Watermelon
0.20
05/01/2010
Celery
Cucumber
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E7–9206 Filed 5–15–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0995; FRL–8120–2]
Pendimethalin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
pendimethalin and its metabolite, 4-[(1ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol in or on beans;
beans, forage; beans, hay; and peas
(except field peas) to replace the current
tolerances for bean, lima, seed; bean,
lima, succulent; bean, forage; bean, hay;
and pea, succulent. BASF Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
16, 2007. Objections and requests for
hearings must be received on or before
July 16, 2007, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
VerDate Aug<31>2005
18:04 May 15, 2007
Jkt 211001
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0995. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some 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
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Philip V. Errico, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
ADDRESSES:
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305–6663; e-mail address:
errico.philip@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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
E:\FR\FM\16MYR1.SGM
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Agencies
[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Rules and Regulations]
[Pages 27452-27456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9206]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0800; FRL-8128-2]
Chlorantraniliprole; Time-Limited Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of chlorantraniliprole in or on apple and apple, wet pomace,
celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash,
tomato and watermelon commodities. DuPont Crop Protection requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
The tolerances will expire on May 1, 2010.
DATES: This regulation is effective May 16, 2007. Objections and
requests for hearings must be received on or before July 16, 2007, 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-2006-0800. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some 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 either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
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
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703 306-0415; e-mail address: kable.davis@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions discussed above. 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 an electronic copy of this Federal
Register document through the electronic docket 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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA
[[Page 27453]]
procedural regulations which govern the submission of objections and
requests for hearings appear in 40 CFR part 178. 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-2006-0800 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 July 16, 2007.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0800, 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'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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of October 13, 2006 (71 FR 198) (FRL-8096-
2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6G7089) by E I. DuPont de Nemours and Company, DuPont Crop Protection,
1090 Elkton Road, Newark, Delaware 19711. The petition requested that
40 CFR part 180 be amended by establishing tolerances for residues of
the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on apple at 0.3 parts per million (ppm), apple,
celery at 7.0 ppm, cucumber at 0.09 ppm, lettuce, head at 4.0 ppm,
lettuce, leaf at 7.5 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach
at 13.0 ppm, squash at 0.25 ppm, tomato at 0.30 ppm and watermelon at
0.20 ppm. This notice referenced a summary of the petition prepared by
E.I. DuPont de Nemours and Company, DuPont Crop Protection, the
registrant, which has been included in the public docket. Several
comments were received from a private citizen on objecting to pesticide
body load, IR-4 profiteering, animal testing, and other related
matters. The Agency has received these same comments from this
commenter on numerous previous occasions. Refer to the Federal Register
of June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR
1354) (FRL-7691-4), and October 29, 2004 69 FR 63096 for the Agency's
response to these objections.
These temporary tolerances will permit the marketing of the above
raw agricultural commodities when treated in accordance with the
provisions of the experimental use permits 352-EUP-170, and 353-EUP-
171, which are being issued under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136).
The scientific data reported and other relevant material were
evaluated, and it was determined that establishment of these temporary
tolerances will protect the public health. Therefore, these temporary
tolerances have been established on the condition that the pesticide be
used in accordance with the experimental use permits. The tolerances
will expire on May 1, 2010.
Section 408(b)(2)(A)(i) of the 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 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.
Section 408(b)(2)(C) of the 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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the 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, consistent with section
408(b)(2) of the FFDCA , for tolerances for residues of
chlorantraniliprole on apple at 0.25 ppm, apple, wet pomace at 0.60
ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm,
lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach
at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at
0.20 ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by chlorantraniliprole as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at
www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
of concern are identified is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
[[Page 27454]]
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for chlorantraniliprole
used for human risk assessment can be found at www.regulations.gov in
Docket ID EPA-HQ-OPP-2006-0800.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Chlorantraniliprole is
a new active ingredient and tolerances have not been established. A
risk assessment was conducted by EPA to assess dietary exposures from
chlorantraniliprole in food (from crops treated under the experimental
permits) as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one day or single exposure. Acute dietary (food and
drinking water) exposure assessments were conducted for
chlorantraniliprole using the Dietary Exposure Evaluation Model (DEEM-
FCID), and reflect the proposed uses on apple, celery, cucumber, head
and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon
crops. The modeled exposure estimates are based on tolerance level
residues (calculated using the maximum residue level calculator)
assuming 100% of crops are treated and surface water estimated drinking
water concentrations (EDWCs) (because surface water EDWCs were higher
than ground water EDWCs).
ii. Chronic exposure. Chronic dietary (food and drinking water)
exposure assessments were conducted for chlorantraniliprole using the
DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber,
head and leaf lettuce, pear, pepper, spinach, squash, tomato and
watermelon crops. The modeled exposure estimates are based on tolerance
level residues (calculated using the maximum residue level calculator)
assuming 100% of crops are treated and surface water estimated drinking
water concentrations (EDWCs) (because surface water EDWCs were higher
than ground water EDWCs).
iii. Cancer. Long-term exposure is not expected to result from use
under these Experimental Use Permits (EUPs). The submitted subchronic
studies in mice, dog and rats, and the in vivo and in vitro
genotoxicity studies, identified no tumors or preneoplastic foci, nor
did they identify mutagenic concern. Therefore, the expected short/
intermediate-term exposure resulting from the EUPs does not indicate a
concern for carcinogenicity.
2. Dietary exposure from drinking water. Clorantraniliprole is an
unregistered chemical, thus, the Agency lacks sufficient monitoring
data to complete a comprehensive dietary exposure analysis and risk
assessment for chlorantraniliprole in drinking water. Because the
Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the physical characteristics of
chlorantraniliprole. Further information regarding EPA drinking water
models used in pesticide exposure assessment can be found at https://
www.epa.gov/oppefed1/models/water/index.htm.
Based on the EPA's pesticide root zone model/exposure analysis
modeling system (PRZM/EXAMS) and screening concentration in groundwater
(SCI-GROW) models, the estimated environmental concentrations (EECs) of
chlorantraniliprole for acute exposures are estimated to be 14 ppb for
surface water and 0.38 ppb for ground water. The EECs for chronic
exposures are estimated to be 2.3 ppb for surface water and 0.38 for
ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Chlorantraniliprole is not registered for use on any sites that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to chlorantraniliprole and
any other substances and chlorantraniliprole does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
chlorantraniliprole has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There were no effects on
fetal growth or development up to the limit dose of 1,000 milligrams
killogram day (mg/kg/day) in rats or rabbits. There were no treatment
related effects on the numbers of litters, fetuses (live or dead),
resorptions, sex ratio, or post-implantation loss. There were no
effects on fetal body weights, skeletal ossification, and external,
visceral, or skeletal malformations or variations.
3. Conclusion. Due to the following, the FQPA Safety Factor does
not need to be retained at this time:
The toxicology database is complete for the characterization of
potential prenatal and postnatal risks to infants and children. No
susceptibility was identified in the toxicological data base, and there
are no residual uncertainties re: prenatal and/or postnatal exposure
(i.e., the developmental and reproduction studies report no adverse
effects related to treatment >= 1,000 mg/kg/day limit dose). Therefore,
a degree of concern analysis for prenatal and/or postnatal
susceptibility is not necessary.
Highly conservative dietary (food and water) exposure estimates are
at least 60,000 times lower than the highest
[[Page 27455]]
dose tested in the mammalian toxicity studies (at which no adverse
observed effects were seen).
E. Aggregate Risks and Determination of Safety
1. Acute/chronic risk. Aggregating routes and/or pathways of
exposure is not relevant, since no hazard was identified via any route
of exposure in the EUP toxicology data base.
2. Short/Intermediate-term risk. Chlorantraniliprole is not
registered for use on any sites that would result in short and
intermediate residential exposure and therefore no risk assessment was
conducted for this scenario.
3. Aggregate cancer risk for U.S. population. Long-term exposure is
not expected to result from use under these EUPs. The submitted
subchronic studies in mice, dog and rats, and the in vivo and in vitro
genotoxicity studies, identified no tumors or preneoplastic foci, nor
did they identify mutagenic concern.
4. Determination of safety. Based on these risk assessments, 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 chlorantraniliprole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
LC/MS/MS methods are available for measuring chlorantraniliprole in
plants and livestock. The registrant submitted an LC/MS/MS method for
the determination of chlorantraniliprole in plants, and an LC/MS/MS
method for the determination of chlorantraniliprole and its metabolites
in livestock.
Adequate method and concurrent recovery data were provided for the
plant LC/MS/MS method, and the fortification levels used in the method
and concurrent validation are adequate to bracket the residue levels
determined in the proposed crops. An analytical method for enforcing
tolerances in livestock commodities is not germane to this EUP as
tolerances in meat, milk, poultry and eggs are not required.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican MRLs
for chlorantraniliprole.
C. Conditions
None.
V. Conclusion
Therefore, time-limited tolerances are established for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm,
celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm,
lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach
at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at
0.20 ppm. These tolerances will expire on May 1, 2010.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, 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) 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 6,
2000) do not apply to this rule. In addition, This 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: May 2, 2007.
Debra Edwards,
Director, 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 180.628 is added to read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
(a) Tolerances are established for residues of the pesticide
chlorantraniliprole (3-bromo-N-[4-chloro-2-methyl-6-
[[Page 27456]]
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following raw agricultural commodities:
----------------------------------------------------------------------------------------------------------------
Expiration/revocation
Commodity Parts per million date
----------------------------------------------------------------------------------------------------------------
Apple 0.25 05/01/2010
----------------------------------------------------------------------------------------------------------------
Apple, wet pomace 0.60 05/01/2010
----------------------------------------------------------------------------------------------------------------
Celery 7.0 05/01/2010
----------------------------------------------------------------------------------------------------------------
Cucumber 0.10 05/01/2010
----------------------------------------------------------------------------------------------------------------
Lettuce, head 4.0 05/01/2010
----------------------------------------------------------------------------------------------------------------
Lettuce, leaf 8.0 05/01/2010
----------------------------------------------------------------------------------------------------------------
Pear 0.30 05/01/2010
----------------------------------------------------------------------------------------------------------------
Pepper 0.50 05/01/2010
----------------------------------------------------------------------------------------------------------------
Spinach 13.0 05/01/2010
----------------------------------------------------------------------------------------------------------------
Squash 0.40 05/01/2010
----------------------------------------------------------------------------------------------------------------
Tomato 0.30 05/01/2010
----------------------------------------------------------------------------------------------------------------
Watermelon 0.20 05/01/2010
----------------------------------------------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-9206 Filed 5-15-07; 8:45 am]
BILLING CODE 6560-50-S