Novaluron; Pesticide Tolerances, 4274-4279 [2010-1609]
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more than 30 days, or both. Nothing
contained in these rules and regulations
shall be construed to abrogate any other
Federal laws or regulations or any State
and local laws and regulations
applicable to any area in which the
property is situated.
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Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 2010–1643 Filed 1–26–10; 8:45 am]
BILLING CODE 7710–12–P
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0273; FRL–8807–2]
Novaluron; Pesticide Tolerances
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AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of novaluron in
or on multiple commodities discussed
later in this document. Additionally,
this regulation removes the established
tolerance on tomato, as it is included as
a member in ‘‘vegetable, fruiting, group
8’’. Interregional Research Project
Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 27, 2010. Objections and
requests for hearings must be received
on or before March 29, 2010, 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–2009–0273. All documents in the
docket are listed in the docket index
available at https://www.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
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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:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
SUPPLEMENTARY 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 Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods & Guidelines’’ on the left-side
navigation menu.
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
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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–2009–0273 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 March 29, 2010.
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–2009–0273, 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 June 10,
2009 (74 FR 27538) (FRL–8417–7), 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 9E7546) by IR-4,
500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.598 be
amended by establishing tolerances for
residues of the insecticide novaluron, N[[[3-chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]phenyl]
amino]carbonyl]-2,6-difluorobenzamide,
in or on berry, low growing, subgroup
13-07G at 0.50 parts per million (ppm);
Swiss chard at 12 ppm; bean, snap,
succulent at 0.60 ppm; bean, dry at 0.20
ppm; vegetable, cucurbit, group 9 at
0.25 ppm; and the following
commodities at 1.1 ppm: cocona;
eggplant, African; eggplant, pea;
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eggplant, scarlet; goji berry; huckleberry,
garden; martynia; naranjilla; okra;
roselle; sunberry; tomato, bush; tomato,
currant; tomato, tree; and vegetable,
fruiting, group 8. That notice referenced
a summary of the petition prepared on
behalf of IR-4 by Makhteshim-Agan of
North America, Inc., 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
several of the proposed tolerance levels.
Additionally, the Agency has revised
the entry for berry, low growing,
subgroup 13-07G to exclude lowbush
blueberry. The reasons for these changes
are explained in Unit IV.C.
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 residues of novaluron on
vegetable, fruiting, group 8 at 1.0 ppm;
vegetable, cucurbit, group 9 at 0.15
ppm; berry, low growing, subgroup 1307G, except lowbush blueberry at 0.45
ppm; cocona at 1.0 ppm; eggplant,
African at 1.0 ppm; eggplant, pea at 1.0
ppm; eggplant, scarlet at 1.0 ppm; goji
berry at 1.0 ppm; huckleberry, garden at
1.0 ppm; martynia at 1.0 ppm; naranjilla
at 1.0 ppm; okra at 1.0 ppm; roselle at
1.0 ppm; sunberry at 1.0 ppm; tomato,
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bush at 1.0 ppm; tomato, currant at 1.0
ppm; tomato, tree at 1.0 ppm; bean,
snap, succulent at 0.60 ppm; bean, dry,
seed at 0.30 ppm; and Swiss chard at 12
ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances 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.
Novaluron has low acute toxicity via
the oral, dermal and inhalation routes of
exposure. It is not an eye or skin irritant
and is not a dermal sensitizer. In
subchronic and chronic toxicity studies,
novaluron primarily produced
hematotoxic effects such as
methemoglobinemia, decreased
hemoglobin, decreased hematocrit, and
decreased RBCs (or erythrocytes)
associated with increased
erythropoiesis. Increased spleen weights
and/or hemosiderosis in the spleen were
considered to be due to enhanced
removal of damaged erythrocytes and
not to an immunotoxic effect.
There was no maternal or
developmental toxicity seen in the rat
and rabbit developmental toxicity
studies up to the limit doses. In the 2–
generation reproductive toxicity study
in rats, both maternal and offspring
toxicity were evidenced by enlargement
of the spleen. Reproductive toxicity
(decreases in epididymal sperm counts
and increased age at preputial
separation in the F1 generation) was
observed only in males.
Signs of neurotoxicity were seen in
the rat acute neurotoxicity study at the
limit dose, including clinical signs
(piloerection, fast/irregular breathing),
functional observation battery (FOB)
parameters (head swaying, abnormal
gait) and neuropathology (sciatic and
tibial nerve degeneration). No signs of
neurotoxicity or neuropathology were
observed in the subchronic
neurotoxicity study in rats or in any
other subchronic or chronic toxicity
study in rats, mice or dogs. Therefore,
there is no concern for neurotoxicity
resulting from exposure to novaluron.
There was no evidence of
carcinogenic potential in either the rat
or mouse carcinogenicity studies and no
evidence of mutagenic activity in the
submitted mutagenicity studies,
including a bacterial (Salmonella, E.
coli) reverse mutation assay, an in vitro
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mammalian chromosomal aberration
assay, an in vivo mouse bone-marrow
micronucleus assay and a bacterial DNA
damage or repair assay. Based on the
results of these studies, EPA has
classified novaluron as ‘‘not likely to be
carcinogenic to humans.’’
Specific information on the studies
received and the nature of the adverse
effects caused by novaluron as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
‘‘Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses
on Vegetable, Fruiting, Group 8;
Vegetable, Cucurbit, Group 9; Berry,
Low-growing, Subgroup 13-07G;
Miscellaneous Fruiting Vegetables;
Bean, Snap; Bean, Dry, Seed; and Swiss
Chard,’’ pages 27–30 in docket ID
number EPA–HQ–OPP–2009–0273.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a benchmark dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
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. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term,
and chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the level of concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
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probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for novaluron used for human
risk assessment can be found at https://
www.regulations.gov in the document
‘‘Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses
on Vegetable, Fruiting, Group 8;
Vegetable, Cucurbit, Group 9; Berry,
Low-growing, Subgroup 13-07G;
Miscellaneous Fruiting Vegetables;
Bean, Snap; Bean, Dry, Seed; and Swiss
Chard,’’ pages 12–13 in docket ID
number EPA–HQ–OPP–2009–0273.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to novaluron, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
novaluron tolerances in 40 CFR 180.598.
EPA assessed dietary exposures from
novaluron in food 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 1–day or single
exposure. No such effects were
identified in the toxicological studies
for novaluron; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
Continuing Surveys of Food Intakes by
Individuals (CSFII). As to residue levels
in food, EPA incorporated anticipated
residues derived from average field trial
residues for pome fruit, sugarcane,
bushberry, Brassica leafy greens, stone
fruit, bell pepper, non-bell pepper,
cucumber, summer squash, cantaloupe,
strawberry, succulent snap bean, dry
bean seed, and Swiss chard; average
greenhouse trial residues for tomato;
empirical processing factors for apple
juice (translated to pear and stone fruit
`
juice), tomato paste and puree; and
Dietary Exposure Evaluation Modeling
(DEEM) default processing factors for
the remaining processed commodities.
In estimating dietary exposure from
secondary residues in livestock, EPA
relied on anticipated residues for meat,
hog, and milk commodities. Onehundred percent crop treated (PCT) was
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assumed for all existing and new uses
of novaluron.
iii. Cancer. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
EPA has classified novaluron as ‘‘not
likely to be carcinogenic to humans.’’
Therefore, a quantitative exposure
assessment to evaluate cancer risk is
unnecessary.
iv. Anticipated residue information.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The residues of concern in
drinking water are novaluron and its
chlorophenyl urea and chloroaniline
degradates. The Agency used screening
level water exposure models in the
dietary exposure analysis and risk
assessment for novaluron and its
degradates in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of novaluron.
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.
The following models were used to
assess residues of concern in drinking
water: the Pesticide Root Zone Model/
Exposure Analysis Modeling System
(PRZM/EXAMS) for parent novaluron in
surface water; the First Index Reservoir
Screening Tool (FIRST) for
chlorophenyl urea and chloroaniline
degradates in surface water; and the
Screening Concentration in Ground
Water (SCI-GROW) model for
novaluron, chlorophenyl urea and
chloroaniline in ground water. The
estimated drinking water concentrations
(EDWCs) of novaluron, chlorophenyl
urea, and chloroaniline for chronic
exposures for non-cancer assessments
are estimated to be 0.76 parts per billion
(ppb), 0.89 ppb and 2.6 ppb,
respectively, for surface water and
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0.0056 ppb, 0.0045 ppb and 0.0090 ppb,
respectively, for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. The
highest drinking water concentrations
were estimated for surface water. Of the
three EDWC values for surface water,
the chronic EDWC for the terminal
metabolite, chloroaniline, is the highest
(assuming 100% molar conversion from
parent to aniline). This is consistent
with the expected degradation pattern
for novaluron. Therefore, for chronic
dietary risk assessment, the water
concentration value for chloroaniline of
2.6 ppb was used to assess the
contribution to drinking 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). Novaluron
is not registered for any specific use
patterns that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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.’’
EPA has not found novaluron to share
a common mechanism of toxicity with
any other substances, and novaluron
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that novaluron does not have
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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
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safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicology
database for novaluron includes rat and
rabbit prenatal developmental toxicity
studies and a 2–generation reproduction
toxicity study in rats. There was no
evidence of increased quantitative or
qualitative susceptibility following in
utero exposure to rats or rabbits in the
developmental toxicity studies and no
evidence of increased quantitative or
qualitative susceptibility of offspring in
the reproduction study. Neither
maternal nor developmental toxicity
was seen in the developmental studies
up to the limit doses. In the
reproduction study, offspring and
parental toxicity (increased absolute and
relative spleen weights) were similar
and occurred at the same dose;
additionally, reproductive effects
(decreases in epididymal sperm counts
and increased age at preputial
separation in the F1 generation)
occurred at a higher dose than that
which resulted in parental toxicity.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for novaluron
is complete except for immunotoxicity
testing. Recent changes to 40 CFR part
158 make immunotoxicity testing
(OPPTS Guideline 870.7800) required
for pesticide registration; however, the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios, and for evaluation of the
requirements under the FQPA.
Although effects were seen in the spleen
in two studies, as explained in Unit
III.A., EPA has concluded that
novaluron does not directly target the
immune system and the Agency does
not believe that conducting a functional
immunotoxicity study will result in a
NOAEL lower than the regulatory dose
for risk assessment; therefore, an
additional database uncertainty factor is
not needed to account for potential
immunotoxicity.
ii. There were signs of neurotoxicity
in the acute neurotoxicity study in rats,
including clinical signs (piloerection,
fast/irregular breathing), functional
observation battery (FOB) parameters
(head swaying, abnormal gait), and
neuropathology (sciatic and tibial nerve
degeneration). However, the signs
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observed were not severe, were seen
only at the limit dose (2,000 milligrams/
kilogram/day (mg/kg/day)) and were not
reproducible. No signs of neurotoxicity
or neuropathology were observed in the
subchronic neurotoxicity study in rats at
doses up to 1,752 mg/kg/day in males
and 2,000 mg/kg/day in females or in
any other subchronic or chronic toxicity
study in rats, mice or dogs, including
the developmental and reproduction
studies. Therefore, novaluron does not
appear to be a neurotoxicant, and there
is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. There is no evidence that
novaluron results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level or anticipated residues
derived from reliable residue field trials.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to novaluron in drinking water.
Residential exposures are not expected.
These assessments will not
underestimate the exposure and risks
posed by novaluron.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, novaluron is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
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chronic exposure, EPA has concluded
that chronic exposure to novaluron from
food and water will utilize 84% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential uses
for novaluron.
3. Short-term and intermediate-term
risk. Sort-term and intermediate-term
aggregate exposure takes into account
short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Novaluron is not registered for any use
patterns that would result in residential
exposure. Therefore, the short-term and
intermediate-term aggregate risk is the
sum of the risk from exposure to
novaluron through food and water and
will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S.
population. There was no evidence of
carcinogenic potential in either the rat
or mouse carcinogenicity studies and no
evidence of mutagenic activity in the
submitted mutagenicity studies;
therefore, novaluron is not expected to
pose a cancer risk to humans.
5. 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, or to infants and children
from aggregate exposure to novaluron
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The following adequate enforcement
methodologies are available to enforce
the tolerance expression: A gas
chromatography/electron-capture
detection (GC/ECD) method and a highperformance liquid chromatography/
ultraviolet (HPLC/UV) method. The
methods may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or
Mexican maximum residue limits
established for residues of novaluron on
commodities associated with this
petition.
C. Revisions to Petitioned-for Tolerances
Based on analysis of the residue field
trial data supporting the petition, EPA
revised the proposed tolerances on
vegetable, cucurbit, group 9 from 0.25
ppm to 0.15 ppm; berry, low growing,
subgroup 13-07G, except lowbush
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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations
blueberry from 0.50 ppm to 0.45 ppm;
bean, dry, seed from 0.20 ppm to 0.30
ppm; and the following commodities
from 1.1 ppm to 1.0 ppm: vegetable,
fruiting, group 8; cocona; eggplant,
African; eggplant, pea; eggplant, scarlet;
goji berry; huckleberry, garden;
martynia; naranjilla; okra; roselle;
sunberry; tomato, bush; tomato, currant;
and tomato, tree. EPA revised these
tolerance levels based on analysis of the
residue field trial data using the
Agency’s Tolerance Spreadsheet in
accordance with the Agency’s Guidance
for Setting Pesticide Tolerances Based
on Field Trial Data. EPA also revised
the entry for berry, low growing,
subgroup 13-07G to exclude lowbush
blueberry. Lowbush blueberry is
included as a member of bushberry
subgroup 13-07B, which has an
established tolerance for novaluron at
7.0 ppm; therefore, because the
established subgroup 13-07B tolerance
is higher (at 7.0 ppm), EPA has
excluded lowbush blueberry from
subgroup 13-07G (at 0.45 ppm).
hsrobinson on DSK69SOYB1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2-(trifluoromethoxy)
ethoxy]phenyl]amino]carbonyl]-2,6difluorobenzamide, in or on vegetable,
fruiting, group 8 at 1.0 ppm; vegetable,
cucurbit, group 9 at 0.15 ppm; berry,
low growing, subgroup 13-07G, except
lowbush blueberry at 0.45 ppm; cocona
at 1.0 ppm; eggplant, African at 1.0
ppm; eggplant, pea at 1.0 ppm; eggplant,
scarlet at 1.0 ppm; goji berry at 1.0 ppm;
huckleberry, garden at 1.0 ppm;
martynia at 1.0 ppm; naranjilla at 1.0
ppm; okra at 1.0 ppm; roselle at 1.0
ppm; sunberry at 1.0 ppm; tomato, bush
at 1.0 ppm; tomato, currant at 1.0 ppm;
tomato, tree at 1.0 ppm; bean, snap,
succulent at 0.60 ppm; bean, dry, seed
at 0.30 ppm; and Swiss chard at 12
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,
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16:37 Jan 26, 2010
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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
PO 00000
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Fmt 4700
Sfmt 4700
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: January 19, 2010.
Lois Rossi,
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. Section 180.598 is amended by:
i. Removing the entry for ‘‘Tomato’’
from the table in paragraph (a); and
■ ii. Alphabetically adding the
following commodities to the table in
paragraph (a) to read as follows:
■
■
§ 180.598 Novaluron; tolerances for
residues.
(a) * * *
Commodity
*
*
*
Bean, dry, seed ..............
Bean, snap, succulent ....
Berry, low growing, subgroup 13-07G, except
lowbush blueberry .......
*
*
*
Cocona ...........................
*
*
*
Eggplant, African ............
Eggplant, pea .................
Eggplant, scarlet .............
*
*
*
Goji berry ........................
*
*
*
Huckleberry, garden .......
Martynia ..........................
*
*
*
Naranjilla .........................
Okra ................................
*
*
*
Roselle ............................
*
*
*
Sunberry .........................
Swiss chard ....................
Tomato, bush ..................
Tomato, currant ..............
Tomato, tree ...................
*
*
*
Vegetable, cucurbit,
group 9 ........................
E:\FR\FM\27JAR1.SGM
27JAR1
Parts per million
*
*
*
*
*
*
*
*
*
*
0.30
0.60
0.45
*
1.0
*
1.0
1.0
1.0
*
1.0
*
1.0
1.0
*
1.0
1.0
*
1.0
*
1.0
12
1.0
1.0
1.0
*
0.15
Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations
Commodity
Vegetable, fruiting, group
8 ..................................
*
*
*
*
*
*
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Phil
1.0 Errico, Registration Division (7505P),
*
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6663; e-mail address:
errico.philip@epa.gov.
SUPPLEMENTARY INFORMATION:
Parts per million
*
*
*
[FR Doc. 2010–1609 Filed 1–26–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2008–0876; FRL–8804–2]
Pendimethalin; Pesticide Tolerances
hsrobinson on DSK69SOYB1PROD with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for combined residues or
residues of pendimethalin, N-(1ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, in or on grass
forage, fodder, and hay crop group 17,
forage; grass forage, fodder, and hay
crop group 17, hay; and grass forage,
fodder, and hay crop group 17, straw.
BASF Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 27, 2010. Objections and
requests for hearings must be received
on or before March 29, 2010, 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–2008–0876. All documents in the
docket are listed in the docket index
available at https://www.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
VerDate Nov<24>2008
16:37 Jan 26, 2010
Jkt 220001
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 Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite 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–2008–0876 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
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
4279
as required by 40 CFR part 178 on or
before March 29, 2010.
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–2008–0876, 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 13,
2009 (74 FR 16866) (FRL–8396–6), 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 8F7396) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709–3528. The
petition requested that 40 CFR 180.361
be amended by establishing tolerances
for combined residues of the herbicide,
pendimethalin, N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine, and
its metabolite 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol,
expressed as the stoichiometric
equivalent of pendimethalin, in or on
grass forage, fodder, and hay crop group
17, forage; grass forage, fodder, and hay
crop group 17, hay; and grass forage,
fodder, and hay crop group 17, straw at
40 parts per million (ppm), 80 ppm, and
4.5 ppm, respectively. That notice
referenced a summary of the petition
prepared by BASF Corporation, the
registrant, which is available to the
public in the docket, at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
E:\FR\FM\27JAR1.SGM
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Agencies
[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Rules and Regulations]
[Pages 4274-4279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1609]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0273; FRL-8807-2]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on multiple commodities discussed later in this
document. Additionally, this regulation removes the established
tolerance on tomato, as it is included as a member in ``vegetable,
fruiting, group 8''. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective January 27, 2010. Objections and
requests for hearings must be received on or before March 29, 2010, 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-2009-0273. All documents in the
docket are listed in the docket index available at https://www.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 Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@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 Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr. To
access the OPPTS harmonized test guidelines referenced in this document
electronically, please go to https://www.epa.gov/oppts and select ``Test
Methods & Guidelines'' on the left-side navigation menu.
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-2009-0273 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 March 29, 2010.
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-2009-0273, 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 June 10, 2009 (74 FR 27538) (FRL-8417-
7), 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
9E7546) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.598 be amended by
establishing tolerances for residues of the insecticide novaluron, N-
[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide,
in or on berry, low growing, subgroup 13-07G at 0.50 parts per million
(ppm); Swiss chard at 12 ppm; bean, snap, succulent at 0.60 ppm; bean,
dry at 0.20 ppm; vegetable, cucurbit, group 9 at 0.25 ppm; and the
following commodities at 1.1 ppm: cocona; eggplant, African; eggplant,
pea;
[[Page 4275]]
eggplant, scarlet; goji berry; huckleberry, garden; martynia;
naranjilla; okra; roselle; sunberry; tomato, bush; tomato, currant;
tomato, tree; and vegetable, fruiting, group 8. That notice referenced
a summary of the petition prepared on behalf of IR-4 by Makhteshim-Agan
of North America, Inc., 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 several of the proposed tolerance levels. Additionally, the
Agency has revised the entry for berry, low growing, subgroup 13-07G to
exclude lowbush blueberry. The reasons for these changes are explained
in Unit IV.C.
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 residues of novaluron on vegetable, fruiting, group 8 at
1.0 ppm; vegetable, cucurbit, group 9 at 0.15 ppm; berry, low growing,
subgroup 13-07G, except lowbush blueberry at 0.45 ppm; cocona at 1.0
ppm; eggplant, African at 1.0 ppm; eggplant, pea at 1.0 ppm; eggplant,
scarlet at 1.0 ppm; goji berry at 1.0 ppm; huckleberry, garden at 1.0
ppm; martynia at 1.0 ppm; naranjilla at 1.0 ppm; okra at 1.0 ppm;
roselle at 1.0 ppm; sunberry at 1.0 ppm; tomato, bush at 1.0 ppm;
tomato, currant at 1.0 ppm; tomato, tree at 1.0 ppm; bean, snap,
succulent at 0.60 ppm; bean, dry, seed at 0.30 ppm; and Swiss chard at
12 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances 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.
Novaluron has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a dermal sensitizer. In subchronic and chronic toxicity studies,
novaluron primarily produced hematotoxic effects such as
methemoglobinemia, decreased hemoglobin, decreased hematocrit, and
decreased RBCs (or erythrocytes) associated with increased
erythropoiesis. Increased spleen weights and/or hemosiderosis in the
spleen were considered to be due to enhanced removal of damaged
erythrocytes and not to an immunotoxic effect.
There was no maternal or developmental toxicity seen in the rat and
rabbit developmental toxicity studies up to the limit doses. In the 2-
generation reproductive toxicity study in rats, both maternal and
offspring toxicity were evidenced by enlargement of the spleen.
Reproductive toxicity (decreases in epididymal sperm counts and
increased age at preputial separation in the F1 generation) was
observed only in males.
Signs of neurotoxicity were seen in the rat acute neurotoxicity
study at the limit dose, including clinical signs (piloerection, fast/
irregular breathing), functional observation battery (FOB) parameters
(head swaying, abnormal gait) and neuropathology (sciatic and tibial
nerve degeneration). No signs of neurotoxicity or neuropathology were
observed in the subchronic neurotoxicity study in rats or in any other
subchronic or chronic toxicity study in rats, mice or dogs. Therefore,
there is no concern for neurotoxicity resulting from exposure to
novaluron.
There was no evidence of carcinogenic potential in either the rat
or mouse carcinogenicity studies and no evidence of mutagenic activity
in the submitted mutagenicity studies, including a bacterial
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus
assay and a bacterial DNA damage or repair assay. Based on the results
of these studies, EPA has classified novaluron as ``not likely to be
carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by novaluron 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 https://www.regulations.gov in the document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Vegetable, Fruiting, Group 8;
Vegetable, Cucurbit, Group 9; Berry, Low-growing, Subgroup 13-07G;
Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry, Seed; and
Swiss Chard,'' pages 27-30 in docket ID number EPA-HQ-OPP-2009-0273.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the level of
concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the
[[Page 4276]]
probability of an occurrence of the adverse effect greater than that
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for novaluron used for
human risk assessment can be found at https://www.regulations.gov in the
document ``Novaluron: Human-Health Risk Assessment for Proposed Section
3 Uses on Vegetable, Fruiting, Group 8; Vegetable, Cucurbit, Group 9;
Berry, Low-growing, Subgroup 13-07G; Miscellaneous Fruiting Vegetables;
Bean, Snap; Bean, Dry, Seed; and Swiss Chard,'' pages 12-13 in docket
ID number EPA-HQ-OPP-2009-0273.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to novaluron, EPA considered exposure under the petitioned-for
tolerances as well as all existing novaluron tolerances in 40 CFR
180.598. EPA assessed dietary exposures from novaluron in food 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 1-day or single exposure. No such effects were
identified in the toxicological studies for novaluron; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA incorporated anticipated residues
derived from average field trial residues for pome fruit, sugarcane,
bushberry, Brassica leafy greens, stone fruit, bell pepper, non-bell
pepper, cucumber, summer squash, cantaloupe, strawberry, succulent snap
bean, dry bean seed, and Swiss chard; average greenhouse trial residues
for tomato; empirical processing factors for apple juice (translated to
pear and stone fruit juice), tomato paste and pur[egrave]e; and Dietary
Exposure Evaluation Modeling (DEEM) default processing factors for the
remaining processed commodities. In estimating dietary exposure from
secondary residues in livestock, EPA relied on anticipated residues for
meat, hog, and milk commodities. One-hundred percent crop treated (PCT)
was assumed for all existing and new uses of novaluron.
iii. Cancer. Based on the lack of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
novaluron as ``not likely to be carcinogenic to humans.'' Therefore, a
quantitative exposure assessment to evaluate cancer risk is
unnecessary.
iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
2. Dietary exposure from drinking water. The residues of concern in
drinking water are novaluron and its chlorophenyl urea and
chloroaniline degradates. The Agency used screening level water
exposure models in the dietary exposure analysis and risk assessment
for novaluron and its degradates in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of novaluron. 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.
The following models were used to assess residues of concern in
drinking water: the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for parent novaluron in surface water; the
First Index Reservoir Screening Tool (FIRST) for chlorophenyl urea and
chloroaniline degradates in surface water; and the Screening
Concentration in Ground Water (SCI-GROW) model for novaluron,
chlorophenyl urea and chloroaniline in ground water. The estimated
drinking water concentrations (EDWCs) of novaluron, chlorophenyl urea,
and chloroaniline for chronic exposures for non-cancer assessments are
estimated to be 0.76 parts per billion (ppb), 0.89 ppb and 2.6 ppb,
respectively, for surface water and 0.0056 ppb, 0.0045 ppb and 0.0090
ppb, respectively, for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The highest drinking water
concentrations were estimated for surface water. Of the three EDWC
values for surface water, the chronic EDWC for the terminal metabolite,
chloroaniline, is the highest (assuming 100% molar conversion from
parent to aniline). This is consistent with the expected degradation
pattern for novaluron. Therefore, for chronic dietary risk assessment,
the water concentration value for chloroaniline of 2.6 ppb was used to
assess the contribution to drinking 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). Novaluron is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
EPA has not found novaluron to share a common mechanism of toxicity
with any other substances, and novaluron does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that novaluron does not
have 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 EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of
[[Page 4277]]
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for novaluron includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There was no evidence of increased quantitative or
qualitative susceptibility following in utero exposure to rats or
rabbits in the developmental toxicity studies and no evidence of
increased quantitative or qualitative susceptibility of offspring in
the reproduction study. Neither maternal nor developmental toxicity was
seen in the developmental studies up to the limit doses. In the
reproduction study, offspring and parental toxicity (increased absolute
and relative spleen weights) were similar and occurred at the same
dose; additionally, reproductive effects (decreases in epididymal sperm
counts and increased age at preputial separation in the F1 generation)
occurred at a higher dose than that which resulted in parental
toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for novaluron is complete except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. Although effects were
seen in the spleen in two studies, as explained in Unit III.A., EPA has
concluded that novaluron does not directly target the immune system and
the Agency does not believe that conducting a functional immunotoxicity
study will result in a NOAEL lower than the regulatory dose for risk
assessment; therefore, an additional database uncertainty factor is not
needed to account for potential immunotoxicity.
ii. There were signs of neurotoxicity in the acute neurotoxicity
study in rats, including clinical signs (piloerection, fast/irregular
breathing), functional observation battery (FOB) parameters (head
swaying, abnormal gait), and neuropathology (sciatic and tibial nerve
degeneration). However, the signs observed were not severe, were seen
only at the limit dose (2,000 milligrams/kilogram/day (mg/kg/day)) and
were not reproducible. No signs of neurotoxicity or neuropathology were
observed in the subchronic neurotoxicity study in rats at doses up to
1,752 mg/kg/day in males and 2,000 mg/kg/day in females or in any other
subchronic or chronic toxicity study in rats, mice or dogs, including
the developmental and reproduction studies. Therefore, novaluron does
not appear to be a neurotoxicant, and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that novaluron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level or anticipated residues derived from
reliable residue field trials. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to novaluron in drinking water. Residential exposures are not
expected. These assessments will not underestimate the exposure and
risks posed by novaluron.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
novaluron is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
novaluron from food and water will utilize 84% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for novaluron.
3. Short-term and intermediate-term risk. Sort-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Novaluron is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term and intermediate-term aggregate
risk is the sum of the risk from exposure to novaluron through food and
water and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. There was no evidence
of carcinogenic potential in either the rat or mouse carcinogenicity
studies and no evidence of mutagenic activity in the submitted
mutagenicity studies; therefore, novaluron is not expected to pose a
cancer risk to humans.
5. 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, or to infants and children from aggregate
exposure to novaluron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The following adequate enforcement methodologies are available to
enforce the tolerance expression: A gas chromatography/electron-capture
detection (GC/ECD) method and a high-performance liquid chromatography/
ultraviolet (HPLC/UV) method. The methods 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
established for residues of novaluron on commodities associated with
this petition.
C. Revisions to Petitioned-for Tolerances
Based on analysis of the residue field trial data supporting the
petition, EPA revised the proposed tolerances on vegetable, cucurbit,
group 9 from 0.25 ppm to 0.15 ppm; berry, low growing, subgroup 13-07G,
except lowbush
[[Page 4278]]
blueberry from 0.50 ppm to 0.45 ppm; bean, dry, seed from 0.20 ppm to
0.30 ppm; and the following commodities from 1.1 ppm to 1.0 ppm:
vegetable, fruiting, group 8; cocona; eggplant, African; eggplant, pea;
eggplant, scarlet; goji berry; huckleberry, garden; martynia;
naranjilla; okra; roselle; sunberry; tomato, bush; tomato, currant; and
tomato, tree. EPA revised these tolerance levels based on analysis of
the residue field trial data using the Agency's Tolerance Spreadsheet
in accordance with the Agency's Guidance for Setting Pesticide
Tolerances Based on Field Trial Data. EPA also revised the entry for
berry, low growing, subgroup 13-07G to exclude lowbush blueberry.
Lowbush blueberry is included as a member of bushberry subgroup 13-07B,
which has an established tolerance for novaluron at 7.0 ppm; therefore,
because the established subgroup 13-07B tolerance is higher (at 7.0
ppm), EPA has excluded lowbush blueberry from subgroup 13-07G (at 0.45
ppm).
V. Conclusion
Therefore, tolerances are established for residues of novaluron, N-
[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide,
in or on vegetable, fruiting, group 8 at 1.0 ppm; vegetable, cucurbit,
group 9 at 0.15 ppm; berry, low growing, subgroup 13-07G, except
lowbush blueberry at 0.45 ppm; cocona at 1.0 ppm; eggplant, African at
1.0 ppm; eggplant, pea at 1.0 ppm; eggplant, scarlet at 1.0 ppm; goji
berry at 1.0 ppm; huckleberry, garden at 1.0 ppm; martynia at 1.0 ppm;
naranjilla at 1.0 ppm; okra at 1.0 ppm; roselle at 1.0 ppm; sunberry at
1.0 ppm; tomato, bush at 1.0 ppm; tomato, currant at 1.0 ppm; tomato,
tree at 1.0 ppm; bean, snap, succulent at 0.60 ppm; bean, dry, seed at
0.30 ppm; and Swiss chard at 12 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: January 19, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.598 is amended by:
0
i. Removing the entry for ``Tomato'' from the table in paragraph (a);
and
0
ii. Alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Bean, dry, seed...................................... 0.30
Bean, snap, succulent................................ 0.60
Berry, low growing, subgroup 13-07G, except lowbush 0.45
blueberry...........................................
* * * * *
Cocona............................................... 1.0
* * * * *
Eggplant, African.................................... 1.0
Eggplant, pea........................................ 1.0
Eggplant, scarlet.................................... 1.0
* * * * *
Goji berry........................................... 1.0
* * * * *
Huckleberry, garden.................................. 1.0
Martynia............................................. 1.0
* * * * *
Naranjilla........................................... 1.0
Okra................................................. 1.0
* * * * *
Roselle.............................................. 1.0
* * * * *
Sunberry............................................. 1.0
Swiss chard.......................................... 12
Tomato, bush......................................... 1.0
Tomato, currant...................................... 1.0
Tomato, tree......................................... 1.0
* * * * *
Vegetable, cucurbit, group 9......................... 0.15
[[Page 4279]]
Vegetable, fruiting, group 8......................... 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-1609 Filed 1-26-10; 8:45 am]
BILLING CODE 6560-50-S