[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Rules and Regulations]
[Pages 65029-65034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29212]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0769; FRL-8799-6]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on bushberry subgroup 13-07B; Brassica, leafy greens,
subgroup 5B; turnip, greens; fruit, stone, group 12, except cherry;
cherry; and plum, prune, dried. This regulation additionally revises an
existing tolerance in or on egg and revises terminology for an existing
tolerance. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective December 9, 2009. Objections and
requests for hearings must be received on or before February 8, 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-2008-0769. All documents in the
docket are listed in the docket index available at http://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 http://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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
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 http://www.gpoaccess.gov/ecfr. To
access the OPPTS Harmonized Test Guidelines referenced in this
document, go directly to the guidelines at http://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-2008-0769 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before February 8, 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-2008-0769, by one of the following methods:
Federal eRulemaking Portal: http://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.
[[Page 65030]]
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8E7425 and PP 8E7426) by IR-4, 500 College Road East, Suite 201 W.,
Princeton, NJ 08540. The petitions 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 bushberry, subgroup 13-07B at 7 parts per million (ppm) (PP
8E7425); fruit, stone, group 12 at 8 ppm (PP 8E7426); Brassica, leafy
greens, subgroup 5B at 25 ppm (PP 8E7426); and turnip, greens at 25 ppm
(PP 8E7426). PP 8E7426 additionally requested to increase the existing
tolerance for residues of novaluron in or on egg from 0.05 ppm to 0.07
ppm; however, the petition number associated with this request was
incorrectly reported. The correct petition number for the request to
increase the existing egg tolerance is PP 9F7630. The notice referenced
summaries of the petitions prepared on behalf of IR-4 by Makhteshim-
Agan of North America, Inc., the registrant, which are available to the
public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the tolerance on stone fruit and has determined that individual
tolerances in or on cherry; and plum, prune, dried are necessary. 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 bushberry subgroup 13-07B at
7.0 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; turnip, greens
at 25 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; cherry at
8.0 ppm; plum, prune, dried at 2.6 ppm; and egg at 0.07 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 http://www.regulations.gov in document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Bushberry Crop Subgroup 13-
07B; Brassica, Leafy Greens, Crop Subgroup 5B; Turnip, Greens; and
Fruit, Stone, Crop Group 12,'' pages 28-31 in docket ID number EPA-HQ-
OPP-2008-0769.
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
[[Page 65031]]
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, 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 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for novaluron used for
human risk assessment can be found at http://www.regulations.gov in
document ``Novaluron: Human-Health Risk Assessment for Proposed Section
3 Uses on Bushberry Crop Subgroup 13-07B; Brassica, Leafy Greens, Crop
Subgroup 5B; Turnip, Greens; and Fruit, Stone, Crop Group 12,'' pages
13-14 in docket ID number EPA-HQ-OPP-2008-0769.
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 from
average field trial residues for pome fruit, sugarcane, bushberries,
Brassica leafy greens, stone fruit and greenhouse tomatoes; empirical
processing factors for apple juice (translated to pear and stone fruit
juice), tomato paste and pur[eacute]e, and dried plums; and 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 and milk commodities but used
tolerance-level residues for poultry commodities. 100 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 http://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 http://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
[[Page 65032]]
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
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 Test 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), 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
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-, intermediate-, 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 83% 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- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- 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- 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: [email protected].
B. International Residue Limits
No Codex, Canadian or Mexican maximum residue limits (MRLs) have
been established for novaluron on bushberries; Brassica, leafy greens;
turnip greens; or stone fruit. Canada has reviewed the use of novaluron
on Brassica, leafy greens and stone fruit
[[Page 65033]]
(including cherry and plum, prune, dried). Canadian and U.S.
recommendations have been harmonized and MRLs for Brassica, leafy
greens, subgroup 5B at 7.0 ppm; stone fruit, group 12, except cherry at
1.9 ppm; cherry at 8.0 ppm; and plum, prune, dried at 2.6 ppm are
expected to be established in Canada.
C. Revisions to Petitioned-For Tolerances
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 revised
the proposed tolerance on fruit, stone, group 12 (excluding cherry; and
plum, prune, dried) from 8.0 ppm to 1.9 ppm and determined that
individual tolerances on cherry at 8.0 ppm and plum, prune, dried at
2.6 ppm are necessary. For peaches, fresh plums and cherries (the
representative commodities for fruit, stone, group 12) the tolerance
spreadsheet recommends tolerances of 1.8 ppm, 1.9 ppm, and 8.0 ppm,
respectively. For plum, prune, dried, the tolerance spreadsheet
recommends a tolerance of 2.6 ppm. Therefore, tolerances of novaluron
in or on fruit, stone, group 12, except cherry at 1.9 ppm; cherry at
8.0 ppm; and plum, prune, dried at 2.6 ppm are appropriate. EPA has
also revised the tolerance expression to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of novaluron not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
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 bushberry subgroup 13-07B at 7.0 ppm; Brassica, leafy greens,
subgroup 5B at 25 ppm; turnip, greens at 25 ppm; fruit, stone, group
12, except cherry at 1.9 ppm; cherry at 8.0 ppm; plum, prune, dried at
2.6 ppm; and egg at 0.07 ppm. EPA also revised the commodity definition
for vegetables, tuberous and corn, subgroup 1C to vegetable, tuberous
and corm, subgroup 1C to reflect the correct commodity definition.
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: November 13, 2009.
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:
i. Revising the introductory text in paragraph (a);
ii. Revising the existing entries for ``Egg'' and ``Vegetables,
tuberous and corn, subgroup 1C'' in the table in paragraph (a) and
alphabetically adding ``Brassica, leafy greens, subgroup 5B'';
``Bushberry subgroup 13-07B''; ``Cherry''; ``Fruit, stone, group 12,
except cherry''; ``Plum, prune, dried''; and ``Turnip, greens'' to the
table in paragraph (a); and
iii. Revising the introductory text in paragraph (b).
The amendments read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide novaluron, including its metabolites and degradates, in or
on the following commodities. Compliance with the tolerance levels
specified in the following table is to be determined by
[[Page 65034]]
measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide),
in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Brassica, leafy greens, subgroup 5B........................ 25
Bushberry subgroup 13-07B.................................. 7.0
* * * * *
Cherry..................................................... 8.0
* * * * *
Egg........................................................ 0.07
* * * * *
Fruit, stone, group 12, except cherry...................... 1.9
* * * * *
Plum, prune, dried......................................... 2.6
* * * * *
Turnip, greens............................................. 25
Vegetable, tuberous and corm, subgroup 1C.................. 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide novaluron, including its
metabolites and degradates, in connection with use of the pesticide
under section 18 emergency exemptions granted by EPA. Compliance with
the tolerance levels specified in the following table is to be
determined by measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-
trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-
difluorobenzamide). These tolerances will expire and are revoked on the
dates specified in the following table:
* * * * *
[FR Doc. E9-29212 Filed 12-8-09; 8:45 am]
BILLING CODE 6560-50-S