Novaluron; Pesticide Tolerances, 74978-74983 [E8-29117]
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Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
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.
I. General Information
[EPA–HQ–OPP–2007–0438 FRL–8391–5]
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 sugarcane, cane and tomato.
Interregional Research Project Number 4
(IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA). It also revokes the
existing, time-limited tolerance for
residues of novaluron in or on
sugarcane, cane and revises the
chemical name for novaluron in 40 CFR
180.598 to reflect EPA’s preferred
nomenclature.
DATES: This regulation is effective
December 10, 2008. Objections and
requests for hearings must be received
on or before February 9, 2009, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0438. 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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2007–0438 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 9, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
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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–2007–0438, 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 July 25,
2007 (72 FR 40877) (FRL–8137–1), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7E7199) by
Interregional Research Project Number 4
(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, 1[3-chloro-4-(1,1,2-trifluoro-2trifluoromethoxyethoxy)phenyl]-3-(2,6difluorobenzoyl)urea, in or on
sugarcane, cane at 0.50 parts per million
(ppm); tomato at 0.40 ppm; and tomato,
paste at 0.80 ppm. 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. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
increased the tolerance on tomato to 1.0
ppm and determined that a separate
tolerance on tomato, paste is not
needed. The reasons for these changes
are explained in Unit IV.D.
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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
sugarcane, cane at 0.50 ppm and tomato
at 1.0 ppm. EPA’s assessment of
exposures and risks associated with
establishing tolerances follows.
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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 red blood corpuscles (RBCs or
erythrocytes) associated with increased
erythropoiesis.
There was no maternal or
developmental toxicity seen in the rat
and rabbit developmental toxicity
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studies up to the limit doses. In the 2generation reproductive toxicity study
in rats, both maternal and offspring
toxicity were evidenced by
spleenomegaly. Reproductive toxicity
(decreases in epididymal sperm counts
and increased age at preputial
separation in the F1 generation) was
observed only in males.
Novaluron does not appear to be a
potent neurotoxicant. Signs of
neurotoxicity were seen in the acute
neurotoxicity study in rats but only at
the limit dose of 2,000 milligrams/
kilogram/day (mg/kg/day). Neurotoxic
signs seen in this study included
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 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.
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 bacterial DNA
damage or repair assay. Based on the
results of these studies, EPA has
classified novaluron as ‘‘not likely to be
carcinogen 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 document PP
7E7199 Novaluron in/on Sugarcane and
Tomato. Health Effects Division (HED)
Risk Assessment, pages 24 to 27 in
docket ID number EPA–HQ–OPP–2007–
0438.
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 the NOAEL
are observed in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the LOAEL
concern are identified or a benchmark
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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
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 document PP7E7199 Novaluron in/on Sugarcane and
Tomato. Health Effects Division (HED)
Risk Assessment, pages 10 to 11 in
docket ID number EPA–HQ–OPP–2007–
0438.
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
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EPA used the food consumption data
from the United States Department of
Agriculture (USDA) 1994–1996 and
1998 Continuing Surveys of Food
Intakes by Individuals (CSFII). As to
residue levels in food, EPA incorporated
anticipated residues (average field trial
residues) for some commodities,
including the new commodities
(sugarcane and tomatoes); empirical
processing factors for apple juice
(translated to pear juice); and DEEM (ver
7.81) 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 results of
carcinogenicity studies in rats and mice,
EPA has classified novaluron as ‘‘not
likely to be carcinogenic to humans;’’
therefore, a quantitative cancer exposure
assessment 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 CallIns 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.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
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Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
novaluron, chlorophenyl urea and
chloroaniline for chronic exposures for
non-cancer assessments are estimated to
be 1.8 parts per billion (ppb), 0.86 ppb
and 2.6 ppb, respectively, for surface
water and 0.0055 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 percent 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.
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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
safety is commonly referred to as the
FQPA safety factor (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 of 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
maternal toxicity (increased absolute
and relative spleen weights) were
similar and occurred at the same dose;
and 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 maternal
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. EPA began requiring functional
immunotoxicity testing of all food and
non-food use pesticides on December
26, 2007. Since this requirement went
into effect after the tolerance petition
was submitted, these studies are not yet
available for novaluron. In the absence
of specific immunotoxicity studies, EPA
has evaluated the available novaluron
toxicity data to determine whether an
additional database uncertainty factor is
needed to account for potential
immunotoxicity. There was no evidence
of adverse effects on the organs of the
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immune system at the LOAEL in any
study novaluron. In addition, novaluron
does not belong to a class of chemicals
(e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons)
that would be expected to be
immunotoxic. Based on the above
considerations, EPA does not believe
that conducting a special series
870.7800 immunotoxicity study will
result in a point of departure less than
the NOAEL of 0.011 mg/kg/day used in
calculation the cPAD for novaluron, and
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 and were seen
only at the limit dose (2,000 mg/kg/day);
further, the neuropathological effects
that were seen at the limit dose also
occurred in a few untreated control
animals. 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 cause significant
neurotoxicant effects, 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% CT 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
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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
chronic exposure, EPA has concluded
that chronic exposure to novaluron from
food and water will utilize 74% of the
cPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of novaluron is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-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 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. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account 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
intermediate-term residential exposure.
Therefore, the intermediate-term
aggregate risk is the sum of the risk from
exposure to novaluron through food and
water, which has already been
addressed, and will not be greater than
the chronic aggregate risk.
5. Aggregate cancer risk for U.S.
population. EPA has classified
novaluron as ‘‘not likely to be
carcinogenic to humans.’’Novaluron is
not expected to pose a cancer risk.
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6. 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
Adequate enforcement methodology
(a gas chromatography/electron-capture
detection (GC/ECD) method; and a high
pressure liquid chromatography/
ultraviolate detection (HPLC/UV)
method) is available to enforce the
tolerance expression. 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
No Canadian or Mexican MRLs have
been established for novaluron on the
sugarcane or tomato commodities. A
CODEX MRL is established for
novaluron (fat soluble) on tomato at 0.02
ppm, significantly below the U.S.
tolerance being established by this
regulation (1.0 ppm). The U.S. tolerance
is based on a different use pattern,
including both a higher application rate
(12.8x higher) and shorter pre-harvest
interval (PHI) (2 days vs. 7 days). For
these reasons, the U.S. tolerance cannot
be harmonized with the CODEX MRL at
this time.
C. Response to Comments
EPA received comments from a
private citizen complaining that she was
unable to open the ‘‘proposal’’ at https://
www.regulations.gov. If by ‘‘proposal,’’
the commenter is referring to the
registrant’s notice of filing, EPA notes
that it is available in the docket in two
common file formats, MicroSoft Word
and Portable Document Format (PDF)
and cannot explain the commenter’s
inability to open it. User support is
available for anyone having trouble
using the regulations website by calling
1–877-ERUL HLP (1–877–378–5457) or
by using the Web form link provided
under ‘‘Contact Us.’’
D. Revisions to Petitioned-For
Tolerances
Based upon review of the data
supporting the petition, EPA
determined that the proposed tolerance
on tomato should be increased to 1.0
ppm and that a separate tolerance on
tomato paste is not needed. EPA revised
the tolerance level for tomato based on
analyses of both field- and greenhouse-
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grown residue trials using the Agency’s
Tolerance Spreadsheet in accordance
with the Agency’s Guidance for Setting
Pesticide Tolerances Based on Field
Trial Data. The tolerance level of 1.0
ppm is based on the spreadsheet results
for greenhouse-grown tomatoes, the
cropping scenario that resulted in the
higher recommended tolerance. The
submitted tomato processing data
indicate that residues of novaluron are
not likely to concentrate in puree but
may concentrate slightly in paste. Based
on the processing factor (1.1x) for paste
and the highest average field trial
(HAFT) residue of 0.365 ppm from the
tomato trials, residues of novaluron in
paste are not expected to exceed the
tolerance for tomato (1.0 ppm);
therefore, no tolerances for tomato
processed commodities are needed.
The tolerance expression at 40 CFR
180.598 uses the International Union of
Pure and Applied Chemistry (IUPAC)
nomenclature for novaluron (1-[3chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-(2,6difluorobenzoyl)urea). Since it is EPA’s
policy to use the Chemical Abstracts
Service (CAS) nomenclature in
tolerance expressions, EPA is revising
the tolerance expression to reflect the
correct CAS designation for novaluron
(N-[[[3-chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide). EPA has
determined that it is reasonable to make
this change final without prior proposal
and opportunity for comment, because
public comment is not necessary, in that
the change has no substantive effect on
the tolerance, but rather is a minor
change in scientific nomenclature
consistent with accepted Agency policy
and practice.
dwashington3 on PROD1PC60 with RULES
V. Conclusion
Therefore, tolerances are established
for residues of novaluron, N-[3-chloro-4[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide, in or on sugarcane,
cane at 0.50 ppm and tomato at 1.0
ppm.
A time-limited tolerance of 0.15 ppm
was established for residues of
novaluron on sugarcane, cane in
connection with a FIFRA section 18
emergency exemption granted by EPA.
This tolerance (set to expire on 12/31/
09) is superseded by the higher
tolerance being established on
sugarcane, cane and is no longer
needed. Therefore, the time-limited
tolerance is being revoked.
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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
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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 25, 2008.
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
removing the entry for sugarcane, cane
from the table in paragraph (b); revising
paragraph (a) introductory text and
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
■
§ 180.598 Novaluron; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide novaluron, N-[[[3-chloro-4[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide, in or on the
following raw agricultural commodities:
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Commodity
*
74983
Parts per million
*
*
*
*
Sugarcane, cane
0.50
Tomato
1.0
*
*
*
*
*
*
*
*
*
*
I. Overview
*
*
*
*
*
Amendments enacted in 1992 to the
Marine Protection, Research, and
Sanctuaries Act (MPRSA) require that
no permits for ocean dumping shall be
issued for an EPA-established ocean
dumping site after January 1, 1997,
unless the site has received a final
designation; therefore, interim ocean
dumping sites that have not received a
final designation are no longer available
for use. Under EPA regulations, the
authority to issue interim ocean
dumping permits expired on April 23,
1978, and interim permits are no longer
issued. Under EPA regulations, interim
criteria for constituents prohibited as
other than trace contaminants in
material proposed for ocean dumping,
as well as interim guidance used to
determine the limiting permissible
concentration for the suspended
particulate and solid phases of the
material proposed to be dumped, were
applicable only until EPA announced
the availability of acceptable procedures
to evaluate materials for ocean
dumping. On April 4, 1991, EPA and
the U.S. Army Corps of Engineers
announced the availability of a testing
manual for dredged material entitled
‘‘Evaluation of Dredged Material
Proposed for Ocean Disposal—Testing
Manual,’’ which revised the 1977 EPA/
U.S. Army Corps of Engineers
document, ‘‘Ecological Evaluation of
Proposed Discharge of Dredged Material
into Ocean Waters.’’ In addition, EPA
published ‘‘Bioassay Procedures for the
Ocean Disposal Permit Program,’’ which
outlines acceptable procedures for nondredged material.
[FR Doc. E8–29117 Filed 12–9–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 220, 221, 222, 223, 224,
227, and 228
[FRL–8748–4]
RIN 2040–AF01
Repeal of Obsolete Regulations Under
the Marine Protection, Research, and
Sanctuaries Act Regarding Interim
Ocean Dumping Sites, Interim Ocean
Dumping Permits, and Interim Ocean
Dumping Criteria
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is taking final action to
repeal expired, and therefore, obsolete
regulatory provisions regarding interim
ocean dumping sites, interim ocean
dumping permits, and interim ocean
dumping criteria. Repeal of all reference
to ‘‘interim’’ provisions is necessary
based on legislation enacted since
promulgation of the reference, EPA
action since promulgation of the
reference, or the passage of a date
specified in a definition of the reference.
This action does not make any
substantive changes to EPA’s ocean
dumping regulations. This is a
housekeeping measure intended only to
eliminate confusion by repealing
obsolete regulatory text.
dwashington3 on PROD1PC60 with RULES
DATES: This rule is effective on January
9, 2009.
FOR FURTHER INFORMATION CONTACT:
David Redford, Oceans and Coastal
Protection Division, Office of Wetlands,
Oceans, and Watersheds, 4504T,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202–566–
1288; fax number: 202–566–1546; e-mail
address: redford.david@epa.gov.
SUPPLEMENTARY INFORMATION:
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II. Background
A. Potentially Affected Entities
Generally, ocean dumping sites and
permits are used by persons,
organizations, or government bodies
seeking to dispose of dredged material
or other material in ocean waters.
However, there are no regulated entities
potentially affected by this action,
because all of the regulatory provisions
being repealed have expired, and
therefore, have become obsolete (see
Section III below). Nothing in this
action alters the jurisdiction or authority
of EPA or the entities regulated under
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the Marine Protection, Research, and
Sanctuaries Act.
B. Marine Protection, Research, and
Sanctuaries Act
The Marine Protection, Research, and
Sanctuaries Act of 1972, as amended,
also known as the Ocean Dumping Act,
regulates the transportation and
dumping of material into ocean waters.
Under the MPRSA, no permit may be
issued for ocean dumping where such
dumping will unreasonably degrade or
endanger human health or the marine
environment. Most material ocean
dumped today is dredged material (i.e.,
sediments) removed from the bottom of
water bodies to maintain navigation
channels and berthing areas. Other
materials that are currently disposed of
in the ocean include fish wastes, human
remains, and vessels.
Ocean dumping cannot occur except
pursuant to a permit under the MPRSA
and its implementing regulations. The
U.S. Army Corps of Engineers (USACE)
issues permits for dumping dredged
material in the ocean, using EPA’s
environmental criteria and subject to
EPA’s concurrence. For all other
materials, EPA is the permitting agency.
EPA also is responsible for designating
recommended ocean dumping sites for
all types of materials, including dredged
material. EPA’s ocean dumping
regulations at 40 CFR Part 228 establish
procedures for the designation and
management of ocean disposal sites and
list the available EPA-designated ocean
dumping sites by EPA Region (40 CFR
228.15).
C. Interim Ocean Dumping Sites,
Permits, Criteria, and Guidance
When EPA originally promulgated the
ocean dumping regulations in the
1970’s, the Agency made provisions for
interim ocean dumping sites, interim
ocean dumping permits, and interim
ocean dumping criteria. These interim
provisions were designed to be
temporary measures that would expire
under certain conditions, primarily
when final sites were designated and
criteria were established. As described
in Section III below, all provisions
related to interim ocean dumping sites,
interim permits, interim criteria, and
interim guidance have expired and are
therefore obsolete.
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Agencies
[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Rules and Regulations]
[Pages 74978-74983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29117]
[[Page 74978]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0438 FRL-8391-5]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on sugarcane, cane and tomato. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA). It also revokes the existing,
time-limited tolerance for residues of novaluron in or on sugarcane,
cane and revises the chemical name for novaluron in 40 CFR 180.598 to
reflect EPA's preferred nomenclature.
DATES: This regulation is effective December 10, 2008. Objections and
requests for hearings must be received on or before February 9, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0438. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR site
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2007-0438 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 9, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0438, 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 July 25, 2007 (72 FR 40877) (FRL-8137-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7199) by Interregional Research Project Number 4 (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, 1-[3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea, in or on
sugarcane, cane at 0.50 parts per million (ppm); tomato at 0.40 ppm;
and tomato, paste at 0.80 ppm. 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. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA has
increased the tolerance on tomato to 1.0 ppm and determined that a
separate tolerance on tomato, paste is not needed. The reasons for
these changes are explained in Unit IV.D.
[[Page 74979]]
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 sugarcane, cane at 0.50 ppm and
tomato at 1.0 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 red blood corpuscles (RBCs or erythrocytes) associated with
increased erythropoiesis.
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 spleenomegaly. Reproductive
toxicity (decreases in epididymal sperm counts and increased age at
preputial separation in the F1 generation) was observed only in males.
Novaluron does not appear to be a potent neurotoxicant. Signs of
neurotoxicity were seen in the acute neurotoxicity study in rats but
only at the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day).
Neurotoxic signs seen in this study included 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 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.
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 bacterial DNA damage or repair assay. Based on the results of
these studies, EPA has classified novaluron as ``not likely to be
carcinogen 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 document PP 7E7199 Novaluron in/on Sugarcane and
Tomato. Health Effects Division (HED) Risk Assessment, pages 24 to 27
in docket ID number EPA-HQ-OPP-2007-0438.
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 the
NOAEL are observed in the toxicology study identified as appropriate
for use in risk assessment. However, if a NOAEL cannot be determined,
the LOAEL concern are identified 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 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
document PP-7E7199 Novaluron in/on Sugarcane and Tomato. Health Effects
Division (HED) Risk Assessment, pages 10 to 11 in docket ID number EPA-
HQ-OPP-2007-0438.
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
[[Page 74980]]
EPA used the food consumption data from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food
Intakes by Individuals (CSFII). As to residue levels in food, EPA
incorporated anticipated residues (average field trial residues) for
some commodities, including the new commodities (sugarcane and
tomatoes); empirical processing factors for apple juice (translated to
pear juice); and DEEM (ver 7.81) 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 results of carcinogenicity studies in
rats and mice, EPA has classified novaluron as ``not likely to be
carcinogenic to humans;'' therefore, a quantitative cancer exposure
assessment 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.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
novaluron, chlorophenyl urea and chloroaniline for chronic exposures
for non-cancer assessments are estimated to be 1.8 parts per billion
(ppb), 0.86 ppb and 2.6 ppb, respectively, for surface water and 0.0055
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 percent 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 safety is commonly referred to as the FQPA safety
factor (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 of 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 maternal toxicity (increased absolute
and relative spleen weights) were similar and occurred at the same
dose; and 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 maternal
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. EPA began requiring functional immunotoxicity
testing of all food and non-food use pesticides on December 26, 2007.
Since this requirement went into effect after the tolerance petition
was submitted, these studies are not yet available for novaluron. In
the absence of specific immunotoxicity studies, EPA has evaluated the
available novaluron toxicity data to determine whether an additional
database uncertainty factor is needed to account for potential
immunotoxicity. There was no evidence of adverse effects on the organs
of the
[[Page 74981]]
immune system at the LOAEL in any study novaluron. In addition,
novaluron does not belong to a class of chemicals (e.g., the
organotins, heavy metals, or halogenated aromatic hydrocarbons) that
would be expected to be immunotoxic. Based on the above considerations,
EPA does not believe that conducting a special series 870.7800
immunotoxicity study will result in a point of departure less than the
NOAEL of 0.011 mg/kg/day used in calculation the cPAD for novaluron,
and 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 and were
seen only at the limit dose (2,000 mg/kg/day); further, the
neuropathological effects that were seen at the limit dose also
occurred in a few untreated control animals. 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 cause significant neurotoxicant
effects, 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% CT 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 74% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of novaluron is not
expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-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 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. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account 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 intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to novaluron through food and water, which has already been addressed,
and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. EPA has classified
novaluron as ``not likely to be carcinogenic to humans.''Novaluron is
not expected to pose a cancer risk.
6. 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
Adequate enforcement methodology (a gas chromatography/electron-
capture detection (GC/ECD) method; and a high pressure liquid
chromatography/ultraviolate detection (HPLC/UV) method) is available to
enforce the tolerance expression. 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
No Canadian or Mexican MRLs have been established for novaluron on
the sugarcane or tomato commodities. A CODEX MRL is established for
novaluron (fat soluble) on tomato at 0.02 ppm, significantly below the
U.S. tolerance being established by this regulation (1.0 ppm). The U.S.
tolerance is based on a different use pattern, including both a higher
application rate (12.8x higher) and shorter pre-harvest interval (PHI)
(2 days vs. 7 days). For these reasons, the U.S. tolerance cannot be
harmonized with the CODEX MRL at this time.
C. Response to Comments
EPA received comments from a private citizen complaining that she
was unable to open the ``proposal'' at https://www.regulations.gov. If
by ``proposal,'' the commenter is referring to the registrant's notice
of filing, EPA notes that it is available in the docket in two common
file formats, MicroSoft Word and Portable Document Format (PDF) and
cannot explain the commenter's inability to open it. User support is
available for anyone having trouble using the regulations website by
calling 1-877-ERUL HLP (1-877-378-5457) or by using the Web form link
provided under ``Contact Us.''
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA
determined that the proposed tolerance on tomato should be increased to
1.0 ppm and that a separate tolerance on tomato paste is not needed.
EPA revised the tolerance level for tomato based on analyses of both
field- and greenhouse-
[[Page 74982]]
grown residue trials using the Agency's Tolerance Spreadsheet in
accordance with the Agency's Guidance for Setting Pesticide Tolerances
Based on Field Trial Data. The tolerance level of 1.0 ppm is based on
the spreadsheet results for greenhouse-grown tomatoes, the cropping
scenario that resulted in the higher recommended tolerance. The
submitted tomato processing data indicate that residues of novaluron
are not likely to concentrate in puree but may concentrate slightly in
paste. Based on the processing factor (1.1x) for paste and the highest
average field trial (HAFT) residue of 0.365 ppm from the tomato trials,
residues of novaluron in paste are not expected to exceed the tolerance
for tomato (1.0 ppm); therefore, no tolerances for tomato processed
commodities are needed.
The tolerance expression at 40 CFR 180.598 uses the International
Union of Pure and Applied Chemistry (IUPAC) nomenclature for novaluron
(1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-
(2,6-difluorobenzoyl)urea). Since it is EPA's policy to use the
Chemical Abstracts Service (CAS) nomenclature in tolerance expressions,
EPA is revising the tolerance expression to reflect the correct CAS
designation for novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide).
EPA has determined that it is reasonable to make this change final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is a minor change in scientific
nomenclature consistent with accepted Agency policy and practice.
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 sugarcane, cane at 0.50 ppm and tomato at 1.0 ppm.
A time-limited tolerance of 0.15 ppm was established for residues
of novaluron on sugarcane, cane in connection with a FIFRA section 18
emergency exemption granted by EPA. This tolerance (set to expire on
12/31/09) is superseded by the higher tolerance being established on
sugarcane, cane and is no longer needed. Therefore, the time-limited
tolerance is being revoked.
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 25, 2008.
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 removing the entry for sugarcane, cane
from the table in paragraph (b); revising paragraph (a) introductory
text and alphabetically adding the following commodities to the table
in paragraph (a) to read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) General. Tolerances are established 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 the following raw agricultural commodities:
[[Page 74983]]
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Sugarcane, cane 0.50
----------------------------------------------------------------------------------------------------------------
Tomato 1.0
* * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
* * * * *
[FR Doc. E8-29117 Filed 12-9-08; 8:45 am]
BILLING CODE 6560-50-S