Novaluron; Pesticide Tolerances, 55807-55814 [2011-22981]
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
acid), including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels is to be determined by
measuring only the sum of the residues
of dicamba (3,6-dichloro-o-anisic acid)
and its metabolite, 3,6-dichloro-5hydroxy-o-anisic acid, calculated as the
stoichiometric equivalent of dicamba, in
or on the following commodities:
Drug, and Cosmetic Act (FFDCA) for
residues of novaluron in or on multiple
commodities which are identified and
discussed later in this document.
Additionally, the Agency is amending
existing tolerances for meat byproducts
and revising commodity terms for hog
and poultry byproducts. Interregional
Research Project Number 4 (IR–4)
requested the sweet corn tolerances;
Makhteshim-Agan of North America,
Parts per
Inc. requested the food and feed
Commodity
million
handling establishment tolerances.
DATES: This regulation is effective
September 9, 2011. Objections and
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Teff, forage .................................
90.0 requests for hearings must be received
Teff, grain ...................................
6.0 on or before November 8, 2011, and
Teff, hay ......................................
40.0 must be filed in accordance with the
Teff, straw ...................................
30.0 instructions provided in 40 CFR part
178 (see also Unit I.C. of the
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SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a
(2) Tolerances are established for
docket for this action under docket
residues of the herbicide dicamba, 3,6identification (ID) number EPA–HQ–
dichloro-o-anisic acid, including its
metabolites and degradates, in or on the OPP–2010–0466. All documents in the
docket are listed in the docket index
commodities in the table below.
available at https://www.regulations.gov.
Compliance with the tolerance levels is
to be determined by measuring only the Although listed in the index, some
information is not publicly available,
residues of dicamba (3,6-dichloro-oe.g., Confidential Business Information
anisic acid) and its metabolite, 3,6(CBI) or other information whose
dichloro-2-hydroxybenzoic acid,
disclosure is restricted by statute.
calculated as the stoichiometric
Certain other material, such as
equivalent of dicamba, in or on the
copyrighted material, is not placed on
following commodities:
the Internet and will be publicly
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available only in hard copy form.
(3) Tolerances are established for
Publicly available docket materials are
residues of the herbicide dicamba, 3,6available in the electronic docket at
dichloro-o-anisic acid, including its
https://www.regulations.gov, or, if only
metabolites and degradates, in or on the
available in hard copy, at the OPP
commodities in the table below.
Regulatory Public Docket in Rm. S–
Compliance with the tolerance levels is
4400, One Potomac Yard (South Bldg.),
to be determined by measuring only the
2777 S. Crystal Dr., Arlington, VA. The
residues of dicamba, 3,6-dichloro-oDocket Facility is open from 8:30 a.m.
anisic acid, and its metabolites, 3,6to 4 p.m., Monday through Friday,
dichloro-5-hydroxy-o-anisic acid, and
excluding legal holidays. The Docket
3,6-dichloro-2-hydroxybenzoic acid,
Facility telephone number is (703) 305–
calculated as the stoichiometric
5805.
equivalent of dicamba, in or on the
FOR FURTHER INFORMATION CONTACT:
following commodities:
Jennifer Gaines, Registration Division
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(7505P), Office of Pesticide Programs,
[FR Doc. 2011–23159 Filed 9–8–11; 8:45 am]
Environmental Protection Agency, 1200
BILLING CODE 6560–50–P
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5967; e-mail address:
ENVIRONMENTAL PROTECTION
gaines.jennifer@epa.gov.
AGENCY
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
I. General Information
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[EPA–HQ–OPP–2010–0466; FRL–8882–1]
Novaluron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances under the Federal Food,
SUMMARY:
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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:
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• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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–2010–0466 in the subject line on
the first page of your. All requests for a
hearing must be in writing, and must be
received by the Hearing Clerk on or
before November 8, 2011. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
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EPA–HQ–OPP–2010–0466, 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. Summary of Petitioned-for Tolerance
In the Federal Register of June 23,
2010 (75 FR 35801) (FRL–8831–3), 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 0F7708) by
Makhteshim-Agan of North America,
Inc., 4515 Falls of Neuse Road, Raleigh,
NC 27609 as well as the filing of a
pesticide petition (PP 0E7723) by IR–4,
500 College Road East, Suite 201W,
Princeton, NJ 08540. The IR–4 petition
(PP 0E7723) requested that 40 CFR
180.598 be amended by establishing
tolerances for residues of the insecticide
novaluron, (N -[[[3-chloro-4-[1,1,2trifluoro-2- (trifluoromethoxy)ethoxy]
phenyl]amino] carbonyl]-2,6difluorobenzamide), in or on corn,
sweet, kernels plus cob with husks
removed at 0.05 parts per million (ppm);
corn, sweet, forage at 20 ppm; and corn,
sweet, stover at 50 ppm and to increase
the established livestock tolerances for
residues of novaluron in or on milk
from 1.0 to 1.5 ppm, and milk fat from
20 to 35 ppm, respectively. The
Makhteshim-Agan petition (PP 0F7708)
requested novaluron tolerances for all
food commodities (other than those
already covered by a higher tolerance as
a result of use on growing crops) in food
handling establishments where food
products are held, processed or
prepared at 0.01 ppm. That notice
referenced a summary of the petitions
prepared by Makhteshim-Agan of North
America, Inc, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing for PP 0F7708.
Comments were received on the notice
of filing for PP 0E7723. EPA’s response
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to these comments is discussed in Unit
IV.C.
Based upon review of the data
supporting the petition, EPA has revised
the tolerances for sweet corn forage and
determined it is not appropriate to raise
the existing tolerances for milk and milk
fat. The EPA also determined it is
appropriate to revise several existing
livestock commodities based on the
proposed sweet corn use. The reasons
for these changes are explained in Unit
IV.D.
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 novaluron
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with novaluron 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.
No ocular or dermal irritation was
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noted. Novaluron is not a dermal
sensitizer. In subchronic and chronic
toxicity studies, novaluron primarily
produced hematotoxic effects (toxicity
to blood) such as methemoglobinemia,
decreased hemoglobin, decreased
hematocrit, and decreased red blood
corpuscles (RBCs or erythrocytes) that
were associated with compensatory
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 twogeneration reproductive toxicity study
in rats, both parental and offspring
toxicity (increased spleen weights) were
observed at the same dose. Reproductive
toxicity (decreases in epididymal sperm
counts and increase age at preputial
separation in the F1 generation) was
observed at a higher dose 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). However, 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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses
on Sweet Corn and in Food—or FeedHandling Establishments’’ at pages 53–
56 in docket ID number EPA–HQ–OPP–
2010–0466.
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B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
55809
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
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 is
shown in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NOVALURON FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Acute dietary (All
populations).
Not applicable ..............................
None .............................................
Chronic dietary
(All populations).
NOAEL = 1.1 mg/kg/day UF =
100.
FQPA SF = 1x
Chronic RfD = cPAD = 0.011 mg/
kg/day.
Dermal short-term
(1 to 30 days).
Not applicable ..............................
None .............................................
Dermal intermediate-term (1
to 6 months).
Oral study NOAEL = 4.38 mg/kg/
day (dermal absorption rate =
100)%.
Residential LOC for MOE < 100 ..
Inhalation shortterm (1 to 30
days).
Oral study NOAEL = 4.38 mg/kg/
day (inhalation absorption rate
= 100%).
Residential/Occupational LOC for
MOE < 100.
Inhalation Intermediate-term (1
to 6 months).
Oral study NOAEL = 1.1 mg/kg/
day (inhalation absorption rate
= 100%).
Residential/Occupational LOC for
MOE < 100.
An endpoint of concern attributable to a single
dose was not identified. An acute RfD was not
established.
Combined chronic toxicity/carcinogenicity feeding
in rat. LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia.
No toxicity was observed at the limit dose in the
dermal study and there were no developmental
toxicity concerns at the limit-dose; therefore,
quantification of short-term dermal risk is not
necessary.
90-day feeding study in rat. LOAEL = 8.64 mg/kg/
day based on clinical chemistry (decreased hemoglobin, hematocrit, and RBC counts) and
histopathology (increased hematopoieses and
hemosiderosis in spleen and liver).
90-day feeding study in rat. LOAEL = 8.64 mg/kg/
day based on clinical chemistry (decreased hemoglobin, hematocrit, and RBC counts) and
histopathology (increased hematopoieses and
hemosiderosis in spleen and liver).
Combined chronic toxicity/carcinogenicity feeding
in rat. LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia.
Exposure/scenario
Cancer .................
Not likely to be carcinogenic to humans.
UF = Uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of exposure, LOC = level of concern.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to novaluron, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
novaluron tolerances in 40 CFR 180.598.
EPA assessed dietary exposures from
novaluron in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
No such effects were identified in the
toxicological studies for novaluron;
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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 from 1994–1996 and
1998 Continuing Surveys of Food
Intakes by Individuals (CSFII). As to
residue levels in food, EPA conducted a
partially refined dietary (food and
drinking water) exposure and risk
assessment for the proposed new uses
on sweet corn and in food—and feed—
handling establishments, all established
uses, and drinking water using the
DEEM–FCID (Dietary Exposure
Evaluation Model-Food Commodity
Ingredient Database), Version 2.03,
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which uses food consumption data from
the USDA 1994–1996 and 1998 CSFII.
As to residue levels in food, EPA
incorporated average percent crop
treated (PCT) data for apples, cabbage,
cotton, pears, and potatoes, and utilized
percent crop treated for new use PCT
estimates for grain sorghum and sweet
corn. 100 PCT was assumed for the
remaining food commodities.
Anticipated residues (ARs) for meat,
milk, hog, and poultry commodities
were calculated using average field trial
residues, PCT estimates for sweet corn
and grain sorghum, average PCT for
apple and cotton, and assumed 100 PCT
for sugarcane and cowpea seed.
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The chronic analysis also
incorporated average greenhouse trial
residues for tomatoes; empirical
processing factors for apple juice
(translated to pear and stone fruit juice),
cottonseed oil, dried plums, and tomato
paste and puree; and DEEM default
processing factors for the remaining
processed commodities; and average
field trial residues for all crops unless
residues were less than LOQ (If residues
were less than LOQ, the chronic
analysis assumed 1⁄2 LOQ values)
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that novaluron does not pose
a cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) 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.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for
existing uses as follows:
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Apples at 15%; cabbage at 10%;
cotton at 2.5%; pears at 10%; and
potatoes at 2.5%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency estimated the PCT for
new uses as follows:
Sweet corn at 59% and sorghum at
5%.
EPA utilized estimated PCT data in
the chronic dietary risk assessment for
the new use on sweet corn and
sorghum, based on the market leader
approach. Sorghum, though not new,
was only registered 1 year ago. Since
sorghum has been registered for such a
relatively short period, EPA has
sorghum to be a ‘‘new use’’ when
estimating the PCT. The market leader
approach is the comparison of the PCT
with all chemicals of a specific type
(i.e., herbicide, insecticide, etc.) on a
specific crop and choosing the highest
PCT (market leader) as the PCT for the
new use. This method of estimating a
PCT for a new use of a registered
pesticide or a new pesticide produces a
high-end estimate that is unlikely, in
most cases, to be exceeded during the
initial 5 years of actual use. The
predominant factors that bear on
whether the estimated PCT could be
exceeded are: The extent of the pest
pressure on the crops in question; the
pest spectrum of the new pesticide in
comparison with the market leaders as
well as whether the market leaders are
well-established for this use; and
resistance concerns with the market
leaders.
Novaluron has a relatively narrow
spectrum of activity compared to the
market leaders. Additionally, there are
no resistance or pest pressure issues
identified for the use of novaluron on
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sweet corn. All information currently
available has been considered for use on
sweet corn, and EPA concludes that it
is unlikely that the actual sweet corn
PCT with novaluron will exceed the
estimated PCT for new uses during the
next 5 years.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which novaluron may be applied in a
particular area.
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 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.
Estimated drinking water
concentrations (EDWCs) were not
generated for the food-and-feed
handling establishment uses because the
use pattern is not expected to result in
the contamination of drinking water.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) for parent
novaluron in surface water; and the
Screening Concentration in Ground
Water (SCI–GROW) models for
novaluron, chlorophenyl urea and
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chloroaniline in ground water, the
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 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 currently registered for any
specific use patterns that would result
in residential exposure. However, the
following uses that could result in
residential exposures are pending
registration and have been assessed:
Indoor and outdoor uses for the control
of roaches and crickets (crack and
crevice and spot treatments) in
residential areas such as homes and
apartment buildings, and their
immediate surroundings, and on modes
of transportation.
There is a potential for exposure in
residential settings during the
application process for homeowners
who use products containing novaluron.
There is also a potential for exposure
from entering novaluron-treated areas
that could lead to exposures to adults
and children. Both residential handler
and post-application scenarios were
assessed for the indoor use since this is
believed to cover the outdoor perimeter
treatment. Residential handler dermal
and inhalation exposures were assessed
for application via low-pressure
handwands and trigger-pump sprayers.
Additionally exposure routes were
assessed for post-application exposures
for adults and children via inhalation
and dermal routes and post-application
incidental oral (hand-to-mouth)
exposure for children (3 to < 6 years
old). Additionally, a combined
residential assessment that consisted of
adult dermal and inhalation post-
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application exposures as well as
children (3 to < 6 years old) dermal,
inhalation, and oral (hand-to-mouth)
post-application exposure was included
which details of the residential risk
exposure and risk assessment are
contained in the EPA public docket
EPA–HQ–OPP–2010–0466 at https://
www.regulations.gov in document
‘‘Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses
on Sweet Corn and in Food- or FeedHandling Establishments’’ on pp. 28–37.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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 Web site 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
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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 and a 90-day inhalation toxicity
study. Recent changes to 40 CFR part
158 make immunotoxicity testing
(OPPTS Guideline 870.7800) required
for pesticide registration; however, the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios, and for evaluation of the
requirements under the FQPA.
Although effects were seen in the spleen
in two studies, as explained in Unit
III.A., EPA has concluded that
novaluron does not directly target the
immune system and the Agency does
not believe that conducting a functional
immunotoxicity study will result in a
NOAEL lower than the regulatory dose
for risk assessment; therefore, an
additional database uncertainty factor is
not needed to account for potential
immunotoxicity. A 90-day inhalation
toxicity study is requested for further
characterization of inhalation risk. Due
to the potential for repeated inhalation
exposure anticipated from the proposed
residential use pattern, there is concern
for toxicity by the inhalation route. An
inhalation study would provide a dose
and endpoint via the route of exposure
of concern (i.e. route-specific study) and
thus would avoid using an oral study
and route-to-route extrapolation.
Although a point of departure from an
oral study was used to assess residential
post-application inhalation risks for
novaluron, the Agency does not believe
this assessment is under-protective. The
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post-application inhalation MOEs
calculated were all greater than 3,000,
thus providing an ample margin of
safety to account for any uncertainties
in route-to-route extrapolation. Further,
the MOE was calculated for postapplication inhalation exposure and risk
using the saturation concentration
which is a very conservative approach.
The saturation concentration represents
what would occur if a large amount of
chemical were spilled in a nonventilated room and allowed to
evaporate until equilibrium is reached.
ii. There were signs of neurotoxicity
in the acute neurotoxicity study in rats,
including clinical signs (piloerection,
irregular breathing), functional
observation battery (FOB) parameters
(increased head swaying, abnormal
gait), and neuropathology (sciateic and
tibial nerve degeneration). However, the
signs observed were not severe, were
seen only at the limit dose (2000 mg/kg/
day) and were not reproducible. No
signs of neurotoxicity or neuropathology
were observed in the subchronic
neurotoxicity study in rats at similar
doses, and no evidence of
neuropathology was observed in
subchronic and chronic toxicity studies
in rats, mice, or dogs. In addition, no
clinical signs were observed in the acute
oral toxicity study (LD50 ≤ 5,000 mg/
kg). 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 using anticipated
residues derived from reliable residue
field trials and PCT assumptions for
some commodities. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to novaluron in
drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of children as
well as incidental oral exposure of
toddlers resulting from the proposed
residential uses of novaluron. 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 dietary pesticide exposures are
safe by comparing aggregate exposure
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estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer 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 appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from 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 72% of the
cPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure. The residential exposure
assessment was conducted using highend estimates of use and potential
exposure providing a conservative,
health protective estimate of risk.
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).
There are potential short-term
exposures from the pending residential
uses for novaluron. The Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to novaluron.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 1,600 for the U.S. population
and 290 for children 1–2 years old.
Because EPA’s level of concern for
novaluron is a MOE of 100 or below,
these MOEs are not of concern.
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).
There are potential intermediate-term
exposures from the pending residential
uses for novaluron. The Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with intermediate-term
residential exposures to novaluron.
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Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in aggregate MOEs of 320 for U.S.
population and 140 for children 1–2
years old. Because EPA’s level of
concern for novaluron is a MOE of 100
or below, these MOEs are not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
novaluron is not expected to pose a
cancer risk to humans.
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
The following adequate enforcement
methodologies (gas chromatography/
electron-capture detection (GC/ECD)
method and a high-performance liquid
chromatography/ultraviolet (HPLC/UV)
method) are 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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
There are no Codex, Canadian, or
Mexican maximum residue limits
(MRLs) established for residues of
novaluron in or on sweet corn, stover,
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forage and kernel plus cob with husks
removed or for all food commodities
based on the use of novaluron in food
and feed handling establishments.
Canada is currently in the process of
reviewing the use of novaluron on sweet
corn. The EPA and the Pest
Management Regulatory Agency
(PMRA) reviewed the sweet corn
petition as a Joint Review Project and
tolerance recommendations are in
agreement at 0.05 ppm for sweet corn
and kernel plus cob with husks
removed. Additionally, PMRA proposed
to increase its MRL for milk to 1.0 ppm
from 0.5 ppm, and as a result the EPA
and PMRA milk tolerances/MRLs will
be in agreement. The PMRA does not
recommend MRLs for livestock feed
commodities and therefore will not
establish MRLs for sweet corn stover
and sweet corn forage.
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C. Response to Comments
EPA received one comment to the
Notice of Filing that made a general
objection to the presence of any
novaluron residues on vegetable crops.
The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that
pesticides should be banned on
agricultural crops. However, the existing
legal framework provided by section
408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. This citizen’s comment
appears to be directed at the underlying
statute and not EPA’s implementation of
it; the citizen has made no contention
that EPA has acted in violation of the
statutory framework. The commenter
also expressed concern that EPA’s risk
assessment for novaluron did no
‘‘combined testing’’ with other
chemicals. EPA, however, does not
require ‘‘combined testing’’ of a
pesticide with other pesticides or other
chemicals due to impracticality. With
regard to the potential for cumulative
effects from exposure to the pesticide
and other substances with a common
mechanism of toxicity, see the
discussion of this issue in Unit III.C.4.,
Cumulative effects from substances with
a common mechanism of toxicity.
D. 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
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corn, sweet, forage from 20 ppm to 16
ppm and determined no change to the
existing milk and milk fat tolerances is
needed.
Based on the proposed use on sweet
corn, the revised reasonably balanced
dietary burdens (RBDBs) for novaluron
are 9.6 ppm for beef cattle, 18.3 ppm for
dairy cattle, 2.4 ppm for poultry, and 2.5
ppm for swine. Accordingly, the Agency
has determined it is appropriate to raise
the existing tolerances for meat
byproducts. However, no changes are
necessary for the tolerances for
secondary residues in/on cattle, goat,
horse, sheep, poultry, and swine
commodities. Additionally, commodity
terms for hog, meat byproducts and
poultry, meat byproducts are being
revised.
Therefore, the tolerances for meat
byproducts are being revised as follows:
Cattle, meat byproducts, except kidney
and liver from 0.60 ppm to 11 ppm;
goat, meat byproducts, except kidney
and liver from 0.60 ppm to 11 ppm;
horse, meat byproducts, except kidney
and liver from 0.60 ppm to 11 ppm;
sheep, meat byproducts, except kidney
and liver from 0.60 ppm to 11 ppm; hog,
meat byproducts from 0.10 ppm to hog,
meat byproducts, except kidney and
liver to 1.5 ppm; and poultry, meat
byproducts from 0.80 ppm to poultry,
meat byproducts, except kidney and
liver to 7.0 ppm.
V. Conclusion
Therefore, tolerances are established
for residues of novaluron, (N-[[[3chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide), in or on corn,
sweet, kernels plus cob with husks
removed at 0.05 ppm; corn, sweet,
forage at 16 ppm; corn, sweet, stover at
50 ppm; cattle, meat byproducts, except
kidney and liver at 11 ppm; goat, meat
byproducts, except kidney and liver at
11 ppm; horse, meat byproducts, except
kidney and liver at 11 ppm; sheep, meat
byproducts, except kidney and liver at
11 ppm; hog, meat byproducts, except
kidney and liver at 1.5 ppm; poultry,
meat byproducts, except kidney and
liver at 7.0 ppm; and Food/feed
commodities (other than those covered
by a higher tolerance as a result of use
on growing crops) in food/feed handling
establishments at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
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55813
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) (Pub. L. 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
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(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.
Parts per
million
Commodity
*
*
*
*
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Corn, sweet, stover ..................
*
16
*
*
*
*
Food commodities and feed
commodities (other than
those covered by a higher
tolerance as a result of use
on growing crops) in food
and feed handling establishments ....................................
*
0.05
50
0.01
*
*
*
*
Goat, meat byproducts, except
kidney and liver .....................
*
11
*
*
*
*
Hog, meat byproducts, except
kidney and liver .....................
*
1.5
*
*
*
*
Horse, meat byproducts, except
kidney and liver .....................
Dated: August 26, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
11
*
*
*
*
Poultry, meat byproducts, except kidney and liver .............
Therefore, 40 CFR chapter I is
amended as follows:
*
*
*
*
*
Sheep, meat byproducts, except kidney and liver .............
*
7.0
*
11
*
*
*
*
*
I. General Information
BILLING CODE 6560–50–P
A. Does this action apply to me?
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.598, paragraph (a), is
amended as follows:
■ a. Revise the commodity entries for
‘‘cattle, meat byproducts, except kidney
and liver’’; ‘‘goat, meat byproducts,
except kidney and liver’’; ‘‘hog, meat
byproducts’’; ‘‘horse, meat byproducts,
except kidney and liver’’; ‘‘poultry, meat
byproducts’’; ‘‘sheep, meat byproducts,
except kidney and liver’’; and
■ b. Add, alphabetically, the
commodities for ‘‘corn, sweet, forage’’;
‘‘corn, sweet, kernel plus cob with
husks removed’’; ‘‘corn, sweet, stover’’;
and ‘‘food and feed commodities (other
than those covered by a higher tolerance
as a result of use on growing crops) in
food and feed handling establishments.’’
The revised and added text reads as
follows:
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■
§ 180.598 Novaluron; tolerances for
residues.
(a) * * *
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Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
[FR Doc. 2011–22981 Filed 9–8–11; 8:45 am]
1. The authority citation for part 180
continues to read as follows:
■
Cattle, meat byproducts, except
kidney and liver .....................
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
PART 180—[AMENDED]
Commodity
identification (ID) number EPA–HQ–
OPP–2010–0905. 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.
Parts per
million
11
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0905; FRL–8881–7]
2,4-D; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of 2,4-D in or on
teff, bran; teff, forage; teff, grain; and
teff, straw. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 9, 2011. Objections and
requests for hearings must be received
on or before November 8, 2011, 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
SUMMARY:
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55807-55814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22981]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0466; FRL-8882-1]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA) for residues of novaluron in or on
multiple commodities which are identified and discussed later in this
document. Additionally, the Agency is amending existing tolerances for
meat byproducts and revising commodity terms for hog and poultry
byproducts. Interregional Research Project Number 4 (IR-4) requested
the sweet corn tolerances; Makhteshim-Agan of North America, Inc.
requested the food and feed handling establishment tolerances.
DATES: This regulation is effective September 9, 2011. Objections and
requests for hearings must be received on or before November 8, 2011,
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-2010-0466. 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: Jennifer Gaines, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5967; e-mail address: gaines.jennifer@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2010-0466 in the subject line on the first
page of your. All requests for a hearing must be in writing, and must
be received by the Hearing Clerk on or before November 8, 2011.
Addresses for mail and hand delivery of objections and hearing requests
are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number
[[Page 55808]]
EPA-HQ-OPP-2010-0466, 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. Summary of Petitioned-for Tolerance
In the Federal Register of June 23, 2010 (75 FR 35801) (FRL-8831-
3), 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
0F7708) by Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse
Road, Raleigh, NC 27609 as well as the filing of a pesticide petition
(PP 0E7723) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The IR-4 petition (PP 0E7723) 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 corn, sweet, kernels plus cob with husks
removed at 0.05 parts per million (ppm); corn, sweet, forage at 20 ppm;
and corn, sweet, stover at 50 ppm and to increase the established
livestock tolerances for residues of novaluron in or on milk from 1.0
to 1.5 ppm, and milk fat from 20 to 35 ppm, respectively. The
Makhteshim-Agan petition (PP 0F7708) requested novaluron tolerances for
all food commodities (other than those already covered by a higher
tolerance as a result of use on growing crops) in food handling
establishments where food products are held, processed or prepared at
0.01 ppm. That notice referenced a summary of the petitions prepared by
Makhteshim-Agan of North America, Inc, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing for PP 0F7708.
Comments were received on the notice of filing for PP 0E7723. EPA's
response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the tolerances for sweet corn forage and determined it is not
appropriate to raise the existing tolerances for milk and milk fat. The
EPA also determined it is appropriate to revise several existing
livestock commodities based on the proposed sweet corn use. The reasons
for these changes are explained in Unit IV.D.
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 novaluron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with novaluron
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. No ocular or dermal irritation was noted. Novaluron
is not a dermal sensitizer. In subchronic and chronic toxicity studies,
novaluron primarily produced hematotoxic effects (toxicity to blood)
such as methemoglobinemia, decreased hemoglobin, decreased hematocrit,
and decreased red blood corpuscles (RBCs or erythrocytes) that were
associated with compensatory 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
two-generation reproductive toxicity study in rats, both parental and
offspring toxicity (increased spleen weights) were observed at the same
dose. Reproductive toxicity (decreases in epididymal sperm counts and
increase age at preputial separation in the F1 generation) was observed
at a higher dose 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). However, no signs of neurotoxicity or
neuropathology were observed in the subchronic neurotoxicity study in
rats or in any other subchronic or chronic toxicity study in rats, mice
or dogs. Therefore, there is no concern for neurotoxicity resulting
from exposure to novaluron.
There was no evidence of carcinogenic potential in either the rat
or mouse carcinogenicity studies and no evidence of mutagenic activity
in the submitted mutagenicity studies, including a bacterial
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus
assay and a bacterial DNA damage or repair assay. Based on the results
of these studies, EPA has classified novaluron as ``not likely to be
carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by novaluron as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Sweet Corn and in Food--or
Feed-Handling Establishments'' at pages 53-56 in docket ID number EPA-
HQ-OPP-2010-0466.
[[Page 55809]]
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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 is shown in
Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Novaluron for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological effects
factors assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Not applicable........ None.................. An endpoint of concern
populations). attributable to a single dose
was not identified. An acute
RfD was not established.
Chronic dietary (All NOAEL = 1.1 mg/kg/day Chronic RfD = cPAD = Combined chronic toxicity/
populations). UF = 100. 0.011 mg/kg/day. carcinogenicity feeding in rat.
FQPA SF = 1x.......... LOAEL = 30.6 mg/kg/day based on
erythrocyte damage and turnover
resulting in a regenerative
anemia.
Dermal short-term (1 to 30 Not applicable........ None.................. No toxicity was observed at the
days). limit dose in the dermal study
and there were no developmental
toxicity concerns at the limit-
dose; therefore, quantification
of short-term dermal risk is
not necessary.
Dermal intermediate-term (1 to Oral study NOAEL = Residential LOC for 90-day feeding study in rat.
6 months). 4.38 mg/kg/day MOE < 100. LOAEL = 8.64 mg/kg/day based on
(dermal absorption clinical chemistry (decreased
rate = 100)%. hemoglobin, hematocrit, and RBC
counts) and histopathology
(increased hematopoieses and
hemosiderosis in spleen and
liver).
Inhalation short-term (1 to 30 Oral study NOAEL = Residential/ 90-day feeding study in rat.
days). 4.38 mg/kg/day Occupational LOC for LOAEL = 8.64 mg/kg/day based on
(inhalation MOE < 100. clinical chemistry (decreased
absorption rate = hemoglobin, hematocrit, and RBC
100%). counts) and histopathology
(increased hematopoieses and
hemosiderosis in spleen and
liver).
Inhalation Intermediate-term Oral study NOAEL = 1.1 Residential/ Combined chronic toxicity/
(1 to 6 months). mg/kg/day (inhalation Occupational LOC for carcinogenicity feeding in rat.
absorption rate = MOE < 100. LOAEL = 30.6 mg/kg/day based on
100%). erythrocyte damage and turnover
resulting in a regenerative
anemia.
----------------------------------------------------------------------------------------------------------------
Cancer........................ Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
UF = Uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-
observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic), RfD = reference dose,
MOE = margin of exposure, LOC = level of concern.
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 from 1994-
1996 and 1998 Continuing Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, EPA conducted a partially
refined dietary (food and drinking water) exposure and risk assessment
for the proposed new uses on sweet corn and in food--and feed--handling
establishments, all established uses, and drinking water using the
DEEM-FCID (Dietary Exposure Evaluation Model-Food Commodity Ingredient
Database), Version 2.03, which uses food consumption data from the USDA
1994-1996 and 1998 CSFII. As to residue levels in food, EPA
incorporated average percent crop treated (PCT) data for apples,
cabbage, cotton, pears, and potatoes, and utilized percent crop treated
for new use PCT estimates for grain sorghum and sweet corn. 100 PCT was
assumed for the remaining food commodities. Anticipated residues (ARs)
for meat, milk, hog, and poultry commodities were calculated using
average field trial residues, PCT estimates for sweet corn and grain
sorghum, average PCT for apple and cotton, and assumed 100 PCT for
sugarcane and cowpea seed.
[[Page 55810]]
The chronic analysis also incorporated average greenhouse trial
residues for tomatoes; empirical processing factors for apple juice
(translated to pear and stone fruit juice), cottonseed oil, dried
plums, and tomato paste and puree; and DEEM default processing factors
for the remaining processed commodities; and average field trial
residues for all crops unless residues were less than LOQ (If residues
were less than LOQ, the chronic analysis assumed \1/2\ LOQ values)
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that novaluron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) 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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for existing uses as follows:
Apples at 15%; cabbage at 10%; cotton at 2.5%; pears at 10%; and
potatoes at 2.5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency estimated the PCT for new uses as follows:
Sweet corn at 59% and sorghum at 5%.
EPA utilized estimated PCT data in the chronic dietary risk
assessment for the new use on sweet corn and sorghum, based on the
market leader approach. Sorghum, though not new, was only registered 1
year ago. Since sorghum has been registered for such a relatively short
period, EPA has sorghum to be a ``new use'' when estimating the PCT.
The market leader approach is the comparison of the PCT with all
chemicals of a specific type (i.e., herbicide, insecticide, etc.) on a
specific crop and choosing the highest PCT (market leader) as the PCT
for the new use. This method of estimating a PCT for a new use of a
registered pesticide or a new pesticide produces a high-end estimate
that is unlikely, in most cases, to be exceeded during the initial 5
years of actual use. The predominant factors that bear on whether the
estimated PCT could be exceeded are: The extent of the pest pressure on
the crops in question; the pest spectrum of the new pesticide in
comparison with the market leaders as well as whether the market
leaders are well-established for this use; and resistance concerns with
the market leaders.
Novaluron has a relatively narrow spectrum of activity compared to
the market leaders. Additionally, there are no resistance or pest
pressure issues identified for the use of novaluron on sweet corn. All
information currently available has been considered for use on sweet
corn, and EPA concludes that it is unlikely that the actual sweet corn
PCT with novaluron will exceed the estimated PCT for new uses during
the next 5 years.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which novaluron may be applied in a particular area.
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 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.
Estimated drinking water concentrations (EDWCs) were not generated
for the food-and-feed handling establishment uses because the use
pattern is not expected to result in the contamination of drinking
water. Based on the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for parent novaluron in surface water; and
the Screening Concentration in Ground Water (SCI-GROW) models for
novaluron, chlorophenyl urea and
[[Page 55811]]
chloroaniline in ground water, the 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
currently registered for any specific use patterns that would result in
residential exposure. However, the following uses that could result in
residential exposures are pending registration and have been assessed:
Indoor and outdoor uses for the control of roaches and crickets (crack
and crevice and spot treatments) in residential areas such as homes and
apartment buildings, and their immediate surroundings, and on modes of
transportation.
There is a potential for exposure in residential settings during
the application process for homeowners who use products containing
novaluron. There is also a potential for exposure from entering
novaluron-treated areas that could lead to exposures to adults and
children. Both residential handler and post-application scenarios were
assessed for the indoor use since this is believed to cover the outdoor
perimeter treatment. Residential handler dermal and inhalation
exposures were assessed for application via low-pressure handwands and
trigger-pump sprayers.
Additionally exposure routes were assessed for post-application
exposures for adults and children via inhalation and dermal routes and
post-application incidental oral (hand-to-mouth) exposure for children
(3 to < 6 years old). Additionally, a combined residential assessment
that consisted of adult dermal and inhalation post-application
exposures as well as children (3 to < 6 years old) dermal, inhalation,
and oral (hand-to-mouth) post-application exposure was included which
details of the residential risk exposure and risk assessment are
contained in the EPA public docket EPA-HQ-OPP-2010-0466 at https://www.regulations.gov in document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Sweet Corn and in Food- or
Feed-Handling Establishments'' on pp. 28-37.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 Web site 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 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 and a 90-day inhalation toxicity study. Recent
changes to 40 CFR part 158 make immunotoxicity testing (OPPTS Guideline
870.7800) required for pesticide registration; however, the existing
data are sufficient for endpoint selection for exposure/risk assessment
scenarios, and for evaluation of the requirements under the FQPA.
Although effects were seen in the spleen in two studies, as explained
in Unit III.A., EPA has concluded that novaluron does not directly
target the immune system and the Agency does not believe that
conducting a functional immunotoxicity study will result in a NOAEL
lower than the regulatory dose for risk assessment; therefore, an
additional database uncertainty factor is not needed to account for
potential immunotoxicity. A 90-day inhalation toxicity study is
requested for further characterization of inhalation risk. Due to the
potential for repeated inhalation exposure anticipated from the
proposed residential use pattern, there is concern for toxicity by the
inhalation route. An inhalation study would provide a dose and endpoint
via the route of exposure of concern (i.e. route-specific study) and
thus would avoid using an oral study and route-to-route extrapolation.
Although a point of departure from an oral study was used to assess
residential post-application inhalation risks for novaluron, the Agency
does not believe this assessment is under-protective. The
[[Page 55812]]
post-application inhalation MOEs calculated were all greater than
3,000, thus providing an ample margin of safety to account for any
uncertainties in route-to-route extrapolation. Further, the MOE was
calculated for post-application inhalation exposure and risk using the
saturation concentration which is a very conservative approach. The
saturation concentration represents what would occur if a large amount
of chemical were spilled in a non-ventilated room and allowed to
evaporate until equilibrium is reached.
ii. There were signs of neurotoxicity in the acute neurotoxicity
study in rats, including clinical signs (piloerection, irregular
breathing), functional observation battery (FOB) parameters (increased
head swaying, abnormal gait), and neuropathology (sciateic and tibial
nerve degeneration). However, the signs observed were not severe, were
seen only at the limit dose (2000 mg/kg/day) and were not reproducible.
No signs of neurotoxicity or neuropathology were observed in the
subchronic neurotoxicity study in rats at similar doses, and no
evidence of neuropathology was observed in subchronic and chronic
toxicity studies in rats, mice, or dogs. In addition, no clinical signs
were observed in the acute oral toxicity study (LD50 > 5,000 mg/kg).
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 using
anticipated residues derived from reliable residue field trials and PCT
assumptions for some commodities. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to novaluron in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers resulting from the
proposed residential uses of novaluron. 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 dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from 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 72% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
The residential exposure assessment was conducted using high-end
estimates of use and potential exposure providing a conservative,
health protective estimate of risk.
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).
There are potential short-term exposures from the pending
residential uses for novaluron. The Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to novaluron.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 1,600 for the
U.S. population and 290 for children 1-2 years old. Because EPA's level
of concern for novaluron is a MOE of 100 or below, these MOEs are not
of concern.
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).
There are potential intermediate-term exposures from the pending
residential uses for novaluron. The Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to novaluron.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 320 for U.S. population and 140 for children 1-2
years old. Because EPA's level of concern for novaluron is a MOE of 100
or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, novaluron is not expected to pose a cancer risk to humans.
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
The following adequate enforcement methodologies (gas
chromatography/electron-capture detection (GC/ECD) method and a high-
performance liquid chromatography/ultraviolet (HPLC/UV) method) are
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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for residues of novaluron in or on sweet corn,
stover,
[[Page 55813]]
forage and kernel plus cob with husks removed or for all food
commodities based on the use of novaluron in food and feed handling
establishments. Canada is currently in the process of reviewing the use
of novaluron on sweet corn. The EPA and the Pest Management Regulatory
Agency (PMRA) reviewed the sweet corn petition as a Joint Review
Project and tolerance recommendations are in agreement at 0.05 ppm for
sweet corn and kernel plus cob with husks removed. Additionally, PMRA
proposed to increase its MRL for milk to 1.0 ppm from 0.5 ppm, and as a
result the EPA and PMRA milk tolerances/MRLs will be in agreement. The
PMRA does not recommend MRLs for livestock feed commodities and
therefore will not establish MRLs for sweet corn stover and sweet corn
forage.
C. Response to Comments
EPA received one comment to the Notice of Filing that made a
general objection to the presence of any novaluron residues on
vegetable crops. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework. The commenter also expressed
concern that EPA's risk assessment for novaluron did no ``combined
testing'' with other chemicals. EPA, however, does not require
``combined testing'' of a pesticide with other pesticides or other
chemicals due to impracticality. With regard to the potential for
cumulative effects from exposure to the pesticide and other substances
with a common mechanism of toxicity, see the discussion of this issue
in Unit III.C.4., Cumulative effects from substances with a common
mechanism of toxicity.
D. 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 corn, sweet, forage from 20 ppm to 16 ppm and
determined no change to the existing milk and milk fat tolerances is
needed.
Based on the proposed use on sweet corn, the revised reasonably
balanced dietary burdens (RBDBs) for novaluron are 9.6 ppm for beef
cattle, 18.3 ppm for dairy cattle, 2.4 ppm for poultry, and 2.5 ppm for
swine. Accordingly, the Agency has determined it is appropriate to
raise the existing tolerances for meat byproducts. However, no changes
are necessary for the tolerances for secondary residues in/on cattle,
goat, horse, sheep, poultry, and swine commodities. Additionally,
commodity terms for hog, meat byproducts and poultry, meat byproducts
are being revised.
Therefore, the tolerances for meat byproducts are being revised as
follows: Cattle, meat byproducts, except kidney and liver from 0.60 ppm
to 11 ppm; goat, meat byproducts, except kidney and liver from 0.60 ppm
to 11 ppm; horse, meat byproducts, except kidney and liver from 0.60
ppm to 11 ppm; sheep, meat byproducts, except kidney and liver from
0.60 ppm to 11 ppm; hog, meat byproducts from 0.10 ppm to hog, meat
byproducts, except kidney and liver to 1.5 ppm; and poultry, meat
byproducts from 0.80 ppm to poultry, meat byproducts, except kidney and
liver to 7.0 ppm.
V. Conclusion
Therefore, tolerances are established for residues of novaluron,
(N-[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6-difluorobenzamide), in or on corn, sweet,
kernels plus cob with husks removed at 0.05 ppm; corn, sweet, forage at
16 ppm; corn, sweet, stover at 50 ppm; cattle, meat byproducts, except
kidney and liver at 11 ppm; goat, meat byproducts, except kidney and
liver at 11 ppm; horse, meat byproducts, except kidney and liver at 11
ppm; sheep, meat byproducts, except kidney and liver at 11 ppm; hog,
meat byproducts, except kidney and liver at 1.5 ppm; poultry, meat
byproducts, except kidney and liver at 7.0 ppm; and Food/feed
commodities (other than those covered by a higher tolerance as a result
of use on growing crops) in food/feed handling establishments at 0.01
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as 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) (Pub. L. 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
[[Page 55814]]
(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: August 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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, paragraph (a), is amended as follows:
0
a. Revise the commodity entries for ``cattle, meat byproducts, except
kidney and liver''; ``goat, meat byproducts, except kidney and liver'';
``hog, meat byproducts''; ``horse, meat byproducts, except kidney and
liver''; ``poultry, meat byproducts''; ``sheep, meat byproducts, except
kidney and liver''; and
0
b. Add, alphabetically, the commodities for ``corn, sweet, forage'';
``corn, sweet, kernel plus cob with husks removed''; ``corn, sweet,
stover''; and ``food and feed commodities (other than those covered by
a higher tolerance as a result of use on growing crops) in food and
feed handling establishments.''
The revised and added text reads as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, meat byproducts, except kidney and liver........... 11
* * * * *
Corn, sweet, forage........................................ 16
Corn, sweet, kernel plus cob with husks removed............ 0.05
Corn, sweet, stover........................................ 50
* * * * *
Food commodities and feed commodities (other than those 0.01
covered by a higher tolerance as a result of use on
growing crops) in food and feed handling establishments...
* * * * *
Goat, meat byproducts, except kidney and liver............. 11
* * * * *
Hog, meat byproducts, except kidney and liver.............. 1.5
* * * * *
Horse, meat byproducts, except kidney and liver............ 11
* * * * *
Poultry, meat byproducts, except kidney and liver.......... 7.0
* * * * *
Sheep, meat byproducts, except kidney and liver............ 11
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-22981 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P