
[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]


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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.

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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 http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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 http://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 http://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: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

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, http://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 http://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 http://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
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                                Point of departure and
       Exposure/scenario           uncertainty/safety   RfD, PAD, LOC for risk   Study and toxicological effects
                                        factors                assessment
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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 http://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 http://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 http://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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the 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


