Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 55807 

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-5- 

hydroxy-o-anisic acid, calculated as the 

stoichiometric equivalent of dicamba, in 

or on the following commodities: 

Commodity Parts per 

million 

* * * * * 

Teff, forage ................................. 90.0 

Teff, grain ................................... 6.0 

Teff, hay ...................................... 40.0 

Teff, straw ................................... 30.0 

* * * * * 

(2) Tolerances are established for 

residues of the herbicide dicamba, 3,6- 

dichloro-o-anisic 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 

residues of dicamba (3,6-dichloro-oanisic acid) and its metabolite, 3,6- 

dichloro-2-hydroxybenzoic acid, 

calculated as the stoichiometric 

equivalent of dicamba, in or on the 

following commodities: 

* * * * * 

(3) Tolerances are established for 

residues of the herbicide dicamba, 3,6- 

dichloro-o-anisic 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 

residues of dicamba, 3,6-dichloro-oanisic acid, and its metabolites, 3,6- 

dichloro-5-hydroxy-o-anisic acid, and 

3,6-dichloro-2-hydroxybenzoic acid, 

calculated as the stoichiometric 

equivalent of dicamba, in or on the 

following commodities: 

* * * * * 

[FR Doc. 2011–23159 Filed 9–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

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 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 

mstockstill on DSK4VPTVN1PROD with RULES

55808 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

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 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 http:// 

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. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 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

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All 

populations).

Not applicable .............................. None ............................................. An endpoint of concern attributable to a single 

dose was not identified. An acute RfD was not 

established. 

Chronic dietary 

(All populations).

NOAEL = 1.1 mg/kg/day UF = 

100.

FQPA SF = 1x 

Chronic RfD = cPAD = 0.011 mg/ 

kg/day.

Combined chronic toxicity/carcinogenicity feeding 

in rat. LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia. 

Dermal short-term 

(1 to 30 days).

Not applicable .............................. None ............................................. 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. 

Dermal intermediate-term (1 

to 6 months).

Oral study NOAEL = 4.38 mg/kg/ 

day (dermal absorption rate = 

100)%.

Residential LOC for MOE < 100 .. 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). 

Inhalation shortterm (1 to 30 

days).

Oral study NOAEL = 4.38 mg/kg/ 

day (inhalation absorption rate 

= 100%).

Residential/Occupational LOC for 

MOE < 100.

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). 

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.

Combined chronic toxicity/carcinogenicity feeding 

in rat. LOAEL = 30.6 mg/kg/day based on 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. 

mstockstill on DSK4VPTVN1PROD with RULES

55810 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 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 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 postapplication 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 FeedHandling 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 

mstockstill on DSK4VPTVN1PROD with RULES

55812 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

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 

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. 

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, 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 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 

mstockstill on DSK4VPTVN1PROD with RULES

55814 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

(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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.598, 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: 

§ 180.598 Novaluron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Cattle, meat byproducts, except 

kidney and liver ..................... 11 

Commodity Parts per 

million 

* * * * * 

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 covered by a higher 

tolerance as a result of use 

on growing crops) in food 

and feed handling establishments .................................... 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 ..................... 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0905; FRL–8881–7] 

2,4-D; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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 

identification (ID) number EPA–HQ– 

OPP–2010–0905. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

mstockstill on DSK4VPTVN1PROD with RULES