Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 29441 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 18, 2010. 

Daniel J. Rosenblatt, 

Acting 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 180.226 is amended as 

follows: 

i. Alphabetically add commodities to 

the table in paragraph (a)(1); 

ii. Revise introductory text in 

paragraph (a)(2)(i); 

iii. Revise paragraph (a)(3); 

iv. Remove paragraph (a)(4); and 

v. Redesignate paragraph (a)(5) as 

(a)(4). 

The amendments read as follows: 

§ 180.226 Diquat; tolerances for residues. 

(a) * * * (1) * * * 

Commodity Parts per million 

* * * * * 

Canola, meal .................. 6.0 

Canola, seed .................. 2.0 

* * * * * 

(2)(i) Tolerances are established for 

residues of the herbicide diquat (6,7 

dihydrodipyrido(1,2-a:2’1’- 

c)pyrazinediium) (calculated as the 

cation) derived from the application of 

the dibromide salt to ponds, lakes, 

reservoirs, marshes, drainage ditches, 

canals, streams, and rivers which are 

slow-moving or quiescent in programs 

of the Corp of Engineers or other Federal 

or State public agencies and to ponds, 

lakes and drainage ditches only where 

there is little or no outflow of water and 

which are totally under the control of 

the user, in or on the following food 

commodities: 

* * * * * 

(3) Tolerances are established for the 

plant growth regulator diquat (6,7 

dihydrodipyrido(1,2-a:2’1’- 

c)pyrazinediium) derived from 

application of the dibromide salt and 

calculated as the cation in or on the 

following food commodites: 

Commodity Parts per million 

Banana1 .......................... 0.05 

Coffee, bean, green1 ...... 0.05 

Soybean, hulls ................ 0.6 

1There are no U.S. registrations as of May 

26, 2010. 

* * * * * 

[FR Doc. 2010–12648 Filed 5–25–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0273; FRL–8825–3] 

Novaluron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of novaluron in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

revises several established tolerances for 

residues of novaluron. MakhteshimAgan of North America, Inc., requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

26, 2010. Objections and requests for 

hearings must be received on or before 

July 26, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0273. 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). 


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• 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 

cite at http://www.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0273 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 26, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0273, 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. Petition for Tolerance 

In the Federal Register of June 10, 

2009 (74 FR 27538) (FRL–8417–7), 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 9F7547) by 

Makhteshim-Agan of North America, 

Inc., 4515 Falls of Neuse Road, Raleigh, 

NC 27609. The petition requested that 

40 CFR 180.598 be amended by 

establishing tolerances for residues of 

the insecticide novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2- 

(trifluoromethoxy)ethoxy]

phenyl]amino]carbonyl]-2,6- 

difluorobenzamide, in or on sorghum, 

grain at 3 parts per million (ppm); 

sorghum, aspirated grain fractions at 25 

ppm; sorghum, forage at 6 ppm; and 

sorghum, stover at 40 ppm. 

Additionally, the petition requested to 

amend existing tolerances of novaluron 

in or on poultry, fat from 0.40 ppm to 

7.0 ppm; poultry, meat from 0.03 ppm 

to 0.40 ppm; poultry, meat byproducts 

from 0.04 ppm to 0.80 ppm; hog, fat 

from 0.05 ppm to 1.5 ppm; hog, meat 

from 0.01 ppm to 0.07 ppm; hog, meat 

byproducts from 0.01 ppm to 0.15 ppm; 

and eggs from 0.05 ppm to 1.5 ppm. 

That notice referenced a summary of the 

petition 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. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance for hog, meat 

byproducts and has additionally 

determined that individual tolerances 

on poultry, liver; poultry, kidney; hog, 

liver; and hog, kidney are necessary. 

The reason for these changes is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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 of 

exposure. It is not an eye or skin irritant 

and is not a dermal sensitizer. In 

subchronic and chronic toxicity studies, 

novaluron primarily produced 

hematotoxic effects (toxicity to blood) 

such as methemoglobinemia, decreased 

hemoglobin, decreased hematocrit, and 

decreased RBCs (or erythrocytes) 

associated with increased 

erythropoiesis. Increased spleen weights 

and/or hemosiderosis in the spleen were 

considered to be due to enhanced 

removal of damaged erythrocytes and 

not to an immunotoxic effect. 


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There was no maternal or 

developmental toxicity seen in the rat 

and rabbit developmental toxicity 

studies up to the limit doses. In the 2– 

generation reproductive toxicity study 

in rats, both parental and offspring 

toxicity (increased spleen weights) were 

observed at the same dose. Reproductive 

toxicity (decreases in epididymal sperm 

counts and increased age at preputial 

separation in the F1 generation) was 

observed at a higher dose than the 

hematotoxicity. 

Clinical signs of neurotoxicity and 

neuropathology were seen in the rat 

acute neurotoxicity study at the limit 

dose. However, no signs of 

neurotoxicity or neuropathology were 

observed in the subchronic 

neurotoxicity study in rats at similar 

doses or in any other subchronic or 

chronic toxicity study in rats, mice or 

dogs. In addition, there were no clinical 

signs of toxicity observed in the acute 

oral toxicity study with novaluron (LD50

>5,000 milligrams/kilogram (mg/kg)). 

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/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 Use 

on Grain Sorghum.’’ at pages 27–30 in 

docket ID number EPA–HQ–OPP–2009– 

0273. 

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 the 

following Table. 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NOVALURON FOR USE IN HUMAN 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 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.011 mg/kg/day 

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. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose. RfD = reference dose. 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 United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food 

Intakes by Individuals (CSFII). As to 

residue levels in food, EPA incorporated 

average percent crop treated (PCT) data 

for apples, cabbage, cotton, pears, and 

potatoes and estimated PCT data for the 

new use on sorghum; 100 PCT was 

assumed for the remaining food 

commodities. The Agency utilized 

anticipated residues (ARs) for most 

commodities, including meat, milk, hog, 

and poultry commodities. Average field 

trial residues were used for pome fruit, 

sugarcane, bushberry, Brassica leafy 

greens, stone fruit, bell pepper, nonbell 

pepper, cucumber, summer squash, 

cantaloupe, strawberry, succulent snap 

bean, dry bean seed, and Swiss chard, 

and average greenhouse trial residues 

for tomato. Empirical processing factors 


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for apple juice (translated to pear and 

stone fruit juice), tomato paste and 

puree, and Dietary Exposure Evaluation 

Model (DEEM) default processing 

factors for the remaining processed 

commodities were used to estimate 

anticipated residues in processed foods. 

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 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 average 

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 USDA/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: 

Grain sorghum at 5%. 

EPA utilized estimated PCT data in 

the chronic dietary risk assessment for 

the new use on grain sorghum, based on 

the market leader approach. 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 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 and specifically targets 

lepidopterous insects, which are not key 

pests of grain sorghum. Additionally, 

there are no resistance or pest pressure 

issues identified for the use of 

novaluron on grain sorghum. All 

information currently available has been 

considered for use on grain sorghum, 

and EPA concludes that it is unlikely 

that the actual grain sorghum 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 and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of novaluron. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

The following models were used to 

assess residues of concern in drinking 

water: The Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) for parent novaluron in 

surface water; the First Index Reservoir 

Screening Tool (FIRST) for 

chlorophenyl urea and chloroaniline 

degradates in surface water; and the 

Screening Concentration in Ground 

Water (SCI-GROW) model for 

novaluron, chlorophenyl urea and 

chloroaniline in ground water. The 

estimated drinking water concentrations 

(EDWCs) of novaluron, chlorophenyl 

urea, and chloroaniline for chronic 

exposures for non-cancer assessments 

are estimated to be 0.76 parts per billion 

(ppb), 0.89 ppb and 2.6 ppb, 

respectively, for surface water and 

0.0056 ppb, 0.0045 ppb and 0.0090 ppb, 

respectively, for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 


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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 registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found novaluron to share a common 

mechanism of toxicity with any other 

substances, and novaluron does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

novaluron does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

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. 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. 

ii. There were signs of neurotoxicity 

in the acute neurotoxicity study in rats, 

including clinical signs (piloerection, 

fast/irregular breathing), functional 

observation battery (FOB) parameters 

(head swaying, abnormal gait), and 

neuropathology (sciatic and tibial nerve 

degeneration). However, the signs 

observed were not severe, were seen 

only at the limit dose (2,000 mg/kg/day) 

and were not reproducible. No signs of 

neurotoxicity or neuropathology were 

observed in the subchronic 

neurotoxicity study in rats at doses up 

to 1,752 mg/kg/day in males and 2,000 

mg/kg/day in females or in any other 

subchronic or chronic toxicity study in 

rats, mice or dogs, including the 

developmental and reproduction 

studies. In addition, no clinical signs of 

toxicity 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. Although storage stability data has 

been requested for grain sorghum forage, 

grain, and stover, there are no residual 

uncertainties identified in the exposure 

databases because acceptable storage 

stability data is available for various 

commodities which demonstrate the 

stability of novaluron in/or on food 

commodities for up to 15.3 months, 

which exceeds the longest storage time 

(9.0 months for grain sorghum forage) of 

the grain sorghum commodities in the 

field trials. The chronic dietary food 

exposure assessment utilized tolerance 

level residues or anticipated residues 

that are based on reliable field trial data, 

and reliable data from processing 

studies or worst case assumptions. The 

chronic assessment also utilized PCT 

data (average PCT for several currently 

registered commodities and estimated 

PCT data for the new use on grain 

sorghum), which have a valid basis and 

are considered to be reliable. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to novaluron in 

drinking water. Residential exposures 

are not expected. These assessments 

will not underestimate the exposure and 

risks posed by novaluron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic 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. 


emcdonald on DSK2BSOYB1PROD with RULES
29446 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 

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 32% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for novaluron. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short- or 

intermediate-term adverse effect was 

identified, novaluron is not expected to 

pose a short- or intermediate-term risk. 

4. 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. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to novaluron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodologies are available to enforce 

the tolerance expression: A gas 

chromatography/electron-capture 

detection (GC/ECD) method and a highperformance liquid chromatography/ 

ultraviolet (HPLC/UV) method. The 

methods may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian or 

Mexican maximum residue limits 

(MRLs) established for residues of 

novaluron in or on grain sorghum 

commodities associated with this 

petition. There are Codex MRLs 

established for poultry, meat; poultry, 

edible offal of; and eggs at 0.01 ppm; 

and meat (mammalian other than 

marine) at 10 ppm. Additionally, there 

are Canadian MRLs established for meat 

of hogs and meat byproducts of hogs at 

0.01 ppm. EPA’s analysis of data used 

to determine the secondary residues in 

animal commodities, including the 

dietary burden in the United States for 

registered/proposed uses of novaluron, 

supports establishing tolerances in 

poultry, meat at 0.40 ppm; poultry, liver 

and kidney at 0.8 ppm; hog, meat at 0.07 

ppm; and egg at 1.5 ppm. Therefore, 

U.S. tolerances on these animal 

commodities cannot be harmonized 

with the associated Codex or Canadian 

MRLs. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the data 

supporting the petition, EPA has revised 

the proposed tolerance for hog, meat 

byproducts from 0.15 ppm to 0.10 ppm. 

Additionally, the Agency has 

determined that individual tolerances 

on poultry, liver at 0.80 ppm; poultry, 

kidney at 0.80 ppm; hog, liver at 0.10 

ppm; and hog, kidney at 0.10 ppm are 

necessary. These revisions are based on 

the following: 

Several tolerances for secondary 

residues in animal commodities have 

been established for novaluron based on 

reasonably balanced dietary burdens 

(RBDBs) derived from feedstuff 

percentages. However, new RBDBs have 

been established based on the proposed/ 

established uses of novaluron, thus 

necessitating revisions in the proposed/ 

established tolerances for secondary 

residues in or on poultry and hog 

commodities. Therefore, the Agency has 

revised the proposed tolerance for hog, 

meat byproducts from 0.15 ppm to 0.10 

ppm and has determined that individual 

tolerances are necessary for hog, liver 

and hog, kidney at 0.10 ppm; and 

poultry, liver and poultry, kidney at 

0.80 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2- 

(trifluoromethoxy)ethoxy]

phenyl]amino]carbonyl]-2,6- 

difluorobenzamide, in or on sorghum, 

grain, grain at 3.0 ppm; grain, aspirated 

fractions at 25 ppm; sorghum, grain, 

forage at 6.0 ppm; sorghum, grain, 

stover at 40 ppm; poultry, fat at 7.0 

ppm; poultry, meat at 0.40 ppm; 

poultry, liver at 0.80 ppm; poultry, 

kidney at 0.80 ppm; poultry, meat 

byproducts at 0.80 ppm; hog, fat at 1.5 

ppm; hog, meat at 0.07 ppm; hog, liver 

at 0.10 ppm; hog, kidney at 0.10 ppm; 

hog, meat byproducts at 0.10 ppm; and 

egg at 1.5 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 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 29447 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 14, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.598 is amended in 

paragraph (a) as follows: 

i. Add alphabetically ‘‘Grain, aspirated 

fractions’’; ‘‘Hog, kidney’’; ‘‘Hog, liver’’; 

‘‘Poultry, kidney’’; ‘‘Poultry, liver’’; 

‘‘Sorghum, grain, forage’’; ‘‘Sorghum, 

grain, grain’’; and ‘‘Sorghum, grain, 

stover’’ to the table; and 

ii. Revise the entries for ‘‘Egg’’; ‘‘Hog, 

fat’’; ‘‘Hog, meat’’; ‘‘Hog, meat 

byproducts’’; ‘‘Poultry, fat’’; ‘‘Poultry, 

meat’’; and ‘‘Poultry, meat byproducts.’’ 

The added and revised entries to read as 

follows: 

§180.598 Novaluron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Egg ................................. 1.5 

*****

Grain, aspirated fractions 25 

*****

Hog, fat ........................... 1.5 

Hog, kidney ..................... 0.10 

Hog, liver ........................ 0.10 

Hog, meat ....................... 0.07 

Hog, meat byproducts .... 0.10 

*****

Poultry, fat ...................... 7.0 

Poultry, kidney ................ 0.80 

Poultry, liver .................... 0.80 

Poultry, meat .................. 0.40 

Poultry, meat byproducts 0.80 

*****

Sorghum, grain, forage ... 6.0 

Sorghum, grain, grain ..... 3.0 

Sorghum, grain, stover ... 40 

*****

* * * * * 

[FR Doc. 2010–12649 Filed 5–25–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 5a 

RIN 0906–AA86 

Public Health Service Act, Rural 

Physician Training Grant Program, 

Definition of ‘‘Underserved Rural 

Community’’ 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Interim final rule with request 

for comment. 

SUMMARY: This interim final rule (IFR) 

with request for comment is meant to 

comply with the statutory directive to 

issue a regulation defining ‘‘underserved 

rural community’’ for purposes of the 

Rural Physician Training Grant Program 

in section 749B of the Public Health 

Service Act, as amended by the Patient 

Protection and Affordable Care Act of 

2010. This IFR is technical in nature. It 

will not change grant or funding 

eligibility for any other grant program 

currently available through the Office of 

Rural Health Policy (ORHP) or HRSA. 

For purposes of the Rural Physician 

Training Grant Program only, HRSA has 

combined existing definitions of 

‘‘underserved’’ and ‘‘rural’’ by using the 

definition of rural utilized by the ORHP 

Rural Health Grant programs and the 

definition of ‘‘underserved’’ established 

by HRSA’s Office of Shortage 

Designation (OSD) in the Bureau of 

Health Professions (BHPr). 

DATES: Effective Date: This interim final 

rule is effective 30 days after May 26, 

2010. 

Comment Date: To be assured 

consideration, written or electronic 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 26, 2010. 

ADDRESSES: You may submit comments, 

identified by the Regulatory Information 

Number (RIN), by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: mgoodman@hrsa.gov. 

Include RIN 0906–AA86 in the subject 

line of the message. 

• Mail: Michelle Goodman, MAA, 

Office of Rural Health Policy, Health 

Resources and Services Administration, 

5600 Fishers Lane, Parklawn Building, 

10B–45, Rockville, MD 20857. 

Instructions: All submissions received 

must include the agency name and RIN 

for this rulemaking. All comments 

received will be available for public 

inspection and copying, including any 

personal information provided, at 

Parklawn Building, 5600 Fishers Lane, 

Room 10B–45, Rockville, Maryland 

20857, weekdays (Federal holidays 

excepted) between the hours of 8:30 

a.m. and 5 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Goodman, MAA, at the mail or 

e-mail address above or by telephone at 

301–443–0835. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Waiver of Proposed Rulemaking and 

Comment 

III. Definition of ‘‘Underserved Rural 

Community’’ 

A. Definition of Rural 

B. Definition of Underserved 

IV. Collection of Information Requirements 

V. Regulatory Impact Analysis 

A. Introduction 

B. Why Is This Rule Needed? 

C. Costs and Benefits 

D. Regulatory Flexibility Act Analysis 

E. Executive Order 13132—Federalism 

F. Unfunded Mandates Reform Act of 1995 

Regulation Text 

I. Background 

The ORHP was authorized in 

December 1987 through Public Law 

100–203 and is located in the HRSA. 

Congress charged ORHP with informing 

and advising HHS on matters affecting 

rural hospitals and health care and 


emcdonald on DSK2BSOYB1PROD with RULES