57040 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Proposed Rules 

(4) In the event that a record company 

authorizes promotional uses in excess of 

the time limitations of paragraph (b) of 

this section, the record company, and 

not the third-party service it has 

authorized, shall be liable for any 

payment due for such uses; provided, 

however, that all rights and remedies of 

the copyright owner with respect to 

unauthorized uses shall be preserved. In 

the event that a third-party service 

exceeds the scope of any authorization 

by a record company, the service, and 

not the record company, shall be liable 

for any payment due for such uses; 

provided, however, that all rights and 

remedies of the copyright owner with 

respect to unauthorized uses shall be 

preserved. 

(c) Interactive streaming of full-length 

musical works through record company 

and artist services. In addition to those 

of paragraph (a) of this section, the 

provisions of this paragraph (c) apply to 

interactive streaming conducted or 

authorized by record companies under 

the promotional royalty rate through a 

service (e.g., a Web site) directly owned 

or operated by the record company, or 

directly owned or operated by a 

recording artist under the authorization 

of the record company, and that is not 

subject to paragraph (d) of this section. 

For the avoidance of doubt and without 

limitation, an artist page or site on a 

third-party service (e.g., a social 

networking service) shall not be 

considered a service operated by the 

record company or artist. Such 

interactive streams may be made or 

authorized by a record company under 

the promotional royalty rate only if— 

(1) The interactive streaming subject 

to this paragraph (c) of a particular 

sound recording is offered or authorized 

by the record company on no more than 

90 days total for all services (i.e., 

interactive streaming under this 

paragraph (c) of a particular sound 

recording may be authorized on no more 

than a total of 90 days, which need not 

be consecutive, and on any such day, 

interactive streams may be offered on 

one or more services operated by the 

record company or artist, subject to the 

provisions of paragraph (b)(2) of this 

section); provided, however, that an 

additional 90 days shall be available 

each time the sound recording is rereleased by the record company in a 

remastered form or as part of a 

compilation with a different set of 

sound recordings than prior 

compilations that include that sound 

recording; 

(2) In the case of interactive streaming 

through a service devoted to one 

featured artist, the interactive streams 

subject to this paragraph (c) of this 

section of a particular sound recording 

are made or authorized by the record 

company on no more than one official 

artist site per artist and are recordings 

of that artist; and 

(3) In the case of interactive streaming 

through a service that is not limited to 

a single featured artist, all interactive 

streaming on such service (whether 

eligible for the promotional royalty rate 

or not) is limited to sound recordings of 

a single record company and its 

affiliates and the service would not 

reasonably be considered to be a 

meaningful substitute for a paid music 

service. 

(d) Interactive streaming of clips. In 

addition to those in paragraph (a) of this 

section, the provisions of this paragraph 

(d) apply to interactive streaming 

conducted or authorized by record 

companies under the promotional 

royalty rate of segments of sound 

recordings of musical works with a 

playing time that does not exceed the 

greater of 

(1) 30 seconds, or 

(2) 10% of the playing time of the 

complete sound recording, but in no 

event in excess of 60 seconds. Such 

interactive streams may be made or 

authorized by a record company under 

the promotional royalty rate without 

any of the temporal limitations set forth 

in paragraphs (b) and (c) of this section 

(but subject to the other conditions of 

paragraphs (b) and (c) of this section, as 

applicable). For clarity, this paragraph 

(d) is strictly limited to the uses 

described herein and shall not be 

construed as permitting the creation or 

use of an excerpt of a musical work in 

violation of 17 U.S.C. 106(2) or 115(a)(2) 

or any other right of a musical work 

owner. 

(e) Activities prior to the publication 

date. Notwithstanding paragraphs (a) 

through (d) of this section, in the case 

of licensed activity prior to the 

publication date, the promotional 

royalty rate shall apply to promotional 

interactive streams, and to limited 

downloads offered in the context of a 

free trial period for a digital music 

subscription service, that in either case 

are authorized by the relevant record 

company, if the condition set forth in 

paragraph (a)(1)(i) of this section is 

satisfied, subject only to the additional 

condition in paragraph (b)(1) of this 

section, and provided that a free trial 

period for a digital music subscription 

service authorized by the relevant 

record company shall be considered to 

be of 30 days’ duration. In the event of 

a dispute concerning the eligibility of 

licensed activity prior to the publication 

date for the promotional royalty rate, a 

service asserting that its licensed 

activity is eligible for the promotional 

royalty rate shall bear the burden of 

proving that its licensed activity was 

authorized by the relevant record 

company and shall certify that the 

condition in paragraph (b)(1) of this 

section was satisfied. 

§ 385.15 Timing of payments. 

Payment for any accounting period for 

which payment otherwise would be due 

more than 180 days after the publication 

date shall be due as otherwise provided 

under 17 U.S.C. 115 and its 

implementing regulations. Payment for 

any prior accounting period shall be due 

180 days after the publication date. 

§ 385.16 Reproduction and distribution 

rights covered. 

A compulsory license under 17 U.S.C. 

115 extends to all reproduction and 

distribution rights that may be necessary 

for the provision of the licensed activity, 

solely for the purpose of providing such 

licensed activity (and no other purpose). 

§ 385.17 Effect of rates. 

In any future proceedings under 17 

U.S.C. 115(c)(3)(C) and (D), the royalty 

rates payable for a compulsory license 

shall be established de novo. 

Dated: September 25, 2008. 

James Scott Sledge, 

Chief Copyright Royalty Judge. 

[FR Doc. E8–23184 Filed 9–30–08; 8:45 am] 

BILLING CODE 1410–72–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0647; FRL–8382–4] 

Chlorantraniliprole; Proposed TimeLimited Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: This document proposes to 

establish time-limited tolerances for 

residues of chlorantraniliprole in or on 

cowpeas, forage and hay; field peas, 

vines and hay; forage, fodder and straw 

of cereal grains, crop group 16; grass 

forage, fodder and hay, crop group 17; 

leaves of root and tuber vegetables, crop 

group 2, leeks, nongrass animal feeds 

(forage, fodder, straw and hay), crop 

group 18; okra; onions, green; onions, 

Welsh; peanuts, hay; shallots; soybeans, 

forage and hay; strawberries and 

sugarcane, sugar under the Federal 

Food, Drug, and Cosmetic Act (FFDCA). 

The tolerances expire on April 25, 2010. 


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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Proposed Rules 57041 

DATES: Comments must be received on 

or before December 1, 2008. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2008–0647, 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. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2008– 

0647. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: 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., 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 either 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 

hours of operation of this Docket 

Facility are 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: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave, NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0415; e-mail address: 

davis.kable@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: 

• 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 provides 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. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM as CBI and then 

identify electronically within the disk or 

CD-ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background and Statutory Findings 

EPA on its own initiative, under 

section 408(e) of FFDCA, 21 U.S.C. 

346a(e), is proposing to establish a 

tolerances for residues of the insecticide 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, in or on cowpeas, forage 

and hay at 0.20 parts per million (ppm); 

field peas, vines and hay at 0.20 ppm; 

forage, fodder and straw of cereal grains, 

crop group 16 at 0.20 ppm, grass forage, 

fodder and hay, crop group 17 at 0.20 

ppm; leaves of root and tuber 

vegetables, crop group 2 at 0.20 ppm; 

leeks at 0.20 ppm; nongrass animal 

feeds (forage, fodder, straw and hay), 

crop group 18 at 0.20 ppm; okra at 0.70 

ppm; onions, green at 0.20 ppm; onions, 


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Welsh at 0.20 ppm; peanuts, hay at 0.20 

ppm; shallots at 0.20 ppm; soybeans, 

forage and hay at 0.20 ppm; strawberries 

at 1.2 ppm; and sugarcane, sugar at 0.20 

ppm. 

Recently, EPA established tolerances 

for chlorantraniliprole on apple, wet 

pomace; brassica, head and stem, 

subgroup 5A; brassica, leafy greens, 

subgroup 5B; cotton, gin byproduct; 

cotton, hulls; cotton undelinted seed; 

fruit, pome, group 11; fruit, stone, group 

12; grape; grape, raisen; potato; 

vegetable, cucurbit, group 9; vegetable, 

fruiting, group 8; vegetable, leafy, except 

brassica, group 4; milk; meat; meat 

byproduct and fat. At that time EPA 

determined rotational crop tolerances 

were required, and that the petitioner 

needed to conduct extensive field 

rotational crop trials. The Agency 

concluded that until the requested data 

are submitted, a restriction should be 

imposed on labels prohibiting the 

rotation to any crop not on the label. In 

response, the registrant submitted 

proposals for the establishment of 

tolerances for inadvertent residues for a 

number of crops pending submission of 

the requested data. After considering the 

registrant’s submission, EPA is now 

proposing time-limited tolerances to 

address rotated crops. 

EPA has decided to propose timelimited rotational crop tolerances for 

chlorantraniliprole. Rotational crop 

trials (2003, 2004, 2005) were conducted 

in Canada and the United States on 

leafy vegetables (Swiss chard, lettuce, 

spinach), root vegetables (radish, beet, 

turnip), cereal grains (wheat, oat) and 

soybean. Based on the data on 

chlorantraniliprole, the Agency believes 

that the residue data would not 

underestimate residues on rotated crops. 

Thus the Agency believes that the 0.20 

ppm tolerances on rotational crops are 

appropriate and protective. EPA also 

determined that adding these proposed 

tolerances would not change its prior 

safety finding for chlorantraniliprole. 

EPA’s updated risk assessment can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0647. 

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. . . . ’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, in or on cowpeas, forage 

and hay at 0.20 ppm; field peas, vines 

and hay at 0.20 ppm; forage, fodder and 

straw of cereal grains, crop group 16 at 

0.20 ppm, grass forage, fodder and hay, 

crop group 17 at 0.20 ppm; leaves of 

root and tuber vegetables, crop group 2 

at 0.20 ppm; leeks at 0.20 ppm; nongrass 

animal feeds (forage, fodder, straw and 

hay), crop group 18 at 0.20 ppm; okra 

at 0.70 ppm; onions, green at 0.20 ppm; 

onions, Welsh at 0.20 ppm; peanuts, hay 

at 0.20 ppm; shallots at 0.20 ppm; 

soybeans, forage and hay at 0.20 ppm; 

strawberries at 1.20 ppm; and 

sugarcane, sugar at 0.20 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance 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. 

Chlorantraniliprole has no significant 

acute toxicity via the oral, dermal, and 

inhalation routes of exposure. This 

substance is not an eye or skin irritant 

and does not cause skin sensitization. In 

short-term studies, the most consistent 

effects are those associated with non 

adverse pharmacological response to the 

xenobiotic, induction of liver enzymes 

and subsequent increase in liver 

weights. Chlorantraniliprole is not 

genotoxic, neurotoxic, immunotoxic, 

carcinogenic, or teratogenic. 

Furthermore, it is not uniquely toxic to 

the conceptus as there were no maternal 

or fetal effects in studies conducted in 

rats and rabbits. Based on the results of 

a 28–day dermal study in rats, as well 

as the dermal LD50 study, 

chlorantraniliprole has relatively low 

dermal toxicity. 

Overall, chlorantraniliprole exhibits 

minimal mammalian toxicity after longterm exposure. The only consistent 

observation in the mammalian 

toxicology studies is an increased 

degree of microvesiculation of the 

adrenal cortex after dermal or dietary 

administration of chlorantraniliprole. 

Based on the lack of adverse effect on 

the function of the adrenal gland, this 

observation was considered treatment 

related, but not ‘‘adverse.’’In addition to 

the adrenal effects, liver effects (e.g., 

increased liver weight and induction of 

cytochrome P450 enzymes) were 

reported in the 90–day oral subchronic 

studies across species and only at the 

highest dose tested (HDT) >1,000 

milligram/kilogram/day (mg/kg/day). 

While in the subchronic studies, these 

effects were considered adaptive, the 

liver effects were more pronounced in 

the 18–month chronic mouse study at 

the HDT. Increased eosinophilic foci 

(preneoplastic foci) were noted in male 

mice at 935 mg/kg/day and liver 

hypertrophy and weight increase were 

evident at the next lower dose (158 mg/ 

kg/day), but progression to tumors was 

not apparent for these effects. Therefore, 

the eosinophilic foci appear to be an 

adverse effect only seen in the HDT and 

was graded minimal in severity. 

Specific information on the studies 

received and the nature of the toxic 

effects caused by chlorantraniliprole as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2007–0275 

in that docket. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 


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risk, the toxicological level of concern 

(LOC) is derived from the highest dose 

at which no adverse effects are observed 

(the NOAEL) in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, the lowest dose 

at which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment. Uncertainty/ 

safety factors (UFs) are used in 

conjunction with the LOC to take into 

account uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic risks by comparing 

aggregate exposure to the pesticide to 

the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable UFs. Short-term, 

intermediate-term, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk and 

estimates risk in terms of the probability 

of occurrence of additional adverse 

cases. Generally, cancer risks are 

considered non-threshold. 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/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

A summary of the toxicological 

endpoints for chlorantraniliprole used 

for human risk assessment can be found 

at http://www.regulations.gov in 

document Chlorantraniliprole (DPXE2Y45): Human Health Risk Assessment 

for Proposed Uses on pome fruit, stone 

fruit, leafy vegetables, brassica leafy 

vegetables, cucurbit vegetables, fruiting 

vegetables, cotton, grapes, potatoes, 

rice, turf and ornamentals pages 22–24 

in docket ID number EPA–HQ–OPP– 

2007–0275. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to chlorantraniliprole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing chlorantraniliprole tolerances 

in (40 CFR 180.628). EPA assessed 

dietary exposures from 

chlorantraniliprole 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 chlorantraniliprole; 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 CSFII. As to residue levels in food, 

EPA assumed all foods for which there 

are tolerances were treated and contain 

tolerance-level residues. 

The inclusion of additional livestock 

feeds such as forage, fodder and straw 

from cowpea, field pea, soybean, cereal 

grains, nongrass animal feeds or peanut 

does not increase the livestock dietary 

burdens and thus the meat and milk 

tolerances. While the addition of 

strawberries, sugarcane, leek, onions, 

shallot, and okra that are considered 

human food results in a miniscule 

increase in exposure, a DEEM analysis 

that incorporates all the new 

commodities does not change the risk 

outcome which remains at 1% of the 

cPAD for the most highly exposed 

population, children ages 1-2. In 

addition, the dietary exposure from 

leeks, onions and shallots is negligible. 

iii. Cancer. Because 

chlorantraniliprole has been classified 

as a ‘‘not likely human carcinogen’’, a 

quantitative exposure assessment 

relative to cancer risk is not necessary. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

chlorantraniliprole in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the environmental fate characteristics of 

chlorantraniliprole. 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. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated 

environmental concentrations (EECs) of 

chlorantraniliprole for acute exposures 

are estimated to be 26.862 parts per 

billion (ppb) for surface water and 1.06 

ppb for ground water. The EECs for 

chronic exposures are estimated to be 

3.650 ppb for surface water and 1.06 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

Because no acute hazard, attributable to 

a single dose, was identified; acute 

dietary risk was not assessed. For 

chronic dietary risk assessment, the 

water concentration value 3.650 ppb 

was used to access 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). 

Chlorantraniliprole is registered for 

use on the following residential nondietary sites: Turfgrass and ornamental 

plants. Although residential exposure 

could occur, due to the lack of toxicity 

identified for short-term and 

intermediate-term durations via the 

relevant routes of exposure, no risk is 

expected from these exposures. 

Additional information on residential 

exposure assumptions can be found at 

www.regulations.gov (Docket ID EPA– 

HQ–OPP–2007–0275, pages 36 through 

37). 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

chlorantraniliprole and any other 

substances and chlorantraniliprole does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

chlorantraniliprole has 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 


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found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (10X) tenfold 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. In applying this 

provision, EPA either retains the default 

value of 10X when reliable data do not 

support the choice of a different factor, 

or, if reliable data are available, EPA 

uses a different additional FQPA safety 

factor value based on the use of 

traditional UFs and/or special FQPA 

safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There were no effects on fetal growth or 

postnatal development up to the limit 

dose of 1,000 mg/kg/day in rats or 

rabbits in the developmental or 2- 

generation reproduction studies. 

Additionally, there were no treatment 

related effects on the numbers of litters, 

fetuses (live or dead), resorptions, sex 

ratio, or post-implantation loss and no 

effects on fetal body weights, skeletal 

ossification, and external, visceral, or 

skeletal malformations or variations. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings: 

i. The toxicology database for 

chlorantraniliprole is complete for the 

purposes of this risk assessment and the 

characterization of potential prenatal 

and postnatal risks to infants and 

children. 

ii. No susceptibility was identified in 

the toxicological database, and there are 

no residual uncertainties re: prenatal 

and/or postnatal exposure. 

iii. There are no treatment-related 

neurotoxic findings in the acute and 

subchronic oral neurotoxicity studies in 

rats. 

iv. The exposure assessment is 

protective: The dietary food exposure 

assessment utilizes tolerance level 

residues and 100 percent crop treated 

(PCT) information for all commodities. 

The submitted field rotational crop 

studies do not match those 

recommended in the guidelines. 

However, data from confined rotational 

crop studies and field rotational crop 

studies show that uptake of 

chlorantraniliprole is below the 

quantification level in roots and grains, 

and range of 0.01 to 0.15 ppm in tops 

of root vegetables and forage, fodder and 

straw of cereal grains and soybean. The 

0.20 ppm tolerances based on the 

collective data should be conservative. 

Also, the tolerances on rotational crops 

strawberry and okra are conservative 

since the strawberry tolerance is based 

on residues in grape from direct 

application of chlorantraniliprole and 

the okra tolerance is based on residues 

resulting from direct treatment on 

tomato and pepper. An exposure 

assessment using conservative residue 

values is expected to be protective. 

The drinking water assessment 

utilizes values generated by models and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations. By using these 

screening-level exposure assessments, 

the chronic dietary (food and drinking 

water) risk is not underestimated. 

v. Although residential exposure is 

expected over the short- and possibly 

intermediate-term (via the dermal and/ 

or incidental oral route), there is no 

hazard expected via these routes/ 

durations, and therefore no risk for 

these scenarios. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

exposure to the pesticide to the aPAD 

and cPAD. The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable UFs. For linear cancer risks, 

EPA calculates the probability of 

additional cancer cases given aggregate 

exposure. Short-term, intermediateterm, and long-term risks are evaluated 

by comparing aggregate exposure to the 

LOC to ensure that the MOE called for 

by the product of all applicable UFs is 

not exceeded. 

1. Acute risk. No acute risk is 

expected because no acute hazard, 

attributable to a single dose, was 

identified. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to chlorantraniliprole 

from food and water will utilize <1% of 

the cPAD for the population group 

children 1-2 years (the highest exposed 

subpopulation). Based the use pattern, 

chronic residential exposure to residues 

of chlorantraniliprole is not expected. 

3. Short-term/intermediate risk. Shortterm aggregate and intermediate-term 

exposure takes into account residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

There is potential for short-term and 

intermediate-term post-application 

dermal (adults and children) and 

incidental oral (children only) exposure 

to chlorantraniliprole. However, due to 

the lack of toxicity via dermal route, as 

well as the lack of toxicity over the 

acute, short-term and intermediate-term 

via the oral route - no risk is expected 

from these exposures. Inhalation 

exposure is not expected due to the low 

vapor pressure of chlorantraniliprole (so 

applied/deposited residues are not 

expected to volatilize into the air). 

4. Aggregate cancer risk for U.S. 

population. Chlorantraniliprole has 

been classified as a ‘‘not likely human 

carcinogen.’’ It 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 

chlorantraniliprole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

liquid chromatography/mass 

spectrometry (LC/MS) is available to 

enforce the tolerance expression. The 

methods may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

There are no international residue 

limits that affect the Agency’s 

recommendations at this time. There are 

no CODEX or Mexican maximum 

residue limits (MRLs) for 

chlorantraniliprole that exists at this 

time. 

C. Conditions 

Tolerances may be made permanent 

following submission of rotational crop 

residue data suitable for establishing 

tolerances. 

V. Conclusion 

Time-limited tolerances are proposed 

for residues of chlorantraniliprole, 3- 

bromo-N-[4-chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, in or on cowpea, forage 

and hay at 0.20 ppm; field pea, vines 

and hay at 0.20 ppm; forage, fodder and 

straw of cereal grains, crop group 16 at 

0.20 ppm, grass forage, fodder and hay, 


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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Proposed Rules 57045 

crop group 17 at 0.20 ppm; leaves of 

root and tuber vegetables, crop group 2 

at 0.20 ppm; leek at 0.20 ppm; nongrass 

animal feeds (forage, fodder, straw and 

hay), crop group 18 at 0.20 ppm; okra 

at 0.70 ppm; onion, green at 0.20 ppm; 

onion, Welsh at 0.20 ppm; peanut, hay 

at 0.20 ppm; shallot at 0.20 ppm; 

soybean, forage and hay at 0.20 ppm; 

strawberries at 1.20 ppm; and 

sugarcane, sugar at 0.20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This proposed rule establishes a 

tolerance 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 proposed rule has been 

exempted from review under Executive 

Order 12866 due to its lack of 

significance, this proposed 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). This proposed rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). The Agency 

hereby certifies, under the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), that this proposed action will not 

have significant negative economic 

impact on a substantial number of small 

entities. A tolerance is one of the 

regulatory requirements needed for use 

of a pesticide and thus establishing a 

tolerance is expected to have no adverse 

economic impact. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This proposed 

rule directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this 

proposed rule does not have any ‘‘tribal 

implications’’ as described in Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000). Executive Order 3175, requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 19, 2008. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be 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 180.628 is amended by 

revising paragraph (d) to read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

* * * * * 

(d) Indirect or inadvertent resisues. 

Time-limited tolerances are established 

for indirect or inadvertent residues of 

the insecticide chlorantraniliprole (3- 

bromo-N-[4-chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide) in or on the following 

commodities. The tolerances will expire 

and are revoked on the dates specified 

in the following table. 

Commodity Parts per million Expiration/revocation date 

Animal feed, nongrass, group 18 ........................................................................ 0.20 4/25/10 

Cowpea, forage ................................................................................................... 0.20 4/25/10 

Cowpea, hay ........................................................................................................ 0.20 4/25/10

Field pea, hay ...................................................................................................... 0.20 4/25/10 

Field pea, vine ..................................................................................................... 0.20 4/25/10 

Grain, cereal, forage, fodder and straw, group 16 .............................................. 0.20 4/25/10 

Grass, forage, fodder and hay, group 17 ............................................................ 0.20 4/25/10 

Leek ..................................................................................................................... 0.20 4/25/10 

Okra ..................................................................................................................... 0.70 4/25/10 

Onion, green ........................................................................................................ 0.20 4/25/10 


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Commodity Parts per million Expiration/revocation date 

Onion, Welsh ....................................................................................................... 0.20 4/25/10

Peanut, hay .......................................................................................................... 0.20 4/25/10 

Shallot .................................................................................................................. 0.20 4/25/10 

Soybean, forage .................................................................................................. 0.20 4/25/10 

Soybean, hay ....................................................................................................... 0.20 4/25/10

Strawberry ............................................................................................................ 1.20 4/25/10 

Sugarcane ............................................................................................................ 0.20 4/25/10 

Vegetable, leaves of root and tuber, group 2 ..................................................... 0.20 4/25/10 

[FR Doc. E8–22946 Filed 9–30–08; 8:45 am] 

BILLING CODE 6560–50–S 


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