58880 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

Approved: July 10, 2008. 

Gordon H. Mansfield, 

Deputy Secretary of Veterans Affairs. 

■ Accordingly, the interim final rule 

amending 38 CFR parts 17 and 59, 

which was published in the Federal 

Register at 66 FR 33845 on June 26, 

2001, is adopted as a final rule with the 

following changes and with the final 

regulatory change made to § 59.50 that 

was effective on February 14, 2007 (72 

FR 6959): 

PART 59—GRANTS TO STATES FOR 

CONSTRUCTION OR ACQUISITION OF 

STATE HOMES 

■ 1. The authority citation for part 59 

continues to read as follows: 

Authority: 38 U.S.C. 101, 501, 1710, 1742, 

8105, 8131–8137. 

■ 2. Amend § 59.20 by revising 

paragraph (a) to read as follows: 

§ 59.20 Initial application requirements. 

(a) For a project to be considered for 

inclusion on the priority list in § 59.50 

of this part for the next fiscal year, a 

State must submit to VA an original and 

one copy of a completed VA Form 10– 

0388–1 and all information, 

documentation, and other forms 

specified by VA Form 10–0388–1 (these 

forms are available on the internet Web 

sites provided in § 59.170 of this part). 

* * * * * 

■ 3. Amend § 59.60 by revising 

paragraphs (a) and (b) to read as follows: 

§ 59.60 Additional application 

requirements. 

* * * * * 

(a) Complete, updated Standard 

Forms 424 (mark the box labeled 

application and submit the information 

requested for an application), 424C, and 

424D (these forms are available on the 

internet Web site provided in § 59.170 

of this part), and 

(b) A completed VA Form 10–0388– 

5 and all information and 

documentation specified by VA Form 

10–0388–5 (this form is available on the 

internet Web site provided in § 59.170). 

* * * * * 

■ 4. Revise § 59.100 to read as follows: 

§ 59.100 Payment of grant award. 

The amount of the grant award will be 

paid to the State or, if designated by the 

State representative, the State home for 

which such project is being carried out 

or any other State agency or 

instrumentality. Such amount shall be 

paid by way of reimbursement, and in 

such installments consistent with the 

progress of the project as the Chief 

Consultant, Geriatrics and Extended 

Care, may determine and certify for 

payment to the appropriate Federal 

institution. Funds paid under this 

section for an approved project shall be 

used solely for carrying out such project 

as so approved. As a condition for the 

final payment, the State must comply 

with the requirements of this part based 

on an architectural and engineering 

inspection approved by VA, must obtain 

VA approval of the final equipment list 

submitted by the State representative, 

and must submit to VA a completed VA 

Form 10–0388–13 (this form is available 

on the internet Web site provided in 

§ 59.170). The equipment list and the 

completed VA Form 10–0388–13 must 

be submitted to the Chief Consultant, 

Geriatrics and Extended Care (114), 

VHA Headquarters; 810 Vermont 

Avenue, NW.; Washington, DC 20420. 

Authority: 38 U.S.C. 101, 501, 1710, 1742, 

8105, 8131–8137 

■ 5. Revise § 59.170 to read as follows: 

§ 59.170. Forms. 

All forms required by this part are 

available on the internet at ‘‘http:/ 

www.va.gov/forms/’’ for VA Forms and 

at ‘‘http://www.gsa.gov’’ for Standard 

Forms, or at the Veterans Health 

Administration, Room 789, 810 

Vermont Ave., NW., Washington, DC 

20420. 

Authority: 38 U.S.C. 101, 501, 1710, 1742, 

8105, 8131–8137, Section 2, 3, 4, and 4a of 

the Architectural Barriers Act of 1968, as 

amended, Pub. L. 90–480, 42 U.S.C. 4151– 

4157 

[FR Doc. E8–23822 Filed 10–7–08; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007-1191; FRL–8382–9] 

Cymoxanil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cymoxanil in 

or on bulb onion subgroup 3-07A; green 

onion subgroup 3-07B; leafy greens 

subgroup 4A; leaf petioles subgroup 4B; 

cilantro leaves; and caneberry subgroup 

13-07A. The Interregional Research 

Project (IR-4) requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). This regulation 

also deletes the tolerances for caneberry 

and head lettuce. 

DATES: This regulation is effective 

October 8, 2008. Objections and 

requests for hearings must be received 

on or before December 8, 2008, 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–2007–1191. 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: 

Barbara Madden, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 


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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 58881 

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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

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–2007–1191 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before December 8, 2008. 

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–2007–1191, 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 March 12, 

2008 (73 FR 13225) (FRL–8354–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 7E7282 and 

7E7283) by IR-4, 500 College Rd. East, 

Suite 201 W, Princeton, NJ 08540. The 

petitions requested that 40 CFR 180.503 

be amended by establishing tolerances 

for residues of the fungicide cymoxanil, 

(2-cyano-N-[(ethylamino)carbonyl]-2- 

(methoxyimino) acetamide), in or on 

bulb vegetables group 3-07 at 1.1 parts 

per million (ppm); leafy greens 

subgroup 4A at 19 ppm; cilantro leaves 

at 19 ppm; caneberry subgroup 13-07A 

at 4 ppm (PP 7E7283); and leaf petioles 

subgroup 4B at 6.0 ppm (PP 7E7282). 

That notice referenced a summary of the 

petition prepared by IR-4 and DuPont, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Several comments 

were received from a private citizen 

objecting to the sale of the pesticide and 

animal testing. The Agency has received 

these same comments from this 

commenter on numerous previous 

occasions. Refer to Federal Register 70 

FR 37686 (June 30, 2005), 70 FR 1354 

(January 7, 2005), 69 FR 63096-63098 

(October 29, 2004) for the Agency’s 

response to these objections. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the tolerance levels for 

bulb vegetables should be set as follows: 

bulb onion subgroup 3-07A at 0.05 ppm; 

green onion subgroup 3-07B at 1.1 ppm. 

The reasons for this change are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of cymoxanil on 

bulb onion subgroup 3-07A at 0.05 ppm; 

green onion subgroup 3-07B at 1.1 ppm; 

leafy greens subgroup 4A at 19 ppm; 

leaf petioles subgroup 4B at 6.0 ppm; 

cilantro leaves at 19 ppm; and caneberry 

subgroup 13-07A at 4.0 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing these 

tolerances 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by cymoxanil as well as the noobserved-adverse-effect-levels 

(NOAELs) and the lowest-observedadverse-effect-levels (LOAELs) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Cymoxanil; Human Health Risk 

Assessment for Proposed Uses on Bulb 

Vegetables (Crop Group 3-07), Leafy 

Greens (Subgroup 4A), and Leaf Petioles 

(Subgroup 4B), page 16 in docket ID 

number EPA–HQ–OPP–2007–1191. 

Cymoxanil has low acute toxicity via 

oral, dermal, and inhalation routes of 

exposure. It is a mild skin irritant, not 

a skin sensitizer, and non-irritating to 

the eye. Systemic toxicity, as evidenced 

by decreased body weights, body weight 

gains, and food consumption, was 

observed in subchronic, chronic, 

developmental, reproductive and 

neurotoxicity studies across species. 

The dog appears to be the most sensitive 

species for cymoxanil-induced toxicity 


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with the thymus gland identified as a 

target organ in this species during 

subchronic and chronic exposures. No 

evidence of immunotoxicity was 

observed following subchronic exposure 

of rats up to 108 milligrams/kilograms/ 

day (mg/kg/day) in males and 117 mg/ 

kg/day in females (108/117 (M/F)) or 

mice up to 218/552 (M/F) mg/kg/day, 

respectively. In a 21–day dermal 

toxicity study in rats, no systemic 

toxicity was observed up to the limit 

dose. In a subchronic neurotoxicity 

study in rats, systemic toxicity was 

observed at 102/137 mg/kg/day (M/F); 

however, no neurotoxicity and/or 

neuropathology were observed up to 

224/333 mg/kg/day (M/F; highest dose 

tested). In addition, no evidence of 

neurotoxicity was observed in the 

developmental toxicity studies in rats or 

rabbits, the 2-generation reproduction 

study in rats, the subchronic or chronic 

dog studies, or the 18–month mouse 

carcinogenicity study. However, in the 

combined chronic toxicity/ 

carcinogenicity study in rats, clinical 

signs of hyperactivity and 

aggressiveness in males (≥30.3 mg/kg/ 

day), as well as retinal atrophy in both 

sexes (≥30.3 mg/kg/day) were observed. 

Increased susceptibility of rats and 

rabbits was observed following in utero 

exposure to cymoxanil. In acceptable 

developmental toxicity studies in both 

of these species, developmental effects 

were seen at doses below those that 

caused maternal toxicity. In the rat 

developmental toxicity studies, skeletal 

anomalies, delays in skeletal 

ossification, and/or increases in overall 

malformations were observed at lower 

doses than those at which maternal 

toxicity was observed. In a rabbit 

developmental study, increased skeletal 

malformations were observed at 8 mg/ 

kg/day (LOAEL), which was also below 

the maternal NOAEL of 32 mg/kg/day. 

Cleft palate was also observed in fetuses 

at 32 mg/kg/day. In the first 2- 

generation reproduction toxicity study 

(1993), decreased pup viability (PND 0- 

4) was observed at maternally toxic 

doses. In a second 2-generation 

reproduction toxicity study (2001), 

decreased body weight was observed 

during lactation in both F1 and F2

offspring at a dose that was lower than 

that at which parental toxicity was 

observed. The increased susceptibility 

of offspring observed in this study was 

concordant with the results obtained in 

the developmental toxicity studies. In a 

developmental neurotoxicity study, 

offspring toxicity – adverse effects 

included decreased pup survival, 

decreased pup weight and body weight 

gain during early lactation, increases in 

morphometric measurements (anterior/ 

posterior cerebrum for males, cerebellar 

height for females) at PND 79-83, and 

decreased retention in the water maze 

task for adult females – was observed at 

the same dose as maternal toxicity 

(slight decreases in body weight, body 

weight gain during gestation, and food 

consumption). The LOAEL for both 

maternal animals and offspring was 100 

mg/kg/day. No residual uncertainties 

exist in the database for pre-/post-natal 

toxicity, and the endpoints selected for 

risk assessment are considered 

protective of effects observed in 

offspring in developmental and 

reproduction toxicity studies. The 

endpoints selected for risk assessment 

are further described in section 3.5 of 

the document: Cymoxanil; Human 

Health Risk Assessment for Proposed 

Uses on Bulb Vegetables (Crop Group 3- 

07), Leafy Greens (Subgroup 4A), and 

Leaf Petioles (Subgroup 4B), page 13 in 

docket ID number EPA–HQ–OPP–2007– 

1191. 

Cymoxanil was not carcinogenic in 

rats and mice and is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

The available studies indicate that 

cymoxanil is not mutagenic in bacteria 

or cultured mammalian cells. There is, 

however, evidence of clastogenic 

activity and induction of unscheduled 

DNA synthesis in vitro. In contrast, 

cymoxanil was neither clastogenic nor 

aneugenic in vivo in mouse bone 

marrow cells and did not induce a 

genotoxic response in rat somatic or 

germinal cells. The negative results from 

the in vivo mouse bone marrow 

micronucleus assay support the lack of 

a carcinogenic effect in long-term rat 

and mouse feeding studies. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

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) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD 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 dietary risks by comparing 

aggregate food and water 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 POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 cymoxanil used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Cymoxanil; Human Health Risk 

Assessment for Proposed Uses on Bulb 

Vegetables (Crop Group 3-07), Leafy 

Greens (Subgroup 4A), and Leaf Petioles 

(Subgroup 4B), page 16 in docket ID 

number EPA–HQ–OPP–2007–1191. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cymoxanil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

cymoxanil tolerances in (40 CFR 

180.503). EPA assessed dietary 

exposures from cymoxanil 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. An acute endpoint of concern 

was not identified for the general U.S. 

population. Therefore, an acute dietary 

exposure assessment was performed 

only for Females 13-49 Years Old, based 

upon the NOAEL of 4 mg/kg/day from 

the rabbit developmental toxicity study. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 


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in food, EPA assumed that cymoxanil 

residues were present in all registered 

and proposed food commodities at 

tolerance levels, and 100 percent crop 

treated (PCT) for all commodities. 

Dietary Exposure Evaluation Model 

(DEEM) version 7.81 default processing 

factors were used for all registered and 

proposed commodities except grapes. 

Processing factors for grape juice (1.4x) 

and raisins (1x) were derived from grape 

processing data. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues or 

anticipated residues (field trial residues) 

and PCT. Anticipated residues were 

calculated from average field trial data 

for cilantro leaves, chive, grape, green 

onion, hops, leaf petioles, and leafy 

greens. DEEM 7.81 default processing 

factors were used for all commodities 

except grapes. Processing factors for 

grape juice (1.4x) and raisins (1x) were 

derived from grape processing data. 

iii. Cancer. Cymoxanil was not 

carcinogenic in rats and mice. EPA 

classified cymoxanil as ‘‘not likely’’ to 

be a human carcinogen; therefore a 

cancer dietary exposure assessment was 

not performed. 

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 used PCT information as 

follows: Cucumber, head lettuce, 

pepper, potato, and tomato at 10%; 

pumpkin, squash, and watermelon at 

1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 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 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 cymoxanil may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cymoxanil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of cymoxanil. 

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 First Index Reservoir 

Screening Tool (FIRST), and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

cymoxanil for acute exposures are 

estimated to be 9.3 parts per billion 

(ppb) for surface water and 0.0018 ppb 

for ground water. EDWCs of cymoxanil 

for chronic exposures for non-cancer 

assessments are estimated to be 0.05 

ppb for surface water and 0.0018 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 9.3 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration 

value of 0.05 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). 

Cymoxanil 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 cymoxanil to share 

a common mechanism of toxicity with 

any other substances, and cymoxanil 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cymoxanil does not have 


dwashington3 on PRODPC61 with RULES
58884 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

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. 

There is an indication of increased 

susceptibility of rats and rabbits to in 

utero exposure to cymoxanil. In several 

developmental toxicity studies in the rat 

and rabbit, developmental toxicity was 

observed at doses that were lower than 

those that caused maternal toxicity. In 

the rat developmental toxicity studies, 

skeletal anomalies, delays in skeletal 

ossification, and/or increases in overall 

malformations were observed at lower 

doses than those at which maternal 

toxicity was observed. However, in the 

developmental neurotoxicity study in 

rat, offspring toxicity was observed at 

the same dose as maternal toxicity. In 

one rabbit developmental study, 

increased skeletal anomalies were 

observed at 8 mg/kg/day (LOAEL), 

which was below the maternal NOAEL 

of 32 mg/kg/day. In a second rabbit 

developmental toxicity study, an 

increased incidence of visceral and 

skeletal anomalies was observed at 25 

mg/kg bw/day; a maternal LOAEL was 

not observed in this study. In the 2- 

generation reproduction toxicity study, 

decreased pup body weight was 

observed at a lower dose than that 

which caused toxicity in adults. 

In the developmental and postnatal 

studies for which there is increased 

susceptibility, the effects are well 

characterized and conservative NOAELs 

were established for developmental and 

offspring effects. In addition, the doses 

selected for risk assessment are based on 

the lowest NOAELs from the 

developmental and reproductive 

toxicity studies, where appropriate, and 

are protective of any potential pre- and 

post-natal effects. Therefore, there are 

low levels of concern and no residual 

uncertainties for pre- and post-natal 

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 for acute risk 

determination. That decision is based 

on the following findings: 

i. The toxicity database for cymoxanil 

is complete for dietary risk assessment 

and includes a developmental 

neurotoxicity study. 

ii. Although there is evidence of 

increased susceptibility in the prenatal 

developmental studies in rats and 

rabbits, there have not been any residual 

uncertainties identified after 

establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment of cymoxanil. The 

degree of concern for pre-and/or 

postnatal toxicity is low. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues, and 

DEEM default processing factors for all 

registered and proposed commodities. 

The chronic dietary food assessment 

was performed incorporating tolerance 

levels or anticipated residues (field trial 

residues) and PCT (potatoes, head 

lettuce, peppers, tomatoes, watermelon, 

cucumber, pumpkin, and summer and 

winter squash). EPA believes that the 

PCT estimates used are based on reliable 

data because PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to cymoxanil in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by cymoxanil. 

EPA has retained the 10X FQPA 

safety factor for assessing risk from 

chronic dietary exposure to cymoxanil 

because the LOAEL from the chronic 

toxicity study in the dog was used to 

assess chronic dietary risk. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. An acute dietary exposure 

assessment was performed for females 

13-49 years old only, since an acute 

endpoint of concern was not identified 

for the general U.S. population. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure to cymoxanil from 

food and water will occupy 89% of the 

aPAD for females 13-49 years old, the 

only population subgroup of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cymoxanil 

from food and water will utilize 74% of 

the cPAD for children 1-2 years old, the 

population group receiving the greatest 

exposure. For the general U.S. 

population, chronic exposure to 

cymoxanil from food and water will 

utilize 48% of the cPAD. There are no 

residential uses for cymoxanil. 

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). Cymoxanil is not 

registered for any use patterns that 

would result in residential exposure. 

Therefore, the short- or intermediateterm aggregate risk is the sum of the risk 

from exposure to cymoxanil through 

food and water and will not be greater 

than the chronic aggregate risk. 

4. Cancer. Because cymoxanil was not 

carcinogenic in rats and mice, EPA 

concludes that the cancer risk to 

humans from exposure to cymoxanil is 

negligible. 

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 cymoxanil 

residues. 


dwashington3 on PRODPC61 with RULES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 58885 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with ultra violet 

detection (HPLC/UV) and HPLC/MS 

(mass spectroscopy)) is available to 

enforce the tolerance expression. The 

method 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 maximum 

residue levels established for cymoxanil 

on any of the commodities for which the 

tolerances are being established. 

C. Response to Comments 

Comments were submitted by a 

private citizen who opposed the 

establishment of cymoxanil tolerances 

for the following reasons: 

1. The availability of numerous 

products previously registered for the 

same purpose as the new uses of 

cymoxanil supported by these 

tolerances, and 

2. Cymoxanil is toxic to aquatic 

plants, bees, and birds, and therefore 

has potentially harmful effects on the 

environment. 

These comments are considered 

irrelevant because the safety standard 

for approving tolerances under section 

408 of the FFDCA focuses on potential 

harm to human health and does not 

permit consideration of effects on the 

environment or the availability of other 

registered products. Environmental 

effects were closely considered in EPA’s 

decision to register cymoxanil under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act. 

D. Revisions to Petitioned-For 

Tolerances 

Because there is a wide variability in 

the field trial residues, EPA has 

concluded that a group tolerance for 

bulb vegetables is not supported by the 

available data. Therefore, EPA has 

determined that the proposed tolerance 

level for bulb vegetables of 1.1 ppm 

should be revised as follows: Bulb onion 

subgroup 3-07A at 0.05 ppm; green 

onion subgroup 3-07B at 1.1 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cymoxanil, (2-cyano-N- 

[(ethylamino)carbonyl]-2- 

(methoxyimino) acetamide), in or on 

bulb onion subgroup 3-07A at 0.05 ppm; 

green onion subgroup 3-07B at 1.1 ppm; 

leafy vegetables subgroup 4A at 19 ppm; 

cilantro leaves at 19 ppm; leaf petioles 

subgroup 4B at 6.0 ppm; and caneberry 

subgroup 13-07A at 4.0 ppm. 

Additionally, the existing entries for 

‘‘Caneberry’’ and ‘‘Lettuce, head’’ are 

deleted. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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: September 29, 2008. 

Donald R. Stubbs, 

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 180.503 is amended in 

paragraph (a) by revising the 

introductory text, and in the table, by 

removing the entry for ‘‘Lettuce, head’’, 

revising the entry for ‘‘Caneberry’’ and 

alphabetically adding the following 

commodities to read as follows: 

§180.503 Cymoxanil; tolerances for 

residues 

(a) General. Tolerances are 

established for residues of the fungicide, 

cymoxanil, 2-cyano -N- 

[(ethylamino)carbonyl]-2- 


dwashington3 on PRODPC61 with RULES
58886 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

(methoxyimino) acetamide, in or on the 

following food commodities: 

Commodity Parts per million 

Caneberry, subgroup 

13A-07 ......................... 4.0 

Cilantro, leaves ............... 19 

* * * * * 

Leafy greens, subgroup 

4A ................................ 19 

Leaf petioles, subgroup 

4B ................................ 6.0 

* * * * * 

Onion, bulb, subgroup 3- 

07A .............................. 0.05 

Onion, green, subgroup 

3-07B ........................... 1.1 

* * * * * 

* * * * * 

[FR Doc. E8–23864 Filed 10–7–08; 8:45 am] 

BILLING CODE 6560–50–S 

OFFICE OF PERSONNEL 

MANAGEMENT 

48 CFR Part 1633 

RIN 3206–AL35 

Federal Employees Health Benefits 

Acquisition Regulation: Board of 

Contract Appeals 

AGENCY: Office of Personnel 

Management. 

ACTION: Final rule. 

SUMMARY: The Office of Personnel 

Management (OPM) is adopting as final, 

without change, the proposed rule 

published April 7, 2008 to remove the 

designation of the Armed Services 

Board of Contract Appeals (ASBCA) 

from the Federal Employees Health 

Benefits Acquisition Regulation 

(FEHBAR). 

DATES: Effective October 8, 2008. 

FOR FURTHER INFORMATION CONTACT: For 

further information contact Marguerite 

Martel, Policy Analyst, at 202–606–1772 

or e-mail: marguerite.martel@opm.gov. 

SUPPLEMENTARY INFORMATION: OPM 

published a proposed rule to remove the 

designation of the ASBCA from the 

FEHBAR on April 7, 2008, at 73 FR 

18729. No comments were received. 

Accordingly, OPM is adopting the 

proposed rule without change. The rule 

implements the provisions of the 

National Defense Authorization Act of 

2006, which created the Civilian Board 

of Contract Appeals (CBCA) with 

authority extending to most civilian 

agencies, including OPM. The CBCA 

has now replaced the ASBCA as the 

venue for claims brought under the Act 

for the Federal Employees Health 

Benefits (FEHB) Program. OPM is 

updating the FEHBAR to eliminate 

reference to the ASBCA to reflect this 

change in the law. 

Collection of Information Requirement 

This rulemaking makes a minor 

clarifying amendment to the Federal 

Employees Health Benefits Acquisition 

Regulations. The rule does not impose 

information collection and 

recordkeeping requirements that meet 

the definition of the Paperwork 

Reduction Act of 1995’s term 

‘‘collection of information,’’ which 

means obtaining, causing to be obtained, 

soliciting, or requiring the disclosure to 

third parties or the public, of facts or 

opinions by or for an agency, regardless 

of form or format, calling for either 

answers to identical questions posed to, 

or identical reporting or recordkeeping 

requirements imposed on ten or more 

persons, other than agencies, 

instrumentalities, or employees of the 

United States; or answers to questions 

posed to agencies, instrumentalities, or 

employees of the United States which 

are to be used for general statistical 

purposes. Consequently, it need not be 

reviewed by the Office of Management 

and Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

requires agencies to analyze options for 

regulatory relief of small businesses. For 

purposes of the RFA, small entities 

include small businesses, nonprofit 

organizations, and government agencies 

with revenues of $11.5 million or less in 

any one year. This rulemaking affects 

FEHB Program carriers and their 

contractual arrangements that exceed 

the dollar threshold. Therefore, I certify 

that this regulation will not have a 

significant economic impact on a 

substantial number of small entities. 

Regulatory Impact Analysis 

We have examined the impact of this 

proposed rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

RFA (September 16, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, the Unfunded Mandates 

Reform Act of 1995, (Pub. L. 104–4), and 

Executive Order 13132. Executive Order 

12866 (as amended by Executive Order 

13258, which merely assigns 

responsibility of duties) directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any one year). This rule is not 

considered a major rule, as defined in 

title 5, United States Code, section 

804(2), because we estimate it will affect 

only FEHB carriers. Any resulting 

economic impact would not be expected 

to exceed the dollar threshold. 

Executive Order 12866, Regulatory 

Review 

This rule has been reviewed by the 

Office of Management and Budget in 

accordance with Executive Order 12866. 

List of Subjects in 48 CFR Part 1633 

Government employees, Government 

procurement, Health insurance. 

Office of Personnel Management. 

Howard Weizmann, 

Deputy Director. 

■ Accordingly, under the authority of 5 

U.S.C. 8913; 40 U.S.C. 486(c); 48 CFR 

1.301 OPM is amending chapter 16 of 

title 48 of the Code of Federal 

Regulations by removing and reserving 

part 1633. 

PART 1633—[RESERVED] 

[FR Doc. E8–23224 Filed 10–7–08; 8:45 am] 

BILLING CODE 6325–39–P 

OFFICE OF PERSONNEL 

MANAGEMENT 

48 CFR Part 2133 

RIN 3206–AL46 

Federal Employees Group Life 

Insurance; Federal Acquisition 

Regulation: Board of Contract Appeals 

AGENCY: Office of Personnel 

Management. 

ACTION: Final rule. 

SUMMARY: The Office of Personnel 

Management (OPM) is adopting as final, 

without change, the proposed rule 

published April 7, 2008 to remove the 

designation of the Armed Services 

Board of Contract Appeals (ASBCA) 

from the Federal Employees Group Life 

Insurance Federal Acquisition 

Regulation (LIFAR). 

DATES: Effective October 8, 2008. 

FOR FURTHER INFORMATION CONTACT: For 

further information contact Marguerite 


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