51998 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Rules and Regulations 

included in the list of products 

described in 21 CFR 1308.34. 

NEW EXEMPT ANABOLIC STEROID PRODUCTS

Trade name Company Form Ingredients Quantity 

Esterified Estrogens and Methyltestosterone, USP (1.25 

mg/2.5 mg).

Interpharm, Inc ...... Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

1.25 mg/Tablet. 

2.5 mg/Tablet. 

Esterified Estrogens and Methyltestosterone, USP (0.625 

mg/1.25 mg).

Interpharm, Inc ...... Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

0.625 mg/Tablet. 

1.25 mg/Tablet. 

Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 

mg).

Lannett Company, 

Inc.

Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

1.25 mg/Tablet. 

2.5 mg/Tablet. 

Methyltestosterone and Esterified Estrogens (Half 

Strength) (1.25 mg/0.625 mg).

Lannett Company, 

Inc.

Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

0.625 mg/Tablet. 

1.25 mg/Tablet. 

Esterified Estrogens/Methyltestosterone, (1.25 mg/2.5 

mg) Tablet.

ANDAPharm, LLC .. Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

1.25 mg/Tablet. 

2.5 mg/Tablet. 

Esterified Estrogens/Methyltestosterone, (0.625 mg/1.25 

mg) Tablet.

ANDAPharm, LLC .. Tablets ..... Esterfied Estrogens ..........

Methyltestosterone ...........

0.625 mg/Tablet. 

1.25 mg/Tablet. 

Dated: August 24, 2006. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. E6–14516 Filed 8–31–06; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0035; FRL–8084–6] 

Benthiavalicarb-Isopropyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for the combined residues of 

benthiavalicarb-isopropyl, 

isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2- 

benzothiazolyl)ethyl]amino] carbonyl]- 

2-methylpropyl]carbamate and 

isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2- 

benzothiazolyl)ethyl]amino] carbonyl]- 

2-methylpropyl]carbamate, in or on 

imported grape at 0.25 parts per million 

(ppm), tomato at 0.45 ppm, and grape, 

raisin at 1.0 ppm. K-I Chemical U.S.A., 

Inc., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 1, 2006. Objections and 

requests for hearings must be received 

on or before October 31, 2006, 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–2005–0035. All documents in the 

docket are listed in the index for the 

docket. 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: 

Mary Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 


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an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2005–0035 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 

on or before October 31, 2006. 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0035, 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’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. Background and Statutory Findings 

In the Federal Register of March 9, 

2005 (70 FR 11648) (FRL–7699–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 3E6545) by K-I 

Chemical U.S.A., Inc., 11 Martine Ave., 

Suite 970, White Plains, NY 10606. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for the combined residues of the 

fungicide isopropyl[(S)-1-[(R)-1-(6- 

fluoro-1,3-benzothiazol-2- 

yl)ethyl]carbamoyl-2- 

methylpropyl]carbamate in or on the 

raw agricultural commodity imported 

grapes at 0.5 ppm, grape processed 

commodities juice and wine at 0.5 ppm, 

imported tomato at 0.5 ppm, tomato 

processed commodities at 0.5 ppm, and 

tomato paste at 1.5 ppm. That notice 

included a summary of the petition 

prepared by K-I Chemical U.S.A., Inc., 

the registrant. One comment from a 

private citizen was received in response 

to the notice of filing. EPA’s response to 

this comment is discussed in Unit IV. 

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 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 combined 

residues of benthiavalicarb-isopropyl on 

imported grape at 0.25 ppm, tomato at 

0.45 ppm, and grape, raisin at 1.0 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

benthiavalicarb-isopropyl as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov under document 

ID number EPA–HQ–OPP–2005–0035–

0001. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

oppfead1/trac/science. 

A summary of the toxicological 

endpoints for benthiavalicarb-isopropyl 

used for human risk assessment is 

shown in Table 1 of this unit: 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENTHIAVALICARB-ISOPROPYL FOR USE IN HUMAN

RISK ASSESSMENT

Exposure/scenario Dose used in risk assessment, 

UF 

Special FQPA SF and level of 

concern for risk assessment Study and toxicological effects 

Acute dietary 

All populations including infants 

and children when applicable 

NOAEL = N/S 

UF = N/A 

Acute RfD = N/A 

FQPA SF = N/A No studies resulted in toxic effects attributable to one or two 

exposures. Therefore an acute 

endpoint was not selected for 

dietary exposure. 

Chronic dietary 

(All populations) 

NOAEL= 9.9 milligrams/kilograms/day (mg/kg/day) 

UF = 100 

Chronic RfD = 0.099 mg/kg/day 

FQPA SF = 1X 

cPAD = 0.099 mg/kg/day 

Chronic oral toxicity in rats 

LOAEL = 249.6 mg/kg/day 

based on nephrotoxicity and 

hepatotoxicity. 

Cancer 

(Oral, dermal, inhalation) 

Likely to be carcinogenic to humans Q1*= 6.2795 x 10-2 Based on increases in male 

mouse liver combined adenomas and/or carcinomas and/or 

blastomas. 

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of 

concern, NA = Not Applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Benthiavalicarb-isopropyl is a 

new chemical and these are the first 

tolerances to be proposed for this 

chemical. Risk assessments were 

conducted by EPA to assess dietary 

exposures from benthiavalicarbisopropyl 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 benthiavalicarb-isopropyl; therefore, 

a quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), for each commodity: Estimates 

of percent crop imported (PCI) were 

used in place of percent crop treated 

(PCT) values as PCI values more 

appropriately estimate exposure to 

benthiavalicarb-isopropyl since the 

chemical is not being proposed for 

registration in the United States and 

residues will only result on imported 

grape and tomato commodities. Average 

field trial values of 0.06958 ppm for 

grapes, 0.1133 ppm for greenhouse 

grown tomatoes, and 0.00767 ppm for 

field grown tomatoes were used. It is 

unlikely that average field trial values 

and PCI values will be exceeded in the 

future. Average field trial values almost 

always exceed the expected residue 

levels found on crops at the time of 

consumption. When field trials are 

performed, the maximum allowable 

application rate is used and crops are 

harvested at the minimum PHI. Samples 

are stored frozen until analysis to ensure 

minimal degradation of residues. 

However, in actual practice, growers 

will not usually use the maximum 

application rates for economic reasons. 

Additionally, it has been observed from 

previous analysis, that monitoring data 

are often one to two orders of magnitude 

lower than field trial data. Moreover, the 

registrant is planning on marketing 

benthiavalicarb-isopropyl in Europe 

only. For this risk assessment, PCI 

estimates were assumed for all imports, 

not just grape and tomato commodities 

from Europe. Lastly, the Agency 

assumes 100% of the imported crop will 

be treated. The actual PCI will likely be 

considerably lower. The following 

processing factors derived from 

processing studies were used: 0.47 for 

grapes juice, 0.97 for grape wine, 3.67 

for raisins, 1.16 for tomato puree, and 

0.49 for tomato juice. Default processing 

factors of 5.4 for tomato paste and 14.3 

for dried tomatoes were used. 

iii. Cancer. The cancer exposure 

assessment was conducted using the 

same exposure assumptions as were 

used in the chronic exposure 

assessment. 

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 

chemicals that have been measured in 

food. If EPA relies on such information, 

EPA must pursuant to FFDCA section 

408(f)(1) require 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. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such data call-ins 

for information relating to anticipated 

residues as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Such 

data call-ins will be required to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

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 the 

Agency can make the following 

findings: 

Condition 1, that 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 such pesticide residue. 

Condition 2, that the exposure 

estimate does not underestimate 

exposure for any significant 

subpopulation group. 

Condition 3, if 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 section 408(b)(2)(F) of 


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FFDCA, EPA may require registrants to 

submit data on PCT. 

The Agency used PCI information as 

follows: Tomatoes–36%, processed 

tomato commodities–5.8%, grapes–

45%, grape juice–44%, wine–23%, and 

raisins–10%. 

The Agency believes that the three 

conditions listed in Unit III. have been 

met. With respect to Condition 1, PCI 

estimates are derived from the U.S. 

Department of Agriculture, Economic 

Research Service data which are reliable 

and have a valid basis. The Agency is 

reasonably certain that the percentage 

crop imported values will not be 

exceeded in the future. The conservative 

assumptions were made that 100% of 

the grape and tomato commodities 

imported from all over the world would 

be treated. Data for grape commodities 

were taken from 5 year averages and 

were compared to the annual data 

points of each data source. It was 

observed that crop production patterns 

and consumption and preferences were 

more stable and changed more slowly. 

For tomatoes commodities, data was 

taken from 1998 to 2004 with no 

increases occurring over that time 

period. It is very unlikely that estimates 

of import would be exceeded in the near 

future due to crop production patterns 

and consumption and preferences are 

more stable and change more slowly. As 

to Conditions 2 and 3, 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 the national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

benthiavalicarb-isopropyl may be 

applied in a particular area. 

2. Dietary exposure from drinking 

water. The proposed tolerances are for 

imported commodities only, and there 

are no current or proposed U.S. 

registrations for this chemical. 

Therefore, there is no potential for 

exposure to benthiavalicarb-isopropyl 

through drinking water, and a drinking 

water assessment was not performed. 

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). 

There are no products containing 

benthiavalicarb-isopropyl proposed or 

registered for residential use or that may 

be applied by commercial applicators to 

residential sites. Therefore, a residential 

exposure assessment was not 

performed. 

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 

benthiavalicarb-isopropyl and any other 

substances and benthiavalicarbisopropyl does not appear to produce a 

toxic metabolite produced by other 

substances. Although benthiavalicarbisopropyl is a carbamate compound, it 

is not a member of the class of 

insecticides known as the N-methyl 

carbamates for which the Agency is 

presently conducting a cumulative risk 

assessment. The substituents on the 

benthiavalicarb-isopropyl nitrogen atom 

are much larger than the methyl group 

in the insecticides. While the N-methyl 

carbamates are neurotoxicants based on 

their ability to inhibit the enzyme 

cholinesterase, there is no evidence of 

neurotoxicity or neuropathology in the 

hazard database for benthiavalicarbisopropyl. Benthiavalicarb-isopropyl is 

also not a member of the thiocarbamate 

class of herbicides or the 

dithiocarbamate class of fungicides. For 

the purposes of this tolerance action, 

therefore, EPA has not assumed that 

benthiavalicarb-isopropyl 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 found to have a common 

mechanism on EPA’s Web site 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 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. 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 safety factor value 

based on the use of traditional UFs and/ 

or special FQPA SFs, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There are no residual uncertainties for 

pre/postnatal toxicity. Developmental 

studies in two species (both rat and 

rabbit) and a 2-generation reproduction 

study in rats did not show any evidence 

of developmental or reproductive 

toxicity. Evidence suggests that there is 

no concern for fetuses exposed to 

benthiavalicarb-isopropyl in utero or 

post-natally. There was no evidence of 

neurotoxicity throughout the entire 

toxicology database and there was an 

absence of adverse developmental and 

reproductive effects. A developmental 

neurotoxicity study is not necessary at 

this time. The Agency determined that 

reliable data support reducing the FQPA 

SF to 1X. This determination was based 

on the following: 

• There is no evidence of increased 

susceptibility to fetuses or pups 

following in utero or postnatal exposure 

in the developmental toxicity studies in 

rats or rabbits, and in the 2-generation 

rat reproduction study. 

• There are no residual uncertainties 

concerning pre and postnatal toxicity 

and no neurotoxicity concerns. 

• The toxicological database is 

complete for FQPA assessment. 

• The chronic and cancer dietary food 

exposure assessments utilizes 

anticipated residues (ARs) calculated 

from average field trial data and 

worldwide estimates of PCI for most 

commodities. Although refined, the 

assessments are based on reliable data 

and will not underestimate exposure or 

risk. 

• There is no potential for drinking 

water exposure. 


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• There is no potential for residential 

exposure. 

3. Conclusion. There is a complete 

toxicity data base for benthiavalicarbisopropyl and exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. EPA determined that the 10X 

SF to protect infants and children 

should be removed. The FQPA factor is 

removed because there are no 

residential uncertainties for pre/ 

postnatal toxicity. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. An acute endpoint was 

not identified in any of the toxicity 

studies. Therefore, no acute risk is 

expected from exposure to 

benthiavalicarb-isopropyl. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to benthiavalicarbisopropyl from food will utilize <1 % of 

the cPAD for the U.S. population, <1 % 

of the cPAD for all infants <1 year old, 

and <1 % of the cPAD for children 1–

2 years old, the most highly exposed 

population subgroup. There are no 

residential uses for benthiavalicarbisopropyl. There are no current or 

proposed U.S. registrations of 

benthiavalicarb-isopropyl and as a 

result there is no expectation of 

exposure through drinking water. 

Therefore, EPA does not expect the 

aggregate exposure (dietary) to exceed 

100% of the cPAD. 

3. Aggregate cancer risk for U.S. 

population. Applying the cancer 

potency (Q1*) value of 0.063 (mg/kg/ 

day)-1 to the exposure value results in a 

cancer risk estimate of 1.6 x 10-6. This 

cancer risk estimate falls within the 

range of 1 x 10-6, the risk level 

considered to be negligible by EPA; 

therefore, the estimated cancer risk is 

below the Agency’s level of concern. 

4. 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, and to infants and children 

from aggregate exposure to 

benthiavalicarb-isopropyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

Gas Chromatography/NitrogenPhosphorous detector (GC/NPD) Method 

RCC. Ho. 665943 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 currently no established 

Codex, Canadian, or Mexican maximum 

residue limits (MRLs) for 

benthiavalicarb-isopropyl. 

C. Response to Comments 

One comment was received from a 

private citizen objecting to profiteering, 

animal testing, and establishing 

tolerances. The comments contained no 

scientific data or evidence to rebut the 

Agency’s conclusion that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

benthiavalicarb-isopropyl, including all 

anticipated dietary exposures and other 

exposures for which there is reliable 

information. The EPA has responded to 

this private citizen’s generalized 

comments on numerous previous 

occasions, for example, on January 7, 

2005 (70 FR 1354) (FRL–7681–9) and on 

October 29, 2004 (69 FR 63096) (FRL–

7691–4). 

V. Conclusion 

Therefore, the tolerances are 

established for combined residues of 

benthiavalicarb-isopropyl, 

isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2- 

benzothiazolyl)ethyl]amino] carbonyl]- 

2-methylpropyl]carbamate and 

isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2- 

benzothiazolyl)ethyl] amino] carbonyl]- 

2-methylpropyl]carbamate, in or on 

imported grape at 0.25 ppm, tomato at 

0.45 ppm, and grape, raisin at 1.0 ppm. 

As residues do not concentrate in wine, 

the 0.25 ppm grape tolerance is 

adequate to cover residues in wine. A 

separate tolerance for wine is not 

needed. Based on processing factors and 

highest average field trial values for 

field grown tomatoes which are used for 

processing, separate tolerances are not 

required for processed tomato 

commodities. 

VI. Statutory and Executive Order 

Reviews 

This final 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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., 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). 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. 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 final 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 


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Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Rules and Regulations 52003 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this 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 6, 2000). Executive 

Order 13175, 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 

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 rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 25, 2006. 

Anne E. Lindsay, 

Acting Director, 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 180.618 is added to read as 

follows: 

§ 180.618 Benthiavalicarb-isopropyl; 

tolerance for residues. 

(a) General. Tolerances are 

established for the combined residues of 

benthiavalicarb-isopropyl, 

isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2- 

benzothiazolyl)ethyl]amino] carbonyl]- 

2-methylpropyl]carbamate and 

isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2- 

benzothiazolyl)ethyl]amino] carbonyl]- 

2-methylpropyl]carbamate, in or on the 

following raw agricultural commodities: 

Commodity Parts per million 

Grape, imported .... 0.25 

Grape, raisin ......... 1.0 

Tomato .................. 0.45 

Note: There are no U.S. registrations as of 

July 30, 2006. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect of inadvertent residues. 

[Reserved] 

[FR Doc. 06–7313 Filed 8–31–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0373; FRL–8081–9] 

2, 6-Diisopropylnaphthalene; TimeLimited Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 2, 

6-Diisopropylnaphthalene, resulting 

from post-harvest applications to potato, 

in or on fat (cattle, goat, hog, horse, and 

sheep) at 0.8 part per million (ppm); 

liver (cattle, goat, hog, horse, and sheep) 

at 0.3 ppm; meat (cattle, goat, hog, 

horse, and sheep) at 0.1 ppm; meat 

byproducts (cattle, goat, hog, horse, and 

sheep) at 0.1 ppm; milk at 0.1 ppm; 

potato at 2.0 ppm; and potato, wet peel 

at 6.0 ppm. Loveland Products, Inc. had 

requested permanent tolerances (in or 

on whole potato and potato peels at 2 

and 6 ppm, respectively) under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

The time-limited tolerances will expire 

on August 1, 2009. 

DATES: This regulation is effective 

September 1, 2006. Objections and 

requests for hearings must be received 

on or before October 31, 2006, 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–2006–0373. All documents in the 

docket are listed in the index for the 

docket. 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 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail 

address:greenway.denise@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 


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