Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 24705 

* * * * * 

■ 3. In § 52.1072, paragraph (d) is 

removed and reserved. 

■ 4. In § 52.1073, paragraph (e) is 

removed and reserved. 

[FR Doc. E9–12139 Filed 5–22–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0270; FRL–8413–7] 

Acibenzolar-S-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acibenzolar-Smethyl in or on onion, bulb, subgroup 

3-07A; and vegetable, cucurbit, group 9. 

It also removes the section 18 timelimited tolerance on onion, bulb which 

is superseded by the new tolerance on 

onion, bulb, subgroup 3-07A. 

Interregional Research Project Number 4 

(IR-4) and Syngenta Crop Protection 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

26, 2009. Objections and requests for 

hearings must be received on or before 

July 27, 2009, 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–2008–0270. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I 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 e-CFR 

cite 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–2008–0270 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 July 27, 2009. 

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–2008–0270, 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 May 16, 

2008 (73FR 28461) (FRL–8361–6), 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 8E7337) by 

Interregional Research Project Number 4 

(IR-4), 500 College Road East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.561 be 

amended by establishing a tolerance for 

residues of the fungicide acibenzolar-Smethyl, benzo(1,2,3)thiadiazole-7- 

carbothioic acid-S-methyl ester, in or on 

onion, bulb, subgroup 3-07A at 0.07 

parts per million (ppm). That notice 

referenced a summary of the petition 

prepared on behalf of IR-4 by Syngenta 

Crop Protection, the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

24706 Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 

In the Federal Register of December 3, 

2008 (73 FR 73644) (FRL–8386–9), 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 8F7352) by 

Syngenta Crop Protection, Regulatory 

Affairs, P.O. Box 18300, Greensboro, NC 

27419-8300. The petition requested that 

40 CFR 180.561 be amended by 

establishing a tolerance for residues of 

the fungicide acibenzolar-S-methyl, 

benzo(1,2,3)thiadiazole-7-carbothioic 

acid-S-methyl ester, in or on vegetable, 

cucurbit, group 9 at 1.0 ppm. That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, the registrant, which is 

available to the public in docket ID 

number EPA–HQ–OPP–2008–0733 at 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the tolerance expression and 

increased the tolerance level for onion, 

bulb, subgroup 3-07A from 0.07 ppm to 

0.1 ppm; and for vegetable, cucurbit, 

group 9 from 1.0 ppm to 2.0 ppm. The 

reasons for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of acibenzolar-Smethyl on onion, bulb, subgroup 3-07A 

at 0.1 ppm; and vegetable, cucurbit, 

group 9 at 2.0 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing 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. 

Acibenzolar-S-methyl showed no 

significant toxicity in a battery of acute 

toxicity tests but showed considerable 

skin-sensitivity. In subchronic and 

chronic oral studies in rats, dogs and 

mice, signs of mild regenerative 

hemolytic anemia were consistently 

observed in all three species. Additional 

toxic effects observed in these studies 

included decreases in body weight, 

body weight gain and/or food 

consumption. No other significant 

treatment-related effects of toxicological 

concern were observed in these 

subchronic and chronic oral studies. No 

neurotoxic effects were seen at the 

highest dose tested in a subchronic 

neurotoxicity study in rats. In a 28–day 

dermal toxicity study in rats no 

systemic or dermal effects were seen at 

the limit dose. 

In developmental toxicity and 

developmental neurotoxicity (DNT) 

studies in rats, treatment-related effects 

(visceral malformations and skeletal 

variations; changes in brain 

morphometrics in the cerebellum) were 

observed in fetuses at levels that were 

not toxic to the parent, indicating 

increased sensitivity of rat fetuses 

compared to adults. Increased 

sensitivity was not observed in a 

developmental toxicity study in rabbits, 

or in 1-generation and 2-generation 

reproduction studies in rats. In a 28–day 

dermal developmental toxicity study in 

rats, no maternal or developmental 

toxicity was observed at dose levels up 

to 500 mg/kg/day, the highest dose level 

tested. 

Acibenzolar-S-methyl was classified 

by EPA as a ‘‘not likely’’ human 

carcinogen based on the lack of 

evidence of carcinogenicity in male and 

female rats and mice and lack of 

evidence of genotoxicity in an 

acceptable battery of mutagenicity 

studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acibenzolar-S-methyl 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

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

document Revised Acibenzolar-Smethyl Human Health Risk Assessment 

for Proposed Use of Acibenzolar-Smethyl on Cucurbits and Bulb Onions 

page 34 in docket ID number EPA–HQ– 

OPP–2008–0270. 

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-term, intermediate-term, 

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 acibenzolar-S-methyl used 

for human risk assessment can be found 

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

document Revised Acibenzolar-SVerDate Nov<24>2008 14:39 May 22, 2009 Jkt 217001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\26MYR1.SGM 26MYR1
Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 24707 

methyl Human Health Risk Assessment 

for Proposed Use of Acibenzolar-Smethyl on Cucurbits and Bulb Onions 

page 21 in docket ID number EPA–HQ– 

OPP–2008–0270. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acibenzolar-S-methyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acibenzolar-S-methyl tolerances 

in 40 CFR 180.561. EPA assessed dietary 

exposures from acibenzolar-S-methyl 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. EPA identified such an effect 

(changes in brain morphometrics in the 

cerebellum of offspring) in the 

developmental neurotoxicity study in 

rats. This acute endpoint is relevant to 

the population subgroup, females 13 to 

49 years old. No acute endpoint of 

concern was identified for the general 

population or other population 

subgroups. 

In estimating acute dietary exposure 

of females 13 to 49 years old, EPA used 

food consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 Nationwide 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). EPA conducted a 

partially refined, probabilistic acute 

dietary exposure assessment using the 

distribution of residues from field trial 

data for each food commodity. The 

probabilistic assessment incorporated 

empirical processing factors for some 

processed commodities (tomato paste, 

puree and juice) and DEEMTM default 

processing factors for the remaining 

processed commodities. Exposure 

estimates were further refined using 

maximum percent crop treated (PCT) 

information for most existing uses of 

acibenzolar-S-methyl. EPA assumed 100 

PCT for the new uses on onions and 

cucurbits. 

The acibenzolar residues of concern 

for risk assessment include acibenzolarS-methyl, benzo(1,2,3) thiadiazole-7- 

carbothioic acid-S-methyl ester, 

convertible to benzo(1,2,3)thiadiazole-7- 

carboxylic acid (CGA-210007), 

expressed as acibenzolar-S-methyl; and 

its 4-hydroxy CGA-210007 (CGA323060) and 5-hydroxy CGA-210007 

(CGA-324041) metabolites. A factor of 

1.5x, based on the relative abundance of 

the hydroxy metabolites (CGA-323060 

and CGA-324041) and residues 

convertible to the carboxylic acid 

metabolite (CGA-210007) found in the 

lettuce metabolism study, was applied 

to estimates of acibenzolar-S-methyl 

residues to account for all of the 

residues of concern for dietary risk 

(including CGA-210007, CGA-323060 

and CGA-324041). 

ii. Chronic exposure. EPA identified 

different chronic effects of concern for 

the general population (hemolytic 

anemia with compensatory response 

observed in the chronic dog study) and 

for females 13 to 49 years old (changes 

in brain morphometrics in the 

cerebellum of offspring in the DNT 

study). The cPAD for the general 

population has been established at 0.25 

mg/kg/day; whereas, the cPAD for 

females 13 to 49 years old is lower 

(0.082 mg/kg/day), due to the more 

sensitive endpoint on which it is based. 

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 assumed tolerancelevel residues (adjusted by a factor of 

1.5x to account for all metabolites of 

concern), DEEMTM default processing 

factors and 100 PCT for all 

commodities. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in male and 

female rats and mice and lack of 

evidence of genotoxicity in an 

acceptable battery of mutagenicity 

studies, EPA classified acibenzolar-Smethyl as a ‘‘not likely’’ human 

carcinogen. Therefore, an exposure 

assessment for evaluating cancer risk is 

not needed for this chemical. 

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: 

Broccoli 5%, cabbage 2.5%, 

cauliflower 5%, celery 1%, lettuce 

(head and leaf) 12%, pepper (bell and 

non-bell) 5%, spinach 30%, and tomato 

5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 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 

24708 Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 

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 acibenzolar-S-methyl may be 

applied in a particular area. 

2. Dietary exposure from drinking 

water. The residues of concern for 

drinking water include acibenzolar-Smethyl and residues convertible to 

CGA-210007. The Agency used 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for acibenzolar-S-methyl 

and CGA-210007 in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

acibenzolar-S-methyl. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

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

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

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

water concentrations (EDWCs) of 

acibenzolar-S-methyl and CGA-210007 

for acute exposures are estimated to be 

0.74 and 14.21 parts per billion (ppb), 

respectively, for surface water and 

0.000041 and 0.557 ppb, respectively, 

for ground water. EDWCs of 

acibenzolar-S-methyl and CGA-210007 

for chronic exposures for non-cancer 

assessments are estimated to be 0.10 and 

9.48 ppb, respectively, for surface water 

and 0.000041 and 0.557 ppb, 

respectively, for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. CGA210007 drinking water residues were 

included in the dietary exposure 

assessment as acibenzolar-S-methyl 

equivalents. CGA 210007 residues were 

converted to acibenzolar-S-methyl 

equivalents based on molecular weight 

(mol. wt. of acibenzolar (210) ÷ mol. wt. 

of CGA 210007 (180) x EDWC for CGA 

210007). For acute dietary risk 

assessment, the water concentration 

value of 17 ppb was used to assess the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 11 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). 

Acibenzolar-S-methyl 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 acibenzolar-Smethyl to share a common mechanism 

of toxicity with any other substances, 

and acibenzolar-S-methyl does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

acibenzolar-S-methyl does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

In previous risk assessments for 

acibenzolar-S-methyl the 10X FQPA 

safety factor was retained for increased 

quantitative susceptibility (umbilical 

hernia) observed in a rat developmental 

toxicity study and the lack of a 

developmental-neurotoxicity (DNT) 

study. A DNT study has now been 

submitted and reviewed by EPA; and, 

based on reevaluation of existing data 

and review of newly submitted data, the 

umbilical hernias are no longer 

considered to be treatment-related. EPA 

concluded that the incidence of 

umbilical hernias at 10 milligram/ 

kilogram/day (mg/kg/day) was not a 

treatment-related adverse effect because 

the effect is not dose-related (i.e., it was 

seen only at the low dose of 10 mg/kg/ 

day); the effect was not seen in dosed 

animals in other studies, including 

developmental toxicity studies and 

reproduction studies; umbilical hernia 

was observed in the control animals in 

the rat dermal developmental toxicity 

study (1/336 fetuses in 1 of 24 litters); 

and the effect is known to occur 

spontaneously in the rat strain used in 

this study. New studies, including a 

DNT study in rats, a developmental 

toxicity study in rats and two nonstandard investigative, phase-specific 

studies, support the finding that 

incidence of umbilical hernias is not 

treatment-related. Based on these 

findings, EPA has reconsidered the 

FQPA safety factor for acibenzolar-Smethyl. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for acibenzolar-S-methyl 

includes acceptable developmental 

toxicity studies in rats (two oral and one 

dermal) and rabbits (one oral); a DNT 

study in the rat; and 1-generation and 2- 

generation reproduction toxicity studies 

in the rat. 

There was no evidence of increased 

susceptibility of fetuses or offspring in 

the rat dermal developmental toxicity 

study, the rabbit developmental toxicity 

study or the rat reproduction toxicity 

studies. No maternal or fetal effects 

were observed in the dermal 

developmental study at any dose tested. 

In the rabbit developmental study, 

maternal effects (mortality, clinical 

signs, decreased maternal body weight 

and food consumption) were seen at a 

lower dose than fetal effects (marginal 

increase in vertebral anomalies). In the 

rat reproduction studies, parental effects 

(increased weights and hemosiderosis of 

the spleen; decreased body weight gain 

and food consumption in females) and 

offspring effects (reduced pup body 

weight gains and lower pup body 

weights during lactation) were seen at 

the same dose. 

In the developmental toxicity and 

DNT studies in rats, treatment-related 

effects (visceral malformations and 

skeletal variations; and changes in brain 

morphometrics in the cerebellum) were 

observed in offspring at levels that were 

not toxic to the parent, indicating 

potential increased quantitative 

susceptibility of offspring compared to 

adults. The developmental no-observed 

Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 24709 

adversed-effect level (NOAEL) from the 

DNT study (8.2 mg/kg/day) is the lowest 

NOAEL from any study in the 

acibenzolar database and is the POD 

used in both the acute and chronic 

dietary exposure assessments for 

females, 13 to 49 years old, the relevant 

population subgroup for assessing 

potential developmental effects. Since 

there is a well-defined NOAEL for these 

effects and the NOAEL is being used as 

the POD in the risk assessment, there 

are no residual uncertainties with regard 

to pre- or postnatal sensitivity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

acibenzolar-S-methyl is complete, 

except for immunotoxicity studies, and 

EPA has determined that an additional 

uncertainty factor is not required to 

account for potential immunotoxicity. 

The reasons for this determination are 

explained below: 

EPA began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Since this requirement is 

relatively new, these studies are not yet 

available for acibenzolar-S-methyl. In 

the absence of specific immunotoxicity 

studies, EPA has evaluated the available 

acibenzolar-S-methyl toxicity data to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

There are no indications in the available 

studies that organs associated with 

immune function, such as the thymus 

and spleen, are affected by acibenzolarS-methyl. While effects on the spleen 

were observed in association with 

hematologic effects, these were 

considered to be secondary to the 

primary effects on blood hematology. 

Effects on the thymus were seen in only 

one study in one animal at a high dose 

(400 mg/kg/day) and were, therefore, 

considered to be spurious. Due to the 

lack of evidence of immunotoxicity for 

acibenzolar-S-methyl, EPA does not 

believe that conducting immunotoxicity 

testing will result in a NOAEL less than 

the chronic NOAELs of 8.2 mg/kg/day 

(females, 13 to 49 years old) or 25 mg/ 

kg/day (all other populations) already 

established for acibenzolar-S-methyl, 

and an additional factor (UFDB) for 

database uncertainties is not needed to 

account for potential immunotoxicity. 

ii. There was no evidence of 

neurotoxicity in the subchronic 

neurotoxicity study submitted for 

acibenzolar-S-methyl. Based on the 

results of this study, EPA has 

determined that an acute neurotoxicity 

study is not required. There was 

evidence of offspring neurotoxicity 

(changes in brain morphometrics in the 

cerebellum) in the rat DNT study in the 

absence of maternal toxicity; however, 

since the NOAEL for these effects is 

being used in the acute and chronic risk 

assessments for females, 13 to 49 years 

old, there are no residual uncertainties 

with regard to these effects and no need 

for additional UFs to account for 

neurotoxicity. 

iii. Although there was evidence of 

increased quantitative susceptibility of 

offspring to acibenzolar-S-methyl in the 

rat developmental toxicity and DNT 

studies, the Agency did not identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional UFs 

to be used in the risk assessment. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed using tolerance levels 

or anticipated residues derived from 

reliable field trials and screening-level 

PCT estimates. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to acibenzolar-Smethyl in drinking water. Residential 

exposure to acibenzolar-S-methyl is not 

expected. These assessments will not 

underestimate the exposure and risks 

posed by acibenzolar-S-methyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (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-term, intermediateterm, 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. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to acibenzolar-Smethyl will occupy 12% of the aPAD for 

females, 13 to 49 years old, the only 

population group for which an acute 

endpoint of toxicological concern was 

identified. 

2. Chronic risk. EPA performed two 

different chronic risk assessments – one 

focusing on females 13 to 49 years old 

and designed to protect against 

neurotoxic effects in offspring and the 

other focusing on chronic effects 

(hemolytic anemia) relevant to all other 

population groups. The more sensitive 

chronic endpoint was seen as to 

offspring effects rather than other 

chronic effects. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that for females, 13 to 49 years old, 

chronic exposure to acibenzolar-Smethyl from food and water will utilize 

5% of the cPAD addressing offspring 

effects. As to other chronic effects, 

chronic exposure to acibenzolar-Smethyl from food and water will utilize 

4% of the cPAD for children, 1 to 2 

years old, the population group 

receiving the greatest exposure. There 

are no residential uses for acibenzolarS-methyl. 

3. Short-term intermediate-term risk. 

Short-term and intermediate-term 

aggregate exposures take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Acibenzolar-S-methyl is not registered 

for any use patterns that would result in 

residential exposure. Therefore, the 

short-term and intermediate-term 

aggregate risk is the sum of the risk from 

exposure to acibenzolar-S-methyl 

through food and water and will not be 

greater than the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Acibenzolar is classified as 

a ‘‘not likely’’ human carcinogen and is, 

therefore, not expected to pose a cancer 

risk. 

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 acibenzolarS-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High Performance Liquid 

Chromatography with Ultraviolet 

Detection (HPLC/UV) Method AG-671A) 

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 

24710 Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

No Codex, Mexican or Canadian 

maximum residue limits have been 

established for acibenzolar-S-methyl on 

any commodity. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioners proposed tolerances 

for residues of ‘‘acibenzolar-S-methyl, 

benzo(1,2,3)thiadiazole-7-carbothioic 

acid-S-methyl ester.’’ Since the 

analytical method for acibenzolar is a 

common-moiety method that converts 

all residues containing the 

benzo(1,2,3)thiadiazole-7-carboxylic 

acid (CGA-210007) moiety to CGA210007, EPA has revised the tolerance 

expression to read ‘‘acibenzolar-Smethyl, benzo(1,2,3)thiadiazole-7- 

carbothioic acid-S-methyl ester, 

including its metabolites and 

degradates. 

EPA has also increased the tolerance 

level for onion, bulb, subgroup 3-07A 

from 0.07 ppm to 0.1 ppm; and for 

vegetable, cucurbit, group 9 from 1.0 

ppm to 2.0 ppm. The residue data 

submitted for onions and previously 

submitted data for tobacco suggest that 

drying may tend to concentrate residues 

of acibenzolar-S-methyl. To ensure that 

the tolerance level is adequate, EPA has 

increased the tolerance for onion, bulb, 

subgroup 3-07A from 0.07 to 0.1 ppm. 

EPA increased the tolerance for 

cucurbits from 1.0 to 2.0 ppm based on 

the indication of variability within and 

between the cucurbit vegetable data sets 

(cantaloupe, cucumber and summer 

squash), as well as the demonstrated 

potential for significant increases in 

acibenzolar-S-methyl residues 0 to 7 

days before harvest. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acibenzolar-S-methyl 

benzo(1,2,3)thiadiazole-7-carbothioic 

acid-S-methyl ester, including its 

metabolites and degradates, in or on 

onion, bulb, subgroup 3-07A at 0.1 ppm; 

and vegetable, cucurbit, group 9 at 2.0 

ppm. Compliance with the specified 

tolerance levels is to be determined by 

measuring only those acibenzolar-Smethyl residues convertible to 

benzo(1,2,3)thiadiazole-7-carboxylic 

acid (CGA-210007), expressed as the 

stoichiometric equivalent of 

acibenzolar-S-methyl, in or on the 

commodity. 

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: May 15, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.561 is amended by 

revising paragraph (a) and paragraph (b) 

in the table by removing the entry for 

onion, bulb to read as follows: 

§ 180.561 Acibenzolar-S-methyl; 

tolerances for residues. 

(a) General. (1) Tolerances are 

established for residues of acibenzolarS-methyl, benzo(1,2,3)thiadiazole-7- 

carbothioic acid-S-methyl ester, in or on 

the following raw agricultural 

commodities: 

Federal Register / Vol. 74, No. 99 / Tuesday, May 26, 2009 / Rules and Regulations 24711 

Commodity Parts per million 

Banana1 ................................................................................................................... 0.1 

Spinach .................................................................................................................... 1.0 

Tomato, paste .......................................................................................................... 3.0 

Vegetable, brassica, leafy, group 5 ......................................................................... 1.0 

Vegetable, fruiting, group 8 ..................................................................................... 1.0 

Vegetable, leafy, group 4 ........................................................................................ 0.25 

1There are no United States registrations for banana. 

(2) Tolerances are established for 

residues of acibenzolar-S-methyl, 

benzo(1,2,3)thiadiazole-7-carbothioic 

acid-S-methyl ester, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only those acibenzolar-Smethyl residues convertible to 

benzo(1,2,3)thiadiazole-7-carboxylic 

acid (CGA-210007), expressed as the 

stoichiometric equivalent of 

acibenzolar-S-methyl, in or on the 

commodity. 

Commodity Parts per million 

Onion, bulb, subgroup 3–07A .................................................................................. 0.1 

Vegetable, cucurbit, group 9 ................................................................................... 2.0 

* * * * * 

[FR Doc. E9–12142 Filed 5–22–09; 8:45 am] 

BILLING CODE 6560–50–S