21670 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by June 11, 2012. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Particulate matter, 

Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: March 29, 2012. 

A. Stanley Meiburg, 

Acting Regional Administrator, Region 4. 

40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart S—Kentucky 

■ 2. Section 52.920(e) is amended by 

adding a new entry at the end of the 

table for ‘‘Huntington-Ashland 1997 

PM2.5 Attainment Plan’’ to read as 

follows: 

§ 52.920 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED KENTUCKY NON-REGULATORY PROVISIONS

Name of non-regulatory SIP 

provision 

Applicable geographic or 

nonattainment area 

State submittal 

date/effective date EPA approval date Explanation 

*******

Huntington-Ashland 1997 

PM2.5 Attainment Plan.

Boyd County; Portion of 

Lawrence County.

12/03/2008 4/11/2012 [Insert citation of 

publication].

For the 1997 PM2.5 NAAQS. 

[FR Doc. 2012–8561 Filed 4–10–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0086; FRL–9343–3] 

Acibenzolar-S-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of acibenzolar-Smethyl in or on berry, low growing, 

subgroup 13–07G. The Interregional 

Research Project No. 4 (IR–4) requested 

the tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

11, 2012. Objections and requests for 

hearings must be received on or before 

June 11, 2012, 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–2011–0086. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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 get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, go to: http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 21671 

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–2011–0086 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 11, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0086, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 6, 2011 

(76 FR 39358) (FRL–8875–6), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 0E7818) by IR–4, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 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 

low growing berry subgroup 13–07G at 

0.15 parts per million (ppm), and by 

amending the tolerance expression to 

read, ‘‘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 

commodity(s) listed. Compliance with 

the tolerance level 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. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc., the registrant, which is available in 

the docket, http://www.regulations.gov. 

One comment on the notice of filing 

was received. EPA’s response to this 

comment is discussed 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 acibenzolar-Smethyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with acibenzolar-Smethyl follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Considerable skin 

sensitizing (contact allergenic) potential 

was demonstrated in a dermal 

sensitization study in guinea pigs. 

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 same studies included 

decreases in body weight, body weight 

gain and/or food consumption. In a 28- 

day dermal study in rats, no systemic or 

dermal effects were observed at dose 

levels up to 1,000 milligrams/kilogram/ 

day (mg/kg/day), the limit dose. No 

neurotoxic effects were observed at any 

dose in a subchronic neurotoxicity 

study in rats. 

Prenatal and postnatal toxicity data 

are available including developmental 

toxicity studies in rats and rabbits, a 

developmental neurotoxicity (DNT) 

study in rats, and a 2-generation 

reproduction toxicity study in rats. 

Based on the developmental toxicity in 

rats and the developmental 

neurotoxicity studies in rats, there is 

concern for increased qualitative and/or 

quantitative susceptibility following in 

utero exposure to acibenzolar-S-methyl. 

In the rat developmental toxicity study, 

treatment related visceral malformations 

and skeletal variations were observed in 

fetuses at 200 mg/kg/day, the no 

observed adverse effect level (NOAEL) 

for maternal toxicity. In the 

developmental neurotoxicity study, 

offspring toxicity was observed at 82 

mg/kg/day while no maternal toxicity 

was observed at 326 mg/kg/day, the 

highest dose tested (HDT). Additional 

developmental toxicity studies in rats 

and rabbits and reproduction studies in 

rats provided no indication of increased 

susceptibility of rat or rabbit fetuses or 

neonates compared to adult animals. In 

a dermal developmental toxicity study 

in rats, no maternal or developmental 

toxicity was observed at dose levels up 

to 500 mg/kg/day, the HDT. 

Acibenzolar-S-methyl was classified 

by the Agency as ‘‘not likely’’ to be a 

human carcinogen based on negative 

carcinogenicity studies in male and 

female rats and mice and generally 

negative results in an acceptable battery 

of mutagenicity studies. 

An immunotoxicity study required as 

part of new 40 CFR part 158 data 

requirements for registration of a 

pesticide has been submitted and is 

being reviewed by the Agency. Based on 

a preliminary review, the study is 


wreier-aviles on DSK5TPTVN1PROD with RULES
21672 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 

acceptable and indicates no evidence of 

immunotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acibenzolar-S-methyl 

as well as the NOAEL and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Acibenzolar-S-methyl 

Human Health Risk Assessment for 

Proposed Use of Acibenzolar-S-methyl 

on Low Growing Berries Crop Subgroup 

13–07G, dated February 23, 2012’’, on 

pages 28–33 in docket ID number EPA– 

HQ–OPP–2011–0086–0007. 

B. Toxicological Points of Departure 

(POD)/Levels of Concern (LOC) 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and LOC to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

lowest dose at which adverse effects of 

concern are identified the LOAEL. 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD)—and a safe 

margin of exposure (MOE). For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for acibenzolar-S-methyl used 

for human risk assessment is shown in 

the following table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACIBENZOLAR-S-METHYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENTS

Exposure/scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (General Population).NOAEL = 8.2 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

FQPA SF = 1x 

aRfD = 0.082 mg/kg/ 

day.

aPAD = 0.082 mg/kg/ 

day 

Developmental Neurotoxicity Toxicity—Rat. 

Developmental LOAEL = 82 mg/kg/day 

based on changes in brain morphometrics 

in the cerebellum in offspring. 

Maternal LOAEL = was not observed. 

NOAEL = 326.2 mg/kg/day HDT. 

Chronic Dietary (Females 13–49 years 

& Young Children).

NOAEL = 8.2 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

FQPA SF = 1x 

aRfD = 0.082 mg/kg/ 

day.

aPAD = 0.082 mg/kg/ 

day 

Developmental Neurotoxicity Toxicity—Rat. 

Developmental LOAEL = 82 mg/kg/day 

based on changes in brain morphometrics 

in the cerebellum in offspring. 

Maternal LOAEL = was not observed. 

NOAEL = 326.2 mg/kg/day HDT. 

Chronic Dietary (Adult 

Males and Females 

50+ yrs).

NOAEL = 25 mg/kg/ 

day.

UFA = 10x .................

UFH = 10x 

FQPA SF = 1x 

cRfD = 0.25 mg/kg/ 

day.

cPAD = 0.25 mg/kg/ 

day.

Chronic Toxicity—Dog; Co-critical; Chronic/ 

Cancer—Rat & Mouse, Reproduction Toxicity—Rat. 

LOAEL = 105 mg/kg/day based on hemolytic 

anemia with compensatory response. 

Incidental Oral ............ NOAEL = 8.2 mg/kg/ 

day.

UFA = 10x .................

UFH = 10x 

Occupational LOC for 

MOE = 100.

Developmental Neurotoxicity Toxicity—Rat. 

Developmental LOAEL = 82 mg/kg/day 

based on changes in brain morphometrics 

in the cerebellum in offspring. 

Maternal LOAEL = was not observed. 

NOAEL = 326.2 mg/kg/day HDT. 

Dermal Short (1–30 

days) and Intermediate (1–6 

months) Term.

DAF = 40% 

NOAEL= 8.2 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

Occupational LOC for 

MOE = 100.

Developmental Neurotoxicity Toxicity—Rat. 

Developmental LOAEL = 82 mg/kg/day 

based on changes in brain morphometrics 

in the cerebellum in offspring. 

Maternal LOAEL = was not observed. 

NOAEL = 326.2 mg/kg/day HDT. 

Inhalation Short (1–30 

days) and Intermediate (1–6 

months) Term.

NOAEL= 8.2 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

Occupational LOC for 

MOE = 100.

Developmental Neurotoxicity Toxicity—Rat. 

Developmental LOAEL = 82 mg/kg/day 

based on changes in brain morphometrics 

in the cerebellum in offspring. 

Maternal LOAEL = was not observed. 

NOAEL = 326.2 mg/kg/day HDT. 

Cancer (all routes) ..... A ‘‘not likely’’ human carcinogen. 

Point of Departure = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of 

extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. 

LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential 

variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted 

dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. DAF = Dermal Absorption Factor. 

Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the 

oral route of exposure (100% absorption factor). mg/kg/day = milligram/kilogram/day. HDT = highest dose tested. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 21673 

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 § 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. Such effects were identified 

for acibenzolar-S-methyl. In estimating 

acute dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA performed a refined 

(probabilistic) acute dietary exposure 

analysis for the general population and 

all population subgroups. The acute 

analysis assumed a distribution of 

residues based on field trial data. 

Empirical and Dietary Exposure 

Evaluation Model (DEEM) default 

processing factors were used to modify 

the field trial data. Maximum screeninglevel percent crop treated (PCT) 

estimates were used for commodities for 

which data were available. If no PCT 

data were available, 100 PCT was 

assumed. 

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, the 

chronic analysis incorporated tolerance 

level residues and 100 PCT assumptions 

were used. DEEM default and empirical 

processing factors were used to modify 

the tolerance values. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that acibenzolar-S-methyl 

does not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 

5 years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. EPA did not use PCT data 

in assessing chronic exposure. 

2. Dietary exposure from drinking 

water. The residues of concern for 

drinking water are acibenzolar-Smethyl, benzo(1,2,3) thiadiazole-7- 

carbothioic acid-S-methyl ester, 

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

carboxylic acid (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 simulations 

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 Tier II Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System and Screening Concentration in 

Ground Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of acibenzolar-S-methyl and 

CGA–210007 for acute exposures are 

estimated to be 0.72 and 20.02 parts per 

billion (ppb), respectively, for surface 

water and 0.0000125 and 0.0812 ppb, 

respectively, for ground water. EDWCs 

of acibenzolar-S-methyl and CGA– 

210007 for chronic exposures for noncancer assessments are estimated to be 

0.02 and 8.09 ppb, respectively, for 

surface water and 0.0000125 and 0.0812 

ppb, respectively, for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. CGA– 

210007 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 

(MW), i.e., (MW of acibenzolar (210) ÷ 

MW of CGA 210007 (180) × EDWC for 

CGA 210007). The acute analysis 

incorporated the entire time distribution 

of estimated drinking water 

concentrations adjusted to account for 

CGA–210007. For chronic dietary risk 

assessment, the water concentration of 

value 9.44 ppb was used to assess the 

contribution of CGA 210007 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 currently 

registered for the following uses that 

could result in residential exposures: 

Turfgrass use on sodfarms, golf courses, 

collegiate athletic fields, and lawns 

around commercial and industrial 

buildings. Residential exposure was 

assessed for adult handlers and for adult 

and child post-application activities. 

Exposure for adult and child golfers was 

used to aggregate adult post-application 

dermal exposure with dietary and 

drinking water exposure. The aggregate 

exposure assessment for children 

combines dermal and incidental oral 

post-application exposure with food and 

water exposure. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/trac/science/ 

trac6a05.pdf. 

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 


wreier-aviles on DSK5TPTVN1PROD with RULES
21674 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 

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 Web site 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for acibenzolar-S-methyl 

includes adequate developmental 

toxicity studies in rats and rabbits, a 

DNT study in rats, and a 2-generation 

reproduction toxicity study in rats. As 

discussed in Unit III.A., several of these 

studies indicate that the young are 

quantitatively and qualitatively more 

sensitive to acibenzolar-S-methyl. 

Nonetheless, there are no residual 

uncertainties with regard to prenatal 

and/or postnatal toxicity since the 

NOAELs and the LOAELs have been 

identified for all effects of concern, a 

clear dose response has been well 

defined, and the PODs selected for risk 

assessment are protective of the fetal/ 

offspring effects. 

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 finalization of EPA’s review of an 

immunotoxicity study. Recent changes 

to 40 CFR part 158 require 

immunotoxicity testing (OPPTS 

Guideline 870.7800) for pesticide 

registration and tolerance establishment. 

An immunotoxicity study has been 

submitted to EPA and is currently under 

review. The study is acceptable and 

preliminary review results show no 

evidence of immunotoxicty. In the 

absence of a completed assessment of 

the immunotoxicity study at this time, 

EPA evaluated available acibenzolar-Smethyl 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 acibenzolar-Smethyl and acibenzolar-S-methyl does 

not belong to a class of chemicals (e.g., 

the organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. Therefore, EPA does not 

believe that the ultimate findings of the 

submitted immunotoxicity study will 

result in a POD lower than those already 

selected for acibenzolar-S-methyl risk 

assessment, and an additional database 

uncertainty factor is not needed to 

account for the lack of this study. 

ii. There is concern for increased 

qualitative and/or quantitative 

susceptibility following in utero 

exposure to acibenzolar-S-methyl based 

on developmental toxicity and 

developmental neurotoxicity studies in 

rats. However, for the reasons noted 

above, the degree of concern for the 

increased susceptibility seen in these 

studies is low. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary risk assessment is 

conservative and will not underestimate 

dietary and/or non-dietary residential 

exposure to acibenzolar-S-methyl. The 

acute analysis assumed a distribution of 

residues based on field trial data and 

maximum PCT estimates were used for 

commodities for which data were 

available. The chronic dietary food 

exposure assessment was performed 

based on 100 PCT and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to acibenzolar-S-methyl 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

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 dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

acibenzolar-S-methyl will occupy 35% 

of the aPAD for children 3–5 years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

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

11% of the cPAD for children 1–2 and 

children 3–5 years old, the population 

groups receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of acibenzolar-S-methyl is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Acibenzolar-S-methyl is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

acibenzolar-S-methyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 700 for females 13–49 years 

old from handler activities, and 1,600 

for females 13–49 years old, and 800– 

1,000 for children 1–2 and 6–12 years 

old, respectively, from post-application 

exposure. Because EPA’s LOC for 

acibenzolar-S-methyl is a MOE of 100 or 

below, these short-term aggregate MOEs 

are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, acibenzolar-Smethyl is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 21675 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for acibenzolar-S-methyl. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

acibenzolar-S-methyl is not expected to 

pose a cancer risk to humans. 

6. 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 ultraviolent 

detection (HPLC/UV) Method AG– 

617A) is available to enforce the 

tolerance expression. This method has 

undergone a successful tolerance 

method validation by the Agency. 

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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for acibenzolar-S-methyl in or on berry, 

low growing, subgroup 13–07G. 

C. Response to Comments 

One comment was received from a 

private citizen who opposed 

authorization by EPA to allow ‘‘all of 

these toxic chemicals since this Agency 

does not test their reaction with 

thousands of other chemicals that are 

already present * * *.’’ 

The Agency has received this same 

comment on numerous previous 

occasions. Refer to Federal Register of 

January 7, 2005, 70 FR 1349 for the 

Agency’s response to this comment. 

V. Conclusion 

Therefore, a tolerance is 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 

berry, low growing, subgroup 13–07G at 

0.15 ppm. Compliance with the 

tolerance level specified is to be 

determined by measuring only those 

acibenzolar-S-methyl residues 

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

carboxylic acid (CGA–210007), 

expressed as the stoichiometric 

equivalent of acibenzolar-S-methyl. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (Pub. L. 

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). 


wreier-aviles on DSK5TPTVN1PROD with RULES
21676 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 27, 2012. 

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) to read as follows: 

§ 180.561 Acibenzolar-S-methyl; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of acibenzolarS-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-S-methyl 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 following raw agricultural 

commodities. 

Commodity Parts per 

million 

Banana 1 ..................................... 0 .1 

Berry, low growing, subgroup 

13–07G ................................... 0 .15 

Onion, bulb, subgroup 3–07A .... 0 .1 

Spinach ....................................... 1 .0 

Tomato, paste ............................. 3 .0 

Vegetable, brassica, leafy, group 

5 .............................................. 1 .0 

Vegetable, cucurbit, group 9 ...... 2 .0 

Vegetable, fruiting, group 8 ........ 1 .0 

Vegetable, leafy, group 4 ........... 0 .25 

1There are no United States registrations 

for banana. 

* * * * * 

[FR Doc. 2012–8355 Filed 4–10–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0934; FRL–9333–6] 

Silicic Acid, Sodium Salt etc.; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Silicic acid, 

sodium salt, reaction products with 

chlorotrimethylsilane and iso-propyl 

alcohol, reaction with 

poly(oxypropylene)-poly(oxyethylene) 

glycol; when used as an inert ingredient 

in a pesticide chemical formulation. 

Dow Corning Corporation submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Silicic acid, sodium salt, 

reaction products with 

chlorotrimethylsilane and iso-propyl 

alcohol, reaction with 

poly(oxypropylene)-poly(oxyethylene) 

glycol on food or feed commodities. 

DATES: This regulation is effective April 

11, 2012. Objections and requests for 

hearings must be received on or before 

June 11, 2012, 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–2011–0934. 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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; email address: 

debesai.alganesh@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. Can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2011–0934 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 


wreier-aviles on DSK5TPTVN1PROD with RULES