30402 Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule fits 

the category selected from paragraph 

(34)(g), as it establishes a temporary 

security zone for a limited period of 

time. 

An environmental analysis checklist 

and a categorical exclusion 

determination are available and 

accessible in the docket as indicated in 

the ADDRESSES section. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.06–1, 6.05–6 and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Section 165.T08–040 is added to 

read as follows: 

§ 165.T08–040 Moving Security Zone, 

Escorted Vessels. 

(a) Location. The following areas are 

security zones: Navigable waters of the 

Lower Mississippi River, from mile 

marker 90.0 to mile marker 110.0, 

extending 300 yards in all directions of 

escorted vessels. Escorted vessels will 

be escorted by one or more Coast Guard 

assets or other federal, state, or local law 

enforcement agency assets clearly 

identifiable by lights, vessel markings, 

or with agency insignia. 

(b) Effective period. This rule is 

effective May 23, 2012 through August 

15, 2012. Beginning April 1, 2012 this 

rule is enforced through actual notice. 

(c) Regulation. (1) Under the general 

regulations in § 165.33 of this part, 

vessels are prohibited from entering or 

transiting the security zones described 

in paragraph (a) of this temporary 

section, § 165.T08–040. 

(2) If granted permission to enter a 

security zone, a vessel must operate at 

the minimum speed necessary to 

maintain a safe course, unless required 

to maintain speed by the Navigation 

Rules, and shall proceed as directed by 

the Coast Guard. When within the 

security zone, no vessel or person is 

allowed within 50 yards of the escorted 

vessel unless authorized by the Coast 

Guard. 

(3) Persons or vessels requiring 

deviations from this rule must request 

permission from the Captain of the Port 

New Orleans through the on-scene Coast 

Guard or other agency asset, via VHF 

Ch. 67 or the Coast Guard Vessel Traffic 

Center at (504) 365–2230. 

(4) All persons and vessels granted 

permission to enter a security zone must 

comply with the instructions of the 

Captain of the Port New Orleans and 

designated personnel. Designated 

personnel include commissioned, 

warrant and petty officers of the U.S. 

Coast Guard, and local, state, and 

federal law enforcement officers on 

clearly identified law enforcement 

agency vessels. 

(d) Informational broadcasts. The 

Captain of the Port or a designated 

representative will inform the public 

through marine safety information 

bulletins or broadcast notices to 

mariners of this regulation. 

Dated: April 1, 2012. 

John J. Arenstam, 

Captain, U.S. Coast Guard, Acting, Captain 

of the Port New Orleans. 

[FR Doc. 2012–12313 Filed 5–22–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0674; FRL–9349–3] 

Acibenzolar- S -methyl; Time-Limited 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

acibenzolar-S-methyl in or on 

grapefruit, apples and pears. Syngenta 

Crop Protection LLC. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

23, 2012. Objections and requests for 

hearings must be received on or before 

July 23, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0674, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 


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West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Rose 

Kearns, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; email address: kearns.

rosemary@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. 

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 

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–2011–0674 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 July 23, 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 part178, 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–2011–0674, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at 

http://www.epa.gov/dockets/contacts.

htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

7, 2011 (76 FR 55331) (FRL–8886–7), 

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 1G7889 by Syngenta 

Crop Protection, LLC, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.561 

be amended by establishing temporary 

tolerances for residues of the fungicide, 

acibenzolar-S-methyl, in or on apples, 

grapefruit and pears 0.05 parts per 

million (ppm) in conjunction with 

approval of an experimental use permit. 

That notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, LLC, the registrant, which is 

available in the docket, http://www.

regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 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 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. 

General information on the toxicity of 

acibenzolar-S-methyl can be found in a 

recent tolerance rulemaking for this 

pesticide in the Federal Register of 

April 11, 2012 (77 FR 21670) (FRL– 


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9343–3). Specific information on the 

studies received and the nature of the 

adverse effects caused by acibenzolar-Smethyl as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-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,’’ on 

page 15 in docket ID number EPA–HQ– 

OPP–2011–0674. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern 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 no adverse effects are 

observed (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 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 

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 recent tolerance 

rulemaking document for acibenzolar-Smethyl in the Federal Register of April 

11, 2012 (77 FR 21670). 

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. 

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 assumed a distribution of 

residues based on field trial data and 

tolerance level residues for apple, 

grapefruit and pear. Empirical and 

Dietary Exposure Evaluation Model 

(DEEM) default processing factors were 

used to modify the field trial data. 

Maximum screening-level 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, EPA 

used a conservative chronic dietary 

exposure analysis for the general U.S. 

population and various population 

subgroups. Tolerance level residues and 

100 crop treated 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 

certain conditions are met. PCT data 

was not used for conducting the chronic 

dietary risk assessment. 

2. Dietary exposure from drinking 

water. The residues of concern for 

drinking water are acibenzolar-S-methyl 

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

acid (-S-methyl ester, convertible to 

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

acid (CGA–210007) in drinking water. 

These simulation model 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 (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

acibenzolar-S-methyl for acute 

exposures are estimated to be 45 parts 

per billion (ppb) for surface water and 

0.08 ppb for ground water, for chronic 

exposures for non-cancer assessments 

are estimated to be 19.1 ppb for surface 

water and 0.08 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 45 ppb was used 

to assess the contribution to drinking 

water. 

For chronic dietary risk assessment, 

the water concentration of value 19.1 

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 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 

were used to aggregate adult postapplication dermal exposure with 

dietary and drinking water exposure. 

The aggregate exposure assessment for 

children combines dermal and 


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Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations 30405 

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 

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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicology database for acibenzolarS-methyl is complete and adequate for 

assessing increased susceptibility under 

FQPA. The pre- and postnatal toxicity 

database for acibenzolar-S-methyl 

includes developmental toxicity studies 

in rats and rabbits, a 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. 

However, the degree of concern for the 

increased susceptibility seen in these 

studies is low as there are no residual 

uncertainties with regard to pre- and/or 

postnatal toxicity since NOAELs and 

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. 

Additionally, the dietary and residential 

risk assessments are conservative and 

will not underestimate dietary exposure 

and there are no residual uncertainties 

in the exposure database. 

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. 

ii. 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, 

tolerance level residues for the 

Experimental Use Permit (EUP) uses 

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 

water and surface water modeling used 

to assess exposure to acibenzolar-Smethyl in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from 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 37% 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 

12% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for acibenzolar-Smethyl. 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 

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 level of 

concern for acibenzolar-S-methyl is a 

MOE of 100 or below, these short-termaggregate 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 

pattern that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 


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Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which at least one 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. 

Because no intermediate-term adverse 

effect was identified, acibenzolar-Smethyl is not expected to pose an 

intermediate-term risk. 

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 using ultra-violet 

detection ((HPLC/UV) Method AG– 

617A) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

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 U.N. 

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. 

There are no established Codex, 

Mexican, or Canadian maximum residue 

limits for acibenzolar-S-methyl in/on 

any commodity. Therefore, international 

harmonization is not an issue for 

acibenzolar-S-methyl. 

V. Conclusion 

Therefore, time-limited tolerances are 

established for residues of acibenzolarS-methyl, in or on apple, grapefruit and 

pear at 0.05 ppm. A time limitation been 

imposed because these tolerances are 

being established in conjunction with 

approval of an EUP to use acibenzolarS-methyl on apple, pear and grapefruit. 

The EUP approval period and timelimited tolerances will expire 12/31/ 

2015 which provides ample time for all 

treated crops to be harvested, stored, 

and out of channels of trade. 

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) (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). 

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 14, 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 as 

follows: 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations 30407 

■ a. Redesignate paragraph (a) as (a)(1); 

and 

■ b. Add paragraph (a)(2). 

The amendments read as follows: 

§ 180.561 Acibenzolar- S -methyl; 

tolerances for residues. 

(a) General. 

(1) * * * 

(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- 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 

Expiration/ 

revocation 

date 

Apple ................. 0.05 12/31/2015 

Grapefruit .......... 0.05 12/31/2015 

Pear .................. 0.05 12/31/2015 

* * * * * 

[FR Doc. 2012–12410 Filed 5–22–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0014; FRL–9349–1] 

1,2-Ethanediamine, N1-(2-aminoethyl)-, 

polymer with 2, 4-diisocyanato-1- 

methylbenzene; 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 1,2- 

ethanediamine, N1-(2-aminoethyl)-, 

polymer with 2,4-diisocyanato-1- 

methylbenzene, when used as an inert 

ingredient in a pesticide chemical 

formulation. ICR, Inc., on behalf of 

Triton Systems, Inc., 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 1,2-ethanediamine, N1- 

(2-aminoethyl)-, polymer with 2,4- 

diisocyanato-1-methylbenzene on food 

or feed commodities. 

DATES: This regulation is effective May 

23, 2012. Objections and requests for 

hearings must be received on or before 

July 23, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0014, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Anthony Britten, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8179; email address: 

britten.anthony@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–2012–0014 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 July 23, 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–2012–0014, 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. Background and Statutory Findings 

In the Federal Register of April 4, 

2012 (77 FR 20334) (FRL–9340–4), EPA 


srobinson on DSK4SPTVN1PROD with RULES