58614 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 

Priority Mail Express & Priority Mail 

Contract 18 

Priority Mail Express & Priority Mail 

Contract 19 

Priority Mail Express & Priority Mail 

Contract 20 

Parcel Select & Parcel Return Service 

Contract 3 

Parcel Select & Parcel Return Service 

Contract 5 

Parcel Select Contract 2 

Parcel Select Contract 3 

Parcel Select Contract 4 

Parcel Select Contract 5 

Parcel Select Contract 6 

Parcel Select Contract 7 

Parcel Select Contract 8 

Parcel Select Contract 9 

Priority Mail—Non-Published Rates 

Priority Mail—Non-Published Rates 1 

First-Class Package Service Contract 16 

First-Class Package Service Contract 17 

First-Class Package Service Contract 18 

First-Class Package Service Contract 19 

First-Class Package Service Contract 20 

First-Class Package Service Contract 21 

First-Class Package Service Contract 22 

First-Class Package Service Contract 23 

First-Class Package Service Contract 24 

First-Class Package Service Contract 25 

First-Class Package Service Contract 26 

First-Class Package Service Contract 27 

First-Class Package Service Contract 28 

First-Class Package Service Contract 29 

First-Class Package Service Contract 30 

First-Class Package Service Contract 31 

First-Class Package Service Contract 32 

First-Class Package Service Contract 33 

First-Class Package Service Contract 34 

First-Class Package Service Contract 35 

First-Class Package Service Contract 36 

First-Class Package Service Contract 37 

Priority Mail Express, Priority Mail & FirstClass Package Service Contract 1 

Priority Mail Express, Priority Mail & FirstClass Package Service Contract 2 

Priority Mail Express, Priority Mail & FirstClass Package Service Contract 3 

Priority Mail Express, Priority Mail & FirstClass Package Service Contract 4 

Priority Mail & First-Class Package Service 

Contract 1 

Priority Mail & First-Class Package Service 

Contract 2 

Priority Mail & First-Class Package Service 

Contract 3 

Priority Mail & First-Class Package Service 

Contract 4 

Priority Mail & First-Class Package Service 

Contract 5 

Priority Mail & First-Class Package Service 

Contract 6 

Priority Mail & First-Class Package Service 

Contract 7 

Outbound International* 

Global Expedited Package Services (GEPS) 

Contracts GEPS 3 

Global Direct Contracts 

Global Direct Contracts 1 

Global Bulk Economy (GBE) Contracts 

Global Plus Contracts 

Global Plus 1C 

Global Plus 2C 

Global Reseller Expedited Package 

Contracts 

Global Reseller Expedited Package Services 

1 

Global Reseller Expedited Package Services 

2 

Global Reseller Expedited Package Services 

3 

Global Reseller Expedited Package Services 

4 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 2 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 3 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 4 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 5 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 6 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 7 

Priority Mail International Regional Rate 

Boxes—Non-Published Rates 

Outbound Competitive International 

Merchandise Return Service 

Agreement with Royal Mail Group, Ltd. 

Priority Mail International Regional Rate 

Boxes Contracts 

Priority Mail International Regional Rate 

Boxes Contracts 1 

Inbound International* 

International Business Reply Service 

(IBRS) Competitive Contracts 

International Business Reply Service 

Competitive Contract 1 

International Business Reply Service 

Competitive Contract 3 

Inbound Direct Entry Contracts with 

Customers 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 1 

Inbound EMS 

Inbound EMS 2 

Inbound Air Parcel Post (at non-UPU rates) 

Royal Mail Group Inbound Air Parcel Post 

Agreement 

Inbound Competitive Multi-Service 

Agreements with Foreign 

PostalOperators 1 

Special Services* 

Address Enhancement Services 

Greeting Cards, Gift Cards, and Stationery 

International Ancillary Services 

International Money Transfer Service— 

Outbound 

International Money Transfer Service— 

Inbound 

Premium Forwarding Service 

Shipping and Mailing Supplies 

Post Office Box Service 

Competitive Ancillary Services 

Nonpostal Services* 

Advertising 

Licensing of Intellectual Property other 

than Officially Licensed Retail Products 

(OLRP) 

Mail Service Promotion 

Officially Licensed Retail Products (OLRP) 

Passport Photo Service 

Photocopying Service 

Rental, Leasing, Licensing or other NonSale Disposition of Tangible Property 

Training Facilities and Related Services 

USPS Electronic Postmark (EPM) Program 

Market Tests* 

Metro Post 

International Merchandise Return Service 

(IMRS)—Non-Published Rates 

Customized Delivery 

Shoshana M. Grove, 

Secretary. 

[FR Doc. 2015–24605 Filed 9–29–15; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0840; FRL–9933–27] 

Acibenzolar-S-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acibenzolar-Smethyl in or on fruit, citrus, group 10– 

10 and fruit, pome, group 11–10. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 30, 2015. Objections and 

requests for hearings must be received 

on or before November 30, 2015, 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–2014–0840, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 58615 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://www.ecfr.gov/cgi-bin/textidx?&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–2014–0840 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 November 30, 2015. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0840, 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 CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (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.html. 

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 February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4F8269) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC. The 

petition requested that 40 CFR 180.561 

be amended by establishing tolerances 

for residues of the fungicide, 

acibenzolar-S-methyl, in or on pome 

fruit, crop group 11–10 at 0.03 parts per 

million (ppm) and citrus fruit, crop 

group 10–10 at 0.01 ppm. That 

document 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. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance for residues of acibenzolarS-methyl in or on fruit, citrus, group 10– 

10 at 0.02 ppm. The reason for this 

change is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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 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. In subchronic and 

chronic oral studies in rats, dogs and 

mice, signs of mild regenerative 

hemolytic anemia were consistently 

observed in all three species. These 

signs frequently included decreased 

erythrocyte counts, decreased 

hemoglobin, decreased hematocrit, 

increased reticulocyte counts, increased 

hemosiderosis in the spleen, liver and/ 

or bone marrow, extramedullary 

hematopoiesis in the spleen, and 

increased spleen weights in both males 

and females. A compensatory response 

(increased erythrocyte production) 

regularly followed the initial anemia. 

Additional toxic effects observed in 

these same studies included decreases 

in body weight, body weight gain and/ 

or food consumption. No other 

significant treatment-related effects of 

toxicological concern were observed in 

these subchronic and chronic oral 

studies. In a 28-day dermal study in 

rats, no systemic or dermal effects were 

observed at dose levels up to 1,000 

milligram (mg)/kilogram (kg)/day, the 

limit dose. No neurotoxic effects were 

observed at any dose in a subchronic 

neurotoxicity study in rats. 

mstockstill on DSK4VPTVN1PROD with RULES

58616 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 

Treatment-related developmental 

malformations, anomalies and 

variations were observed in a 

developmental toxicity study in rats at 

or below the no observable adverse 

effect level (NOAEL) for maternal 

toxicity. At the highest dose tested in 

this study (400 mg/kg/day), both 

maternal toxicity (hemorrhagic perineal 

discharge) and considerable 

developmental toxicity (including total 

litter resorptions, fetal malformations, 

anomalies and variations) were 

observed. The fetal malformations noted 

at this dose included treatment-related 

effects on nervous system tissues 

(hydrocephaly, craniorachisis and 

anophthalmia/microphthalmia). At the 

next lower dose tested (200 mg/kg/day), 

treatment-related visceral malformations 

and skeletal variations were 

demonstrated in the absence of 

significant maternal toxicity. A similar 

increased sensitivity of fetuses or pups 

(as compared to adults) was not 

observed in a developmental toxicity 

study in rabbits or in 2-generation and 

1-generation (range-finding) studies in 

rats. 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 

highest dose tested. 

In a battery of mutagenicity studies, 

results were negative in all studies 

except in an in vitro chromosome 

aberration study in Chinese hamster 

ovary (CHO) cells, in which there was 

evidence of a clastogenic response in 

the absence of S–9 activation. 

In a 2-year chronic toxicity/

carcinogenicity study in rats and an 18- 

month carcinogenicity study in mice, 

acibenzolar-S-methyl was negative for 

carcinogenicity when administered at 

dose levels adequate for the testing of 

carcinogenic potential. 

Acibenzolar-S-methyl showed no 

significant toxicity in a battery of acute 

toxicity tests (Toxicity Category III or IV 

in all tests). Considerable skin 

sensitizing (contact allergenic) potential 

was demonstrated in a dermal 

sensitization study in guinea pigs for the 

technical grade material. The end-use 

product did not show dermal 

sensitization in guinea pigs. 

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 titled ‘‘Acibenzolar-S-Methyl. 

A Human Health Risk Assessment to 

support Section 3 Use of Acibenzolar-SMethyl Uses on Citrus Crop Group 10– 

10, and Pome Crop Group 11–10 at 

pages 39–44 in docket ID number EPA– 

HQ–OPP–2014–0840. 

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 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 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACIBENZOLAR-S-METHYL FOR USE IN HUMAN

HEALTH RISK ASSESSMENT

Exposure/scenario 

Point of 

departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (Females 13–49 

years old and children 1–12 

years old).

NOAEL = 8.2 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 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 NOAEL = 326.2 mg/kg/day (highest dose tested); no 

effects observed in maternal animals. 

Chronic Dietary (Females 13– 

49 years old and children 1– 

12 years old).

NOAEL = 8.2 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.082 

mg/kg/day.

cPAD = 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 NOAEL = 326.2 mg/kg/day (highest dose tested); no 

effects observed in maternal animals. 

Chronic Dietary (Males 12+ yrs. 

and Females 50+ yrs.).

NOAEL = 25 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.25 

mg/kg/day.

cPAD = 0.25 mg/kg/

day.

Chronic Toxicity—Dog; Co-critical; Chronic/Cancer—Rat and 

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 NOAEL = 326.2 mg/kg/day (highest dose tested); no 

effects observed in maternal animals. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 58617 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACIBENZOLAR-S-METHYL FOR USE IN HUMAN

HEALTH RISK ASSESSMENT—Continued 

Exposure/scenario 

Point of 

departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (all routes) .................... EPA has determined that acibenzolar-S-methyl is not likely to be a human carcinogen. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members 

of the human population (intraspecies). 

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 for females 13– 

49 years old and children 1–12 years 

old. No acute endpoint was identified 

for the general population/adults. In 

estimating acute dietary exposure, EPA 

used food consumption data from the 

U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA) 2003– 

2008. A probabilistic assessment was 

performed for the acute analysis. Foods 

were classified as blended, partially 

blended, or non-blended. The acute 

analysis assumed a distribution of 

residues based on field-trial data for 

non-blended and partially blended 

commodities. For blended commodities, 

the mean field-trial values were used as 

a point estimate. A value of 1⁄2 level of 

quantification (LOQ) was used for 

samples that contained less than LOQ 

residues. Time-limited tolerance values 

were used (0.05 ppm) for the 

Experimental Use Permit (EUP) 

commodities, i.e., apple, pear, and 

grapefruit. Section 3 tolerance-level 

residues were used for all other citrus 

and pome fruit commodities. Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors were used for 

apple juice, cranberry juice, dried 

apples, dried pears, dried onion, dried 

banana, dried plantain, and dried 

tomato. Empirical processing factors 

were used for citrus juice (1.0), tomato 

paste (7.1), tomato puree (2.9), and 

tomato juice (1.0). Residues of 

acibenzolar-S-methyl did not 

concentrate in citrus juice or oil. The 

acute analysis used available maximum 

percent crop treated (MPCT) estimates 

and assumed 100 PCT for commodities 

for which no PCT data were available. 

Based on the lettuce metabolism data, a 

factor of 1.5X was applied to estimates 

of acibenzolar-S-methyl residues to 

account for all of the residues of 

concern for dietary risk (including 

CGA–210007, CGA–323060 and CGA– 

324041). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 

NHANES/WEIA 2003–2008. A 

conservative chronic dietary exposure 

analysis was performed for the general 

U.S. population and various population 

subgroups. In the chronic dietary 

exposure analysis, tolerance-level 

residues were used and 100% CT was 

assumed for all commodities. 

Temporary tolerance values were used 

for apple, pear, and grapefruit, since 

they are higher that the new section 3 

tolerances, and do not expire until 12/ 

31/2015. Section 3 tolerance levels are 

used for all other crop group 10–10, and 

pome crop group 11–10 commodities. 

DEEM default processing factors were 

used for apple juice, dried apples, 

cranberry juice, dried apple, dried 

pears, dried onion, dried banana, dried 

plantain, and dried tomato. A 

processing factor was not used for 

tomato paste because a separate 

tolerance has been established for this 

processed commodity. In the submitted 

tomato processing study, processing 

factors of 1.0 and 2.9 were reported for 

tomato juice and tomato puree, 

respectively. These processing factors 

were used in the dietary exposure 

assessment. Residues of acibenzolar-Smethyl did not concentrate in citrus 

juice or oil based on a processing study, 

so a processing factor of 1.0 was used. 

A factor of 1.5X was applied to 

estimates of acibenzolar-S-methyl 

residues to account for all of the 

residues of concern for dietary risk 

(including CGA–210007, CGA–323060 

and CGA–324041). 

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 percent 

crop treated information. 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. 

For the acute dietary analysis, EPA 

estimated PCT for the following crops 

for which uses of acibenzolar-S-methyl 

are currently registered based on 

available MPCT estimates: Broccoli: 

10%; cabbage: 2.5%; cauliflower: 10%; 

lettuce: 10%; peppers: 10%; spinach: 

50%; and tomatoes: 10%. 

In the chronic dietary exposure 

analysis, 100% CT was assumed for all 

commodities. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses a maximum 

mstockstill on DSK4VPTVN1PROD with RULES

58618 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for acibenzolar-S-methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of acibenzolar-S-methyl. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

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

water/index.htm. 

Surface water estimated drinking 

water concentrations (EDWCs) were 

generated for the total residues of 

acibenzolar and CGA 210007 using the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/

EXAMS) model for all proposed uses. 

Exposure in ground water due to 

leaching was assessed with the Pesticide 

Root Zone Model Ground Water 

(PRZM–GW). The EDWCs of 

acibenzolar-S-methyl for acute 

exposures are estimated to be 47.19 

microgram per liter (mg/L) for surface 

water (citrus) and 13.33 mg/L for ground 

water. For chronic exposures (noncancer) assessments the EDWC is 13.33 

mg/L for surface water (apple). 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 47.19 mg/L was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 13.33 mg/L was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Acibenzolar-S-methyl is not being 

registered for any specific use patterns 

that would result in residential 

exposure in this action. However, a 

revised post-application residential 

exposure assessment was conducted to 

update the residential exposures based 

on the 2012 revised Residential SOPs. 

There is the potential for postapplication exposure for individuals 

exposed as a result of being in an 

environment that has been previously 

treated with acibenzolar-S-methyl. The 

quantitative exposure/risk assessment 

for residential post-application 

exposures is based on the following 

scenarios: Adult, 11 to <16 years old, 

and 6 to <11 years old dermal exposure 

from playing golf on treated golf courses 

(short-term dermal 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the rat developmental toxicity study, 

treatment-related visceral malformations 

and skeletal variations were observed in 

fetuses at 200 mg/kg/day, the 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. 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. 

3. Conclusion. The FQPA factor for 

increased susceptibility to infants and 

children is reduced to 1x based on the 

following considerations. 

i. The toxicology database for 

acibenzolar-S-methyl is complete and 

adequate for assessing increased 

susceptibility under FQPA. The preand postnatal toxicity database for 

acibenzolar-S-methyl includes 

developmental toxicity studies in rats 

and rabbits, a developmental 

neurotoxicity study (DNT) study in rats, 

and a 2-generation reproduction toxicity 

study in rats. 

ii. There is some evidence of potential 

neurotoxicity in a developmental 

neurotoxicity study. Although there 

were no treatment-related offspring 

effects seen on survival, clinical signs, 

functional observational battery (FOB), 

developmental land marks, brain 

weights or neuropathology, significant 

morphometric changes (decreased 

thickness of the molecular layer of the 

cerebellum) were observed in male 

offspring on postnatal date (PND) 63 at 

82 mg/kg/day. At the high dose, 

treatment-related offspring effects 

included decreased body weights, 

increased auditory startle response and 

increased thickness in the corpus 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 58619 

callosum in females. No effects were 

observed in maternal animals at the 

highest dose tested. However, in a 

subchronic neurotoxicity study in rats, 

no compound-related effects were 

observed in the FOB, motor activity, 

gross pathology or neuropathology at 

the highest doses (575/628 mg/kg/day, 

male/female) tested. 

iii. 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 (1) NOAELs and 

LOAELs have been identified for all 

effects of concern, (2) a clear dose 

response has been well defined, and (3) 

the points of departure selected for risk 

assessment are protective of the fetal/

offspring effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The refined acute dietary assessment 

utilizes maximum percent crop treated 

estimates but is still considered 

conservative, since it is based on field 

trial data treated at the shorest 

preharvest interval and maximum use 

rate. The chronic dietary and residential 

risk assessments are also conservative. 

These assessments will not 

underestimate dietary and/or nondietary residential exposure to 

acibenzolar-S-methyl. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to acibenzolarS-methyl in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure. 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 33% 

of the aPAD for children 1–2 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 

13% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. 

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). There is potential shortterm exposure to acibenzolar-S-methyl 

via the dietary pathway and the 

residential pathway (golfing on treated 

golf courses). 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 1,300 for 

children 6 to <11 years old. Because 

EPA’s level of concern for acibenzolarS-methyl is a MOE of 100 or below, 

these 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). 

Since the short- and intermediate-term 

PODs are the same and short-term 

exposure estimates are greater than their 

intermediate-term counterparts, the 

short-term aggregate risk assessment is 

protective of the intermediate-term 

aggregate exposure. 

5. Aggregate cancer risk for U.S. 

population. An aggregate cancer risk 

was not calculated because acibenzolarS-methyl was classified as ‘‘not likely to 

be carcinogenic 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 

HPLC/UV Method AG–617A is 

available for tolerance enforcement. The 

method consists of an initial hydrolysis 

with NaOH to convert acibenzolar-Smethyl to CGA–210007 followed by 

methanol extraction. Residues are then 

diluted with HCl and purified by a 

series of solid-phase extraction steps. 

Prior to HPLC/UV analysis, residues are 

partitioned into ethyl acetate, dried 

down, and re-dissolved in phosphoric 

acid. This method has a LOQ of 0.02 

ppm. The method includes optional 

detection via HPLC/MS, giving a means 

of residue confirmation. 

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. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance level for fruit, citrus, 

group 10–10 (0.02 ppm) is being set at 

the LOQ of the enforcement method 

which is higher than the petitioned-for 

tolerance (0.01 ppm). The names of the 

crop groups for citrus and pome fruit are 

being corrected to fruit, citrus, group 

10–10 and fruit, pome, group 11–10. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acibenzolar-S-methyl, 

fungicide, in or on fruit, citrus, group 

10–10 at 0.02 ppm and fruit, pome, 

group 11–10 at 0.03 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action 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 

mstockstill on DSK4VPTVN1PROD with RULES

58620 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

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 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 4, 2015. 

Susan Lewis, 

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. In § 180.561, is amended by adding 

alphabetically the entries for ‘‘Fruit, 

citrus, group’’, and ‘‘Fruit, pome, group’’ 

to the table in paragraph (a)(1) to read 

as follows: 

§ 180.561 Acibenzolar-S-methyl; 

tolerances for residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, citrus, group 10–10 ......... 0.02 

Fruit, pome, group 11–10 ......... 0.03 

* * * * * 

* * * * * 

[FR Doc. 2015–24463 Filed 9–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2015–0136, 0137, 0138, 

0140, and 0141; FRL–9934–75–OSWER] 

National Priorities List 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

(‘‘CERCLA’’ or ‘‘the Act’’), as amended, 

requires that the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (‘‘NCP’’) include a list 

of national priorities among the known 

releases or threatened releases of 

hazardous substances, pollutants or 

contaminants throughout the United 

States. The National Priorities List 

(‘‘NPL’’) constitutes this list. The NPL is 

intended primarily to guide the 

Environmental Protection Agency (‘‘the 

EPA’’ or ‘‘the agency’’) in determining 

which sites warrant further 

investigation. These further 

investigations will allow the EPA to 

assess the nature and extent of public 

health and environmental risks 

associated with the site and to 

determine what CERCLA-financed 

remedial action(s), if any, may be 

appropriate. This rule adds five sites to 

the General Superfund section of the 

NPL. 

DATES: The document is effective on 

October 30, 2015. 

ADDRESSES: Contact information for the 

EPA Headquarters: 

• Docket Coordinator, Headquarters; 

U.S. Environmental Protection Agency; 

CERCLA Docket Office; 1301 

Constitution Avenue NW., William 

Jefferson Clinton Building West, Room 

3334, Washington, DC 20004, 202/566– 

0276. 

The contact information for the 

regional dockets is as follows: 

• Holly Inglis, Region 1 (CT, ME, MA, 

NH, RI, VT), U.S. EPA, Superfund 

Records and Information Center, 5 Post 

Office Square, Suite 100, Boston, MA 

02109–3912; 617/918–1413. 

• Ildefonso Acosta, Region 2 (NJ, NY, 

PR, VI), U.S. EPA, 290 Broadway, New 

York, NY 10007–1866; 212/637–4344. 

• Lorie Baker (ASRC), Region 3 (DE, 

DC, MD, PA, VA, WV), U.S. EPA, 

Library, 1650 Arch Street, Mailcode 

3HS12, Philadelphia, PA 19103; 215/

814–3355. 

• Jennifer Wendel, Region 4 (AL, FL, 

GA, KY, MS, NC, SC, TN), U.S. EPA, 61 

Forsyth Street SW., Mailcode 9T25, 

Atlanta, GA 30303; 404/562–8799. 

• Todd Quesada, Region 5 (IL, IN, MI, 

MN, OH, WI), U.S. EPA Superfund 

Division Librarian/SFD Records 

Manager SRC–7J, Metcalfe Federal 

Building, 77 West Jackson Boulevard, 

Chicago, IL 60604; 312/886–4465. 

• Brenda Cook, Region 6 (AR, LA, 

NM, OK, TX), U.S. EPA, 1445 Ross 

Avenue, Suite 1200, Mailcode 6SFTS, 

Dallas, TX 75202–2733; 214/665–7436. 

• Preston Law, Region 7 (IA, KS, MO, 

NE), U.S. EPA, 11201 Renner Blvd., 

mstockstill on DSK4VPTVN1PROD with RULES