Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 52985 

address: Director, Office of 

Management, Planning and Analysis 

(014), Board of Veterans’ Appeals, 810 

Vermont Avenue NW., Washington, DC 

20420. Depending upon the ruling on 

the motion, action will be taken as 

follows: 

* * * * * 

(Authority: 38 U.S.C. 5121A, 5902, 5903, 

5904, 7104, 7105, 7105A) 

[FR Doc. 2014–21139 Filed 9–4–14; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0445; FRL–9915–32] 

Flazasulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flazasulfuron 

in or on tree nut group 14–12. ISK 

Biosciences Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 5, 2014. Objections and 

requests for hearings must be received 

on or before November 4, 2014, 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–2013–0445, 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: Lois 

Rossi, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

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–2013–0445 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 4, 2014. 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– 

2013–0445, 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 December 

30, 2013 (78 FR 79361) (FRL–9903–69), 

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 3F8173) by ISK 

Biosciences Corporation, 7470 Auburn 

Road, Suite A, Concord, Ohio 44077. 

The petition requested that 40 CFR 

180.655 be amended by establishing 

tolerances for residues of the herbicide 

flazasulfuron, N-[[4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide, in or on tree nut 

group 14–12 at 0.01 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

ISK Biosciences Corporation, 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 added 

a tolerance for almond, hulls. The 

reason for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 


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52986 Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 

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 flazasulfuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flazasulfuron 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. 

Flazasulfuron exhibits low acute 

toxicity via oral, dermal and inhalation 

routes of exposure. It is not irritating to 

the skin or eyes and is not a dermal 

sensitizer. Subchronic studies in 

animals indicated decreased body 

weight gain, slight anemia in rats, and 

liver abnormalities in dogs. Dermal or 

systemic toxicity was not seen in a 

subchronic dermal study in rabbits at 

dose levels up to the limit dose. 

In the longer-term mammalian 

toxicity studies, the kidney and liver 

were the primary target organs of 

flazasulfuron toxicity. Observed effects 

included adverse changes in kidney 

function (chronic nephropathy) and 

kidney physiology (enlargement, dark 

color of kidney), increases in liver 

weight and hepatocellular hypertrophy, 

increases in inflammatory cell 

infiltration, hepatocellular necrosis, 

hepatocellular swelling, and bile duct 

proliferation. 

Developmental toxicity was observed 

in both rats and rabbits. Reduced fetal 

weights and delays in ossification were 

seen in a developmental toxicity study 

with Sprague-Dawley rats; an increased 

incidence of visceral malformations 

(intraventricular septal defect) was seen 

in a developmental study with Wistar 

rats. The developmental study in rabbits 

showed high incidences of abortion at 

the highest dose tested. Decreases in 

body weight and chronic nephropathy 

were observed in offspring in a 2- 

generation rat reproduction toxicity 

study. The effects on offspring in these 

studies occurred at dose levels which 

were also toxic to the parents. 

A transient decrease in motor activity 

5 hours post-dosing on Day 0 was 

observed at the mid-dose in an acute 

neurotoxicity study. This observation 

may be associated with a systemic effect 

and not with neurotoxicity since there 

was no corroborating indication of 

neurotoxicity in the subchronic 

neurotoxicity study. There are no 

indications of immunotoxicity potential 

from the repeated dose studies in the 

toxicity database. In addition, 

preliminary assessment of the available 

immunotoxicity study (currently under 

detailed review) shows no 

immunotoxicity in female mice when 

tested up to levels near the limit dose. 

Therefore, there are no concerns for 

immunotoxicity. 

There was no evidence of 

carcinogenicity in the mouse 

oncogenicity study or the combined 

chronic toxicity/carcinogenicity study 

in the rat and no evidence of genotoxic 

potential in in vitro and in vivo 

mutagenicity studies. Based on the 

results of these studies, EPA has 

classified flazasulfuron as ‘‘no evidence 

of carcinogenicity to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flazasulfuron as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Flazasulfuron: Human Health Risk 

Assessment for Proposed Uses on Tree 

Nuts,’’ at p. 28 in docket ID number 

EPA–HQ–OPP–2013–0445. 

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 

LOAEL are identified. 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 flazasulfuron used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLAZASULFURON 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 (General population 

including females, 13–49 

years of age).

NOAEL = 50 mg/

kg/day.

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

UFH = 10x .............

FQPA SF = 1x ......

Acute RfD = 0.5 mg/kg/day ..................

aPAD = 0.5 mg/kg/day 

Acute neurotoxicity (rat) LOAEL = 1,000 mg/kg/day based 

on transient decrease in motor activity observed at Day 

0 (5 hours post-dosing). 


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Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 52987 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLAZASULFURON 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 

Chronic dietary ......

(All populations) .....

NOAEL= 1.3 mg/

kg/day.

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

UFH = 10x .............

FQPA SF = 1x ......

Chronic RfD = 0.013 mg/kg/day ...........

cPAD = 0.013 mg/kg/day 

Combined Chronic Toxicity/Carcinogenicity in rats LOAEL 

= 13.3 mg/kg/day based on adverse change in kidney 

function (chronic nephropathy). 

Incidental oral 

short-term.

(1 to 30 days) and 

Intermediate 

Term (1 to 6 

months).

NOAEL= 2 mg/kg/

day.

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

UFH = 10x .............

FQPA SF = 1x ......

LOC for MOE = 100 ............................. 90-Day Oral Toxicity (dog) LOAEL = 10 mg/kg/day based 

on changes in liver (increase in: Deposition of brown 

pigments, glutamic pyruvic transaminase, creatine 

phosphokinase, inflammatory cell infiltration, 

microgranulomas). 

Dermal short-term ..

(1 to 30 days) and 

IntermediateTerm (1 to 6 

months).

No hazard was identified at the limit dose following dermal exposure. 

Inhalation shortterm.

(1 to 30 days) and 

IntermediateTerm (1 to 6 

months).

NOAEL= 2 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF =1x 

LOC for MOE = 100 ............................. 90-Day oral toxicity (dog) LOAEL = 10 mg/kg/day based 

on changes in liver (increase in: Deposition of brown 

pigments, glutamic pyruvic transaminase, creatine 

phosphokinase, inflammatory cell infiltration, 

microgranulomas). 

Cancer (Oral, dermal, inhalation).Classification: No evidence of carcinogenicity to humans based on lack of carcinogenic effects in the rat and mouse carcinogenicity studies and lack of a mutagenicity concern. 

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. UF = uncertainty factor. 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 flazasulfuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing flazasulfuron tolerances in 40 

CFR 180.655. EPA assessed dietary 

exposures from flazasulfuron 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 flazasulfuron. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed tolerance level 

residues and 100% of the crop was 

treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA made the 

same assumptions (tolerance level 

residues and 100 PCT) as in the acute 

dietary exposure assessment. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flazasulfuron does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flazasulfuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

flazasulfuron. 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 Tier II PRZM–EXAMS— 

Index Reservoir model and PRZM–GW 

model, the estimated drinking water 

concentrations (EDWCs) of flazasulfuron 

for acute exposures are estimated to be 

26.9 parts per billion (ppb) for surface 

water and 90.8 ppb for ground water 

and for chronic exposures for noncancer assessments are estimated to be 

4.67 ppb for surface water and 55.6 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 90.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 55.6 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). There are 

no residential uses being requested at 

this time. Therefore, residential handler 

and post-application scenarios were not 

assessed for the proposed tree nut use. 

However, there are existing residential 

uses that have been previously assessed 

and are used in the aggregate assessment 

presented in this document. 

Flazasulfuron is currently registered for 

the following uses that could result in 

residential exposures: Golf courses, sod 

farms, professionally managed athletic 


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fields, commercial lawns, Christmas 

trees, and industrial vegetation 

management areas. EPA assessed 

residential exposure using the following 

assumptions: 

i. Residential Handler Exposures. 

Residential short-term (1–30 days) 

dermal and inhalation exposures are 

expected from flazasulfuron handler 

activities associated with the residential 

spot treatment use. Since no hazard was 

identified for the dermal route of 

exposure, dermal risks were not 

assessed. A MOE greater than 100 for 

the inhalation route is deemed adequate 

to protect residential flazasulfuron 

handlers. Handler scenarios resulted in 

MOEs ranging from 27,000 to 6,800,000 

for inhalation exposures and, therefore 

are not of concern. 

ii. Residential Post-application 

Exposures. Since the use sites include 

recreational parks, there is a potential 

for short-term dermal and incidental 

oral exposures to occur for children 

from the broadcast use of flazasulfuron. 

When determining the potential for 

residential exposure, the Agency 

considers residues, leaf to skin/hand 

residue transfer, children’s hand-tomouth transfer, and exposure time. 

Since no hazard was identified for the 

dermal route of exposure, dermal risks 

were not assessed. All children postapplication scenarios resulted in MOEs 

ranging from 2,900 to 1,300,000 for 

incidental oral exposures and, therefore 

are not of concern. 

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 flazasulfuron to share a common 

mechanism of toxicity with any other 

substances, and flazasulfuron does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

flazasulfuron 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 pre- and postnatal toxicity database 

for flazasulfuron includes 

developmental toxicity studies in rats 

(Sprague-Dawley and Wistar) and 

rabbits and a 2-generation reproduction 

toxicity study in rats. 

There was no evidence of increased 

quantitative susceptibility of fetuses or 

offspring to flazasulfuron in any of the 

developmental or reproductive toxicity 

studies, since the effects on offspring 

occurred at dose levels which were also 

toxic to the parents. There is a potential 

concern for increased qualitative 

susceptibility of offspring based on the 

intraventricular septal defect seen in 

offspring at minimally toxic maternal 

dose levels in the Wistar rat 

developmental toxicity study; however, 

this effect was not seen in the 

developmental study in Sprague-Dawley 

rats tested up to the limit dose, and this 

concern is further addressed by the 

presence of clear NOAELs and LOAELs, 

and by the selection of regulatory 

endpoints that are protective of this 

effect. Therefore, EPA has no concerns 

for increased qualitative susceptibility. 

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 

flazasulfuron is complete. 

ii. There is no concern for increased 

quantitative or qualitative susceptibility 

in offspring. 

iii. There are no neurotoxicity 

concerns. 

iv. There are no residual uncertainties 

regarding exposure. 

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 

flazasulfuron will occupy 3% of the 

aPAD for infants less than one year 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 flazasulfuron 

from food and water will utilize 23% of 

the cPAD for infants less than one year 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

flazasulfuron 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). The short-term 

aggregate exposure for adults, which 

accounts for inhalation exposure while 

treating turf and dietary exposure from 

food and water, resulted in an MOE of 

1,600 and is not of concern. The shortterm aggregate exposure for children 

ages 1<2, which accounts for incidental 

oral exposure from hand-to-mouth 

activities on treated turf and dietary 

exposure from food and water, resulted 

in an MOE of 810 and is 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 intermediate-term residential 

exposures are not likely to occur, 

intermediate-term aggregate risks were 

not assessed. 

5. Aggregate cancer risk for U.S. 

population. Because there was no 

evidence of carcinogenicity in the rat 

and mouse carcinogenicity studies, 


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flazasulfuron 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 flazasulfuron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography/tandem mass 

spectrometry with multiple reaction 

monitoring (HPLC/MS–MS/MRM) is 

available to enforce the tolerance 

expression. 

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 flazasulfuron. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has added a tolerance for 

almond, hulls. Almond hulls are listed 

separately as a raw agricultural 

commodity for almonds in Table 1 of 

OCSPP 860.1000, and are included in 

Table 1 Feedstuffs (June 2008); 

therefore, a tolerance is required for 

almond hulls. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flazasulfuron, N-[[4,6- 

dimethoxy-2- 

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide, in or on tree nut 

group 14–12 at 0.01 ppm and on almond 

hulls at 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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 of 1995 

(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: August 27, 2014. 

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. In § 180.655, add alphabetically the 

following commodities to the table in 

paragraph (a), to read as follows: 

§ 180.655 Flazasulfuron; tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

Almond, hulls ............................ 0.01 

*****

Nut, tree, group 14–12 ............. 0.01 

*****

* * * * * 

[FR Doc. 2014–21068 Filed 9–4–14; 8:45 am] 

BILLING CODE 6560–50–P 


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