10962 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Rules and Regulations 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

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 

involves establishment of a temporary 

security zone on a portion of the East 

River and Bronx Kill during the arrival 

and departure of the President of the 

United States to and from Randalls and 

Wards Islands. An environmental 

analysis checklist and a categorical 

exclusion determination will be 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine security, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, and 

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; 50 U.S.C. 191, 195; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T01–0092 to read as 

follows: 

§ 165.T01–0092 Security Zone, East River 

and Bronx Kill; Randalls and Wards Islands, 

NY 

(a) Location. The following area is a 

temporary security zone: All waters of 

the East River between the Hell Gate 

Rail Road Bridge (mile 8.2), and a line 

drawn from a point at approximate 

position 40°47′27.12′′ N, 073°54′35.14′′ 

W (Lawrence Point, Queens) to a point 

at approximate position 40°47′52.55′′ N, 

073°54′35.25′′ W (Port Morris Stacks), 

and all waters of the Bronx Kill 

southeast of the Bronx Kill Rail Road 

Bridge (mile 0.6). 

(b) Definitions. For purposes of this 

section ‘‘Designated on-scene 

representative’’ is any Coast Guard 

commissioned, warrant, or petty officer 

who has been designated by the COTP 

to act on the COTP’s behalf. 

(c) Effective period. This section is 

effective from 4 p.m. until 11:30 p.m. on 

March 1, 2012. 

(d) Regulations. (1) All persons are 

required to comply with the general 

regulations governing security zones 

found in 33 CFR 165.33. 

(2) Entry, transit, or anchoring within 

the security zone described in paragraph 

(a) of this section is prohibited unless 

authorized by the COTP or the COTP’s 

designated representative. The 

designated on-scene representative may 

be on a Coast Guard vessel, or onboard 

a federal, state, or local agency vessel 

that is authorized to act in support of 

the Coast Guard. 

(3) The COTP will provide notice of 

this security zone by appropriate means, 

which may include but are not limited 

to a Local Notice to Mariners or 

Broadcast Notice to Mariners. 

(4) Vessel operators given permission 

to enter or operate in the security zone 

must comply with all directions given to 

them by the COTP or the designated onscene representative. Those vessels may 

be required to anchor or moor up to a 

waterfront facility. 

(5) Vessel operators desiring to enter 

or operate within the security zone shall 

telephone the COTP at 718–354–4356 or 

the designated on-scene representative 

via VHF channel 16 to obtain 

permission to do so. 

Dated: February 14, 2012. 

G.P. Hitchen, 

Captain, U.S. Coast Guard, Acting Captain 

of the Port New York. 

[FR Doc. 2012–4270 Filed 2–23–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0494; FRL–8883–1] 

Flazasulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 


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ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flazasulfuron 

in or on citrus fruit, grape, and 

sugarcane. ISK Biosciences Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 24, 2012. Objections and 

requests for hearings must be received 

on or before April 24, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0494. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; email address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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

Title40/40tab_02.tpl. To access the 

harmonized 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–2010–0494 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 April 24, 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–2010–0494, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 4, 

2010 (75 FR 46926) (FRL–8834–9), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 0F7666) by ISK 

Biosciences Corporation, 7470 Auburn 

Rd., Suite A, Concord, OH 44077. The 

petition requested that 40 CFR part 180 

be amended by adding a section for the 

herbicide flazasulfuron and establishing 

tolerances therein for residues of 

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

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide, in or on fruit, 

citrus, group 10 at 0.01 parts per million 

(ppm); grapes at 0.01 ppm; and 

sugarcane at 0.01 ppm. That notice 

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. 

EPA has made minor changes to the 

citrus and grape commodity terms. The 

reason for these changes 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 


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10964 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Rules and Regulations 

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 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. The effect 

was reversed by the next scheduled 

observation (Day 7), and 

neurohistopathologic evaluation of 

tissues from the central and peripheral 

nervous systems of high dose and 

control animals did not demonstrate any 

test material-related neurotoxic lesions. 

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 

Citrus, Grapes, Sugarcane, Christmas 

Trees, and Industrial Vegetation,’’ at 

p. 36 in docket ID number EPA–HQ– 

OPP–2010–0494. 

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-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (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 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 

old, infants and children).

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 study in rats. 

LOAEL = 1,000 mg/kg/day based 

on transient decrease in motor 

activity at Day 0 (5 hours postdosing). 

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). 


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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 

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. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

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. No other 

tolerances have been established for 

flazasulfuron. 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 

United States 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 

that 100% of citrus fruit, grape, and 

sugarcane commodities are treated with 

flazasulfuron and that residues on these 

commodities are present at the tolerance 

levels. 

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 

made the same assumptions (tolerancelevel residues and 100 percent crop 

treated (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 residues of concern in 

drinking water include flazasulfuron 

and its identified degradates DTPU (N- 

(4,6-dimethoxy-2-pyrimidinyl)-N-[3- 

(trifluoromethyl)-2-pyridinyl]urea), 

DTPP (4,6-dimethoxy-N-[3- 

(trifluoromethyl)-2-pyridinyl]-2- 

pyrimidinamine), TPSA (3- 

(trifluoromethyl)-2- 

pyridinesulfonamide), ADMP (2-amino4,6-dimethoxypyrimidine), HTPP (6- 

methoxy-2-[[3-(trifluoromethyl)-2- 

pyridinyl]amino]-4-pyrimidinol), and 

2,3-GTP (3-trifluoromethyl-2- 

pyridylguanidine). The Agency used 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for flazasulfuron and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flazasulfuron 

and its degradates. 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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of flazasulfuron 

and its degradates for acute exposures 

are estimated to be 26.9 parts per billion 

(ppb) for surface water and 102 ppb for 

ground water. EDWCs of flazasulfuron 

and its degradates for chronic exposures 

for non-cancer assessments are 

estimated to be 4.67 ppb for surface 

water and 102 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessment, the water concentration 

value of 102 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). 

Flazasulfuron is currently registered for 

use on non-residential turf, including 

recreation areas (golf courses and 

professionally managed sports fields). 

There is a potential for post-application 

short-term dermal exposure of adults 

and children entering recreation areas 

which have been treated with 

flazasulfuron. However, since no hazard 

associated with dermal exposure was 

identified in the toxicity database for 

flazasulfuron, flazasulfuron is not 

expected to pose a risk from postapplication dermal exposure. 

In accordance with current policy, 

EPA did not conduct a quantitative 

assessment of post-application 

inhalation exposure to flazasulfuron; 

however, volatilization of pesticides 

may be a source of post-application 

inhalation exposure of individuals 

nearby pesticide applications. The 

Agency sought expert advice and input 

on issues related to volatilization of 

pesticides from its Federal Insecticide, 

Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in 

December 2009, and received the SAP’s 

final report on March 2, 2010 http:// 

www.epa.gov/scipoly/SAP/meetings/ 

2009/120109meeting.html. EPA is 

currently in the process of evaluating 

the SAP report and may, as appropriate, 

develop policies and procedures to 

identify the need for and, subsequently, 

the way to incorporate post-application 

inhalation exposure into the Agency’s 

risk assessments. In the case of 

flazasulfuron, although EPA has not 

conducted a quantitative assessment of 

post-application inhalation exposure, 

the Agency’s concern for such 

exposures is low due to flazasulfuron’s 

low vapor pressure (<1 × 10¥7 torr) and 

low acute toxicity. 

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 


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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. 

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, 

the concern for the increased 

susceptibility is low, and EPA did not 

identify any residual uncertainties after 

establishing toxicity endpoints and 

traditional uncertainty factors (UFs) to 

be used in the risk assessment for 

flazasulfuron. There was a clear NOAEL 

and LOAEL in the Wistar rat study, and 

thus the dose response for the observed 

effect is well defined. In addition, since 

the Agency is using PODs for risk 

assessment that are lower than the 

NOAEL in the Wistar rat study, the 

PODs are protective of the adverse 

developmental effect. 

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, except for an 

immunotoxicity study (OPPTS 

Guideline 870.7800) and a subchronic 

neurotoxicity study (OPPTS Guideline 

870.6200b). These studies are now 

requirements under 40 CFR 158.500 for 

pesticide registration. In the absence of 

specific immunotoxicity and subchronic 

neurotoxicity studies, EPA has 

evaluated the available flazasulfuron 

toxicity database to determine whether 

an additional database uncertainty 

factor is needed to account for potential 

immunotoxicity or neurotoxicity. 

With the exception of a transient 

decrease in motor activity at a high dose 

level (1,000 mg/kg/day) in the acute 

neurotoxicity study, which may be 

associated with a systemic effect, there 

is no evidence of neurotoxicity in the 

flazasulfuron toxicity database. There is 

no evidence of immunotoxicity in the 

database, as indicated by hematology, 

lymphoid organ weights and 

histopathology in standard studies. 

Consequently, EPA believes the existing 

data are sufficient for endpoint selection 

for exposure/risk assessment and for 

evaluation of the requirements under 

FQPA, and an additional database 

uncertainty factor is not needed to 

account for the lack of these studies. 

ii. Although there was evidence of 

potential increased qualitative 

susceptibility of fetuses in the 

developmental toxicity study in Wistar 

rats, EPA’s concern for increased 

qualitative susceptibility is low and the 

Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment for 

flazasulfuron. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to flazasulfuron in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by flazasulfuron. 

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 aPAD and 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 4% 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 54% 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). Although there is 

potential for short-term residential 

dermal and inhalation post-application 

exposure to flazasulfuron, no short-term 

dermal hazard was identified for 

flazasulfuron and inhalation exposure is 

expected to be negligible; therefore, EPA 

relies on the chronic dietary risk 

assessment for evaluating short-term 

aggregate exposure to flazasulfuron. 

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, flazasulfuron is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

flazasulfuron. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flazasulfuron is not expected to pose a 

cancer risk to humans. 


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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. 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. 

The Codex has not established a MRL 

for flazasulfuron. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the citrus fruit crop 

group and grape commodity terms. 

‘‘Grapes’’ has been changed to ‘‘grape’’ 

to agree with the Agency’s Food and 

Feed Vocabulary. ISK Biosciences 

Corporation petitioned for a tolerance 

on the crop group ‘‘fruit, citrus, group 

10.’’ In the Federal Register of 

December 8, 2010 (75 FR 76284) (FRL– 

8853–8), EPA issued a final rule that 

revised the crop grouping regulations. 

As part of this action, EPA expanded 

and revised the citrus fruit crop group. 

Changes to crop group 10 included 

adding Australian desert lime, 

Australian finger lime, Australian round 

lime, Brown River finger lime, Japanese 

summer grapefruit, Mediterranean 

mandarin, Mount White lime, New 

Guinea wild lime, Russell River lime, 

sweet lime, Tachibana orange, Tahiti 

lime, tangelo, tangor, trifoliate orange, 

and uniq fruit; creating subgroups; 

revising the representative commodities; 

and naming the new crop group citrus 

fruit group 10–10. EPA indicated in the 

December 8, 2010 final rule as well as 

the earlier January 6, 2010 proposed 

rule (75 FR 807) (FRL–8801–2) that, for 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. That is possible 

here because, despite the revisions to 

the representative commodities for the 

crop group, the petitioner’s residue data 

submission pertaining to the 

representative commodities for the 

earlier version of the crop group meets 

the residue data requirements for the 

revised representative commodities. 

Additionally, EPA assessed the risk 

taking into account the additional crops 

included in the revised crop group. 

Therefore, consistent with this 

December 8, 2010 rule, EPA is 

establishing a tolerance on the revised 

subgroup ‘‘fruit, citrus, group 10–10.’’ 

V. Conclusion 

Therefore, tolerances are established 

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

dimethoxy-2- 

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide, including its 

metabolites and degrades, as set forth in 

the regulatory text. 

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 


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10968 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Rules and Regulations 

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: February 9, 2012. 

Steven Bradbury, 

Director, 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 180.655 is added to read as 

follows: 

§ 180.655 Flazasulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of flazasulfuron, 

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 

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

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide). 

Commodity Parts per 

million 

Fruit, citrus, group 10–10 ........... 0.01 

Grape .......................................... 0.01 

Sugarcane .................................. 0.01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–4332 Filed 2–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0364; FRL–9336–9] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluopyram in 

or on multiple commodities which are 

identified and discussed later in this 

document. Bayer Crop Science 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 24, 2012. Objections and 

requests for hearings must be received 

on or before April 24, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0364. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Jones, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 308–9424; 

email address: jones.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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

Title40/40tab_02.tpl. To access the 

harmonized 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–2009–0364 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 April 24, 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–2009–0364, 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 


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