Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66715 

inserting USCG–2012–0965 in the 

‘‘Keyword’’ box and then clicking 

‘‘Search’’. They are also available for 

inspection or copying at the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email David H. Sulouff, Chief, Bridge 

Section, Eleventh Coast Guard District; 

telephone 510–437–3516, email 

David.H.Sulouff@uscg.mil If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The City 

of San Francisco requested a temporary 

change to the operation of the Third 

Street Drawbridge, mile 0.0, over China 

Basin, at San Francisco, CA. The Third 

Street Drawbridge navigation span 

provides a vertical clearance of 7 feet 

above Mean High Water in the closedto-navigation position. The draw opens 

on signal if at least one hour notice is 

given as required by 33 CFR 117.149. 

Navigation on the waterway is 

recreational. 

The drawspan will be secured in the 

closed-to-navigation position 9 a.m. to 6 

p.m. on November 10, 2012, to allow 

spectators to the RedBull Flugtag to 

cross the bridge during the event. This 

temporary deviation has been 

coordinated with the waterway users. 

No objections to the proposed 

temporary deviation were raised. The 

drawspan can be operated upon 30 

minutes advance notice for emergencies 

requiring the passage of waterway 

traffic. 

Vessels that can transit the bridge, 

while in the closed-to-navigation 

position, may continue to do so at any 

time. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: October 23, 2012. 

D.H. Sulouff, 

Bridge Section Chief, Eleventh Coast Guard 

District. 

[FR Doc. 2012–27242 Filed 11–6–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2011–0492; FRL– 9749–4] 

Approval and Promulgation of 

Implementation Plans; California; 

Determinations of Attainment for the 

1997 8-Hour Ozone Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of direct final rule. 

SUMMARY: Due to the receipt of an 

adverse comment, EPA is withdrawing 

the September 14, 2012, direct final rule 

that makes several determinations 

relating to certain 1997 8-hour ozone 

nonattainment areas in California. EPA 

will address the comment in a 

subsequent final action based upon the 

proposed rulemaking action, also 

published on September 14, 2012. EPA 

will not institute a second comment 

period on this action. 

DATES: The direct final rule published at 

77 FR 56775 on September 14, 2012, is 

withdrawn as of November 7, 2012. 

FOR FURTHER INFORMATION CONTACT: John 

Ungvarsky, Air Planning Office, AIR–2, 

EPA Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901, 

telephone number (415) 972–3963, or 

email ungvarsky.john@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA is 

withdrawing the September 14, 2012 (77 

FR 56775), direct final rule that makes 

several determinations relating to 1997 

8-hour ozone nonattainment areas in 

California and thereby suspending 

certain attainment-related requirements 

for as long as these areas continue to 

meet the 1997 8-hour ozone national 

ambient air quality standard. The 

subject areas include Amador and 

Calaveras Counties, Chico, Kern County, 

Mariposa and Tuolumne Counties, 

Nevada County, Sutter County, and 

Ventura County. In the direct final rule, 

EPA stated that if adverse comments 

were received by October 15, 2012, the 

rule would be withdrawn and not take 

effect. On September 10, 2012, EPA 

received a comment, which it interprets 

as adverse and, therefore, EPA is 

withdrawing the direct final rule. EPA 

will address the comment in a 

subsequent final action based upon the 

proposed rulemaking action, also 

published on September 14, 2012 (77 FR 

56797). EPA will not institute a second 

comment period on this action. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: October 29, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Accordingly, the amendment to 40 

CFR 52.282 published in the Federal 

Register on September 14, 2012 (77 FR 

56775) on page 56782 is withdrawn as 

of November 7, 2012. 

[FR Doc. 2012–27054 Filed 11–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0756; FRL–9366–8] 

Fluridone; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

fluridone in or on cotton. This action is 

in response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

cotton. This regulation establishes a 

maximum permissible level for residues 

of fluridone in or on cotton 

commodities. The time-limited 

tolerances expire on December 31, 2014. 

DATES: This regulation is effective 

November 7, 2012. Objections and 

requests for hearings must be received 

on or before January 7, 2013, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0756, 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), EPA West 

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 


srobinson on DSK4SPTVN1PROD with 
66716 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Debra Rate, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0309; email address: 

rate.debra@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at: http:// 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0756 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 January 7, 2013. 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– 

2012–0756, 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.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6) of, 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing time-limited 

tolerances for residues of fluridone, 

1-methyl-3-phenyl-5-(3- 

(trifluoromethyl)phenyl)-4(1H)- 

pyridinone, its metabolites and 

degradates, in or on cotton, undelinted 

seed at 0.1 parts per million (ppm). 

These time-limited tolerances expire on 

December 31, 2014. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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 * * *.’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for Fluridone 

on Cotton and FFDCA Tolerances 

This is the first section 18 request 

received for the use of fluridone on 

cotton. Since the introduction of 

glyphosate resistant cotton in 1997, 

twenty-one weed species have 

developed resistance to glyphosate. 

Glyphosate-resistant palmer amaranth is 

the most serious of these species across 

all the major agronomic crops in the 

southern U.S. Glyphosate-resistant 

palmer amaranth was confirmed in 

Arkansas in 2006. Since 2006, it has 

become the most severe weed problem 

that Arkansas cotton producers face. 

Greater than 95% of Arkansas cotton 

and 80% of soybean contain the 

glyphosate tolerant gene and thus 

glyphosate is the base herbicide for 

weed control. A significant economic 

loss is expected to occur on nearly 25% 

of acres grown or about 160,000 acres. 

After having reviewed the Arkansas 

emergency exemption application, EPA 

determined that an emergency condition 

exists for this State, and that the criteria 

for approval of an emergency exemption 

are met. EPA has authorized a specific 

exemption under FIFRA section 18 for 

the use of fluridone on cotton for 

control of glyphosate-resistant palmer 

amaranth in Arkansas. 

As part of its evaluation of the 

emergency exemption application, EPA 


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Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66717 

assessed the potential risks presented by 

residues of fluridone in or on cotton. In 

doing so, EPA considered the safety 

standard in FFDCA section 408(b)(2), 

and EPA decided that the necessary 

tolerance under FFDCA section 408(l)(6) 

would be consistent with the safety 

standard and with FIFRA section 18. 

Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in FFDCA section 408(l)(6). 

Although these time-limited tolerances 

expire on December 31, 2014, under 

FFDCA section 408(l)(5), residues of the 

pesticide not in excess of the amounts 

specified in the tolerance remaining in 

or on cotton, undelinted seed after that 

date will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether fluridone 

meets FIFRA’s registration requirements 

for use on cotton or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of fluridone by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

Arkansas to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for fluridone, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of fluridone on cotton, 

undelinted seed at 0.1 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing timelimited tolerances follows. 

A. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates non-threshold 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 fluridone used for human 

risk assessment is shown in Table 1. of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLURIDONE 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 of age).

NOAEL = 125 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

aRfD = 1.25 mg/kg/ 

day.

aPAD = 1.25 mg/kg/ 

day. 

Developmental toxicity—rabbit. 

LOAEL = 300 mg/kg/day based on increased incidences of 

abortions. 

Chronic dietary (All populations) NOAEL = 15 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

cRfD = 0.15 mg/kg/ 

day.

cPAD = 0.15 mg/kg/ 

day. 

2 yr. cancer study in mice. 

LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of heptocellular 

hyperplasia. 


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66718 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLURIDONE 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 

Incidental oral short-term (1–30 

days) and intermediate-term 

(1–6 months) oral, dermal, 

and inhalation exposures.

NOAEL = 15 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 2 yr. cancer study in mice (same as above). 

Cancer (oral, dermal, inhalation).Fluridone is classified as ‘‘not likely’’ to be a human carcinogen, based on the lack of evidence of carcinogenicity in mice and rats. Quantitative cancer risk assessment is not required. 

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). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluridone, EPA considered 

exposure under the time-limited 

tolerances established by this action as 

well as all existing fluridone tolerances 

in 40 CFR 180.420. EPA assessed dietary 

exposures from fluridone in food as 

follows: 

i. Acute exposure. Such effects were 

identified for fluridone. In estimating 

acute dietary exposure for the 

subpopulation, females 13–49 years, 

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 used tolerance level 

residues, DEEM (Ver. 7.81) default 

processing factors (as necessary) and 

100 percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues, DEEM 

(Ver. 7.81) default processing factors (as 

necessary) and 100 PCT for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit IV.A., EPA has 

concluded that fluridone does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for fluridone. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluridone in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluridone. 

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 FQPA Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluridone for acute exposures are 

estimated to be 9.6 parts per billion 

(ppb) for surface water and 0.67 ppb for 

ground water. EDWCs of fluridone for 

chronic exposures for non-cancer 

assessments are estimated to be 2.5 ppb 

for surface water and 0.67 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 9.6 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 2.5 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, 

swimming in treated water, and flea and 

tick control on pets). 

Fluridone is currently registered for 

one use that could result in residential 

handler and residential post-application 

exposures: Consumer use to control 

aquatic weeds in ponds. EPA assessed 

residential exposure using the following 

assumptions: Residents or consumers 

may experience short-term (1–30 days) 

skin contact or inhalation exposures. 

These exposures are assessed through 

residential handler scenarios. Postapplication exposures of children and 

adults through contact with treated 

swimming ponds are also anticipated. 

These exposures are expected to be 

short- and intermediate-term (1–6 

months) in duration through dermal, 

ingestion, aural, buccal/sublingual, and 

nasal/orbital exposure. All residential 

handler and post-application scenarios 

from the uses of fluridone have been 

assessed and no risks of concern have 

been identified (MOE ≤100). The 

scenarios for residential handler and 

post-application exposure (combined 

dermal and inhalation) resulted in 

MOEs of 1,800 and 23,000, respectively. 

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 fluridone to share 

a common mechanism of toxicity with 

any other substances, and fluridone 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluridone 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 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66719 

http://www.epa.gov/pesticides/ 

cumulative. 

C. Safety Factor for Infants and Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

Based on the results in the 

developmental toxicity studies in rats 

and rabbits and in a three-generation 

reproduction study, no increased 

sensitivity of fetuses or pups (as 

compared to adults) was demonstrated 

for fluridone. There are no concerns or 

residual uncertainties for prenatal/ 

postnatal toxicity following exposure to 

fluridone. 

3. Conclusion. EPA has determined 

that reliable data show that 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 fluridone 

is complete except for the lack of an 

immunotoxicity study and a 

neurotoxicity battery (i.e., acute and 

subchronic neurotoxicity) that meets the 

new data requirements in 40 CFR part 

158 for conventional pesticide 

registration. However, the existing 

toxicology database for fluridone does 

not show any evidence of treatmentrelated effects on either the nervous or 

the immune system. In addition, 

fluridone does not belong to any class 

of compounds (e.g., the organotins, 

heavy metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on the 

currently available data for fluridone, 

the Agency expects that findings from 

the additional studies will not result in 

a lower point of departure POD than 

that currently in use for overall risk 

assessment, and therefore, a database 

uncertainty factor is not needed to 

account for the lack of these studies. 

ii. There is no indication that 

fluridone is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

fluridone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

utilized 100 PCT and tolerance-level 

residues (established or recommended). 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluridone in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluridone. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. An adverse effect resulting from 

a single oral exposure was identified for 

only the subpopulation females 13–49 

years. Using the exposure assumptions 

described in this unit for acute 

exposure, EPA has concluded that acute 

exposure to fluridone from food and 

water will utilize less than 1% of the 

aPAD for females 13–49 years. 

Therefore, fluridone is not expected to 

pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluridone from 

food and water will utilize 4% of the 

cPAD for children 1–2 years, the 

population group receiving the greatest 

exposure. Based on the explanation in 

the unit regarding residential use 

patterns, chronic residential exposure to 

residues of fluridone is not expected. 

3. Short-and Intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure or intermediateterm residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fluridone is currently registered for 

uses that could result in short- and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to fluridone. 

Using the exposure assumptions 

described in this unit for short-term and 

intermediate-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

and the intermediate-term food, water, 

and residential exposures each result in 

aggregate MOEs of 290 (liquids for 

pouring applications + swimming 

exposure) to 340 (liquids for garden 

hose end sprayer + swimming 

exposure). Because EPA’s level of 

concern for fluridone is a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluridone 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 fluridone 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

(enzyme-linked immunosorbant assay 

(ELISA), high performance liquid 

chromatography with ultraviolet 

detection (HLPC/UV), and liquid 

chromatography with tandem mass 

spectroscopy (LC–MSMS)) are 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). 


srobinson on DSK4SPTVN1PROD with 
66720 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

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 an MRL for fluridone. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of fluridone, 1- 

methyl-3-phenyl-5-(3- 

(trifluoromethyl)phenyl)-4(1H)- 

pyridinone, including its metabolites 

and degradates, in or on cotton, 

undelinted seed at 0.1 ppm. This 

tolerance expires on December 31, 2014. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances 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). 

VIII. 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: October 26, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR part 180 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 § 180.420, revise paragraph (b) to 

read as follows: 

§ 180.420 Fluridone; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the herbicide fluridone, 1- 

methyl-3-phenyl-5-(3- 

(trifluoromethyl)phenyl)-4(1H)- 

pyridinone, including its metabolites 

and degradates in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) section 18 

emergency exemptions. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only fluridone. The tolerances expire on 

the date specified in the table. 

Commodity Parts per 

million 

Expiration 

date 

Cotton, undelinted seed ................................................................................................................................................... 0.1 12/31/14 

* * * * * 

[FR Doc. 2012–27066 Filed 11–6–12; 8:45 am] 

BILLING CODE 6560–50–P 


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