Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9367 

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (59 FR 

22951, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, 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, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 12, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.275 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) to read as follows: 

§ 180.275 Chlorothalonil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per million 

*****

Lychee ..................................................................................................................... 15 

*****

Starfruit .................................................................................................................... 3.0 

*****

* * * * * 

[FR Doc. E9–4364 Filed 3–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0066; FRL–8401–1] 

Fluazifop-P-butyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazifop-Pbutyl in or on beans, dry, seed; peanut; 

peanut, meal and soybean, seed. 

Syngenta Crop Protection, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or 

before May 4, 2009, 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–2008–0066. 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: 

Joanne I. Miller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6224; e-mail address: 

miller.joanne @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 

9368 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of 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–2008–0066 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before May 4, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0066, 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. Petition for Tolerance 

In the Federal Register of February 6, 

2008 (73 FR 6964) (FRL–8350–9), 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 7F7289) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.411 

be amended by establishing tolerances 

for residues of the herbicide fluazifopP-butyl, butyl(R)-2-[4-[[5- 

(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, in 

or on dry beans at 25 parts per million 

(ppm); peanuts at 1.5 ppm; soybean at 

2.5 ppm; soybean meal at 2.5 ppm; and 

soybean refined oil at 0.01 ppm. That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Based upon review of the field trial 

data supporting the petition and to 

harmonize with the Food and Feed 

Commodity Vocabulary at http:// 

www.epa.gov/opphed01/foodfeed/ 

index.htm. EPA has amended the 

commodity listing to read: Beans, dry, 

seed at 50 ppm; peanut at 1.5 ppm; 

peanut, meal at 2.2 ppm; and soybean, 

seed at 2.5 ppm. EPA is also editorially 

combining the tolerance sections and 

correcting the tolerance expressions to 

delete references to the unresolved 

isomer fluazifop-butyl that is no longer 

a registered pesticide under FIFRA. 

Background information is provided in 

the docket associated fluazifop-P-butyl; 

Tolerance Reassessment Decision. The 

Notice of Availability was published in 

the Federal Register of October 21, 2005 

(70 FR 61287) (FRL–7726–2). 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of fluazifop-Pbutyl on beans, dry, seed; peanut; 

peanut, meal; and soybean, seed at 50 

ppm, 1.5 ppm, 2.2 ppm, 2.5 ppm, 

respectively. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

In characterizing the toxicity of 

fluazifop-P-butyl, EPA considered data 

on both fluazifop-P-butyl and fluazifopbutyl. Fluazifop-P-butyl is the purified 

(R) enantiomer of the mixed isomeric 

(RS) fluazifop-butyl product and the 

data show them to be toxicological 

equivalent. Fluazifop-P-butyl has shows 

no indication of being an eye or skin 

irritant in acute or 21–day dermal 

studies, and is not a skin sensitizer. 

Fluazifop-P-butyl does show similar 

toxicity by both the inhalation and oral 

routes because of its metabolization by 

blood into the acid form and excretion 

in this manner. The liver and kidney 

have demonstrated to be its target 

organs expressed for the most part as 

liver toxicity in the presence of 

peroxasome proliferation and 

exacerbation of age related kidney 

toxicity. In general, there were no 

carcinogenicity concerns in any 

acceptable studies in the rat with 

fluazifop-butyl or in the hamster for 

fluazifop-P-butyl. The hamster was 

selected for cancer study because liver 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9369 

peroxasome proliferation more closely 

resembled what was found for human 

liver cells. There were no mutagenicity 

concerns evident for fluazifop-butyl or 

fluazifop-P-butyl. There were no 

concerns for neurotoxicity resulting 

from fluazifop-P-butyl which were 

evident at relevant exposure levels. 

There was also no evidence of clinical 

signs which would indicate 

neurotoxicity or neuropathology in the 

available studies as well. Marginal 

increases in brain weights at 

termination were observed in a subchronic toxicity study in rats, and in a 

carcinogenicity study performed on 

hamsters, but only at higher doses. In 

all, it was concluded that there is no 

concern for developmental 

neurotoxicity resulting from exposure to 

fluazifop-butyl or fluazifop-P-butyl. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazifop-p-butyl as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

Fluazifop-P-Butyl. Amended Human 

Health Risk Assessment to Support Use 

on Dry Beans, Peanuts, and the PostBloom Application to Soybeans, page 11 

in docket ID number EPA–HQ–OPP– 

2008–0066. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 fluazifop-P-butyl used for 

human risk assessment is discussed at 

http://www.regulations.gov in the 

document Fluazifop-P-Butyl. Amended 

Human Health Risk Assessment to 

Support Use on Dry Beans, Peanuts, and 

the Post-Bloom Application to 

Soybeans, page 11 in docket ID number 

EPA–HQ–OPP–2008–0066.. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazifop-P-butyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluazifop-P-butyl tolerances in 

(40 CFR 180.411). EPA assessed dietary 

exposures from fluazifop-P-butyl 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. 

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 all foods for 

which there are tolerances (current and 

proposed) were treated (100% crop 

treated (PCT) assumption)) and contain 

tolerance-level residues with ratio 

adjustments to account for additional 

metabolites of concern. PCT and/or 

anticipated residues were not used in 

the acute risk assessment. 

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 

assumed average residue levels 

observed in applicable field trials and 

PCT were used. 

iii. Cancer. The Agency has 

determined that fluazifop-P-butyl is 

‘‘not likely to be a human carcinogen’’ 

based on the lack of evidence of 

carcinogenicity in rats and hamsters and 

no mutagenicity concerns. Therefore, a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(F) of 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT. 

The Agency used PCT information as 

follows: Almonds 100%, asparagus 1%, 

carrots 10%, nectarines 1%, onions 

15%, peaches 1%, pistachios 100%, 

pomegranates 100%, soybeans 100%, 

and watermelons 100%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

9370 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fluazifop-P-butyl may be applied 

in a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluazifop-P-butyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluazifop-P-butyl. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model /Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluazifop-P-butyl for acute exposures are 

estimated to be 23.9 parts per billion 

(ppb) for surface water and 0.59 ppb for 

ground water. For chronic exposures 

assessments are estimated to be 5.1 ppb 

for surface water and 0.59 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 23.9 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 5.1 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fluazifop-P-butyl is currently 

registered for the following uses that 

could result in residential exposures: 

Lawns, walks, driveways, and 

ornamental planting beds. EPA assessed 

residential exposure using the following 

assumptions: Homeowners that apply 

fluazifop-P-butyl products may become 

exposed for short-term durations via the 

dermal and inhalation routes. FluazifopP-butyl can be used in a number of 

residential areas which may be 

frequented by the general population 

such as on home lawns. This provides 

the potential for short-term dermal 

(adults and children) and incidental oral 

exposure (children) following 

residential applications of fluazifop-Pbutyl. 

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 fluazifop-P-butyl 

to share a common mechanism of 

toxicity with any other substances, and 

fluazifop-P-butyl does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fluazifop-P-butyl 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 website 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 prenatal and postnatal toxicity 

database for fluazifop-P-butyl includes 

the rat and rabbit developmental 

toxicity studies and the 2–generation 

reproduction toxicity study in rats. 

There is some evidence of quantitative 

susceptibility following oral and dermal 

exposures to rats. Following in-utero 

exposures, developmental effects 

(characterized as delayed ossification) 

were seen in the absence of maternal 

toxicity in two strains of rats. There is 

no evidence (quantitative or qualitative) 

of susceptibility following in-utero oral 

exposure in rabbits or in the 2– 

generation reproduction toxicity study 

in rats. No evidence of neurotoxicity 

was seen. 

Although increased prenatal and 

postnatal quantitative susceptibility was 

seen in rats, the Agency concluded that 

there is a low degree of concern and no 

residual uncertainties for prenatal and/ 

or postnatal toxicity effects of fluazifopP-butyl because: 

i. The short-term dermal and 

inhalation endpoint of concern (delayed 

ossification) is considered to be a 

developmental delay rather than a 

malformation or variation. 

ii. The developmental endpoint of 

concern (diaphragmatic hernia) used for 

assessing acute dietary risk was only 

found in one of the five developmental 

rat toxicity studies conducted. 

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 fluazifopP-butyl is complete except for a 

confirmatory immunotoxicity study. 

EPA began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Since this requirement went 

into effect well after the tolerance 

petition was submitted, these studies 

are not yet available for fluazifop-Pbutyl. In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available fluazifop-P-butyl 

toxicity data to determine whether an 

additional database uncertainty factor is 

needed to account for potential 

immunotoxicity. The slight 

immunotoxicity findings in the chronic 

dog study are unreliable due to the fact 

the dogs were unhealthy and no 

immunotoxic effects were noted in the 

subchronic dog study where the dogs 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9371 

were healthy. No other potential 

immunotoxicity effects were evident in 

the toxicity database for fluazifop-Pbutyl. The liver and kidney are the 

primary target organs and the most 

sensitive species is the rat (due to longer 

retention time of the major metabolite in 

this species). Based on these 

considerations, EPA does not believe 

that conducting a special series 

870.7800 immunotoxicity study will 

result in a point of departure less than 

the NOAEL of 0.74 milligram/kilogram/ 

day used in calculating the cPAD for 

fluazifop-P-butyl; therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

ii. There is no indication that 

fluazifop-P-butyl is a neurotoxic 

chemical at relevant exposure levels and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There are no residual uncertainties 

for prenatal and/or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessments were performed based on 

reliable data on average residue levels 

observed in applicable field trials and 

PCT. Chronic exposure will not be 

underestimated. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluazifop-P-butyl 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 fluazifop-P-butyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluazifop-P-butyl will occupy 12.1% of 

the aPAD for (females 13-49 years old) 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluazifop-Pbutyl from food and water will utilize 

74.9% of the cPAD for (children 1-2 

years 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 fluazifop-P-butyl 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). 

Fluazifop-P-butyl is currently 

registered for uses that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

fluazifop-P-butyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate margins of exposure 

(MOEs) of 150 for the general U.S. 

population, 150 for adult females and 

240 for children; all below EPA’s level 

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). 

Fluazifop-P-butyl is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to fluazifop-P-butyl through 

food and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. 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 fluazifop-Pbutyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography-mass 

spectrometry) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex Maximum 

Residue Limits (MRLs) established for 

fluazifop residues. Canada has 

established a 1 ppm tolerance for 

fluazifop-butyl calculated as the acid in 

soybeans, and a Mexico MRL is 

established for fluazifop-p-butyl in soya 

at 1 ppm. The proposed U.S. tolerances 

cannot be harmonized with the 

Canadian or Mexican MRLs for soybean, 

because higher residues were observed 

in the U.S. crop field trials. 

C. Response to Comments 

Public comments were received from 

B. Sachau who objected to the proposed 

tolerances because of the amounts of 

pesticides already consumed and 

carried by the American population. 

She further indicated that testing 

conducted on animals have absolutely 

no validity and are cruel to the test 

animals. B. Sachau’s comments 

contained no scientific data or evidence 

to rebut the Agency’s conclusion that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to fluazifop-P-butyl, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has responded 

to B. Sachau’s generalized comments on 

numerous previous occasions, 70 FR 

1349-1354 (January 7, 2005); 69 FR 

63083- 63096 (October 29, 2004). 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazifop-P-butyl, 

butyl(R)-2-[4-[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on beans, 

dry, seed; peanut; peanut, meal; and 

soybean, seed at 50 ppm, 1.5 ppm, 2.2 

ppm, and 2.5 ppm, respectively. 

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 

9372 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 12, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.411 is amended by 

revising the section heading and 

paragraphs (a) and (c) to read as follows: 

§ 180.411 Fluazifop-P-butyl; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide, 

fluazifop-P-butyl, butyl(R)-2-[4-[[5- 

(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on the 

following commodities: 

Commodity Parts per million 

Beans, dry, seed ...................................................................................................... 50 

Carrot, roots ............................................................................................................. 2.0 

Cattle, fat ................................................................................................................. 0.05 

Cattle, meat ............................................................................................................. 0.05 

Cattle, meat byproducts ........................................................................................... 0.05 

Cotton, oil ................................................................................................................. 0.2

Cotton, undelinted seed ........................................................................................... 0.1 

Egg ........................................................................................................................... 0.05 

Endive ...................................................................................................................... 6.0

Fruit, stone ............................................................................................................... 0.05

Goat, fat ................................................................................................................... 0.05 

Goat, meat ............................................................................................................... 0.05 

Goat, meat byproducts ............................................................................................ 0.05 

Hog, fat .................................................................................................................... 0.05 

Hog, meat ................................................................................................................ 0.05 

Hog, meat byproducts ............................................................................................. 0.05 

Horse, fat ................................................................................................................. 0.05

Horse, meat ............................................................................................................. 0.05 

Horse, meat byproducts .......................................................................................... 0.05 

Milk ........................................................................................................................... 0.05 

Nut, macadamia ....................................................................................................... 0.1 

Onion, bulb .............................................................................................................. 0.5 

Peanut ...................................................................................................................... 1.5

Peanut, meal ............................................................................................................ 2.2 

Pecans ..................................................................................................................... 0.05

Poultry, fat ................................................................................................................ 0.05 

Poultry, meat ............................................................................................................ 0.05 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9373 

Commodity Parts per million 

Poultry, meat byproducts ......................................................................................... 0.05 

Sheep, fat ................................................................................................................ 0.05 

Sheep, meat ............................................................................................................ 0.05 

Sheep, meat byproducts .......................................................................................... 0.05 

Soybean, seed ......................................................................................................... 2.5 

Spinach .................................................................................................................... 6.0 

Sweet Potato, roots ................................................................................................. 0.05 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established for residues 

of the herbicide, fluazifop-P-butyl, 

butyl(R)-2-[4-[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on the 

following commodities: 

Commodity Parts per million 

Asparagus ................................................................................................................ 3.0 

Coffee, bean ............................................................................................................ 0.1 

Pepper, tabasco ....................................................................................................... 1.0 

Rhubarb ................................................................................................................... 0.5 

* * * * * 

[FR Doc. E9–4368 Filed 3–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0065; FRL–8400–4] 

Propoxycarbazone; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

propoxycarbazone and its Pr-2-OH 

metabolite in or on grass, forage and 

grass, hay. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or May 

4, 2009, 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–2008–0065. 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: 

Joanne I. Miller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6224; e-mail address: 

miller.joanne@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of 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