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 

9374 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

identify docket ID number EPA–HQ– 

OPP–2008–0065 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–2008–0065, 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 7F7304) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.600 be amended by 

establishing tolerances for combined 

residues of the herbicide 

propoxycarbazone, 2-[[[(4,5-dihydro-4- 

methyl-5-oxo-3-propoxy-1H-1,2,4- 

triazol-1-yl)carbonyl]amino]sulfonyl] 

benzoate in or on grass, forage and grass, 

hay at 20 parts per million (ppm) and 

25 ppm and to amend the tolerances in 

40 CFR 180.600 by increasing the 

established tolerances for residues of the 

herbicide propoxycarbazone, methyl 2- 

[[[(4,5-dihydro-4-methyl-5-oxo-3- 

propoxy-1H-1,2,4-triazol-1- 

yl)carbonyl]amino]sulfonyl]benzoate 

(Pr-2-OH MKH-6561) in or on the food 

commodities cattle, goat, horse, sheep 

meat from 0.05 ppm to 0.1 ppm; meat 

byproducts from 0.3 ppm to 1.0 ppm; 

and milk from 0.03 ppm to 0.05 ppm. 

That notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. 

Based upon review of the data 

supporting the petition, EPA 

recalculated a maximum reasonable 

dietary burden (MRDB) for cattle that is 

lower than used previously. No changes 

are required in the established 

tolerances for milk or livestock 

commodities for this petition. 

Comments were received on the 

notice of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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 combined residues of 

propoxycarbazone and its Pr-2-OH 

metabolite on grass, forage and grass, 

hay at 20 ppm and 25 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. 

Propoxycarbazone has low acute 

toxicity via the oral, dermal, and 

inhalation routes. It is not an eye or 

dermal irritant or a dermal sensitizer. 

No toxicity was seen at the limit dose 

in a 28–day dermal toxicity study in 

rats. The main target organ appears to be 

the gastrointestinal (GI) tract (gastric 

irritation), with irritation observed in 

the 2-generation reproduction toxicity 

study in rats, developmental toxicity 

study in rabbits, and the 90–day feeding 

study in rats. In the 64–day and 1–year 

toxicity studies in dogs, no toxicity was 

observed at doses ≥1,181 milligram/ 

kilogram/day (mg/kg/day) and, ≥605 

mg/kg/day, respectively. Increased 

incidence of gastric irritation was 

observed at a very high-dose (limit dose) 

in a 90–day feeding study in rats. In a 

combined chronic toxicity/ 

carcinogenicity study in rats, decreased 

body weight, increased urinary pH and 

histopathological changes in the kidney, 

indicate the kidney as the target organ. 

An effect on body weight was evident in 

both subchronic and chronic toxicity 

studies in mice. 

There was no evidence of 

neurotoxicity in any study. No 

quantitative or qualitative evidence of 

increased susceptibility was seen 

following in utero exposure to rats or 

rabbits in developmental toxicity 

studies. No quantitative or qualitative 

evidence of increased susceptibility was 

seen following the prenatal or postnatal 

exposure to rats in a 2-generation 

reproduction toxicity study in rats. No 

evidence of carcinogenicity was 

observed in a carcinogenicity study in 

mice at doses up to the limit dose. In a 

chronic toxicity/carcinogenicity study 

in rats, there was an increase in the 

incidence of mononuclear cell leukemia 

(MNCL) in mid- and high-dose males; 

however, EPA concluded that MNCL 

was not treatment-related. 

Propoxycarbazone has been classified as 

‘‘not likely to be carcinogenic to 

human’’ based on lack of 

carcinogenicity in mice and rats and 

negative findings in various 

mutagenicity assays. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propoxycarbazone 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 document 

Propoxycarbazone-sodium; HumanVerDate Nov<24>2008 15:05 Mar 03, 2009 Jkt 217001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\04MRR1.SGM 04MRR1
Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9375 

Health Risk Assessment for Proposed 

Section 3 New Use on Pasture and 

Rangeland Grasses at page 12 in docket 

ID number EPA–HQ–OPP–2008–0065 

and in the Federal Register of July 7, 

2004 (69 FR 40774) (FRL–7365–7). 

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 (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 effect 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-term, intermediate-term, 

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 propoxycarbazone used 

for human risk assessment can be found 

at http://www.regulations.gov in 

document Propoxycarbazone-sodium; 

Human-Health Risk Assessment for 

Proposed Section 3 New Use on Pasture 

and Rangeland Grasses at page 12 in 

docket ID number EPA–HQ–OPP–2008– 

0065 and in the Federal Register of July 

7, 2004 (69 FR 40774) (FRL–7365–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propoxycarbazone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propoxycarbazone tolerances in 

(40 CFR 180.600). EPA assessed dietary 

exposures from propoxycarbazone 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. 

No such effects were identified in the 

toxicological studies for 

propoxycarbazone; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

that tolerance-level residues were for all 

food commodities at current or 

proposed propoxycarbazone tolerances, 

and that 100% of the crops included in 

the analysis were treated. 

iii. Cancer. The Agency has 

determined that propoxycarbazone is 

‘‘not likely to be a carcinogenic to 

humans’’ based on the lack of evidence 

of carcinogenicity in mice and rats and 

no mutagenicity concerns. Therefore, a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for propoxycarbazone. Tolerance level 

residues and/or 100% crop treated (CT) 

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 propoxycarbazone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propoxycarbazone. 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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWCs) of 

propoxycarbazone for chronic exposures 

for non-cancer assessments are 

estimated to be 1.79 parts per billion 

(ppb) for surface water and 0.36 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 1.79 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). 

Propoxycarbazone is not registered for 

any specific use patterns that would 

result in residential exposure. 

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 propoxycarbazone 

to share a common mechanism of 

toxicity with any other substances, and 

propoxycarbazone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that propoxycarbazone 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. 

9376 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility of rat or rabbit fetuses to 

in utero exposure to propoxycarbazone. 

In the rat developmental toxicity study, 

no developmental or maternal toxicity 

was observed at doses up to 1,000 mg/ 

kg/day (limit dose). In the 

developmental toxicity study in rabbits, 

developmental effects (abortion, postimplantation loss) were seen at a higher 

dose (limit dose) than the maternally 

toxic dose. There is no qualitative and/ 

or quantitative evidence of increased 

susceptibility to propoxycarbazone 

following prenatal or postnatal exposure 

in a 2-generation reproduction study in 

rats. Although propoxycarbazone 

caused increased post implantation loss 

and decreased live litter size in the F2 

litters at a dose level of 1,230.7–1,605.3 

mg/kg/day, EPA did not consider this as 

evidence for increased susceptibility 

since it occurred in the presence of 

severe maternal toxicity 

(histopathological lesions in the 

stomach) and only at doses above the 

limit dose. 

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 

propoxycarbazone is complete, except 

for immunotoxicity testing. 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 propoxycarbazone. In the 

absence of specific immunotoxicity 

studies, EPA has evaluated the available 

propoxycarbazone toxicity data to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

There was no evidence of adverse 

effects on the organs of the immune 

system in any study with 

propoxycarbazone. In addition, 

propoxycarbazone does not belong to a 

class of chemicals (e.g., the organotins, 

heavy metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on these 

considerations, EPA does not believe 

that conducting a special series 

(Harmonized Guideline 870.7800) 

immunotoxicity study will result in a 

point of departure less than the NOAEL 

of 74.8 mg/kg/day used in calculating 

the cPAD for propoxycarbazone; 

therefore, an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

ii. There is no indication that 

propoxycarbazone 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 

propoxycarbazone 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 assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

propoxycarbazone in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by propoxycarbazone. 

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. Shortterm, intermediate-term, and chronicterm 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. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, propoxycarbazone 

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 

propoxycarbazone from food and water 

will utilize less than 1% of the cPAD for 

(children 1 to 2 years old) the 

population group receiving the greatest 

exposure. There are no residential uses 

for propoxycarbazone. 

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). 

Propoxycarbazone is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to 

propoxycarbazone through food and 

water and will not be greater than the 

chronic aggregate risk. 

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). 

Propoxycarbazone 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 propoxycarbazone through 

food and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Propoxycarbazone is 

classified as ‘‘not likely to be a 

carcinogenic to humans’’ based on the 

lack of evidence of carcinogenicity in 

mice and rats and no mutagenicity 

concerns. Therefore, propoxycarbazone 

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 

Propoxycarbazone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology— 

liquid chromatography with tandem 

mass spectrometry detection (LC/MS/ 

MS), 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, Canadian or 

Mexican maximum residue limits 

established for propoxycarbazone. 

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 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9377 

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 propoxycarbazone, 

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. January 7, 2005, (70 

FR 1349)(FRL–7691–4); October 29, 

2004, (69 FR 63083) (FRL–7681–9). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of 

propoxycarbazone, methyl 2-[[[(4,5- 

dihydro-4-methyl-5-oxo-3-propoxy-1H1,2,4-triazol-1- 

yl)carbonyl]amino]sulfonyl] benzoate 

and its Pr-2-OH metabolite, methyl 2- 

[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4- 

methyl-5- oxo-1H-1,2,4-triazol-1- 

yl)carbonyl]amino]sulfonyl] benzoate in 

or on grass, forage and grass, hay at 20 

ppm and 25 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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. 

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 180.600 is amended by 

adding alphabetically the following 

commodities to the table in paragraph 

(a)(1) to read as follows: 

§ 180.600 Propoxycarbazone: tolerance for 

residue. 

(a) * * * (1) * * * 

Commodity Parts per million 

Grass, forage ........................................................................................................... 20 

Grass, hay ............................................................................................................... 25 

*****

* * * * * 

[FR Doc. E9–4352 Filed 3–3–09; 8:45 am] 

BILLING9 CODE 6560–50–S