18644 Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Rules and Regulations 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone. 

Dated: April 9, 2009. 

Bharat Mathur, 

Acting Regional Administrator, Region 5. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart YY—Wisconsin 

■ 2. Section 52.2585 is amended by 

adding paragraph (v) to read as follows: 

§ 52.2585 Control Strategy: Ozone. 

* * * * * 

(v) On July 28, 2008, the Wisconsin 

Department of Natural Resources 

requested that EPA find that the 

Milwaukee-Racine, WI nonattainment 

area, attained the revoked 1-hour ozone 

National Ambient Air Quality Standard 

(NAAQS). After review of this 

submission, EPA approves this request. 

[FR Doc. E9–9364 Filed 4–23–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0526; FRL–8411–9] 

Penoxsulam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of penoxsulam in 

or on almond hulls; grape; nut, tree, 

group 14; and pistachio. Dow 

AgroSciences, LLC., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

24, 2009. Objections and requests for 

hearings must be received on or before 

June 23, 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–2008–0526. 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: 

Philip V. Errico, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6663; e-mail address: 

errico.philip@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. 

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–2008–0526 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 June 23, 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–2008–0526, 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 


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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 August 13, 

2008 (73 FR 47186) (FRL–8375–8), 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 8F7369) by Dow 

AgroSciences, LLC., 9330 Zionsville 

Rd., Indianapolis, IN 46268. The 

petition requested that 40 CFR 180.605 

be amended by establishing tolerances 

for residues of the herbicide 

penoxsulam, 2-(2,2-difluoroethoxy)-N- 

(5,8-dimethoxy[1,2,4]triazolo[1,5- 

c]pyrimidin-2-yl)-6-(trifluoromethyl) 

benzenesulfonamide in or on nut, tree, 

group14; grape; almond, hulls, and 

pistachio all at 0.1 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Dow AgroSciences LLC, the registrant, 

which is available to the public in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 penoxsulam 

on almond hulls; grape; nut, tree, group 

14, and pistachio all at 0.01 ppm. 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. 

Penoxsulam exhibited minimal acute 

toxicity in the available studies. In 

subchronic and chronic feeding studies 

in rats and dogs, the most sensitive 

target organ was the urothelium of the 

urinary system. In subchronic and 

chronic feeding studies in mice, no 

effects of toxicological significance were 

observed. No developmental toxicity 

was observed in the developmental 

toxicity studies in rats and rabbits and 

there was no increased quantitative or 

qualitative susceptibility of fetuses, as 

compared to dams. In a two-generation 

reproduction study in rats, delays in 

preputial separation were noted; 

however, no other endpoints of 

reproductive toxicity or offspring 

growth and survival were affected by 

treatment. There was no increased 

quantitative or qualitative susceptibility 

of fetuses or offspring, as compared to 

adults. No treatment-related 

neurotoxicity was observed in acute or 

chronic neurotoxicity studies in rats, or 

in any of the other available studies on 

penoxsulam. No systemic or dermal 

toxicity was noted in a 28–day dermal 

toxicity study in rats. 

With respect to carcinogenicity, 

penoxsulam was classified as having 

suggestive evidence of carcinogenicity. 

The classification was based on an 

increase in large granular lymphocyte 

leukemia (also called mononuclear cell 

leukemia (MNCL)). EPA concluded that 

the cancer risk to humans is negligible. 

The MNCL seen in the Fisher 344 rat 

study appears not to be treatment 

related because it was only seen in male 

rats, there was a lack of dose-response 

across the treatment groups (i.e., 

incidence did not increase with 

increasing dose), and Fisher 344 rats are 

known to be susceptible to MNCL, 

especially as they age. MNCL in Fisher 

344 rats has not been found in other 

mammals, and there is no comparable 

tumor seen in humans. Finally, there is 

no other evidence on penoxsulam to 

indicate a cancer concern, including the 

fact that no cancer concerns were 

identified in the mouse carcinogenicity 

study; there is no evidence that 

penoxsulam is genotoxic; and other 

chemicals in the class of compounds 

(triazolopyrimidines) have not shown 

evidence of MNCL in Fisher 344 rats. 

EPA determined that the chronic 

assessment is considered to be 

protective of potential cancer risks. 

Penoxsulam did not demonstrate any 

mutagenic potential in a battery of four 

mutagenicity studies. There is not a 

concern for mutagenicity resulting from 

exposure to penoxsulam. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by penoxsulam as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

Penoxsulam Risk Assessment at 

Appendix A in docket ID number EPA– 

HQ–OPP–2008–0526 and in the final 

rule published in the Federal Register 

of September 24, 2004 (EPA–HQ–OPP– 

2004–0286), (FRL–7678–6). 

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). 


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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 penoxsulam used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Penoxsulam Risk Assessment at 

Appendix A in docket ID number EPA– 

HQ–OPP–2008–0526 and in the final 

rule published in the Federal Register 

of September 24, 2004 (EPA–HQ–OPP– 

2004–0286), (FRL–7678–6). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to penoxsulam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing penoxsulam tolerances in 40 

CFR 180.605. 

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 penoxsulam; 

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 U.S. Department of Agriculture 

1994–1996 and 1998 Continuiing 

Survey of Food Intake by Individuals. 

As to residue levels in food, EPA used 

tolerance level residues and 100% crop 

treated, and incorporated default 

processing factors for processed food 

forms. 

iii. Cancer. Penoxsulam has been 

classified as having ‘‘suggestive 

evidence for carcinogenic potential’’ 

based on some evidence of mononuclear 

cell leukemia (MNCL) in a penoxsulam 

cancer study in Fisher 344 rats. 

However, the Agency concluded that 

the cancer risk to humans is negligible 

based on the following considerations. 

First, it is questionable that the MNCL 

seen in the Fisher 344 rat study was 

treatment related because it was only 

seen in male rats, there was a lack of 

dose-response across the treatment 

groups (i.e., incidence did not increase 

with increasing dose), and Fisher 344 

rats are known to be susceptible to 

MNCL, especially as they age. Second, 

MNCL in Fisher 344 rats is of 

questionable significance for humans 

because it has not been found in other 

mammals, and there is no comparable 

tumor seen in humans. Finally, there is 

no other evidence on penoxsulam to 

indicate a cancer concern, including the 

fact that no cancer concerns were 

identified in the mouse carcinogenicity 

study; there is no evidence that 

penoxsulam is genotoxic; and other 

chemicals in the class of compounds 

(triazolopyrimidines) have not shown 

evidence of MNCL in Fisher 344 rats. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for penoxsulam. Tolerance level 

residues and/or 100% crop treated were 

assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency considered screening 

level water exposure models in the 

dietary exposure analysis and risk 

assessment for penoxsulam in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of penoxsulam. 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 model for surface 

water and the Screening Concentratin in 

Ground Water (SCI-GROW) model for 

ground water, the estimated drinking 

water concentrations (EDWCs) of 

penoxsulam for chronic exposures for 

non-cancer assessments are estimated to 

be 0.9 parts per billion (ppb) for surface 

water and 23.3 ppb for ground water. 

In addition to uses that may result in 

the transport of penoxsulam residues to 

surface and/or ground water, 

penoxsulam may be applied directly to 

water, at a maximum rate of 150 ppb, for 

aquatic weed control. For chronic 

dietary risk assessment, the water 

concentration value of 150 ppb from the 

registered aquatic use 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). 

Penoxsulam is currently registered for 

the following uses that could result in 

residential exposures following use on 

lawns and treatment of residential 

aquatic sites. EPA assessed residential 

exposure using the following 

assumptions: exposures can be of shortand intermediate-term durations and 

can be through dermal or oral routes. 

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 penoxsulam to 

share a common mechanism of toxicity 

with any other substances, and 

penoxsulam does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that penoxsulam 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. 

No developmental toxicity was observed 

in the developmental toxicity studies in 

rats and rabbits and there was no 

increased quantitative or qualitative 

susceptibility of fetuses, as compared to 

dams. In a two-generation reproduction 

study in rats, delays in preputial 

separation were noted; however, no 

other endpoints of reproductive toxicity 

or offspring growth and survival were 

affected by treatment. There was no 

increased quantitative or qualitative 

susceptibility of fetuses or offspring, as 

compared to adults. There are no 

residual uncertainties for pre- and/or 

post-natal toxicity resulting from 

exposure to penoxsulam and there is no 


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evidence of quantitative or qualitative 

susceptibility in the toxicological data. 

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 

penoxsulam 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 penoxsulam. In the absence 

of specific immunotoxicity studies, EPA 

has evaluated the available penoxsulam 

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 

penoxsulam. 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 14.7 milligrams/ 

kilograms/day (mg/kg/day) used in 

calculating the cPAD for penoxsulam; 

therefore, an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

ii. There is no indication that 

penoxsulam 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 

penoxsulam results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment utilizes proposed tolerance 

level residues and 100% crop treated for 

all commodities. EPA made 

conservative (protective) assumptions in 

the residue estimates used to assess 

exposure to penoxsulam in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by penoxsulam. 

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. 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, penoxsulam 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 penoxsulam 

from food and water will utilize 7.1% of 

the cPAD for all infants, the population 

group receiving the greatest exposure. 

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). 

Penoxsulam is currently registered for 

use(s) 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 penoxsulam. 

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 MOEs of 1,500 to children 

from oral post application exposure 

from turf treated with penoxsulam and 

5,500 from adults applying penoxsulam 

to residential turf. As the aggregate MOE 

is greater than 100, the short-term 

aggregate risks to children and adults do 

not exceed 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). 

Penoxsulam is currently registered for 

use(s) that could result in intermediateterm residential exposure. However, the 

Agency has determined that it is not 

appropriate to aggregate these 

intermediate-term exposures with 

chronic exposure to penoxsulam 

through food and water. Therefore, 

intermediate-term aggregate risk 

estimates are equivalent to the chronic 

aggregate risk estimates discussed 

above. 

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 penoxsulam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectroscopy-mass spectroscopy 

detector (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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no CODEX maximum 

residue limits (MRLs) for residues of 

penoxsulam in almond, hulls; grape; 

nut, tree, group 14, and pistachio. 

V. Conclusion 

Therefore, tolerances are established 

for residues of penoxsulam on almond 

hulls; grape; nut, tree, group 14, and 

pistachio all at 0.01 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 


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18648 Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Rules and Regulations 

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 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 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: April 17, 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 180.605 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.605 Penoxsulam; tolerances for 

residues. 

(a) *** 

Commodity Parts per 

million 

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

* * * * * 

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

Nut, tree, group 14 ....................... 0.01 

Pistachio ....................................... 0.01 

* * * * * 

* * * * * 

[FR Doc. E9–9441 Filed 4–23–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 228 

[EPA–R10–OW–2008–0826; FRL–8893–1] 

Ocean Dumping; Designation of Ocean 

Dredged Material Disposal Sites 

Offshore of the Umpqua River, Oregon 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This action finalizes the 

designation of the Umpqua River ocean 

dredged material sites pursuant to the 

Marine Protection, Research and 

Sanctuaries Act, as amended (MPRSA). 

The new sites are needed primarily to 

serve the long-term need for a location 

to dispose of material dredged from the 

Umpqua River navigation channel, and 

to provide a location for the disposal of 

dredged material for persons who have 

received a permit for such disposal. The 

newly designated sites will be subject to 

ongoing monitoring and management 

specified in this rule and in the Site 

Management and Monitoring Plan, 

which is also finalized as part of this 

action. The monitoring and management 

requirements will help to ensure 

ongoing protection of the marine 

environment. 

DATES: Effective Date: This final rule 

will be effective May 26, 2009. 

ADDRESSES: For more information on 

this final rule, Docket ID No. EPA–R10– 

OW–2008–0826 use one of the following 

methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for accessing the 

docket and materials related to this final 

rule. 

• E-mail: 

Freedman.Jonathan@epa.gov 

• Mail: Jonathan Freedman, U.S. 

Environmental Protection Agency, 

Region 10, Office of Ecosystems, Tribal 

and Public Affairs (ETPA–083), Aquatic 

Resources Unit, 1200 Sixth Avenue, 

Suite 900, Seattle, Washington 98101. 

Publicly available docket materials 

are available either electronically at 

http://www.regulations.gov, or in hard 

copy during normal business hours at 

the U.S. Environmental Protection 

Agency, Region 10, Library, 10th Floor, 

1200 Sixth Avenue, Suite 900, Seattle, 

Washington 98101. For access to the 

documents at the Region 10 Library, 

contact the Region 10 Library Reference 

Desk at (206) 553–1289, between the 

hours of 9 a.m. to 11:30 a.m., and 

between the hours of 1 p.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays, for an appointment. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Freedman, U.S. Environmental 

Protection Agency, Region 10, Office of 

Ecosystems, Tribal and Public Affairs 

(ETPA–083), Aquatic Resources Unit, 

1200 Sixth Avenue, Suite 900, Seattle, 

Washington 98101, phone number: 

(206) 553–0266, e-mail: 

freedman.jonathan@epa.gov, or contact 

Jessica Winkler, U.S. Environmental 

Protection Agency, Region 10, Office of 

Ecosystems, Tribal and Public Affairs 

(ETPA–083), Aquatic Resources Unit, 

1200 Sixth Avenue, Suite 900, Seattle, 

Washington 98101, phone number: 

(206) 553–7369, e-mail: 

winkler.jessica@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

November 25, 2008, EPA published a 

proposed rule at 73 FR 71575 to 

designate two new ocean dredged 

material disposal sites near the mouth of 

the Umpqua River, Oregon and to 

withdraw an earlier proposed rule to 

designate a single site. EPA received one 

comment on the proposed rule. 


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