57188 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

informing and advising any small 

governments that may be significantly 

or uniquely impacted by the rule. 

EPA has determined that the approval 

action does not include a Federal 

mandate that may result in estimated 

costs of $100 million or more to either 

state, local, or tribal governments in the 

aggregate, or to the private sector. This 

Federal action approves pre-existing 

requirements under state or local law, 

and imposes no new requirements. 

Accordingly, no additional costs to 

state, local, or tribal governments, or to 

the private sector, result from this 

action. 

Executive Order 13132, Federalism 

Federalism (64 FR 43255, August 10, 

1999) revokes and replaces Executive 

Orders 12612 (Federalism) and 12875 

(Enhancing the Intergovernmental 

Partnership). Executive Order 13132 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by state and local officials 

in the development of regulatory 

policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ Under 

Executive Order 13132, EPA may not 

issue a regulation that has federalism 

implications, that imposes substantial 

direct compliance costs, and that is not 

required by statute, unless the Federal 

government provides the funds 

necessary to pay the direct compliance 

costs incurred by state and local 

governments, or EPA consults with state 

and local officials early in the process 

of developing the proposed regulation. 

EPA also may not issue a regulation that 

has federalism implications and that 

preempts state law unless the Agency 

consults with state and local officials 

early in the process of developing the 

proposed regulation. 

EPA has concluded that this rule may 

have federalism implications. The only 

reason why this rule may have 

federalism implications is if in the 

future a CISWI unit is found within the 

State of New Jersey the unit will become 

subject to the Federal Plan until a State 

Plan is approved by EPA. However, it 

will not impose substantial direct 

compliance costs on state or local 

governments, nor will it preempt state 

law. Thus, the requirements of sections 

6(b) and 6(c) of the Executive Order do 

not apply to this rule.

Executive Order 13175, Coordination 

With Indian Tribal Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination With 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), 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.’’ This final rule does not 

have tribal implications, as specified in 

Executive Order 13175. It 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. 

Thus, Executive Order 13175 does not 

apply to this rule. 

Executive Order 13045, Protection of 

Children From Environmental Health 

Risks and Safety Risks 

Protection of Children from 

Environmental Health Risks and Safety 

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

applies to any rule that: (1) Is 

determined to be ‘‘economically 

significant’’ as defined under Executive 

Order 12866, and (2) concerns an 

environmental health or safety risk that 

EPA has reason to believe may have a 

disproportionate effect on children. If 

the regulatory action meets both criteria, 

the Agency must evaluate the 

environmental health or safety effects of 

the planned rule on children, and 

explain why the planned regulation is 

preferable to other potentially effective 

and reasonably feasible alternatives 

considered by the Agency. 

This rule is not subject to Executive 

Order 13045 because it does not involve 

decisions intended to mitigate 

environmental health or safety risks. 

Executive Order 13211, Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) because it is 

not a significant regulatory action under 

Executive Order 12866. 

National Technology Transfer and 

Advancement Act 

Section 12 of the National Technology 

Transfer and Advancement Act 

(NTTAA) of 1995 requires Federal 

agencies to evaluate existing technical 

standards when developing a new 

regulation. To comply with NTTAA, 

EPA must consider and use ‘‘voluntary 

consensus standards’’ (VCS) if available 

and applicable when developing 

programs and policies unless doing so 

would be inconsistent with applicable 

law or otherwise impractical. 

The EPA believes that VCS are 

inapplicable to this action. Today’s 

action does not require the public to 

perform activities conducive to the use 

of VCS.

List of Subjects in 40 CFR Part 62 

Environmental protection, Air 

pollution control, Acid gases, Carbon 

monoxide, commercial and industrial 

solid waste incinerators, 

Intergovernmental relations, Organics, 

Particulate matter, Lead, Reporting and 

recordkeeping requirements.

Dated: September 16, 2004. 

Jane M. Kenny, 

Regional Administrator, Region 2.

■ Part 62, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows:

PART 62—[AMENDED]

■ 1. The authority citation for part 62 

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

Subpart FF—New Jersey

■ 2. Part 62 is amended by adding new 

§ 62.7604 and an undesignated heading 

to subpart FF to read as follows: 

Air Emissions From Existing 

Commercial and Industrial Solid Waste 

Incinerator Units

§ 62.7604 Identification of plan—negative 

declaration. 

Letter from the New Jersey 

Department of Environmental 

Protection, submitted March 4, 2004, 

certifying that there are no commercial 

and industrial solid waste incinerators 

in the State of New Jersey subject to part 

60, subpart DDDD of this chapter.

[FR Doc. 04–21496 Filed 9–23–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0286; FRL–7678–6]

Penoxsulam, 2-(2,2-difluoroethoxy)-N-

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

c]pyrimidin-2-yl)-6-

(trifluoromethyl)benzenesulfonamide; 

Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57189

SUMMARY: This regulation establishes a 

tolerance for residues of 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 rice,grain and rice, straw. Dow 

AgroSciences LLC requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), as amended 

by the Food Quality Protection Act of 

1996 (FQPA).

DATES: This regulation is effective 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0286. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Joanne I. Miller, Registration Division 

(7505C), 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:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides 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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two 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/.

II. Background and Statutory Findings

In the Federal Register of August 6, 

2003 (68 FR 46609) (FRL–7320–4), 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 3F6542) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268–1054. The 

petition requested that 40 CFR part 180 

be amended by establishing a tolerance 

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 rice, grain at 0.01 parts per 

million (ppm), rice, straw at 0.5 ppm, 

rice, hulls at 0.01 ppm, rice, bran at 0.01 

ppm, and rice, polished rice at 0.01 

ppm. That notice included a summary 

of the petition prepared by Dow 

AgroSciences LLC, the registrant. There 

were no comments received in response 

to the notice of filing. The tolerance for 

rice grain was increased to 0.02 ppm to 

reflect the submitted field residue data. 

Residues of penoxsulam do not 

concentrate in the processed 

commodities, rice hull, bran, or 

polished rice, therefore any residues of 

penoxsulam on these commodities will 

be covered by the tolerance on rice, 

grain.

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and 

Determination of Safety

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

penoxsulam on rice, grain at 0.02 ppm 

and rice, straw at 0.5 ppm. No 

tolerances were necessary for the rice 

process commodities, rice hulls, bran, or 

polished rice, because residues will not 

exceed the established tolerance in rice, 

grain. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerance follows.

57190 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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. The nature of the 

toxic effects caused by penoxsulam are 

discussed in Table 1 of this unit as well 

as the no-observed-adverse-effect-level 

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

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90-day oral toxicity-rat NOAEL = Male (M): 50/Female (F): 250 milligrams/kilogram/day (mg/kg/day) 

LOAEL = M: 250 mg/kg/day based on decease body weight/body weight gain (bw/

bwg), decease food consumption, and decease RBC parameters and F:500 mg/

kg/day based on increase mineralization and hyperplasia of the kidney pelvic epithelium

870.3100 90-day oral toxicity-mouse NOAEL= M:1027 highest dose tested (HDT)/F:1029 HDT mg/kg/day 

LOAEL= M: Not determined, >1027 HDT/F:>1029 HDT mg/kg/day

870.3150 90-day oral toxicity- dog NOAEL = M: 17.8/F: 19.9 mg/kg/day 

LOAEL = M:49.4/F:57.1 mg/kg/day based on histopathologic changes in kidney

870.3200 28-day dermal Test Material: technicalNOAEL = M:1,000/F:1,000 mg/kg/day 

LOAEL = M:>1,000 HDT/F: >1,000 HDT

870.3200 Test Material: 21.9% formulated GF-443 material, ratNOAEL= M:500/F:1,000 mg/kg/day 

LOAEL = M:1,000 mg/kg/day based on very slight hyperplasia at test site and 

F:>1,000 HDT mg/kg/day

870.3700 Prenatal developmentalratMaternal NOAEL = 500 mg/kg/day 

Maternal LOAEL = 1,000 mg/kg/day based on decease bwg, decease food consumption, and decease kidney weights

Developmental NOAEL = 1,000 HDT mg/kg/day

Developmental LOAEL = >1,000 HDT

870.3700 Prenatal developmentalrabbitMaternal NOAEL = 25 mg/kg/day 

Maternal LOAEL = 75 mg/kg/day based on death, clinical signs, decease bwg, and 

decease food consumption

Developmental NOAEL = 75 mg/kg/day

Developmental LOAEL = >75 HDT

870.3800 2-Generation Reproduction and fertility effects 

in rats

Parental/Systemic NOAEL = M:100/F:30 mg/kg/day 

Parental/Systemic LOAEL = M:300 mg/kg/day based on decease bw of F1 males

Parental/Systemic LOAEL = F:100 mg/kg/day based on kidney lesions

Reproductive/Offspring NOAEL = 30 mg/kg/day

Reproductive/Offspring LOAEL = 100 mg/kg/day based on delayed preputial separation

870.4100 Chronic toxicity-dogs NOAEL = M:14.7/F:44.8 HDT mg/kg/day 

LOAEL = M:46.2 mg/kg/day based on slight multifocal hyperplasia in the kidney epithelium and F:> 44.8 HDT

870.4100 Chronic toxicity- rats NOAEL = M:50/F:50 mg/kg/day 

LOAEL = M:250 mg/kg/day based on decease bw/bwg, decease RBC parameters, 

increase BUN, increase urine volume, decease urine specific gravity, increase kidney wt., increase crystals/calculi in kidney and urinary bladder, hyperplasia of kidney pelvis epithelium and urinary bladder mucosa, and increase severity of chronic glomerulonephropathy

870.4200 Carcinogenicity- rats LOAEL = F:250 mg/kg/day based on decease bw/bwg, increase urine volume, increase crystals/calculi in urinary bladder, hyperplasia of kidney pelvis epithelium 

and urinary bladder mucosa

870.4200 Carcinogenicity Evidence of carcinogenicity in male rats based on possibly treatment related increase incidence of Large Granular Lymphocyte (LGL) Leukemia at 5, 50, & 250 

mg/kg/day. Also increase severity at 250 mg/kg/day. 

Female rats - negative for carcinogenicity, but dosing was only marginally adequate.

870.4300 Carcinogenicity-mice NOAEL = M:>375 HDT/F:>750 HDT mg/kg/day 

LOAEL = M:>375 HDT/F:>750 HDT

In males, negative for carcinogenicity at doses tested. Dosing inadequate.

In females, negative for carcinogenicity at the doses tested. Dosing adequate (750 

mg/kg/day is sufficiently close to limit dose of 1,000 mg/kg/day).

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57191

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results 

870.5100 MUTA-Reverse Gene mutation - S.typhimurium/

E. coli

Negative with and without rat S-9 activation

870.5300 Muta-forward gene mutation (CHO Cells/HGPRT 

locus)

Negative with and without rat S-9 activation

870.5375 Muta-in vitro Mammalian 

Cytogenetics (Chromosomal aberrations in primary rat lymphocytes)

Negative with and without rat S-9 activiation

870.5395 Muta-in vivo Micronucleus, Mice (bone 

marrow cells)

Negative at oral doses (once per day on two consecutive days) of up to 2,000 mg/kg

870.6200 Acute neurotoxicity 

screening battery

NOAEL = M/F 2,000 HDT mg/kg/day 

LOAEL = M/F >2,000 HDT

870.6200 Chronic neurotoxicity 

screening battery

NOAEL = M/F 250 mg/kg/day 

LOAEL = M/F >250 (HDT) mg/kg/day

B. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 107). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for penoxsulam used for 

human risk assessment is shown in 

Table 2 of this unit:

57192 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PENOXSULAM FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

Special FQPA SF* and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (all populations) None 

UF = N/A

Not applicable No toxicological endpoint attributable to a single exposure was identified in the available 

toxicology studies on penoxsulam.

Chronic Dietary (all populations) NOAEL= 14.7 mg/kg/day 

UF = 100

Chronic RfD = 0.147 mg/

kg/day

Special FQPA SF = 1x 

cPAD = chronic RfD

Special FQPA SF = 0.147 

mg/kg/day

1-Year Chronic Feeding Study in Dogs. 

LOAEL = 46.2 mg/kg/day based on multifocal 

hyperplasia of the pelvic epithelium of the 

kidney.

Incidental Oral Short-Term (1 - 

30 days)

NOAEL = 17.8 mg/kg/day Residential LOC for MOE = 

100

Occupational = NA

13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on 

histopathologic changes in kidneys

Incidental Oral IntermediateTerm (1 - 6 months)NOAEL = 17.8 mg/kg/day Residential LOC for MOE = 

100

Occupational = NA

13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on 

histopathologic changes in kidneys.

Dermal Short-Term (1 - 30 

days)

None Not applicable No dermal, systemic, neuro or developmental 

toxicity concerns.

Dermal Intermediate-Term (1 - 6 

months)

Oral study 

NOAEL= 17.8 mg/kg/day 

(dermal absorption rate = 

50%)

Residential LOC for MOE = 

100

Occupational LOC for MOE 

= 100

13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on 

histopathologic changes in kidneys.

Dermal Long-Term > 6 months) Oral study 

NOAEL= 14.7 mg/kg/day 

(dermal absorption rate = 

50%)

Residential LOC for MOE = 

100

Occupational LOC for MOE 

= 100.

1-Year Chronic Feeding Study in Dogs. 

LOAEL = 46.2 mg/kg/day based on multifocal 

hyperplasia of the pelvic epithelium of the 

kidney.

Inhalation Short-Term (1 - 30 

days)

Oral study 

NOAEL= 17.8 mg/kg/day 

(inhalation absorption 

rate = 100%)

Residential LOC for MOE = 

100

Occupational LOC for MOE 

= 100

13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on 

histopathologic changes in kidneys.

Inhalation Intermediate-Term (1 

- 6 months)

Oral study 

NOAEL= 17.8 mg/kg/day 

(inhalation absorption 

rate = 100%)

Residential LOC for MOE = 

100

Occupational LOC for MOE 

= 100

13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on 

histopathologic changes in kidneys.

Inhalation Long-Term (> 6 

months)

Oral study 

NOAEL= 14.7 mg/kg/day 

(inhalation absorption 

rate = 100%)

Residential LOC for MOE = 

100

Occupational LOC for MOE 

= 100

1-Year Chronic Feeding Study in Dogs. 

LOAEL = 46.2 mg/kg/day based on multifocal 

hyperplasia of the pelvic epithelium of the 

kidney.

Cancer (oral, dermal, inhalation) Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of 

concern, N/A = Not Applicable.

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.605) for the 

residues of penoxsulam, in or on a 

variety of raw agricultural commodities. 

Tolerances are established in/on rice, 

grain at 0.02 ppm and rice, straw at 0.5 

ppm. Risk assessments were conducted 

by EPA to assess dietary exposures from 

penoxsulam in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide, if a toxicological study 

has indicated the possibility of an effect 

of concern occurring as a result of a oneday or single exposure.

EPA did not identify a treatmentrelated effect observed in any of the 

available toxicity studies on 

penoxsulam that could be considered to 

have resulted from a single dose of the 

test material.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the LifelineTM Model Version 2.0, 

which uses food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: The chronic dietary 

analysis for penoxsulam was conducted 

using tolerance levels and 100% Crop 

Treated (CT) for the use on rice.

iii. Cancer. The Agency has classified 

penoxsulam as Suggestive Evidence of 

Carcinogenicity, But not sufficient to 

assess human carcinogenic potential 

and, therefore, quantification of human 

cancer risk is not required. The weightVerDate jul<14>2003 15:28 Sep 23, 2004 Jkt 203001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\24SER1.SGM 24SER1
Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57193

of-the-evidence for this classification is 

as follows: 

a. Evidence of carcinogenicity 

(mononuclear cell leukemia (MNCL)) 

was seen in one sex (males) of one 

species (rat).

b. There was an increased incidence 

of MNCL at all dose levels with all 

incidences exceeding the laboratory 

historical control, however, the doseresponse was flat over a wide range of 

doses. 

c. Although MNCL is recognized as a 

common neoplasm in Fischer rats, the 

mechanism of producing MNCL is not 

completely understood. Therefore, the 

significance of MNCL and its biological 

relevance for human cancer risk remains 

uncertain and cannot be discounted.

d. There is no mutagenicity concern 

for penoxsulam.

e. SAR data are negative for MNCL.

Note: Although dosing in the male mice 

was not considered to be adequate, the 

Agency concluded that an additional mouse 

carcinogenicity study was not required. This 

was based on the following:

1. No treatment-related effects were seen 

up to the limit dose of a 1,000 mg/kg/day in 

a subchronic mouse study;

2. No hyperplasia was seen in the mouse 

carcinogenicity study at 350 mg/kg/day in 

males and 750 mg/kg/day in females;

3. No structural alerts were seen with the 

SAR data;

4. Rat data indicate saturation of 

absorption at 250 mg/kg/day; and

5. No mutagenic activity. Based on these 

data, the CARC determined that a repeat of 

the male mouse cancer study would have no 

impact on the regulation of penoxsulam.

iv. Anticipated residue and percent 

crop treated (PCT) information. For this 

analysis the tolerance levels and 100% 

CT for rice commodities were used.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

penoxsulam in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

penoxsulam.

The standard models used by EPA in 

assessing potential high end pesticide 

levels in surface water are not designed 

to address the agricultural practices 

involved in rice farming. EPA has 

recently developed a Tier I Aquatic 

Exposure Assessment method of 

estimating screening level 

concentrations in surface water to 

support regulatory decisions for 

pesticides used in rice agriculture that 

require ecological and human health 

risk assessments.

Under this method estimated 

environmental concentrations (EEC’s) 

and estimated drinking water 

concentrations (EDWCs) for the use of 

pesticides in rice paddies are estimated 

by applying the total annual application 

to the paddy and partitioning the 

pesticide between the water and the 

paddy sediment according to a linear or 

Kd partitioning model. The EEC/EDWC 

(μg. L-1) represents the dissolved 

concentration occurring in the water 

column and the concentration in water 

released from the paddy. Movement of 

pesticide on suspended sediment is not 

considered. The equation to use for this 

calculation is:

EEC = 109 MT/VT + msedKd

where MT is the total mass of pesticide 

in kg applied per ha of paddy, VT is 

1.067 x106 L ha-1 which is the volume 

of water in a paddy 4 inches (10.16 cm) 

deep, and includes the pore space in a 

1 cm sediment interaction zone. The 

mass of sediment, msed, is the amount 

found in the top 1 cm interaction zone 

and is 130,000 kg ha-1 when the 

sediment bulk density was assumed to 

be 1.3 kg L-1, a standard assumption for 

the bulk density of surface horizons of 

mineral soils (Brady, Nyle C. 1984. The 

Nature and Properties of Soils, Ninth 

Edition. Macmillan Publishing 

Company, New York ; Hillel, Daniel. 

1982. Introduction to Soil Physics. 

Academic Press. Orlando, Florida). The 

109 constant converts the units of mass 

from kg to μg. For chemicals that have 

a valid Koc, the Kd can be calculated 

using a sediment carbon content of 2% 

(Koc*0.02). An organic carbon content of 

2% represents a typical value for a high 

clay soil that might be used to grow rice 

in the Mississippi Valley or Gulf Coast 

regions. Both Kd and Koc should be 

estimated according to the methods 

recommended for other surface water 

models in EFED’s Input Parameter 

Guidance (USEPA, 2002). References 

can be viewed on the EPA Pesticide Site 

at http://www.epa.gov/oppefed1/

models/water/

input_guidance2_28_02.htm.

This model is considered 

conservative, because the residues 

calculated by this method are screening 

estimates and as such are expected to 

exceed the true values found in the 

environment the great majority of the 

time. Based on preliminary assessment 

of rice monitoring data, predicted 

pesticide concentrations as derived 

above (assuming a 1 cm sediment 

interaction zone) exceed the observed 

peak pesticide concentrations. These 

EEC’s are expected to exceed the 

concentrations measured in the paddy, 

because degradation processes and 

dilution with uncontaminated water 

outside the paddy is not considered. 

This calculation does not represent a 

concentration expected in drinking 

water, as it represents paddy discharge 

water. Rather, it represents an upper 

bound on the drinking water 

concentrations, and is therefore suitable 

for use in screening assessments. The 

concentrations found at drinking water 

facilities impacted by rice culture would 

be expected to be less than this value (in 

some cases much less), because of the 

aforementioned degradation processes, 

dilution by water from areas in the basin 

not in rice culture, and the fact that in 

most cases less than 100% of the rice 

paddies in a specific area will be treated 

with the pesticide.

Based on the methodology to estimate 

screening level concentrations of 

pesticides in rice and SCI-GROW 

models, the EECs of penoxsulam for 

acute and chronic exposures are 

estimated to be 45 parts per billion 

(ppb) for surface water and 5.86 ppb for 

combined residues of penoxsulam in 

ground 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 not registered for use 

on any sites 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

penoxsulam and 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 

not assumed that penoxsulam has 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 the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

57194 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

from substances found to have a 

common mechanism on EPA’s web site 

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

cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate.

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of susceptibility in rats or 

rabbits following in utero exposures. No 

developmental toxicity was seen at the 

highest dose tested in either species. 

Following pre/post-natal exposure in 

the two-generation study, offspring 

toxicity was seen at the same dose that 

induced parental toxicity and was not 

more severe than maternal toxicity.

3. Conclusion. There is a complete 

toxicity data base for penoxsulam and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

uncertainty factor (UF) is 100 based on 

10X for interspecies extrapolation and 

10X for intraspecies variability. EPA 

determined that the 10X safety factor 

(SF) to protect infants and children 

should be removed based on the 

following:

i. There was no toxicologically 

significant evidence observed of 

neurotoxicity in either the acute or 

chronic neurotoxicity study.

ii. No definitive quantitative or 

qualitative susceptibility was observed 

in either of the developmental rat or 

rabbit studies.

iii. Significant dose-related effects in 

the two-generation reproduction study 

were limited to the delay in preputial 

separation. No other endpoints of 

reproductive toxicity or offspring 

growth and survival were affected by 

treatment.

iv. The chronic dietary food exposure 

assessment utilizes proposed tolerance 

level residues and 100% CT information 

for all commodities. By using these 

conservative assessments, actual and 

chronic exposures/risks will not be 

underestimated.

v. The dietary drinking water 

assessment (Tier 1 estimates) utilizes 

values generated by model and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. A quantitative acute 

exposure/risk assessment was not 

performed, because no treatment-related 

effect was identified in any of the 

available toxicity studies on 

penoxsulam that could be considered to 

have resulted from a single dose of 

penoxsulam. 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 exposure to penoxsulam from food 

will utilize <1 % of the cPAD for the 

U.S. population, <1 % of the cPAD for 

all infants (<1 year old), and <1 % of the 

cPAD for all children (1 - 12). There are 

no residential uses for penoxsulam that 

result in chronic residential exposure to 

penoxsulam. In addition, there is 

potential for chronic dietary exposure to 

penoxsulam in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 3 of this 

unit:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PENOXSULAM

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb),/

CHED≤

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 0.147 <1 45 5.86 5,100

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57195

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PENOXSULAM—Continued

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb),/

CHED≤

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

All Infants <1 year old 0.147 <1 45 5.86 1,500

Children 1-2 years old 0.147 <1 45 5.86 1,500

Children 3-5 years old 0.147 <1 45 5.86 1,500

Children 6-12 years old 0.147 <1 45 5.86 1,500

Youth 13-19 years old 0.147 <1 45 5.86 5,100

Adults 20-49 years old 0.147 <1 45 5.86 5,100

Females 13-49 years old 0.147 <1 45 5.86 4,400

Adults 50+ years old 0.147 <1 45 5.86 5,100

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Penoxsulam is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Penoxsulam is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

5. Aggregate cancer risk for U.S. 

population. Penoxsulam is classified as 

Suggestive Evidence of Carcinogenicity, 

but Not Sufficient to Assess Human 

Carcinogenic Potential. A human cancer 

risk assessment is not required. A 

rational for this classification has been 

provided in Unit.III.C.1.iii. of this 

document.

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, and to infants and children 

from aggregate exposure to penoxsulam 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An analytical methodology (LC/MS/

MS method) has been subjected to an 

independent laboratory validation, and 

will be available for use as an 

enforcement method.

Adequate enforcement methodology 

(using 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 International Residue 

Limits for penoxsulam use on rice.

C. Conditions

The modifications recommended by 

the independent laboratory and EPA’s 

Analytical Chemistry Branch will be 

made to the final written enforcement 

method.

The final report of the ongoing storage 

stability study must be submitted in 

support of any future food uses. Storage 

stability data for future uses will require 

the receipt and acceptance of the final 

rice report as well as any data required 

for the additional use.

V. Conclusion

Therefore, the tolerance is established 

for residues of 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 rice, grain at 0.02 ppm and rice, 

straw at 0.5 ppm. Separate rice 

processed commodity tolerances are not 

needed. Any residues of penoxsulam, 

per. se., in/on rice processed 

commoditites will be covered by the 

tolerance on rice, grain at 0.02 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0286 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 

on or before November 23, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

57196 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Tolerance fee payment. If you file 

an objection or request a hearing, you 

must also pay the fee prescribed by 40 

CFR 180.33(i) or request a waiver of that 

fee pursuant to 40 CFR 180.33(m). You 

must mail the fee to: EPA Headquarters 

Accounting Operations Branch, Office 

of Pesticide Programs, P.O. Box 

360277M, Pittsburgh, PA 15251. Please 

identify the fee submission by labeling 

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee 

requirement ‘‘when in the judgement of 

the Administrator such a waiver or 

refund is equitable and not contrary to 

the purpose of this subsection.’’ For 

additional information regarding the 

waiver of these fees, you may contact 

James Tompkins by phone at (703) 305–

5697, by e-mail at 

tompkins.jim@epa.gov, or by mailing a 

request for information to Mr. Tompkins 

at Registration Division (7505C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

If you would like to request a waiver 

of the tolerance objection fees, you must 

mail your request for such a waiver to: 

James Hollins, Information Resources 

and Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

3. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0286, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–-0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. The Agency hereby 

certifies that this rule will not have 

significant negative economic impact on 

a substantial number of small entities. 

In addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57197

‘‘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.

VIII. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: September 17, 2004.

James Jones,

Director, Office of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

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

■ 2. Section 180.605 is added to read as 

follows:

§ 180.605 Penoxsulam; tolerances for 

residues.

(a) General. Tolerances are 

established for 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/on the following raw agricultural 

commodities:

Commodity Parts per million 

Rice, grain ...................... 0.02

Rice, straw ...................... 0.50

(b) Section 18 emergency exemptions. 

[Reserved]

(c) Tolerances with regional 

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 04–21502 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0315; FRL–7680–1]

Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of dimethenamid 

in or on onions (dry bulb), garlic, 

shallots (dry bulb), tuberous and corm 

vegetables, sugar beets, garden beets, 

and horseradish. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). In addition, this 

regulatory action is part of the tolerance 

reassessment requirements of section 

408(q) of the FFDCA 21 U.S.C. 346a(q), 

as amended by the FQPA of 1996. By 

law, EPA is required to reassess all 

tolerances in existence on August 2, 

1996 by August 2006. This regulatory 

action will count for thirteen 

reassessments towards this August 2006 

deadline.

DATES: This regulation is effective 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0315. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT: Jim 

Tompkins, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@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:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides 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.