[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Rules and Regulations]
[Pages 57188-57197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21502]


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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.

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[[Page 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 <greek-i>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:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> 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.

[[Page 57190]]

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-observed-adverse-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          NOAEL = M:1,000/F:1,000 mg/kg/day
                                          Material: technical        LOAEL = M:>1,000 HDT/F: >1,000 HDT
----------------------------------------------------------------------------------------------------------------
870.3200                                 Test Material: 21.9%        NOAEL= M:500/F:1,000 mg/kg/day
                                          formulated GF-443          LOAEL = M:1,000 mg/kg/day based on very
                                          material, rat               slight hyperplasia at test site and
                                                                      F:>1,000 HDT mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental-rat  Maternal 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 developmental-     Maternal NOAEL = 25 mg/kg/day
                                          rabbit                     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   Parental/Systemic NOAEL = M:100/F:30 mg/kg/
                                          and fertility effects in    day
                                          rats                       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).
----------------------------------------------------------------------------------------------------------------

[[Page 57191]]

 
870.5100                                 MUTA-Reverse Gene mutation  Negative with and without rat S-9
                                          - S.typhimurium/E. coli     activation
----------------------------------------------------------------------------------------------------------------
870.5300                                 Muta-forward gene mutation  Negative with and without rat S-9
                                          (CHO Cells/HGPRT locus)     activation
----------------------------------------------------------------------------------------------------------------
870.5375                                 Muta-in vitro Mammalian     Negative with and without rat S-9
                                          Cytogenetics (Chromosomal   activiation
                                          aberrations in primary
                                          rat lymphocytes)
----------------------------------------------------------------------------------------------------------------
870.5395                                 Muta-in vivo Micronucleus,  Negative at oral doses (once per day on two
                                          Mice (bone marrow cells)    consecutive days) of up to 2,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = M/F 2,000 HDT mg/kg/day
                                          screening battery          LOAEL = M/F >2,000 HDT
----------------------------------------------------------------------------------------------------------------
870.6200                                 Chronic neurotoxicity       NOAEL = M/F 250 mg/kg/day
                                          screening battery          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<SUP>-</SUP>\5\), one in a million (1 X 10<SUP>-</SUP>\6\), or one in 
ten million (1 X 10<SUP></SUP>\7\). 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 (MOE<INF>cancer</INF> = 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:

[[Page 57192]]



      Table 2.--Summary of Toxicological Dose and Endpoints for Penoxsulam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (all populations)        None                     Not applicable           No toxicological
                                       UF = N/A...............                            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    Special FQPA SF = 1x     1-Year Chronic Feeding
                                       UF = 100...............  cPAD = chronic RfD.....   Study in Dogs.
                                       Chronic RfD = 0.147 mg/  Special FQPA SF = 0.147  LOAEL = 46.2 mg/kg/day
                                        kg/day.                  mg/kg/day.               based on multifocal
                                                                                          hyperplasia of the
                                                                                          pelvic epithelium of
                                                                                          the kidney.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1 - 30     NOAEL = 17.8 mg/kg/day   Residential LOC for MOE  13-Week Feeding Study
 days)                                                           = 100                    in Dogs.
                                                                Occupational = NA......  LOAEL = 49.4 mg/kg/day
                                                                                          based on
                                                                                          histopathologic
                                                                                          changes in kidneys
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1 - NOAEL = 17.8 mg/kg/day   Residential LOC for MOE  13-Week Feeding Study
  6 months)                                                      = 100                    in Dogs.
                                                                Occupational = NA......  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        Oral study               Residential LOC for MOE  13-Week Feeding Study
 months)                               NOAEL= 17.8 mg/kg/day     = 100                    in Dogs.
                                        (dermal absorption      Occupational LOC for     LOAEL = 49.4 mg/kg/day
                                        rate = 50%).             MOE = 100.               based on
                                                                                          histopathologic
                                                                                          changes in kidneys.
----------------------------------------------------------------------------------------------------------------
Dermal Long-Term > 6 months)           Oral study               Residential LOC for MOE  1-Year Chronic Feeding
                                       NOAEL= 14.7 mg/kg/day     = 100                    Study in Dogs.
                                        (dermal absorption      Occupational LOC for     LOAEL = 46.2 mg/kg/day
                                        rate = 50%).             MOE = 100.               based on multifocal
                                                                                          hyperplasia of the
                                                                                          pelvic epithelium of
                                                                                          the kidney.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1 - 30 days)    Oral study               Residential LOC for MOE  13-Week Feeding Study
                                       NOAEL= 17.8 mg/kg/day     = 100                    in Dogs.
                                        (inhalation absorption  Occupational LOC for     LOAEL = 49.4 mg/kg/day
                                        rate = 100%).            MOE = 100.               based on
                                                                                          histopathologic
                                                                                          changes in kidneys.
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-Term (1 - 6    Oral study               Residential LOC for MOE  13-Week Feeding Study
 months)                               NOAEL= 17.8 mg/kg/day     = 100                    in Dogs.
                                        (inhalation absorption  Occupational LOC for     LOAEL = 49.4 mg/kg/day
                                        rate = 100%).            MOE = 100.               based on
                                                                                          histopathologic
                                                                                          changes in kidneys.
----------------------------------------------------------------------------------------------------------------
Inhalation Long-Term (> 6 months)      Oral study               Residential LOC for MOE  1-Year Chronic Feeding
                                       NOAEL= 14.7 mg/kg/day     = 100                    Study in Dogs.
                                        (inhalation absorption  Occupational LOC for     LOAEL = 46.2 mg/kg/day
                                        rate = 100%).            MOE = 100.               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 food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one-day 
or single exposure.
    EPA did not identify a treatment-related 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 Lifeline\TM\ 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 weight-

[[Page 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 dose-response 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 K<INF>d</INF> 
partitioning model. The EEC/EDWC ([mu]g. L<SUP>-</SUP>\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 = 10\9\ M<INF>T</INF>/V<INF>T</INF> + 
m<INF>sed</INF>K<INF>d</INF>
where M<INF>T</INF> is the total mass of pesticide in kg applied per ha 
of paddy, V<INF>T</INF> is 1.067 x10\6\ L ha<SUP>-</SUP>\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, m<INF>sed</INF>, is the amount found in the top 1 cm 
interaction zone and is 130,000 kg ha<SUP>-</SUP>\1\ when the sediment 
bulk density was assumed to be 1.3 kg L<SUP>-</SUP>\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 
10\9\ constant converts the units of mass from kg to [mu]g. For 
chemicals that have a valid K<INF>oc</INF>, the K<INF>d</INF> can be 
calculated using a sediment carbon content of 2% (K<INF>oc</INF>*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 K<INF>d</INF> and K<INF>oc</INF> 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 non-occupational, 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

[[Page 57194]]

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
----------------------------------------------------------------------------------------------------------------
                                                                             Surface
                                                 cPAD mg/kg/     % cPAD     Water EEC      Ground      Chronic
              Population Subgroup                    day         (Food)      (ppb),/     Water EEC   DWLOC (ppb)
                                                                              CHED>        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.147           <1           45         5.86        5,100
----------------------------------------------------------------------------------------------------------------

[[Page 57195]]

 
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; 
e-mail address: <a href="/cdn-cgi/l/email-protection#6f1d0a1c060b1a0a020a1b07000b1c2f0a1f0e41080019"><span class="__cf_email__" data-cfemail="344651475d5041515951405c5b5047745144551a535b42">[email protected]</span></a>.

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

[[Page 57196]]

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 <a href="/cdn-cgi/l/email-protection#7a0e15170a11131409541013173a1f0a1b541d150c"><span class="__cf_email__" data-cfemail="b2c6dddfc2d9dbdcc19cd8dbdff2d7c2d39cd5ddc4">[email protected]</span></a>, 
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 e-mail to: <a href="/cdn-cgi/l/email-protection#422d32326f262d21292736022732236c252d34"><span class="__cf_email__" data-cfemail="9cf3ececb1f8f3fff7f9e8dcf9ecfdb2fbf3ea">[email protected]</span></a>. 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

[[Page 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:


Sec.  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


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