[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Rules and Regulations]
[Pages 40774-40781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15210]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0172; FRL-7365-7]


Propoxycarbazone-sodium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of propoxycarbazone-sodium and its metabolite in or on meat, meat 
byproducts, wheat and milk. Bayer CropScience 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 July 7, 2004. Objections and 
requests for hearings must be received on or before September 7, 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 
ID number OPP-2004-0172. 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., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 Bell Street, 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: 
[email protected].

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/. The OPPTS Harmonized Test Guidelines 
referenced in this document are avaiable at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

 II. Background and Statutory Findings

    In the Federal Register of August 21, 2002 (67 FR 54188) (FRL-7195-
2), 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 
0F6094) by Bayer Corporation, 8400 Hawthorn Road, Kansas City MO, 
64120-0013. That notice included a summary of the petition prepared by 
Bayer Corporation, the registrant. There were no comments received in 
response to the notice of filing. The company name and address were 
subsequently changed to Bayer CropScience, P.O. Box 12014, 2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709.
    The petition requested that 40 CFR 180 be amended by establishing 
tolerances for residues of the herbicide, propoxycarbazone-sodium, 
methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-
yl)carbonyl]amino]sulfonyl]benzoate, sodium salt and its metabolite, 
methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-(2'-hydroxy-propoxy)-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate, in or on the raw 
agricultural commodities (RACs) wheat forage, wheat hay, wheat straw, 
wheat grain, meat, and meat byproducts, (cattle, sheep, goats, horses, 
hogs), and milk at 1.5, 0.15, 0.05, 0.01, 0.05, and 0.002 parts per 
million (ppm); respectively. Bayer CropScience subsequently amended the 
petition by requesting that 40 CFR 180 be amended establishing 
tolerances for residues of the herbicide, propoxycarbazone, methyl 2-
[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-
yl)carbonyl]amino]sulfonyl]benzoate, sodium salt and its metabolite, 
methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5-oxo-1H-1,2,4-
triazol-1-yl)carbonyl]amino]sulfonyl]benzoate, in

[[Page 40775]]

or on Wheat, forage at 1.5 ppm, Wheat, hay at 0.15 ppm, Wheat, straw at 
0.05 ppm, and Wheat, grain at 0.02 ppm and for residues of the 
herbicide propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-
propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in or on 
the Meat of cattle, sheep, goat and horse at 0.05 ppm, Meat byproducts 
of cattle, sheep, goat and horse at 0.05 ppm and Milk at 0.004 ppm.
    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 tolerances for combined residues of 
propoxycarbazone-sodium and its metabolite on Wheat, forage at 1.5 ppm, 
Wheat, hay at 0.15 ppm, Wheat, straw at 0.05 ppm, and Wheat, grain at 
0.02 ppm and for residues of propoxycarbazone-sodium in or on the Meat 
of cattle, sheep, goat and horse at 0.05 ppm, Meat byproducts of 
cattle, sheep, goat and horse at 0.05 ppm and Milk at 0.004 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by propoxycarbazone-
sodium 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--      NOAEL = 286.4 males (M) and 350.6 females
                                          rodents (rat)               (F) milligrams/kilogram/day (mg/kg/day)
----------------------------------------
                                                                     LOAEL = 1507.5 (M) and 1769.9 (F) mg/kg/day
                                                                      based on gastric irritation
870.3100                                 90-Day oral toxicity--      NOAEL = 205 (M) and 1159 (F) mg/kg/day
                                          rodents (mouse)            LOAEL = 860 (M) and 5109 (F) mg/kg/day
                                                                      based on decreased body weight, body
                                                                      weight gain and food efficiency
----------------------------------------
870.3150                                 64-Day oral toxicity--      NOAEL = 1,407 (M) and 1,181 (F) mg/kg/day
                                          nonrodents (dog)(range-     Highest Dose Tested (HTD)
                                          finding)                   LOAEL not determined
----------------------------------------
870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day (HTD)
                                                                     LOAEL not determined
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL equal or greater than (>=)
                                          rodents (rat)               1,000 mg/kg/day (HTD)
                                                                     Maternal LOAEL not determined
                                                                     Developmental NOAEL >= 1,000 mg/kg/day
                                                                      (HTD)
                                                                     Developmental LOAEL not determined
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 100 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = 500 mg/kg/day based on
                                                                      reduced body weight gain and food
                                                                      consumption, GI toxicity and decreased
                                                                      water consumption and urination
                                                                     Developmental NOAEL = 500 mg/kg/day
                                                                     Developmental LOAEL = 1,000 mg/kg/day based
                                                                      on an abortion, decrease in mean fetal
                                                                      weights, and elevated pre- and post-
                                                                      implantation loss.
----------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 74.8-79.6 (M) and
                                          effects                     373.5-413.5 (F) mg/kg/day
                                                                     Parental/Systemic LOAEL = 297.1-322.9 (M)
                                                                      and 1605.3-1907.5 (F) mg/kg/day based on
                                                                      microscopic lesions of the stomach.
                                                                     Reproductive NOAEL = 1230.7-1313.9 (M) and
                                                                      373.5-413.5 (F) mg/kg/day
                                                                     Reproductive LOAEL = 1605.3-1907.5 (F) mg/
                                                                      kg/day based on increased in diestrous/
                                                                      metestrous
                                                                     Offspring NOAEL = 297.1-322.9 (M) and 373.5-
                                                                      413.5 (F) mg/kg/day
                                                                     Offspring LOAEL = 1230.7-1313.9 (M) and
                                                                      1605.3-1907.5 (F) mg/kg/day based on
                                                                      increased postimplantation loss and
                                                                      decreased live litter size in the F2
                                                                      litters
----------------------------------------

[[Page 40776]]

 
870.4100                                 Chronic toxicity--dogs      NOAEL = 630.7 mg/kg/day
                                                                     LOAEL > 630.7 mg/kg/day
----------------------------------------
870.4300                                 Combined chronic toxicity   NOAEL = 43 (M) and 49 (F) mg/kg/day
                                          carcinogenicity - rodents  LOAEL = 459 (M) and 525 (F) mg/kg/day based
                                          (rats)                      on decreased body weight and increased
                                                                      urinary pH (preceding histological changes
                                                                      in the kidney of rats in the mid- and high-
                                                                      dose groups such as: Foci of
                                                                      mineralization of pelvis, dilated and
                                                                      cystic renal tubules filled with
                                                                      proteinaceous material, regenerative
                                                                      tubular epithelium, glomerular and
                                                                      interstitial fibrosis, and hyperplasia of
                                                                      the pelvic epithelium).
                                                                     No evidence of carcinogenicity
----------------------------------------
870.4300                                 Carcinogenicity--mice       NOAEL = 369.0 (M) mg/kg/day and 3,106.1 (F)
                                                                      mg/kg/day (HTD)
                                                                     LOAEL = 1,880.9 (M) mg/kg/day based on
                                                                      decreased body weight gain combined with
                                                                      lower food efficiency.
                                                                     No evidence of carcinogenicity
----------------------------------------
870.5100                                 Gene mutation--Ames         Negative
----------------------------------------
870.5100                                 Gene mutation--Ames         Negative
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870.5100                                 Gene mutation--Ames         Negative
----------------------------------------
870.5300                                 Gene mutation--In vitro     Negative
                                          Chinese hamster V79-HPRT
----------------------------------------
870.5375                                 Cytogenetics--In vitro      Negative
                                          Chinese hamster
---------------------------------------------------------------------
870.5375                                 Cytogenetics--In vitro      Negative
                                          Chinese hamster
---------------------------------------------------------------------
870.5395                                 Cytogenetics--Hsd/Win:      Negative
                                          NMRI mouse bone marrow
                                          micronucleus
---------------------------------------------------------------------
870.5550                                 Other effects--UDS          Negative
---------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = 2,000 (M) and 800 (F) mg/kg (HDT)
                                          screening battery          LOAEL = 2,000 (F) mg/kg/day based on
                                                                      decrease in body weight gains
---------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL >= 1,321 (M) and 1,651 (F) mg/kg/day
                                          screening battery           (HDT)
                                                                     LOAEL not established
---------------------------------------------------------------------
870.7485                                 Metabolism and              Based on the amount of radiolabel recovered
                                          pharmacokinetics            in the urine, 23-26% of the radiolabeled
                                                                      test material was absorbed by the males,
                                                                      with females absorbing slightly more
                                                                      (31%). Absorption in male rats that
                                                                      received 200 mg/kg was 21%. Radiolabel
                                                                      position did not influence absorption.
                                                                      Plasma Tmax was rapid, being 0.33 hours
                                                                      regardless of radiolabel position in rats
                                                                      that received 2 mg/kg and 0.81 hours in
                                                                      rats that received 200 mg/kg. No
                                                                      bioaccumulation or tissue reservoirs were
                                                                      found; this result confirmed by whole body
                                                                      autoradiography. Plasma clearance was
                                                                      biphasic and rapid, with a T1/81/25/29/
                                                                      21/13/23/85/83/8 for the first
                                                                      phase of 1.1 hours for the compound
                                                                      labeled in the triazol position and 0.6
                                                                      hours for the compound labeled in the
                                                                      phenyl position, regardless of dose. No
                                                                      radiolabel effects were noted in the
                                                                      second phase plasma T1/81/25/29/
                                                                      21/13/23/85/83/8 which was 11
                                                                      hours at 2 and 200 mg/kg of test material.
                                                                      Plasma area under the curve (AUC) was 3.6
                                                                      [mu]g/mLhour for rats that
                                                                      received 2 mg/kg radiolabeled
                                                                      propoxycarbazone-sodium and  45 times
                                                                      greater (169 [mu]g/mLhour) in rats
                                                                      that received 200 mg/kg. The radiolabeled
                                                                      test material was primarily eliminated
                                                                      unchanged in the urine and feces (75-88%
                                                                      of the administered dose), with
                                                                      essentially none eliminated by the lungs.
                                                                      Of the absorbed radiolabeled test
                                                                      material, 90% was excreted into the urine
                                                                      while the remaining was recovered from the
                                                                      bile. However, radiolabel position
                                                                      influenced the metabolic products. Two
                                                                      minor metabolites that contributed <2% of
                                                                      the administered radiolabel were
                                                                      identified in the urine, MKH 7284 and MKH
                                                                      7283, of rats dosed with propoxycarbazone-
                                                                      sodium labeled in the phenyl position. No
                                                                      metabolites were found in the urine of
                                                                      rats that received propoxycarbazone-sodium
                                                                      labeled in the triazol position. One
                                                                      metabolite, STJ 4934, was recovered in the
                                                                      feces of rats that received
                                                                      propoxycarbazone-sodium labeled in the
                                                                      phenyl position and accounted for 2-9% of
                                                                      the fecal radioactivity. The primary fecal
                                                                      metabolite found from rats treated with
                                                                      the triazol-labeled test material was
                                                                      identified as MKH 7017 and accounted for
                                                                      3% of the recovered radioactivity. The
                                                                      metabolite Pr-2-OH MKH 6561, a product of
                                                                      wheat metabolism, was essentially not
                                                                      found in the urine or feces of treated
                                                                      rats.
----------------------------------------------------------------------------------------------------------------


[[Page 40777]]

B. Toxicological Endpoints

    The dose at which 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 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 10-\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 (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for propoxycarbazone-
sodium used for human risk assessment is shown in Table 2 of this unit:

                   Table 2.--Summary of Toxicological Dose and Endpoints for propoxycarbazone-sodium for Use in Human Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Dose Used in Risk Assessment, Interspecies   Special FQPA SF and LOC     Study and Toxicological
                 Exposure Scenario                     and Intraspecies and any Traditional UF       for Risk Assessment               Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary                                            An endpoint of concern attributable to a single dose (exposure) was not identified from the
                                                                             available studies. An acute RfD was not established
---------------------------------------------------------------------------------------------------
Chronic dietary (all populations)                                           NOAEL= 74.8 mg/kg/day     Special FQPA SF = 1X   Two-generation reproduction
                                                                                        UF = 100X     cPAD = chronic RfD /                 study in rats
                                                                    Chronic RfD = 0.748 mg/kg/day  Special FQPA SF = 0.748       LOAEL = 297.1 mg/kg/day
                                                                                                                 mg/kg/day  based on microscopic lesions
                                                                                                                              of the stomach in parental
                                                                                                                                               male rats
---------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                          Not likely to be a carcinogen for humans based on the lack of carcinogenicity in a rat
                                                          carcinogenicity study, an mouse carcinogenicity study and a battery of mutagenic studies.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have not 
been previously established (40 CFR 180) for the residues of 
propoxycarbazone-sodium in or on raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
propoxycarbazone-sodium 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 1-day or 
single exposure.
    An effect of concern attributable to a single exposure (dose) was 
not identified from the oral toxicity studies including the 
developmental toxicity studies in rat and rabbits. Abortions seen in 
the developmental toxicity study in rabbits at 1,000 mg/kg/day during 
GD 19-28, were not considered to be a single dose effect. Since they 
occur late in gestation after repeated exposures.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-

[[Page 40778]]

FCID\TM\), which incorporates 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: For the chronic analyses, 
tolerance-level residues were assumed for all food commodities with 
current or proposed propoxycarbazone-sodium tolerances, and it was 
assumed that all of the crops included in the analysis were treated. 
Percent Crop Treated (PCT) and/or anticipated residues were not used in 
the chronic risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for propoxycarbazone-sodium 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 propoxycarbazone-sodium.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The screening concentration in ground water (SCI-GROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
LOC.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in 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 from residential uses. 
Since DWLOCs address total aggregate exposure to propoxycarbazone-
sodium they are further discussed in the aggregate risk sections in 
Unit E.
    Based on the FIRST and SCI-GROW models, the EECs of 
propoxycarbazone-sodium for acute exposures are estimated to be 2.3 
parts per billion (ppb) for surface water and 0.4 ppb for ground water. 
The EECs for chronic exposures are estimated to be 0.9 ppb for surface 
water and 0.4 ppb for 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).
    Propoxycarbazone-sodium 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.''
    EPA does not have, at this time, available data to determine 
whether propoxycarbazone-sodium has a common mechanism of toxicity with 
other substances. 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 
propoxycarbazone-sodium and any other substances and propoxycarbazone-
sodium 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 propoxycarbazone-sodium 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 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. Conclusion. The toxicology database is complete for FQPA 
purposes and there are no residual uncertainties for pre-/post-natal 
toxicity. Based on the quality of the exposure data, EPA determined 
that the 10X SF to protect infants and children should be removed. The 
FQPA factor is removed based on the following:
    (i) There is no quantitative or qualitative evidence of increased 
susceptibility of rat and rabbit fetuses to in utero exposure to 
propoxycarbazone-sodium in developmental toxicity studies. There is no 
quantitative or qualitative evidence of increased susceptibility to 
propoxycarbazone-sodium following pre-/post-natal exposure to a 2-
generation reproduction study.
    (ii) There is no concern for developmental neurotoxicity resulting 
from exposure to propoxycarbazone-sodium. A developmental neurotoxicity 
study (DNT) study is not required.
    (iii) The toxicological database is complete for FQPA assessment.

[[Page 40779]]

    (iv) The chronic dietary food exposure assessment utilizes HED-
recommended tolerance level residues and 100% CT information for all 
commodities. By using these screening-level assessments, actual 
exposures/risks will not be underestimated.
    (v) The dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.

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, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA 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, EPA 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. An effect of concern attributable to a single 
exposure (dose) was not identified from the oral toxicity studies 
including the developmental toxicity studies in rat and rabbits. No 
acute risk is expected from exposure to propoxycarbazone-sodium.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
propoxycarbazone-sodium from food will utilize < 1% of the cPAD for the 
U.S. population, < 1% of the cPAD for all infant subpopulations, and < 
1% of the cPAD for all children subpopulations. There are no 
residential uses for propoxycarbazone-sodium that result in chronic 
residential exposure to propoxycarbazone-sodium. In addition, there is 
potential for chronic dietary exposure to propoxycarbazone-sodium 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 propoxycarbazone-sodium
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.748         < 1%          0.9          0.4       26,200
--------------------------------------------------------------
All infants (< 1 year old)                             0.748         < 1%          0.9          0.4        7,480
--------------------------------------------------------------
Children (1-2) years old                               0.748         < 1%          0.9          0.4        7,480
--------------------------------------------------------------
Females (13-49 years old)                              0.748         < 1%          0.9          0.4       22,400
----------------------------------------------------------------------------------------------------------------

    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).
    Propoxycarbazone-sodium 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 LOC.
    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).
    Propoxycarbazone-sodium 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 LOC.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to propoxycarbazone-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectroscopy) 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: 
[email protected].

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for propoxycarbazone-sodium on wheat, meat, meat byproducts 
or milk.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-

[[Page 40780]]

1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate, sodium salt and 
its metabolite, methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-
5-oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate, in or on 
wheat, forage at 1.5 ppm, wheat, hay at 0.15 ppm, wheat, straw at 0.05 
ppm, and wheat, grain at 0.02 ppm and for residues of the herbicide 
propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in or on the meat 
of cattle, sheep, goat and horse at 0.05 ppm, meat byproducts of 
cattle, sheep, goat and horse at 0.05 ppm and milk at 0.004 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-2004-0172 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 September 
7, 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 
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, 14\th\ 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 [email protected], 
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-2004-0172, 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:  [email protected]. 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

[[Page 40781]]

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. 
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 ``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: June 24, 2004.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.600 is added to read as follows:


Sec.  180.600  Propoxycarbazone; tolerances for residues

    (a) General. (1) Tolerances are established for combined residues 
of the herbicide propoxycarbazone methyl 2-[[[(4,5-dihydro-4-methyl-5-
oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate 
and its metabolite methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-
methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in/
on the following raw agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Wheat, forage........................................                1.5
Wheat, grain.........................................               0.02
Wheat, hay...........................................               0.15
Wheat, straw.........................................               0.05
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
propoxycarbazone methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in/on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, meat.........................................               0.05
Cattle, meat byproducts..............................               0.05
Goat, meat...........................................               0.05
Goat, meat byproducts................................               0.05
Horse, meat..........................................               0.05
Horse, meat byproducts...............................               0.05
Milk.................................................              0.004
Sheep, meat..........................................               0.05
Sheep, meat byproducts...............................               0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 04-15210 Filed 7-6-04; 8:45 am]
BILLING CODE 6560-50-S