[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Rules and Regulations]
[Pages 47013-47022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17510]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0100; FRL-7368-8]


Propamocarb hydrochloride; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes tolerances for residues of 
propamocarb hydrochloride in or on lettuce, leaf; lettuce, head; 
vegetable, cucurbit, group 9; vegetable, fruiting, group 8; and tomato 
paste. 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 August 4, 2004. Objections and 
requests for hearings must be received on or before October 4, 2004.

[[Page 47014]]


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-2004-100. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Mary Waller, Registration Division 
7505C, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-9354; 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/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of March 10, 2004 (69 FR 11426-11431) (FRL-
7340-7), 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 
0F6123) by Bayer CropScience, 2TW Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.499 be amended 
by establishing a tolerance for residues of the fungicide propyl [3-
(dimethylamino) propyl] carbamate mono-hydrochloride, also known as 
propamocarb hydrochloride, in or on the raw agricultural commodities 
(RACs) lettuce, leaf, at 65 parts per million (ppm), lettuce, head, at 
50 ppm, wheat, grain, at 0.05 ppm, wheat, straw, at 0.10 ppm, wheat, 
forage, at 0.30 ppm, wheat, hay, at 0.30 ppm, vegetable, cucurbit, 
group 9, at 1.5 ppm, vegetable, fruiting, group 8, at 2.0 ppm, and 
tomato, paste, at 5.0 ppm. That notice included a summary of the 
petition prepared by Bayer CropScience, the registrant. There were no 
comments received in response to the notice of filing.
    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 residues of propamocarb 
hydrochloride on vegetable, cucurbit, group 9 at 1.5 ppm; lettuce, head 
at 50 ppm; lettuce, leaf at 90 ppm; vegetable, fruiting, group 8 at 2.0 
ppm and tomato, paste at 5.0 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 propamocarb 
hydrochloride 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.

[[Page 47015]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 363 mg/kg/
                                   toxicity in         day in females
                                   rodents             and 646 mg/kg/day
                                                       in males
                                                      LOAEL = 716 mg/kg/
                                                       day in females,
                                                       based on
                                                       decreased body
                                                       weight and body
                                                       weight gain and
                                                       decreased food
                                                       efficiency. LOAEL
                                                       in males is 1,363
                                                       mg/kg/day based
                                                       on decreased food
                                                       efficiency
---------------------------------
870.3150                          90-day oral         NOAEL was not
                                   toxicity in         achieved
                                   nonrodents         LOAEL = 22.75 mg/
                                                       kg/day based upon
                                                       body weight gain
                                                       depression,
                                                       decreased food
                                                       efficiency and
                                                       focal or multi-
                                                       focal chronic
                                                       erosive gastritis
---------------------------------
870.3200                          21/28-day dermal    NOAEL >=150 mg/kg/
                                   toxicity in         day for both
                                   rabbits             sexes
                                                      LOAEL = 525 mg/kg/
                                                       day based on dose-
                                                       related skin
                                                       irritation and
                                                       depressed body
                                                       weight gain
---------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       221 mg/kg/day
                                   toxicity in rats   Maternal LOAEL =
                                                       740 mg/kg/day
                                                       based on
                                                       mortality
                                                      Developmental
                                                       NOAEL = 221 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 740mg/kg/
                                                       day based on GD
                                                       20 fetal death
                                                       and a possible
                                                       increase in minor
                                                       skeletal
                                                       anomalies
---------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       150 mg /kg/day
                                   toxicity in        Maternal LOAEL =
                                   rabbits             300 mg /kg/day
                                                       based on
                                                       decreased body
                                                       weight gains for
                                                       GD 6-18 and
                                                       possible
                                                       increased
                                                       abortions
                                                      Developmental
                                                       NOAEL = 150 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 300 mg/kg/
                                                       day based on
                                                       increased post-
                                                       implantation loss
---------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 65.41 mg/
                                   in rats             kg/day for males
                                                       and 76.78 mg/kg/
                                                       day for females
                                                      Parental/Systemic
                                                       LOAEL = 406.69 mg/
                                                       kg/day for males
                                                       and 467.13 mg/kg/
                                                       day for females
                                                       based on
                                                       decreased body
                                                       weights
                                                      Reproductive/
                                                       Offspring NOAEL =
                                                       65.41 mg/kg/day
                                                       for males and
                                                       76.78 mg/kg/day
                                                       for females
                                                      Reproductive/
                                                       Offspring LOAEL =
                                                       406.69 mg/kg/day
                                                       for males and
                                                       467.13 mg/kg/day
                                                       for females based
                                                       on reduced pup
                                                       weights
---------------------------------
870.4100                          Chronic toxicity    NOAEL = >=25.6 mg/
                                   in rodents          kg/day
                                                      LOAEL = >25.6 mg/
                                                       kg/day. There
                                                       were no signs of
                                                       toxicity
                                                       attributable to
                                                       treatment at any
                                                       dose level
---------------------------------
870.4100                          Chronic toxicity    NOAEL was not
                                   in dogs             achieved.
                                                      LOAEL = 22.75 mg/
                                                       kg/day based upon
                                                       body weight gain
                                                       depression,
                                                       decreased food
                                                       efficiency and
                                                       focal or multi-
                                                       focal chronic
                                                       erosive gastritis
---------------------------------
870.4200                          Carcinogenicity in  NOAEL = 84 mg/kg/
                                   rats                day in males, 112
                                                       mg/kg/day in
                                                       females
                                                      LOAEL = 682 mg/kg/
                                                       day in males, 871
                                                       mg/kg/day in
                                                       females based on
                                                       decreased body
                                                       weight and body
                                                       weight gain,
                                                       decreased food
                                                       consumption, and
                                                       an increased
                                                       incidence of
                                                       vacuolation of
                                                       choroid plexus
                                                       ependymal cells
                                                       in the brain in
                                                       both sexes and
                                                       decreased water
                                                       consumption in
                                                       the females
                                                      no evidence of
                                                       carcinogenicity
---------------------------------
870.4200                          Carcinogenicity in  NOAEL = 12 mg/kg/
                                   mice                day in females
                                                       and >=690.0 mg/kg/
                                                       day in males
                                                      LOAEL = 95 mg/kg/
                                                       day in females
                                                       based on
                                                       decreased body
                                                       weight and body
                                                       weight gains
                                                      no evidence of
                                                       carcinogenicity
---------------------------------
870.5100                          Reverse gene        No evidence of
                                   mutation assay in   induced mutant
                                   bacteria            colonies over
                                                       background
---------------------------------
870.5375                          Cytogenetics        Increases in
                                  in vitro mammalian   aberrant
                                   cytogenetics        metaphases were
                                   assay.              within the
                                                       historical
                                                       control range
---------------------------------
870.5395                          Bone marrow         No significant
                                   micronucleus        increase in the
                                   assay               frequency of
                                                       micronucleated
                                                       polychromatic
                                                       erythrocytes in
                                                       bone marrow at
                                                       any dose tested
---------------------------------
870.5395                          Bone marrow         No significant
                                   micronucleus        increase in the
                                   assay               frequency of
                                                       micronucleated
                                                       polychromatic
                                                       erythrocytes in
                                                       bone marrow after
                                                       any treatment
                                                       time
---------------------------------

[[Page 47016]]

 
870.5575                          Other Genotoxicity  No evidence of
                                   Saccharomyces       gene conversion
                                   cerevisiae,         in the tested
                                   mitotic             strains with
                                   recombination,      activation
                                   gene conversion
                                   assay
---------------------------------
870.5575                          Saccharomyces       No evidence of
                                   cerevisiae,         gene conversion
                                   mitotic             in the tested
                                   recombination,      strains without
                                   gene conversion     activation
                                   assay
---------------------------------
870.5575                          Saccharomyces       Under the
                                   cerevisiae,         conditions of the
                                   mitotic             study, no
                                   recombination,      evidence of gene
                                   gene conversion     conversion
                                   assay
---------------------------------
870.6200                          Acute               NOAEL = 200 mg/kg/
                                   neurotoxicity       day
                                   screening battery  LOAEL =2,000 mg/kg/
                                   in rats             day based on
                                                       soiled fur coat
                                                       (both sexes) and
                                                       decreased motor
                                                       activity 8 hours
                                                       post-dosing
                                                       (females only)
---------------------------------
870.6200                          Subchronic          NOAEL = 1,320.8 mg/
                                   neurotoxicity       kg/day in males
                                   screening battery   and 1485.6 mg/kg/
                                   in rats             day in females
                                                      LOAEL = not
                                                       observed
---------------------------------
870.7485                          Metabolism in rats  A higher dose (at
                                                       least equivalent
                                                       to levels of
                                                       human exposure)
                                                       should have been
                                                       tested, and the
                                                       metabolites
                                                       should have been
                                                       identified
---------------------------------
N/A                               Special Study -     One male and one
                                   cholinesterase      female died
                                   inhibition study    within 43 min;
                                                       exhibited
                                                       tremors,
                                                       convulsions,
                                                       respiratory,
                                                       standstill, and
                                                       death. ChE
                                                       inhibition dead
                                                       animals, plasma -
                                                       no effect; RBC -
                                                       19 - 54%, and
                                                       brain decrease 10
                                                       X the controls.
                                                       No appreciable
                                                       decrease in ChE
                                                       in the surviving
                                                       dog
                                                      Conclusion: The
                                                       cholinesterase
                                                       inhibition
                                                       studies were of
                                                       questionable
                                                       quality. The
                                                       chemical does not
                                                       cause any
                                                       appreciable
                                                       inhibition of
                                                       cholinesterase
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) 
fromthe toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 10-6), or one in ten 
million (1 X 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 propamocarb 
hydrochloride used for human risk assessment is shown in Table 2 of 
this unit:

[[Page 47017]]



    Table 2.--Summary of Toxicological Dose and Endpoints for propamocarb hydrochloride for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 150 mg/kg/day    FQPA SF = 1X             Developmental toxicity
 age)                                  UF = 100...............  aPAD = acute RfD / FQPA   study - rabbit
                                       Acute RfD = 1.5 mg ai/    SF = 1.5 mg/kg/day.     developmental LOAEL =
                                        kg/day.                                           300 mg/kg/day based on
                                                                                          increased post-
                                                                                          implantation loss
--------------------------------------
Acute dietary general population       NOAEL= 200 mg/kg/day     FQPA SF = 1X             Acute neurotoxicity
 including infants and children        UF = 100...............  aPAD = acute RfD / FQPA   screening battery -
                                       Acute RfD = 2.0 mg/kg/    SF = 2.0 mg/kg/day.      rat
                                        day.                                             LOAEL = 2000 mg ai/kg/
                                                                                          day, based on
                                                                                          decreased body weight
                                                                                          gain and decreased
                                                                                          motor activity
--------------------------------------
Chronic dietary all populations        NOAEL= 12 mg/kg/day      FQPA SF = 1X             Carcinogenicity study -
                                       UF = 100...............  cPAD = chronic RfD /      mouse
                                       Chronic RfD = 0.12 mg/    FQPA SF = 0.12 mg/kg/   LOAEL = 95 mg/kg/day,
                                        kg/day.                  day.                     based on decreased
                                                                                          body weight and body
                                                                                          weight gain in females
--------------------------------------
Short-term oral (1 - 30 days)          NOAEL = 65.41 mg/kg/day  Residential LOC for MOE  2-generation
 (Residential)                                                   = 100                    reproduction toxicity
                                                                                          study - rat
                                                                                         Offspring LOAEL = 406.7
                                                                                          mg/kg/day, based on
                                                                                          reduced pup weights in
                                                                                          F0 and F1 during Day
                                                                                          14 - 21 of lactation
--------------------------------------
Intermediate-term oral (1 - 6          NOAEL = 65.41 mg/kg/day  Residential LOC for MOE  2-Generation
 months)(Residential)                                            = 100                    reproduction toxicity
                                                                                          study - rat
                                                                                         Offspring LOAEL = 406.7
                                                                                          mg/kg/day, based on
                                                                                          reduced pup weights in
                                                                                          F0 and F1 during Day
                                                                                          14 - 21 of lactation
--------------------------------------
Cancer (oral, dermal, inhalation)      ``not likely to be
                                        carcinogenic to
                                        humans''
----------------------------------------------------------------------------------------------------------------
 UF = uncertainty factor, FQPA SF = 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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.499(a)) for the residues of propamocarb 
hydrochloride, on potatoes. Risk assessments were conducted by EPA to 
assess dietary exposures from propamocarb hydrochloride 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.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM), 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 acute exposure assessments: 
Tolerance-level residues of propamocarb hydrochloride were assumed for 
all plant commodities with current or proposed propamocarb 
hydrochloride tolerances. The following residues of propamocarb 
hydrochloride and the metabolites of concern in livestock N-oxide 
propamocarb, 2-hydroxypropamocarb, and oxazolidine were assumed to be 
present in livestock commodities: 0.15 ppm in meat, 0.60 ppm in liver, 
0.20 ppm in kidney, 0.15 ppm in meat by-products excluding liver and 
kidney, 0.05 ppm in fat and 0.85 ppm in milk. EPA assumed that all of 
the crops included in the analysis were treated. Percent crop treated 
(PCT) and anticipated residue values were not used in the acute risk 
assessment.
    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-FCIDTM), 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: Tolerance-level residues of propamocarb hydrochloride were 
assumed for all plant commodities with current or proposed propamocarb 
hydrochloride tolerances. The following residues of propamocarb 
hydrochloride and the metabolites of concern in livestock N-oxide 
propamocarb, 2-hydroxy propamocarb, and oxazolidine were assumed to be 
present in livestock commodities: 0.15 ppm in meat, 0.60 ppm in liver, 
0.20 ppm in kidney, 0.15 ppm in meat by-products excluding liver and 
kidney, 0.05 ppm in fat and 0.85 ppm in milk. It was assumed that all 
of the crops included in the analysis were treated. Percent crop 
treated (PCT) and anticipated residue values 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 propamocarb hydrochloride 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 propamocarb hydrochloride.

[[Page 47018]]

    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 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 
levels of concern.
    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 propamocarb 
hydrochloride they are further discussed in the aggregate risk sections 
in Unit E., Aggregate Risks and Determination of Safety, below.
    Based on the FIRST and SCI-GROW models, the EECs of propamocarb 
hydrochloride for acute exposures are estimated to be 972 parts per 
billion (ppb) for surface water and 2.99 ppb for ground water. The EECs 
for chronic exposures are estimated to be 77 ppb for surface water and 
2.99 ppb for ground water. These EEC's are based on application rates 
on turf which yield higher projected surfacewater and groundwater 
concentrations than the proposed application rates on cucurbit 
vegetables; fruiting vegetables and lettuce.
    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).
    Propamocarb hydrochloride is currently registered for use on the 
following residential non-dietary sites: commercial sod farms, 
greenhouses growing plants for sale, plant nurseries and golf courses. 
There are two end-use products registered for these uses: Banol (EPA 
Registration Number 432-942, contains 66.5% propamocarb hydrochloride) 
and Banol C (EPA Registration Number 432-961, contains 30.5% 
propamocarb hydrochloride and 30.5% chlorothalonil). An MOE of 100 is 
assumed to adequately ensure protection from propamocarb hydrochloride 
via the dermal and inhalation routes for residential exposures. The 
high-end scenario for residential post-application exposure is to 
golfers on a course treated with propamocarb hydrochloride. The post-
application risk assessment is based on generic assumptions as 
specified by the newly proposed Residential Standard Operating 
Procedures (SOPs) and recommended approaches by the Health Effects 
Division's (HED's) Exposure Science Advisory Committee. Short-term 
post-application exposures are expected for the adult and adolescent 
golfer (high end exposure scenario). Golfer exposure is expected 
through minimal hand contact with the golf ball and dermal contact to 
the lower legs from treated plant surfaces. Since it is assumed that 
the adolescent golfer would have a proportionally similar exposure to 
adults, a dermal post-application assessment was performed for the 
adult golfer only. The calculated MOE for the golfer is 980 and, 
therefore, does not exceed EPA's level of concern. Since the short- and 
intermediate-term toxicological endpoints are the same, the golfer 
post-application exposure assessment is expected to provide adequate 
exposure estimates for both the short- and intermediate-term exposure 
scenarios. In the event of intermediate-term exposure, propamocarb 
hydrochloride residues are expected to dissipate over time. Therefore, 
this assessment is expected to present a high-end conservative estimate 
of actual 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 propamocarb hydrochloride 
and any other substances and propamocarb hydrochloride 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 
propamocarb hydrochloride 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 Office of Pesticide Programs (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. Prenatal and postnatal sensitivity. EPA determined that there 
are no residual concerns for propamocarb for prenatal and postnatal 
toxicology based on the following:

[[Page 47019]]

     There is no quantitative or qualitative evidence of 
increased susceptibility of rat and rabbit fetuses to in utero exposure 
to propamocarb hydrochloride in developmental toxicity studies. There 
is no quantitative or qualitative evidence of increased susceptibility 
to propamocarb hydrochloride following prenatal/postnatal exposure to a 
2-generation reproduction study.
     There is no concern for developmental neurotoxicity 
resulting from exposure to propamocarb hydrochloride. A developmental 
neurotoxicity study (DNT) is not required.
    3. Conclusion. There is a complete toxicity data base for 
propamocarb hydrochloride and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. Given the completeness of the data base and the lack of 
concern for prenatal and postnatal toxicity, EPA concluded that 
reliable data shows an additional safety factor of 10X is not needed 
for the protection of infants and children.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
propamocarb hydrochloride will occupy 4% of the aPAD for the U.S. 
population, 6% of the aPAD for females 13 years and older, 2% of the 
aPAD for infants < 1 year old, and 5% of the aPAD for children between 
1 and 2 years of age. In addition, there is potential for acute dietary 
exposure to propamocarb hydrochloride 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 aPAD, as shown in Table 3 of this unit:

               Table 3.--Aggregate Risk Assessment for Acute Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface
              Population Subgroup                aPAD (mg/kg/    %aPAD      Water EEC    Water EEC   Acute DWLOC
                                                     day)        (food)     ([mu]g/L)    ([mu]g/L)    ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          2.0            4         2.99          972       67,000
------------------------------------------------
All infants (<1 year old)                                2.0            2         2.99          972       19,000
------------------------------------------------
Children (1-2 years old)                                 2.0            5         2.99          972       19,000
------------------------------------------------
Children (3-5 years old)                                 2.0            5         2.99          972       19,000
------------------------------------------------
Children (6-12 years old)                                2.0            4         2.99          972       19,000
------------------------------------------------
Youth (13-19 years old)                                  2.0            4         2.99          972       67,000
------------------------------------------------
Adults (20-49 years old)                                 2.0            4         2.99          972       67,000
------------------------------------------------
Adults (50+ years old)                                   2.0            4         2.99          972       67,000
------------------------------------------------
Females (13-49 years old)                                1.5            6         2.99          972       42,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
propamocarbhydrochloride from food will utilize 18% of the cPAD for the 
U.S. population, 11% of the cPAD for infants less than 1 year old, 36% 
of the cPAD for children between 1 and 2 years of age and 30% of the 
cPAD for children between 3 and 5 years of age. Based on the use 
pattern, chronic residential exposure to residues of propamocarb 
hydrochloride is not expected. In addition, there is potential for 
chronic dietary exposure to propamocarb hydrochloride 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 4 of this unit:

[[Page 47020]]



       Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface      Chronic
              Population Subgroup                cPAD (mg/kg/    %cPAD      Water EEC    Water EEC      DWLOC
                                                     day)        (Food)     ([mu]g/L)    ([mu]g/L)    ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.12           18         2.99           77        3,500
------------------------------------------------
All infants (< 1 year old)                              0.12           11         2.99           77        1,100
------------------------------------------------
Children (1-2 years old)                                0.12           36         2.99           77          760
------------------------------------------------
Children (3-5 years old)                                0.12           30         2.99           77          840
------------------------------------------------
Children (6-12 years old)                               0.12           22         2.99           77          930
------------------------------------------------
Youth (13-19 years old)                                 0.12           16         2.99           77        3,500
------------------------------------------------
Adults (20-49 years old)                                0.12           16         2.99           77        3,500
------------------------------------------------
Females (13-49 years old)                               0.12           17         2.99           77        3,000
------------------------------------------------
Adults (50+ years old)                                  0.12           14         2.99           77        3,600
----------------------------------------------------------------------------------------------------------------

    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).
    Propamocarb hydrochloride is currently registered for use on golf 
courses that could result in short-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic food 
and water and short-term exposures for propamocarb hydrochloride.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 870 for females 13-50 years old, 
1,000 for youth 13-19 years old and 980 for the general U.S. 
population. The short-term aggregate risk assessment estimates risks 
likely to result from 1-7 day exposure to propamocarb hydrochloride 
residues in food, drinking water, and residential pesticide uses. High-
end estimates of the residential exposure are used in the short-term 
assessment. Average values are used for food and drinking water 
exposure. For short-term aggregate exposure risk, the oral and dermal 
exposures can be combined since both are based on the same toxicity 
endpoint (decreased body weight). An MOE of 100 is adequate to ensure 
protection from propamocarb hydrochloride via the dermal route for 
residential exposures. According to the 1995 RED for propamocarb 
hydrochloride (Estimated Usage of Pesticide, p. 3), ``almost all usage 
of propamocarb hydrochloride in the United States is concentrated on 
golf courses with approximately 100,000 to 200,000 lbs ai applied per 
year.'' The labels for Banol (EPA Registration Number 432-942) and 
Banol C (EPA Registration Number 432-961) both state that only 
protected handlers may be present in the treated area during 
application. For these reasons, it is assumed that this product will be 
used by commercial applicators, mainly on golf courses. The high-end 
scenario for residential post-application exposure is the golf course 
use of Banol. Therefore, in aggregating short-term risk, the Agency 
considered background chronic dietary exposure (food and drinking 
water) and short-term golfer dermal exposure.
    These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of propamocarb hydrochloride in ground and surface water. 
After calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 5 of this unit:

            Table 5.--Aggregate Risk Assessment for Short-Term Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface      Ground/     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General US Population                                    980          100         2.99           77       47,000
-----------------------------------------------
Females 13-49 years old                                  870          100         2.99           77       40,000
-----------------------------------------------
Youth 13-19 years old                                  1,000          100         2.99           77       48,000
----------------------------------------------------------------------------------------------------------------

    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). The short-
term aggregate assessment adequately addresses both the short- and 
intermediate-term golfer dermal exposures. The short- and intermediate-
term dermal endpoints were chosen from the 21-day dermal rabbit 
toxicity study. The short-term golfer exposure was calculated assuming 
1 to 7 days exposure to propamocarb hydrochloride. The intermediate-
term aggregate risk assessment estimates risks likely to result from 7 
days to 3 months of exposure. In the event of intermediate-term 
exposure, propamocarb hydrochloride residues are

[[Page 47021]]

expected to dissipate over time. Therefore, the short-term aggregate 
assessment is expected to present a high-end conservative estimate of 
intermediate-term risk. As the short-term aggregate risk assessment 
represents the high-end scenario, an intermediate-term assessment was 
not performed.
    5. Aggregate cancer risk for U.S. population. A quantitative cancer 
risk analysis was not performed since there is no concern for mutagenic 
potential and there is no evidence of carcinogenic potential in either 
the rat or mouse. Propamocarb has been classified as ``not likely to be 
carcinogenic in humans.''
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to propamocarb hydrochloride residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography/nitrogen-phosphorus detection (GC/
NPD) method (Xenos Report Number: XEN97-37) has been submitted. This 
method has undergone a successful independent laboratory validation 
(ILV) and petition method validation (PMV). The GC/NPD has been sent to 
the Food and Drug Administration (FDA) and is currently listed in the 
Pesticide Analytical Manual (PAM) Vol. II for determining residues of 
propamocarb hydrochloride in plant commodities.
    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

    The Codex Alimentarius Commission (Codex) has established 
tolerances (maximum residue levels) for propamocarb hydrochloride in 
the following raw agricultural commodities: Beetroot at 0.2 ppm, 
brussel sprouts at 1.0 ppm, cabbage (head) at 0.1 ppm, cauliflower at 
0.2 ppm, celery at 0.2 ppm, cucumber at 2.0 ppm, lettuce (head) at 10 
ppm, pepper (sweet) at 1.0 ppm, radish at 5.0 ppm, strawberry at 0.1 
ppm and tomato at 1.0 ppm.
    Proposed tolerances for vegetable, cucurbit, Group 9, lettuce head; 
vegetables, fruiting, group 8; and tomato paste vary from established 
Codex MRL's due to varying agricultural practices and environmental 
conditions.

V. Conclusion

    Therefore, tolerances are established for residues of propamocarb 
hydrochloride on vegetable, cucurbit, group 9 at 1.5 ppm; lettuce, head 
at 50 ppm; lettuce, leaf at 90 ppm; vegetable, fruiting, group 8 at 2.0 
ppm; tomato, paste at 5.0 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-2004-0100 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 October 
4, 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 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. 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-2004-100, 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

[[Page 47022]]

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. 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: July 19, 2004.
Lois Rossi,
Director, Registration Division, 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 180.499 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.499  Propamocarb Hydrochloride; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Lettuce, head..............................................           50
Lettuce, leaf..............................................           90
                                * * * * *
Vegetable, cucurbit, group 9...............................          1.5
Vegetable, fruiting, group 8...............................          2.0
Tomato, paste..............................................          5.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-17510 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S