[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58390-58399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25049]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301057; FRL-6745-8]
RIN 2070-AB78


Propamocarb hydrochloride; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY:  This regulation establishes a tolerance for residues of 
propyl[3-(dimethylamino)propyl]carbamate monohydrochloride known as 
propamocarb hydrochloride in or on potatoes. Aventis CropScience USA LP 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES:  This regulation is effective September 29, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301057, 
must be received by EPA on or before November 28, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301057 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Mary L. Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-9354; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:   

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                      Affected  Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental

[[Page 58391]]

Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301057. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 12, 1997 (62 FR 11433) (FRL-5589-
7), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (PP) for tolerance by Aventis 
CropScience USA LP, 2 T.W. Alexander Drive, Research Triangle Park, NC 
27709. This notice included a summary of the petition prepared by 
Aventis CropScience, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.499 be amended by 
establishing a tolerance for residues of the fungicide propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride, known as propamocarb 
hydrochloride, in or on potatoes, and the following livestock 
commodities: meat, meat byproducts, fat and milk of cattle, goats, 
hogs, horses and sheep at 0.05 part per million (ppm).
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 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), 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), for a tolerance for residues of propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride on potatoes at 0.06 
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 propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride are discussed in the 
following Table 1 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.--Toxicity Profile of Propamocarb Hydrochloride
------------------------------------------------------------------------
         Guideline No.              Study type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 363 mg/kg/day
                                 toxicity in        in females and 646
                                 rodents            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
                                                    1363 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
                                 toxicity in        mg/kg/day for both
                                 rabbits            sexes.
                                                   LOAEL = 525 mg/kg/day
                                                    based on dose-
                                                    related skin
                                                    irritation and
                                                    depressed body
                                                    weight gain
------------------------------------------------------------------------
870.3250                        90-Day dermal      NA
                                 toxicity in rats
 
------------------------------------------------------------------------
870.3465                        90-Day inhalation  NA
                                 toxicity in rats

[[Page 58392]]

 
 
------------------------------------------------------------------------
870.3700a                       Prenatal           Maternal NOAEL = 221
                                 developmental      mg/kg/day. LOAEL =
                                 toxicity in rats   740 mg/kg/day based
                                                    on mortality.
                                                    Developmental NOAEL
                                                    = 221 mg/kg/day.
                                                   LOAEL = 740 mg/kg/day
                                                    based on GD 20 fetal
                                                    death and a possible
                                                    increase in minor
                                                    skeletal anomalies.
------------------------------------------------------------------------
870.3700b                       Prenatal           Maternal NOAEL = 150
                                 developmental      mg/kg/day. LOAEL =
                                 toxicity in        300 mg /kg/day based
                                 rabbits            on decreased body
                                                    weight gains for GD
                                                    6-18 and possible
                                                    increased abortions.
                                                    Developmental NOAEL
                                                    = 150 mg/kg/day.
                                                   LOAEL = 300 mg/kg/day
                                                    based on increased
                                                    post-implantation
                                                    loss.
------------------------------------------------------------------------
870.3800                        Reproduction and   Parental/Systemic
                                 fertility          NOAEL = 65.41 mg/kg/
                                 effects in rats    day for males and
                                                    76.78 mg/kg/day for
                                                    females. 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.
                                                   LOAEL = 406.69 mg/kg/
                                                    day for males and
                                                    467.13 mg/kg/day for
                                                    females based on
                                                    reduced pup weights
------------------------------------------------------------------------
870.4100a                       Chronic toxicity   NOAEL = 25.6 mg/kg/day.
                                                   LOAEL = >25.6 mg/kg/
                                                    day. There were no
                                                    signs of toxicity
                                                    attributable to
                                                    treatment at any
                                                    dose level
------------------------------------------------------------------------
870.4100b                       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
------------------------------------------------------------------------
870.4200a                       Carcinogenicity    NOAEL = 84 mg/kg/day
                                 in rats            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
------------------------------------------------------------------------
870.4200b                       Carcinogenicity    NOAEL = 12 mg/kg/day
                                 in mice            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                        Gene Mutation:     There was no evidence
                                 reverse gene       of induced mutant
                                 mutation assay     colonies over
                                 in bacteria        background
 
------------------------------------------------------------------------
870.5375                        Cytogenetics: in   Increases in aberrant
                                 vitro mammalian    metaphases were
                                 cytogenetics       within the
                                 assay              historical control
                                                    range
 
------------------------------------------------------------------------
870.5395                        Bone marrow        There was no
                                 micronucleus       significant increase
                                 assay              in the frequency of
                                                    micronucleated
                                                    polychromatic
                                                    erythrocytes in bone
                                                    marrow at any dose
                                                    tested.
 
------------------------------------------------------------------------
870.5395                        Bone marrow        There was no
                                 micronucleus       significant increase
                                 assay              in the frequency of
                                                    micronucleated
                                                    polychromatic
                                                    erythrocytes in bone
                                                    marrow after any
                                                    treatment time.
 
------------------------------------------------------------------------
870.5575                        Other              There was no evidence
                                 Genotoxicity:      of gene conversion
                                 Saccharomyces      in the tested
                                 cerevisiae,        strains with
                                 mitotic            activation.
                                 recombination,
                                 gene conversion
                                 assay
 
------------------------------------------------------------------------
870.5575                        Saccharomyces      There was no evidence
                                 cerevisiae,        of gene conversion
                                 mitotic            in the tested
                                 recombination,     strains without
                                 gene conversion    activation.
                                 assay
 
------------------------------------------------------------------------
870.5575                        Saccharomyces      Under the conditions
                                 cerevisiae,        of the study there
                                 mitotic            was no evidence of
                                 recombination,     gene conversion.
                                 gene conversion
                                 assay

[[Page 58393]]

 
 
------------------------------------------------------------------------
870.6200a                       Acute              NOAEL = 200 mg/kg/
                                 neurotoxicity      day.
                                 screening
                                 battery in rats
                                                   LOAEL = 2000 mg/kg/
                                                    day based on soiled
                                                    fur coat (both
                                                    sexes) and decreased
                                                    motor activity 8
                                                    hours post-dosing
                                                    (females only)
------------------------------------------------------------------------
870.6200b                       Subchronic         NOAEL = 1320.8 mg/kg/
                                 neurotoxicity      day in males and
                                 screening          1485.6 mg/kg/day in
                                 battery in rats    females.
                                                   LOAEL = not observed
------------------------------------------------------------------------
870.6300                        Developmental      NA
                                 neurotoxicity in
                                 rats
 
------------------------------------------------------------------------
870.7485                        Metabolism in      A higher dose (at
                                 rats               least equivalent to
                                                    levels of human
                                                    exposure) should
                                                    have been tested,
                                                    and the metabolites
                                                    should have been
                                                    identified.
 
------------------------------------------------------------------------
870.7600                        Dermal             NA
                                 penetration
 
------------------------------------------------------------------------
NA                              Special studies    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 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 dose at which the 
LOAEL of concern are identified 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.
    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 the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, 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 FQPA 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 is expressed as 1 x 10-\6\ or one in a million). 
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 propyl[3-(dimethylamino)propyl]carbamate 
monohydrochloride used for human risk assessment is shown in the 
following Table 2:

       Table 2.--Summary of Toxicological Dose and Endpoints for Propyl[3-(dimethylamino)propyl]carbamate
                              Monohydrochloride for Use in Human Risk Assessment\1\
----------------------------------------------------------------------------------------------------------------
                                                                FQPA SF\2\ and level of
          Exposure scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   NOAEL = 150 mg ai/kg/    FQPA SF = 1X. aPAD =     Developmental Toxicity
 age                                    day. UF = 100. Acute     acute RfD        Study--rabbit.
                                        RfD = 1.5 mg ai/ kg/     FQPA SF = 1.5 mg/kg/     Developmental LOAEL =
                                        day.                     day                      300 mg ai/kg/day based
                                                                                          on increased post-
                                                                                          implantation loss
Acute Dietary general population       NOAEL = 200 mg ai/kg/    FQPA SF = 1X. aPAD =     Acute Neurotoxicity
 including infants and children         day. UF = 100. Acute     acute RfD        Screening Battery--
                                        RfD = 2.0 mg/kg/day.     FQPA SF = 2.0 mg/kg/     rat. LOAEL = 2000 mg
                                                                 day                      ai/kg/day based on
                                                                                          decreased body weight
                                                                                          gain and decreased
                                                                                          motor activity

[[Page 58394]]

 
Chronic Dietary all populations        NOAEL = 12 mg ai/kg/     FQPA SF = 1X. cPAD =     Carcinogenicity Study--
                                        day. UF = 100. Chronic   chronic RfD      mouse. LOAEL = 95 mg
                                        RfD = 0.12 mg/kg/day.    FQPA SF = 0.12 mg/kg/    ai/kg/day based on
                                                                 day                      decreased body weight
                                                                                          and body weight gain
                                                                                          in females
Short-Term (1-7 days) and              dermal study NOAEL =     LOC for MOE = 100        21-Day Dermal Toxicity
 Intermediate-Term (1 week-several      150 mg ai/kg/day.        (Occupational). LOC      Study--rabbit. LOAEL =
 months) Dermal (Occupational/                                   for MOE = 100            525 mg/kg/day based on
 Residential)                                                    (Residential)            decreased body weight
                                                                                          gain in females
Short-Term (1-7 days) and              inhalation (or oral)     LOC for MOE = 100        Developmental Toxicity
 Intermediate-Term (1 week-several      study NOAEL = 150 mg     (Occupational). LOC      Study--rabbit.
 months) Inhalation (Occupational/      ai/kg/day (inhalation    for MOE = 100.           Developmental LOAEL =
 Residential)                           absorption rate =        (Residential)            300 mg ai/ kg/day
                                        100%)                                             based on increased
                                                                                          post-implantation
                                                                                          loss. Maternal LOAEL =
                                                                                          300 mg ai/kg/day based
                                                                                          on decreased body
                                                                                          weight gain
Cancer (oral, dermal, inhalation)      ``not likely''           not applicable           Acceptable oral rat and
                                                                                          mouse carcinogenicity
                                                                                          studies; no evidence
                                                                                          of carcinogenic or
                                                                                          mutagenic potential.
----------------------------------------------------------------------------------------------------------------
1 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, LOC = level of concern
2 The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In addition to the 
currently proposed tolerance for potatoes, tolerances have been 
established under the section 18 program (40 CFR 180.499) for the 
residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, 
in or on the raw agricultural commodity, potatoes and tomatoes. Risk 
assessments were conducted by EPA to assess dietary exposures from 
propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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. The Dietary Exposure Evaluation Model 
(DEEM) analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1989-1992 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: Tier 1 acute analyses were 
performed for females 13-50 years old and the general U.S. population 
(including infants and children); therefore, the acute risk was 
analyzed at the 95th percentile. The aPAD for females 13-50 years old 
and the general U.S. population (including infants and children) are 
1.5 mg/kg/day and 2.0 mg/kg/day, respectively. For acute dietary risk 
estimates, EPA's level of concern is >100% aPAD. The results of the 
acute analysis indicate that the acute dietary risk estimates for the 
general U.S. population and all population subgroups (at the 95th 
percentile) associated with the proposed uses of propamocarb 
hydrochloride do not exceed EPA's level of concern.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 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: A Tier 1 
chronic analysis was performed for the general U.S. population and all 
population subgroups. The cPAD for the general U.S. population and all 
subgroups is 0.12 mg/kg/day. For chronic dietary risk estimates, EPA's 
level of concern is >100% cPAD. The results of the chronic analysis 
indicate that the chronic dietary risk estimates for the general U.S. 
population and all population subgroups associated with the proposed 
uses of propamocarb hydrochloride do not exceed EPA's level of concern.
    iii. Cancer. There is no concern for mutagenic potential, and there 
is no evidence of carcinogenic potential in either the rat or mouse. 
Propamocarb hydrochloride has been classified as ``not likely to be 
carcinogenic in humans.'' Therefore, a cancer dietary exposure analysis 
was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride 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 propyl[3-(dimethylamino)propyl]carbamate 
monohydrochloride.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes 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 coarse screen for sorting out pesticides for 
which it is highly unlikely that

[[Page 58395]]

drinking water concentrations would ever 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) from these models 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 propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride in surface water and 
ground water for acute exposures are estimated to be 1030 parts per 
billion (ppb) for surface water and 2.08 ppb for ground water. The EECs 
for chronic exposures are estimated to be 340 ppb for surface water and 
2.08 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).
    Propyl[3-(dimethylamino)propyl]carbamate monohydrochloride is 
currently registered for use on the following residential non-dietary 
sites: turfgrass and ornamentals at residential, recreational and golf 
course sites. However, the usage information in the 1995 Reregistration 
Eligibility Decision (RED) for propamocarb hydrochloride and the label 
statement that only protected handlers may be present in the treated 
area during application, indicate that only commercial applicators will 
apply the registered end-use product Banol (EPA Registration Number 
432-942, contains 66.5% propamocarb hydrochloride) mainly on golf 
courses and there will be no use on residential or recreational turf. 
The risk assessment was conducted using the following residential 
exposure assumptions: An MOE of 100 is adequate to ensure protection 
from propamocarb hydrochloride via the dermal and inhalation routes for 
residential exposures. The high-end scenario for residential post-
application exposure is the golf course use. 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 Health Effects Division's (HED's) Exposure 
Science Advisory Committee. Short-term post-application exposures are 
expected for the adult and adolescent golfer. 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. 
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 exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride has 
a common mechanism of toxicity with other substances or how to include 
this pesticide in a cumulative risk assessment. Unlike other pesticides 
for which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, propyl[3-(dimethylamino)propyl]carbamate 
monohydrochloride 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 propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 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 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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. There is no evidence of 
quantitative or qualitative enhanced susceptibility to infants and 
children. In the rat, developmental effects occur only at doses that 
cause mortality in the dams. The Maternal LOAEL of 740 mg ai/kg/day is 
based on mortality. The Maternal NOAEL is 221 mg ai/kg/day. The 
Developmental LOAEL of 740 mg ai/kg/day is based on increased gestation 
day (GD) 20 fetal death and a possible increase in minor skeletal 
anomalies. The Developmental NOAEL is 221 mg ai/kg/day.
     In the rabbit, developmental effects occur only at doses where 
there is maternal toxicity. It was felt by the Hazard Identification 
Assessment Review Committee (HIARC) that the post implantation loss is 
actually due to the increased abortions in the does. The Maternal LOAEL 
of 300 mg ai/kg/day is based on decreased body weight gains for GD 6-18 
and possible increased abortions. The Maternal NOAEL is 150 mg ai/kg/
day. The Developmental LOAEL of 300 mg ai/kg/day is based on increased 
post-implantation loss. The Developmental NOAEL is 150 mg ai/kg/day.
     In the reproduction toxicity study, offspring effects only 
occurred at levels resulting in maternal toxicity. The LOAEL for 
systemic/parental toxicity is 8000 ppm based on decreased body weights 
of F0 and F1 adults. The systemic/parental 
toxicity NOAEL is 1250 ppm.
    iii. Conclusion. There is a complete toxicity data base for 
propyl[3-(dimethylamino)propyl]carbamate

[[Page 58396]]

monohydrochloride and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. EPA 
determined that the 10X safety factor to protect infants and children 
should be removed. The FQPA factor is removed because the prenatal and 
postnatal toxicology database is complete and there is no indication of 
increased susceptibility. A developmental neurotoxicity study is not 
required. The dietary (food and drinking water) exposure assessments 
will not underestimate the potential exposures for infants and children 
from the use of propamocarb hydrochloride.

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 the model estimates of 
a pesticide's concentration in water (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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/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, the Office of Pesticide Programs (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 
propyl[3-(dimethylamino)propyl]carbamate monohydrochloride will occupy 
1 % of the aPAD for the U.S. population, 1 % of the aPAD for females 13 
years and older, 3% of the aPAD for all infants    (< 1 year old) and 3 
% of the aPAD for children 1-6 years old. In addition, there is 
potential for acute dietary exposure to propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride 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 the following Table 3:

       Table 3.--Aggregate Risk Assessment for Acute Exposure to propyl[3-(dimethylamino)propyl]carbamate
                                                monohydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 a PAD (mg/     % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
All infants < 1year old                                  2.0            3         1030         2.08        19000
Children 1-6 years old                                   2.0            3         1030         2.08        19000
 Females 13-50 years old                                 1.5            1         1030         2.08        45000
General U.S. population                                  2.0            1         1030         2.08        69000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride from food will 
utilize 7% of the cPAD for the U.S. population, 9% of the cPAD for all 
infants < 1 year old and 23 % of the cPAD for children 1-6 years old. 
It has been assumed that there are no residential uses for propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride that result in 
chronic residential exposure to propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride, as shown in the 
following Table 4:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to propyl[3-
                                (dimethylamino)propyl]carbamate monohydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
 Infants < 1 year old                                   0.12            9          340         2.08         1100
Children 1-6 years old                                  0.12           23          340         2.08          920
Females 13-50 years old                                 0.12            5          340         2.08         3400
U.S. Population                                         0.12            7          340         2.08         3900
----------------------------------------------------------------------------------------------------------------


[[Page 58397]]

    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).
    Propyl[3-(dimethylamino)propyl]carbamate monohydrochloride is 
currently registered for use 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 propyl[3-(dimethylamino)propyl]carbamate 
monohydrochloride.
    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 950, 1100 and 1100 for females 
13-50 years old, males 13-19 years old and the general U.S. population, 
respectively. 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 label 
for Banol states 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 propyl[3-(dimethylamino)propyl]carbamate 
monohydrochloride 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 the following Table 5:

     Table 5.--Aggregate Risk Assessment for Short-Term Exposure to propyl[3-(dimethylamino)propyl]carbamate
                                                monohydrochloride
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                  950          100         1030         2.08        40000
Males 13-19 years old                                   1100          100         1030         2.08        63000
General U.S. Population                                 1100          100         1030         2.08        63000
----------------------------------------------------------------------------------------------------------------

    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 
1-7 day exposure to propamocarb hydrochloride. The intermediate-term 
aggregate risk assessment estimates risks likely to result from 7 days 
to 3 months exposure. In the event of intermediate-term exposure, 
propamocarb hydrochloride residues are 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. An aggregate 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 
residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner utilized a gas chromatography method for the 
determination of propamocarb hydrochloride residues in/on raw 
agricultural commodity samples collected from the potato field study 
and field rotational crop study. The reported limit of quantitation was 
0.05 ppm. The method validation and concurrent method recovery data 
indicate that this method is adequate for data collection.
    An identical method is proposed for tolerance assessment. The 
proposed method has undergone a successful independent lab validation 
and petition validation method. EPA concludes that the requirements for 
a plant enforcement method have been fulfilled for the purpose of this 
petition.
    A ruminant feeding study is required. Conclusions about the need 
for livestock tolerances and appropriate enforcement analytical method 
are deferred until receipt of the ruminant feeding study and 
determination of the residues of concern in livestock.

B. International Residue Limits

    No Codex limit has been established for propamocarb hydrochloride 
in/on the raw agricultural commodity (RAC) potato or its processed 
commodities, or animal (except poultry) commodities of meat, meat 
byproducts, or milk. Canadian and Mexican maximum residue limits (MRLs) 
have been established for the use on the RAC potato at 0.5 ppm. 
Harmonization is not possible because the submitted crop

[[Page 58398]]

field data support the establishment of a tolerance on potatoes at 0.06 
ppm. Canadian tolerances were established based, in part, on field 
studies from Europe where, in at least one test, dosages higher than 
those proposed in the U.S. were applied more frequently and closer to 
harvest.

C. Conditions

    The conditions of registration will include submission of a 
livestock feeding study (which determines the metabolites N-oxide 
propamocarb, 2-hydroxy propamocarb and oxazolidine) and storage 
stability data from the livestock feeding study. The need for a 
livestock analytical enforcement method and livestock tolerances will 
be determined after receipt of the ruminant feeding study and 
determination of the residues of concern in livestock. A corrosion 
characteristics study must be submitted as soon as completed.

V. Conclusion

    Therefore, the tolerance is established for residues of propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride, known as propamocarb 
hydrochloride, in or on potatoes at 0.06 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301057 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
28, 2000.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    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.
    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.
    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 Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301057, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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 file format 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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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). 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

[[Page 58399]]

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any prior consultation as specified by 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998); special 
considerations as required by Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA 
section 408(d), 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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 21, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.


    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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

    2. Section 180.499 is amended by adding text to paragraph (a) to 
read as follows:


Sec. 180.499   Propamocarb hydrochloride; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
propyl[3-(dimethylamino)propyl]carbamate monohydrochloride also known 
as propamocarb hydrochloride in or on the following raw agricultural 
commodity:

 
 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 Potato                                     0.06
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-25049 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S