Propamocarb hydrochloride; Pesticide Tolerance

[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58390-58399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-12]

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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.

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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:
Waller.Mary@epa.gov.

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

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870.3465 90-Day inhalation NA
toxicity in rats

[[Page 58392]]

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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.

------------------------------------------------------------------------
870.5575 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 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

Propamocarb hydrochloride; Pesticide Tolerance

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