Propamocarb Hydrochloride; Pesticide Tolerances for Emergency Exemptions

[Federal Register: September 21, 2001 (Volume 66, Number 184)]
[Rules and Regulations]
[Page 48577-48585]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se01-20]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301162; FRL-6797-2]
RIN 2070-AB78

Propamocarb Hydrochloride; Pesticide Tolerances for Emergency
Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation revises time-limited tolerances for residues
of propamocarb hydrochloride in or on tomato and tomato, paste and
revokes the time limited tolerance for residues of propamocarb
hydrochloride in or on tomato, puree. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on tomatoes. This regulation revises maximum
permissible levels for residues of propamocarb hydrochloride in these
food commodities. The revised tolerances will expire and are revoked on
December 31, 2003.

DATES: This regulation is effective September 21, 2001. Objections and
requests for hearings, identified by docket control number OPP-301162,
must be received by EPA on or before November 20, 2001.

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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301162 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703 308-9364; and e-mail address:
pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected 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
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301162. 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, 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

EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is revising the tolerances for residues of the fungicide
propamocarb hydrochloride, propyl [3-(dimethylamino)propyl]
carbamate
monohydrochloride, by increasing the residue levels in or on tomato and
tomato, paste, to 2 and 5 ppm, respectively, and removing the level for
tomato, puree. These revised tolerances will expire and are revoked on
December 31, 2003. EPA will publish a document in the Federal Register
to remove the revoked tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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

[[Page 48578]]

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. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Propamocarb hydrochloride on Tomato
and FFDCA Tolerances

Failure to control late blight in tomatoes with the registered
fungicides have been caused almost exclusively by immigrant strains of
late blight (Phytophthora infestans), which are resistant to the
control of choice, metalaxyl. Before the immigrant strains of late
blight arrived, all of the strains in the United States were previously
controlled by treatment with metalaxyl. Presently, there are no
fungicides registered in the United States that will provide adequate
control of the immigrant strains of late blight. EPA has authorized
under FIFRA section 18 the use of propamocarb hydrochloride on tomato
for control of late blight in California. After having reviewed the
submission, EPA concurs that an emergency condition exists for this
State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of propamocarb hydrochloride
in or on tomato and tomato paste. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is revising these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on December 31,
2003, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
tomato and tomato paste after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed the levels that were authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether propamocarb
hydrochloride meets EPA's registration requirements for use on tomato
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that these tolerances
serve as a basis for registration of propamocarb hydrochloride by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than California to
use this pesticide on this crop under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemption for propamocarb hydrochloride, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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).
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
propamocarb hydrochloride and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for time-limited
tolerances for residues of propamocarb hydrochloride in or on tomato
and tomato paste at 2 and 5 ppm, respectively ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerances follows.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (NOAEL) from the
toxicology study identified as appropriate for use in risk assessment
is used to estimate the toxicological endpoint. However, the lowest
dose at which adverse effects of concern are identified (LOAEL) is
sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
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 level of concern (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.

[[Page 48579]]

To estimate risk, a ratio of the point of departure to exposure
(MOE_cancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for propamocarb hydrochloride
used for human risk assessment is shown in the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Propamocarb hydrochloride for Use in Human Risk
Assessment
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FQPA SF* 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/kg/day FQPA SF = 1X Rabbit Developmental
age UF = 100............... aPAD = acute RfD....... LOAEL = 300 mg/kg/day
Acute RfD = 1.5 mg/kg/ FQPA SF = 1.5 mg/kg/day based on increased
day. post-implantation loss
----------------------------------------------------------------------------------------------------------------
Acute dietary general population NOAEL = 200 mg/kg/day FQPA SF = 1X Acute neurotoxicity
including infants and children UF = 100............... aPAD = acute RfD....... screening battery-Rat
Acute RfD = 2.0 mg/kg/ FQPA SF = 2.0 mg/kg/day LOAEL = 2,000 mg/kg/
day. day based on decreased
body weight gain and
decreased motor
activity
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 12 mg/kg/day FQPA SF = 1X Carcinogenicity study-
UF = 100............... cPAD = chronic RfD..... Mouse LOAEL = 95 mg/kg/
Chronic RfD = 0.12 mg/ FQPA SF = 0.12 mg/kg/ day based on decreased
kg/day. day. body weight and body
weight gain in females
----------------------------------------------------------------------------------------------------------------
Short-term (1 to 7 days) and Dermal study NOAEL= 150 LOC for MOE = 100 21-day dermal toxicity
Intermediate-term (1 week-several mg/kg/day (Occupational) study-Rabbit
months) LOC for MOE = 100 LOAEL = 525 mg/kg/day
Dermal (occupational/residential).... (Residential). based on decreased
body weight gain in
females
----------------------------------------------------------------------------------------------------------------
Short-term (1 to 7 days) and Inhalation (or oral) LOC for MOE = 100 Developmental toxicity
Intermediate-term (1 week-several study NOAEL= 150 mg/kg/ (Occupational) study-Rabbit
months) day (inhalation LOC for MOE = 100 Developmental LOAEL =
Inhalation (occupational/residential) absorption rate = (Residential). 300 mg/kg/day based on
100%) increased post-
implantation loss
Maternal LOAEL = 300 mg/
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
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.499) for the residues of propamocarb
hydrochloride, in or on potatoes. Time-limited tolerances for
inadvertent residues have been established in or on wheat and wheat by-
products. In addition, time-limited tolerances for residues in or on
tomato and tomato, paste, and puree have also been established at
levels lower than those described in this document. Risk assessments
were conducted by EPA to assess dietary exposures from propamocarb
hydrochloride in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
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: Acute analyses were performed for females 13-50
years old and the general U.S. population (including infants and
children); 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\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments: A
chronic

[[Page 48580]]

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 propamocarb hydrochloride in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of propamocarb hydrochloride.
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 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 propamocarb hydrochloride,
they are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of propamocarb
hydrochloride for acute exposures are estimated to be 1,030 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).
Propamocarb hydrochloride 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 propamocarb hydrochloride 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,
propamocarb hydrochloride does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that propamocarb hydrochloride
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. Safety factor for infants and children.--i. In general. FFDCA
section

[[Page 48581]]

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 milligrams
active ingredient/kilogram/day (mg a.i./kg/day) is based on mortality.
The maternal NOAEL is 221 mg a.i./kg/day. The developmental LOAEL of
740 mg a.i./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 a.i./kg/day. In the rabbit, developmental
effects occur only at doses where there is maternal toxicity. EPA
believes that the post implantation loss is actually due to the
increased abortions in the does. The maternal LOAEL of 300 mg a.i./kg/
day is based on decreased body weight gains for GD 6-18 and possible
increased abortions. The maternal NOAEL is 150 mg a.i./kg/day. The
developmental LOAEL of 300 mg a.i./kg/day is based on increased post-
implantation loss. The developmental NOAEL is 150 mg a.i./kg/day. In
the reproduction toxicity study, offspring effects only occurred at
levels resulting in maternal toxicity. The LOAEL for systemic/parental
toxicity is 8,000 ppm based on decreased body weights of F₀
and F₁ adults. The systemic/parental toxicity NOAEL is 1,250
ppm.
2. Conclusion. There is a complete toxicity data base for
propamocarb hydrochloride and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. 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 data base 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.

D. 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 + chronic non-dietary, non-occupational 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, EPA concludes with reasonable certainty that
exposures to propamocarb hydrochloride in drinking water (when
considered along with other sources of exposure for which EPA has
reliable data) would not result in unacceptable levels of aggregate
human health risk at this time. Because EPA considers the aggregate
risk resulting from multiple exposure pathways associated with a
pesticide's uses, levels of comparison in drinking water may vary as
those uses change. If new uses are added in the future, EPA will
reassess the potential impacts of propamocarb hydrochloride on drinking
water as a part of the aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
propamocarb hydrochloride will occupy 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, despite the potential for acute dietary
exposure to propamocarb hydrochloride in drinking water, after
calculating DWLOCs and comparing them to conservative model EECs of
propamocarb hydrochloride in surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 2.0 3 1,030 2.08 19,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 2.0 3 1,030 2.08 19,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 1.5 1 1,030 2.08 45,000
----------------------------------------------------------------------------------------------------------------
General U.S. population 2.0 1 1,030 2.08 69,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
propamocarb hydrochloride from food will utilize 7% of the cPAD for the
U.S. population; 9%

[[Page 48582]]

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 propamocarb hydrochloride that result in chronic
residential exposure to propamocarb hydrochloride. Based on the use
pattern, chronic residential exposure to residues of propamocarb
hydrochloride is not expected. In addition, despite the potential for
chronic dietary exposure to propamocarb hydrochloride in drinking
water, after calculating DWLOCs and comparing them to conservative
model EECs of propamocarb hydrochloride in surface and ground water,
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
as shown in the following Table 3:

Table 3.-Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Propamocarb Hydrochloride
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.12 7 340 2.08 3,900
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year old) 0.12 9 340 2.08 1,100
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.12 23 340 2.08 920
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.12 5 340 2.08 3,400
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Propamocarb
hydrochloride is currently registered for use(s) that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for propamocarb hydrochloride.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 950, 1,100 and 1,100 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 pounds (lb) active ingredient (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 propamocarb hydrochloride
in ground water 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 4:

Table 4.-Aggregate Risk Assessment for Short-Term Exposure to Propamocarb Hydrochloride
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 950 100 1,030 2.08 40,000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 1,100 100 1,030 2.08 63,000
----------------------------------------------------------------------------------------------------------------
General U.S. population 1,100 100 1,030 2.08 63,000
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational 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

[[Page 48583]]

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 propamocarb hydrochloride residues.

V. Other Considerations

A. Analytical Enforcement Methodology

A gas chromatography method was utilized 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 to support the time-limited tolerances associated
with this action. 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.
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.
The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

A CODEX MRL of 1 mg/kg has been established for residues of
propamocarb per se in/on tomatoes. The use pattern used for determining
the CODEX MRL differs from that in this section 18 exemption (maximum
use rate overseas is 3.2 lb a.i./acre per application, the maximum use
rate in the United States is 0.9 lb a.i./acre. No Canadian or Mexican
residue limits have been established.

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.

VI. Conclusion

Therefore, the tolerances are revised for residues of propamocarb
hydrochloride, propyl [3-(dimethylamino)propyl]carbamate
monohydrochloride, in or on tomato and tomato, paste at 2 and 5 ppm,
respectively. In addition, the tolerance for residues of propamocarb
hydrochloride in or on tomato puree is hereby revoked.

VII. 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-301162 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
20, 2001.
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.

[[Page 48584]]

3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-301162, 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 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).

VIII. Regulatory Assessment Requirements

This final rule revises and revokes time-limited tolerances under
FFDCA section 408. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerances 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).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.''

IX. 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 10, 2001.
Peter Caulkins,
Acting Director, Registration Division, 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), 346(a) and 371.

[[Page 48585]]

2. In Sec. 180.499, the table in paragraph (b) is amended by
revising the entry for Tomato, paste, by removing the entries for
Tomato, puree and Tomatoes, and by adding an entry for Tomato to read
as follows:

Sec. 180.499 Propamocarb hydrochloride; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
* * * * *
Tomato 2.0 12/31/03
Tomato, paste 5.0 12/31/03
* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-23608 Filed 9-20-01; 8:45 am]
BILLING CODE 6560-50-S

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Propamocarb Hydrochloride; Pesticide Tolerances for Emergency Exemptions

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