United States Prevention, Pesticides EPA-738-F-95-031
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
R.E.D. FACTS
Propamocarb
Hydrochloride
PGStJCJdG All pesticides sold or distributed in the United States must be
R0TGClistration registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984 be reregistered to ensure that
they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
mitigation measures or any regulatory controls needed to effectively manage
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 3124, propamocarb hydrochloride.
USG ProfilG Propamocarb hydrochloride is a fungicide used to control Pythium
spp. and Phytophthora spp. on turf, outdoor woody and herbaceous
ornamentals. The fungicide is formulated as a soluble concentrate/liquid.
Propamocarb hydrochloride is applied as a bare-root dip, drench and foliar
application. Propamocarb hydrochloride cannot be applied through any type
of irrigation system. For terrestrial uses, it cannot be applied directly to
water or to areas where water is present or to intertidal areas below the
mean high water mark. Propamocarb hydrochloride treated clippings
cannot be fed to animals or animals allowed to graze in treated areas.
Finally, propamocarb hydrochloride cannot be used in California or on sod
farms in Arizona.
Almost all usage of propamocarb hydrochloride in the United States is
concentrated on golf courses with approximately 100,000 to 200,000 pounds
of active ingredient applied per year.
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Regulatory
History
Propamocarb hydrochloride was first registered as a pesticide in the
U.S. in 1984. Currently, one product, Banol (EPA Reg. No. 45639-88), is
registered. Three Data Call-In notices (DCIs) have been issued for
propamocarb hydrochloride. The first DCI was issued on September 30,
1991, under Phase IV of the reregistration program. It required submission
of acute avian, invertebrate toxicity, hydrolysis, photodegradation, and
neurotoxicity data due to associated use patterns and the fungicide being a
carbamate. On March 10, 1995, a second DCI was issued for propamocarb
hydrochloride and other pesticide active ingredients registered for
applications on residential turf. Under this DCI, submission of foliar
residue dissipation, post-application dermal passive exposure and post-
application inhalation dosimetry exposure data were required. The post-
application dermal passive exposure and post-application inhalation
dosimetry exposure studies may be waived pending completion of the
database on agricultural and residential post-application/reentry exposure
currently being developed by the Agricultural Reentry Task Force and
Outdoor Exposure Task Force, provided the registrant is a member of both
Task Forces. A third DCI was issued on October 11, 1995, requiring avian
reproduction, fish life cycle, aquatic plant growth, and seedling
germination/seedling emergence studies due to use patterns associated with
the fungicide. In addition, foliar residue dissipation, dermal passive
dosimetry exposure, inhalation passive dosimetry exposure, honey bee acute
contact, estimation of dermal exposure and estimation of inhalation exposure
data were required for uses that were not addressed in the March 10, 1995,
DCI.
Human Health
Assessment
Toxicity
In studies using mammalian laboratory animals, propamocarb
hydrochloride generally has been shown to be practically non-toxic to
slightly toxic in terms of acute toxicity. Propamocarb hydrochloride was
classified as slightly toxic for oral, dermal and eye irritation in terms of
acute toxicity and practically non-toxic in terms of acute inhalation and
dermal irritation. The fungicide was also observed not to be a dermal
sensitizer. In terms of systemic effects, a NOEL of 150 mg/kg/day was
established.
Maternal and developmental toxicity studies were conducted.
However, due to the high dose at which fetal toxicity was observed, no
definite conclusion can be made regarding developmental toxicity.
No evidence of mutagenicity or neurotoxicity was associated with the
fungicide. Propamocarb hydrochloride is classified a Group D carcinogen,
not classifiable as to human carcinogenicity. This classification is used for
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materials with inadequate human and animal evidence of carcinogenicity due
to a lack adequate data, as in the case of propamocarb hydrochloride.
The reference dose (RfD) for propamocarb hydrochloride was
calculated to be 0.11 mg/kg/day. The RfD is an estimate of the acceptable
daily intake of a pesticide taking into account uncertainty factors of the
estimation. This RfD was based on a LOEL of 1000 ppm (33.3 mg/kg/day)
of a 2-year feeding study in beagle dogs.
Dietary Exposure
As uses of propamocarb hydrochloride are currently limited to
applications to ornamentals and turf, no dietary exposure is expected.
Occupational and Residential Exposure
There is potential exposure to occupational handlers during
mixing/loading/application of propamocarb hydrochloride products using
groundboom sprayers, high volume/low-pressure sprayers, low pressure
handwand sprayers, high pressure handwand sprayers, backpack sprayers,
hose-end sprayers, hand-held sprinkler cans, and transplant dip by hand.
There is also potential exposure to persons entering treated sites after
application is complete.
Human Risk Assessment
The Agency is concerned that the risks from post-application
exposures to treated turf grown for sod and to ornamentals (greenhouse and
nursery) grown for sale may be unacceptable based on the risk endpoints
identified above for entry immediately following applications. However, no
estimate can be made for the high volume/low pressure sprayer (commercial
turfgrass sprayer) use and the hand-dip use due to the absence of sufficient
exposure data at this time.
Environmental
Assessment Environmental Fate
Propamocarb hydrochloride is relatively non-persistent, is stable to
photodegradation in water, is photodegradable on soil with a half-life of 35
days, degrades fairly rapidly by microbial-mediated metabolism, is
persistent to anaerobic metabolism, dissipates rapidly under field conditions,
has limited hydrolytic potential and bioconcentration in fish, and has
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variable mobility from mobile to relatively immobile. Volatilization is not
considered a probable route of dissipation. Abiotic hydrolysis is not a
significant dissipation process. However, base-catalyzed hydrolysis may
occur at extremely slow rates.
Ecological Effects
Propamocarb hydrochloride was observed to be practically nontoxic in
terms of avian acute oral toxicity, avian subacute dietary toxicity,
freshwater fish acute toxicity, freshwater invertebrate acute toxicity, and
slightly to practically non-toxic in terms of mammalian acute oral toxicity.
Estuarine/marine acute toxicity ranged from practically non-toxic for mysid
shrimp and sheepshead minnow to slightly toxic for eastern oyster. No
estimate can be provided in terms of terrestrial plant or chronic avian
toxicity due to the absence of sufficient data at this time.
Environmental Risk Assessment
The LOCs for acute and chronic toxicity for freshwater fish are not
exceeded for any current use nor for freshwater invertebrates. The use of
propamocarb hydrochloride on field-grown ornamentals exceeds the Level
of Concern (LOG) for birds, mammals and estuarine and marine mammals.
In addition, the lack of data on chronic freshwater fish and honey-bee
exposure does not allow the Agency to conduct the corresponding risk
assessments. However, the registrant has proposed to amend their label to
eliminate the field-grown ornamental use. Thus, the Agency believes this
action will mitigate the LOG exceedance for birds, mammals and estuarine
and marine mammals plus requirements for a chronic freshwater fish and
honey-bee exposure studies.
As mentioned above, the Agency has required avian reproduction to
evaluate chronic risks to birds. Additional data are also being required
concerning terrestrial and semi-aquatic and aquatic plant toxicity to perform
the corresponding plant risk assessments.
Risk Mitigation To lessen the risks of human exposure posed by propamocarb
hydrochloride, EPA is requiring the following risk mitigation measures:
o For uses within the scope of the WPS, the Agency is requiring persons
entering treated areas before a 24-hour restricted-entry interval has expired
to wear early-entry personal protective equipment consisting of coveralls
over short-sleeve shirt and short pants, chemical-resistant footwear plus
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socks, chemical resistant headgear for overhead exposures, and chemical-
resistant gloves.
o For occupational uses outside the scope of the WPS, EPA is restricting
entry into treated areas until sprays have dried.
Additional Data EPA has required the following additional generic studies for
propamocarb hydrochloride to confirm its regulatory assessments and
conclusions:
o confirmatory data for post-application exposures for uses on turfgrass at
residential sites and at sod-farm sites and for uses on ornamentals in
greenhouses.
o exposure data for handler activities associated with high volume/low
pressure spray and hand-dipping applications.
o chronic avian and aquatic invertebrate data and additional terrestrial plant
phytotoxicity data.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Product LabGling All propamocarb hydrochloride end-use products must comply with
ChanQGS Required EPA's current pesticide product labeling requirements and with the
following.
To remain in compliance with FIFRA, manufacturing use-product
(MP) labeling must be revised to comply with all current EPA regulations,
PR Notices and applicable policies. The MP labeling must bear the
following statement under Directions For Use:
" Only for formulation into a fungicide for the following use (s) :
ornamental sod farms (turf) , ornamental lawns and turf, and cutting
beds and seedling areas for ornamental herbaceous plants, ornamental
woody shrubs and vines. "
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the
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reformulation of the product for a specific use or all additional uses
supported by a formulator or user group:
(a) "This product may be used to formulate products for
specific use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S.EPA
submission requirements regarding the support of such
use (s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S.
EPA submission requirements regarding the support of
such use (s)."
Personal Protective Equipment (PPE) Requirements for Pesticide
Handlers
Sole active ingredient end-use products that contain propamocarb
hydrochloride must be revised to adopt the handler PPE requirements set
forth in this section. Any conflicting PPE requirements on the current
labeling must be removed.
Multiple active ingredient end-use products that contain propamocarb
hydrochloride must compare the handler personal protective equipment
requirements set forth in this section to the PPE requirements on the current
labeling and retain the more protective. For guidance on which PPE is
considered more protective, refer to PR Notice 93-7.
Products Intended for Occupational Use
Minimum PPE requirements (WPS and nonWPS uses): The
minimum PPE for all WPS and nonWPS uses for which groundboom
applications can be employed is:
"For groundboom applications, mixers and loaders must
wear long-sleeved shirt and long pants, chemical-resistant
gloves, and shoes plus socks".
PPE requirements for all other WPS and nonWPS uses: The
PPE for all other WPS and nonWPS uses will be based on the
acute toxicity of the end-use product. This PPE must be
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compared to the minimum (baseline) (PPE). The more
protective PPE must be placed on the product labeling. For
guidance on which PPE is considered more protective, see PR
Notice 93-7.
Placement in labeling: The PPE must be placed on the end-use
product labeling in the location specified in PR Notice 93-7 and
the format and language of the PPE requirements must be the
same as is specified in PR Notice 93-7.
Reentry Requirements
Reentry Interval (REI for WPS uses): A 24-hour REI is
required for uses within the scope of the WPS (see PR Notice
93-7) on all end-use products (see tests in PR Notices 93-7 and
93-11). This REI must be inserted into the standardized REI
statement required by Supplement Three of PR Notice 93-7.
Early reentry PPE requirements: The PPE label language
required for early entry into WPS treated sites is:
"For early entry, wear coveralls over short-sleeve shirt and
short pants, chemical-resistant gloves, chemical-resistant
footwear plus socks, and chemical-resistant headgear for
overhead exposures."
WPS Notification Statement (WPS uses): The following
statement must be added to all end-use product labeling that
contain directions for one or more WPS uses:
"Notify workers of the application by warning them orally and
by posting warning signs at entrances to treated areas."
Placement in labeling: The REI must be inserted into the
standardized REI statement required by Supplement Three of PR
Notice 93-7. The PPE required for early entry must be inserted
into the standardized early entry PPE statement required by
Supplement Three of PR Notice 93-7. The double notification
statement must be inserted into the Agricultural Use
Requirements box in the location required by Supplement Three
of PR Notice 93-7.
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Entry restrictions for NonWPS uses: The Agency is
establishing the following entry restrictions for all nonWPS
occupational uses of propamocarb hydrochloride end-use
products:
"Do not enter or allow others to enter the treated area until
sprays have dried."
Placement in labeling:
If WPS uses are also on label, then follow the instructions in PR
Notice 93-7 for establishing a Non-Agricultural Use
Requirements box and place the appropriate nonWPS entry
restriction in that box. If no WPS uses are on label, then add
the appropriate nonWPS entry restriction to the labels of all end-
use products, except products primarily intended for homeowner
use, in a section in the Directions For Use with the heading:
"Entry Restrictions:"
Engineering controls
The following engineering control statement is required on
product labeling:
"When handlers use closed systems, enclosed cabs, or aircraft in
a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240(d) (4-6), the handler PPE requirements may be reduced
or modified as specified in the WPS."
Application restrictions
These additional use restrictions are required for
propamocarb hydrochloride labels:
"Do not apply this product in a way that will contact workers,
other people or pets, either directly or from drift. Keep people
and pets out of the area during application. Only protected
handlers may be in the area during application"
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"Do not apply more than a total of 12 fl. oz. (equivalent to 0.57
Ib/ai) of propamocarb hydrochloride per 1000 sq. ft. (25 Ibs
ai/acre/year) of turfgrass per year."
"Do not use for field-grown ornamentals."
User safety requirements
Add the following user safety requirement to the end-use
product labeling ONLY if PPE (other than long-sleeve shirt,
long pants, shoes, and socks) are required on the label due to the
acute toxicity of the end-use product:
"Follow manufacturer's instructions for cleaning/maintaining
protective clothing and equipment. If there are no such
instructions for washables, use detergent and hot water. Keep
and wash protective clothing and equipment separate from other
laundry."
User safety recommendations
"Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if
pesticide gets inside. Then wash thoroughly and put
on clean clothing."
Add the following user safety recommendation to the end-use
product labeling ONLY if PPE (other than long-sleeve shirt,
long pants, shoes, and socks) are required on the label due to the
acute toxicity of the end-use product:
"Users should remove protective clothing and equipment immediately afte
handling this product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly and change into clean clothing."
Regulatory Conclusion
The Agency has determined that all uses of propamocarb
hydrochloride, with the exception of the use on field-grown ornamental
plants plus the high volume/low pressure and hand dipping application
scenarios, are eligible for reregistration. A decision on the field-grown
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For More
Information
ornamentals use plus the high volume/low pressure and hand dipping
application scenarios cannot be made at this time because insufficient data
are available to conduct a risk assessment for chronic effects to the
environment or to characterize the risk to handlers of propamocarb
hydrochloride via high volume/low pressure and hand-dip uses. The
registrant has proposed voluntarily deleting the use for field-grown
ornamentals from the product registration and is amending their label to
reduce the maximum application rate for turf.
These products will be reregistered once the required confirmatory
generic data, product specific data, CSFs, and revised labeling are received
and accepted by EPA. Products which contain active ingredients in addition
to propamocarb hydrochloride will be reregistered when all of their other
active ingredients also are eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for propamocarb hydrochloride during a 60-day
time period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED document or to submit
written comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA. GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the [name] RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the propamocarb hydrochloride RED, or reregistration of the individual
product containing propamocarb hydrochloride, please contact the Special
Review and Reregistration Division (7508W), OPP, US EPA, Washington,
DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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