&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-95-036
September 1995
Re registration
Eligibility Decision (RED)
Propamocarb
Hydrochloride
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
APR 3 J996
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case propamocarb
hydrochloride which includes the active ingredient propamocarb hydrochloride. The enclosed
Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base
of these chemicals, its conclusions of the potential human health and environmental risks of
the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Edward Setren at (703) 308-8166. Address any questions on required generic data to the
Special Review and Reregistration Division representative Paul Lewis at (703) 308-8018.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATIQN ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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United States,
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-031
September 1995
R.E.D. FACTS
Propamocarb
Hydrochloride
Pesticide AH pesticides, sold or distributed in the.United States must be
Rereqistration 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.
Use Profile
Propamocarb hydrochloride is a fungicide used to control Pythium
spp. and Phytophihora 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 Propamocarb hydrochloride was first registered as a pesticide in the
History 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 carcinqgeniqity due
to a lack adequate data, as in the case of propamoearb 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.
- "v " - _•' . • " ,
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.
Risk Mitigation
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.
To lessen the risks of human exposure posed by propamocarb
hydrochloride, EPA is requiring the following risk mitigation measures:
° 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
Required 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 Labeling All propamocarb hydrochloride end-use products must comply with
Changes 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 aft
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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REREGISTRATION ELIGIBILITY DECISION
PROPAMOCARB HYDROCHLORIDE
LIST C
CASE 3124
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
PROPAMOCARB HYDROCHLORIDE REREGISTRATION ELIGIBILITY DECISION
TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 4
m. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
•1. Toxicology Assessment 5
a. Acute Toxicity 6
b. Subchronic Toxicity 6
c. Chronic Toxicity and Carcinogenicity
7
d. Carcinogenicity Classification 8
e. Developmental Toxicity 8
f. Mutagenicity 9
g. Neurotoxicity . . . 9
h. Toxicity Endpoints of Concern .... 10
-------2. Exposure Assessment 11
a. Dietary Exposure 11
b. Occupational Exposure 11
3. Risk Assessment 14
a. Dietary 14
b. Occupational and Residential 14
C. Environmental Assessment • 17
1. Ecological Toxicity Data 17
a. Toxicity to Terrestrial Animals .... 18
b. Toxicity to Aquatic Animals 19
c. Toxicity to Plants 22
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2. Environmental Fate 23
a. Environmental Fate Summary .... 24
b. Environmental Fate and Transport . 25
c. Water Resources 31
3. Exposure and Risk Characterization 31
a. Ecological Exposure and Risk
Characterization 31
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 40
A. Determination of Eligibility 40
1. Uses Eligible or Not Eligible at This Time 41
B. Regulatory Position 41
1. Use Deletion; Application Rate Reduction 41
2. Generic Data Gaps 42
3. Endangered Species 42
4. Labeling Rationale 43
V. ACTIONS REQUIRED OF REGISTRANTS 47
A. Manufacturing-Use Products 47
1- Additional Generic Data Requirements ... 47
2. Labeling Requirements for Manufactured Use Products
48
B. End-Use Products 48
1. Additional Product-Specific Data Requirements . . 48
2- Labeling Requirements for End-Use Products
48
C. Existing Stocks 52
VI. APPENDICES 53
APPENDIX A. Table of Use Patterns Subject to Reregistration ... 54
APPENDIX B. Table of the Generic Data Requirements and Studies
Used to Make the Reregistration Decision 57
APPENDIX C. Citations Considered to be Part of the Data Base
Supporting the Reregistration of Propamocarb Hydrochloride
64
APPENDIX D. Product Specific Data Call-in 79
Attachment 1. Chemical Status Sheets 91
Attachment 2. Product Specific Data Call-in Response Forms
(Form A inserts) Plus Instructions 94
Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts)
and Instructions 99
Attachment 4. EPA Batching of End-Use Products for Meeting
Data Requirements for Reregistration . . . 102
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Attachment
Attachment
5. List of All Registrants Sent This Data Call-In
(insert) Notice . 103
6. Cost Share, Data Compensation Forms,
Confidential Statement of Formula Form and
Instructions 104
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PROPAMOCARB HYDROCHLORIDE REREGISTRATION ELIGIBILITY DECISION
TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Gail Tomimatsu
Steve Jarboe
Jihad Alsadek
Harry Gaede
Environmental Fate and Effects Division
Harry Craven
William R. Effland
Mary Powell
Linda Kutney
Health Effects Division
Alberto Protzel
Winston Dang
Mary Clock
Olga Odiott
Registration Division
Sidney Jackson
Al Smith
Special Review and Reregistration Division
Paul Lewis
Mark Wilhite
Kathleen Depukat
Office of Enforcement and Compliance:
Beverly Updike
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Economic Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Toxicology Branch II
Occupational and Residential Exposure Branch
Risk Characterization and Analysis Branch
Rish Characterization and Analysis Branch
Fungicide-Herbicide Branch, Team 21
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES , Dietary Risk Evaluation System ;
D WEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur. • . • -
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern . .. •
LOD Limit of Detection . . .
LOEL Lowest Observed Effect Level .
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
jig/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
As required under the Federal Insecticide, Fungicide and Rodenticide Act, as amended in
1988, the U.S. Environmental Protection Agency (hereafter referred to as the "Agency" or
"EPA") has completed its reregistration eligibility decision (RED) for the pesticide active
ingredient propamocarb hydrochloride. This decision includes a comprehensive reassessment of
the required target data base and use patterns of the currently registered products. The Agency
compared its risk assessment to current science and regulatory policies. Where appropriate, it has
imposed changes to the terms for continued registration in order to reduce human health and
environmental risks.
The Agency has determined that all uses of propamocarb hydrochloride, with the exception
of the field-grown ornamental use plus the high volume/low pressure and hand dipping application
scenarios, are eligible for reregistration. A decision on the field-grown 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 amending their label to reduce the
maximum application rate for turf.
Because the Agency has identified lexicological endpoints for short and intermediate term
exposure, it is imposing reentry restrictions of 24 hours for uses within the scope of the Worker
Protection Standard (WPS) for agricultural pesticides or until after sprays have dried for other
uses. Personal protective equipment (PPE) are being required for mixers and loaders for ground
boom applications and for early reentry to certain sites. The Agency also is requiring exposure-
related data to confirm the exposure assessments and adequacies of the PPE and reentry
restrictions, as well as, confirmatory data for the assessment of the ecotoxicity and environmental
fate of propamocarb hydrochloride.
Uses
Propamocarb hydrochloride is used to control the plant disease "damping-off" and has
fungicidal activity against Pythium spp. and Phytophthora spp. Current use sites include
ornamental lawns and turf, ornamental sod farms (turf), ornamental herbaceous plants, ornamental
woody shrubs and vines.
Human Health Risk
From its review of the toxicology data, the Agency concluded that the technical grade
active propamocarb hydrochloride is slightly toxic to practically non-toxtc when administrated by
inhalation, dermal or oral routes of acute exposure. In addition, the chemical was determined not
to be a dermal sensitizer.
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A battery of mutagenicity studies were negative for mutagenic effects. Propamocarb
hydrochloride is classified a Group D carcinogen, that is not classifiable as to human
carcinogenicity.
The lexicological endpoint selected by the Agency for both the short-term and
intermediate-term occupational/residential exposure is a NOEL of 150 mg/kg/day. This is the
maternal NOEL in rabbits for reduced body weight gain during days 6-18 of gestation and the
developmental NOEL for increased post-implantation loss as demonstrated in a developmental
toxicology study. It is also the NOEL from a 21-day dermal toxicology study with rabbits in
which there was decreased body weight gain in females.
Based on the fact that the NOEL for systemic effects was 150 mg/kg/day by both the oral
and the dermal routes and in the absence of dermal absorption measurements, the Agency assumes
100% dermal absorption for its occupational/residential exposure assessments.
The Agency has determined that the Reference Dose (RfD) for propamocarb hydrochloride
should be 0.11 mg/kg/day based on a 2-year feeding study in dogs. This decision is based on the
threshold LOEL of 1000 ppm (33.3 mg/kg/day in males and females), the lowest dose tested in
that study. Body weight gain depression, decreased food efficiency and gastritis were observed
in males of this dose group. The Agency applied an uncertainty factor (UF) of 100 to account
for both interspecies extrapolation and intraspecies variability. An additional UF of 3 was used
to account for the lack of a NOEL. The Agency believes that the NOEL is slightly lower than
the lowest dose tested as explained in the summary of the 2-year chronic feeding study with dogs.
For short and intermediate term occupational exposures, the Agency calculated margins
of exposure (MOE = NOEL/exposure) for propamocarb hydrochloride product handlers
(mixer/loaders/applicators). These indicated acceptable margins of exposure (MOEs^ 100),
where MOEs could be calculated. However, the Agency is requiring exposure data for handler
activities associated with high volume/low pressure spray and hand-dipping applications since
exposure data are unavailable for these use practices. For uses within the scope of the WPS, the
Agency is also 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 socks, chemical resistant headgear
for overhead exposures, and chemical-resistant gloves. For occupational uses outside the scope
of the WPS, EPA is restricting entry into treated areas until sprays have dried. In addition, the
Agency is requiring confirmatory post-application exposure data for uses on turfgrass at
residential sites and at sod-farm sites and for uses on ornamentals in greenhouses. The requested
information has been required through issuance of a Data-Call In (DCI) prior to publication of
this document.
Environmental Risk Assessment
Adequate data are available to assess the acute ecological hazard of propamocarb
hydrochloride, but the Agency does not have sufficient data to assess chronic avian and aquatic
VI
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invertebrate hazards or adequately characterize the risk to terrestrial or aquatic plant growth and
terrestrial plant emergence. Available data indicate propamocarb hydrochloride is slightly toxic
to practically nontoxic to birds, small mammals, freshwater and estuarine/marine fish and
invertebrates. Based upon the developmental and reproductive effects demonstrated in rats
(including fetal death at low doses in developmental lexicological studies), chronic effects in avian
organisms may be expected. From limited phytotoxicity data, the fungicide was observed to be
toxic to plants. The Agency also has concerns that the use oil field-grown ornamentals would
exceed the acute Levels of Concern (LOG) for non-endangered and endangered birds, mammals,
estuarine and marine animals. However, the registrant has proposed to amend their propamocarb
hydrochloride product registration to eliminate the field-grown ornamental use from the label,
thereby mitigating these concerns. Because of these remaining ecotoxicological concerns and data
gaps, the Agency has required, through a DCI issued prior to publication of this document,
submission of chronic avian and aquatic invertebrate data and additional terrestrial plant
phytotoxicity data to confirm its conclusions about propamocarb hydrochloride's risks to the
environment.
Product Reregistration • ' - , :
Before reregistering the products containing propamocarb hydrochloride, the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration.and acute toxicity testing. After reviewing these
data and any revised labels and finding them acceptable in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister a product. Those products which contain other active
' ingredients will be eligible for reregistration only when the other active ingredients are determined
to be eligible for reregistration.
Vll
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L
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of propamocarb hydrochloride. The document consists of six sections. Section
I is the introduction. Section n describes propamocarb hydrochloride, its uses, data requirements
and regulatory history. Section HI discusses the human health and environmental assessment based
on the data available to the Agency. Section IV presents the reregistration decision for
propamocarb hydrochloride. Section V discusses the reregistration requirements for propamocarb
hydrochloride. Finally, Section VI is the Appendices which support this Reregistration Eligibility
Decision. Additional details concerning the Agency's review of applicable data are available on
request.
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CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name:
propamocarb hydrochloride
Chemical Name:
propyl[3-(dimethylamino)propyl]carbamate
monohydrochloride
• CAS Registry Number: 25606-41-1
OPP Chemical Code:
119302
Empirical Formula:
C9H21C1N2O2
Basic Manufacturer:
AgrEvo
B. Use Profile
The following is information on the currently registered uses of propamocarb
hydrochloride with an overview of use sites and application methods. A detailed table of
these uses is provided in Appendix A. Please note that recently proposed changes are not
presented here.
Type of Pesticide: fungicide
Use Sites:
terrestrial nonfood crop: ornamental lawns and turf, ornamental sod farms (turf)
terrestrial + greenhouse non-food crop: ornamental herbaceous plants, ornamental
woody shrubs and vines, cutting beds, and seedling areas
Note: the registrant has applied to eliminate the field-grown ornamental use. This
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will result in the terrestrial ornamental herbaceous plants, terrestrial ornamental
woody shrubs and vines, terrestrial cutting beds, and terrestrial seedling areas uses
being deleted.
Target Pests: Pythium spp. and Phytophthora spp..
Formulation Types Registered: soluble concentrate/liquid of 66.5% of
propamocarb hydrochloride
Method, Rate and Timing of Application:
herbaceous ornamentals - at potted stage, dip bare-rooted plants at 0.01 Ib
ai/gal. After potted stage or at containerized stage, drench at 0.0003 Ib
ai/4-in. pot or 0.015 Ib ai/10 sq. ft., respectively. At seed bed or
; transplant stage, apply at 0.01 to 0.02 Ib ai/10 sq, ft. Apply at weekly
intervals.
woody ornamentals - drench at 0.12 Ib ai/10 gallons water. Repeat
applications at three to four month intervals.
turf - as a preventive treatment, apply O.QfS.to 0.09.Ib ai/1000 sq. ft. As
a curative treatment, apply 0.14 to 0.19 Ib ai per 1000 sq. ft. Applications
are made immediately after germination or at 7 to 21 day intervals. The
lower and higher rates are used for, the shorter and longer application
intervals, respectively.
Use Practice Limitations:
' ' ' - .; ' 1
Do not apply through any type of irrigation system. For terrestrial uses,
do not apply directly to water or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not feed treated clippings to
animals or graze treated areas. Do not use in California or on sod farms in
Arizona. .
C. Estimated Usage of Pesticide
Almost all usage of propamocarb hydrochloride in the United States is concentrated
on golf courses with approximately 100,000 to 200,000 Ib/ai applied per year. This
estimate is derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual
fluctuations in use patterns as well as the variability in using data from various information
sources.
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D. Data Requirements
The Agency issued three Data Call-Ins (DCIs) to registrants for propamocarb
hydrochloride products. 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.
E. Regulatory History
Pesticide products containing propamocarb hydrochloride were first registered in
the United States to Nor-Am Chemical Company in 1984 for use as a fungicide.
Currently, one product, Banol, (EPA 45639-88) is registered. The formulation of the
product is an aqueous solution at 66.5% A.I. Appendix B includes all data requirements
identified by the Agency for currently registered uses needed to support reregistration.
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Chemical name: propyl[3-(dimethylamino)propyl]carbamate
monohydrochloride
Common name: propamocarb hydrochloride
Chemical formula: C9H21C1N2O2
Molecular weight: 224.73
Color: colorless to yellow
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Physical state:
Odor:
Melting point:
Density:
.Solubility:,.
Solubility in
water:,
Vapor pressure:
pH:
Stability:
Oxidizing or
reducing action:
Storage stability:
Viscosity:
Corrosion
characteristics:
pure active ingredient - solid
technical grade active ingredient - liquid
odorless
64.2° C
. 1.083 g/mL
Solvent
Hexane
Methanol
Dichloromethane
Toluene
Acetone
Ethyl acetate
g/L
<0.01
>656
>256
0.14
560.3
4.34
>700g/L
8 x 10'5 Pa (Pascals) at 25°C
4.70
stable at room and elevated temperatures (30 to 150° C)
oxidizing agent
stable stored below 28° C for > 11 years
34.23 mpa at 20° C
corrosive to iron, copper and brass
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for propamocarb hydrochlbride adequately
characterizes the potential toxicological effects from the active ingredient as it
relates to the current registered use patterns. The Agency's assessment of the
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relevant studies are discussed and summarized below.
a. Acute Toxicity
A variety of acute toxicity tests have been performed with
propamocarb hydrochloride (as 66.5% - 70.0% aqueous solutions). The
acute toxicity values for propamocarb hydrochloride are summarized in
Table 1 below.
Table 1; Acute Toxicity
Test
Oral LD50 - rat
Dermal LD50 - rat
Acute inhalation LC30 - rat
Eye irritation - rabbit *
Dermal irritation - rabbit *
Dermal sensitization -
guinea pig *
MRID number
41278115
41278116
93193044
41278117
41278118
00083808
Results
2900 mg/kg (M); 2000 mg/kg
(F)
> 3000 mg/kg
> 7.9 mg/1
Irritation cleared by 72 hours
No erythema after 24 hours
Non-sensitizer
Category
III
III
IV
III
IV
Not applicable
* This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For propamocarb
hydrochloride, data have been generated on the TGAI and are presented here for informational purposes.
b. Subchronic Toxicity
A 90-day feeding study was performed in specific pathogen free
albino rats at concentrations of propamocarb hydrochloride of 0, 20, 50,
100 or 500/1000 ppm in the diet (approximately 0, 1, 2.5, 5 or 25/50
mg/kg/day, using a food factor of 0.05) (MRID 00100723). This study by
itself does not satisfy the reregistration requirements for a subchronic study
in rodents. However, the reregistration requirement was satisfied when
this study was considered together with a 2-year feeding carcinogenicity
study in rats (MRID 00101638), as discussed below.
A 90-day feeding study was performed in beagle dogs at
propamocarb hydrochloride concentrations of 0, 50, 100, 500 or
1000/2000 ppm in the diet (approximately 0, 1.25, 2.5, 12.5 or 25/50
mg/kg/day, using a food factor of 0.025). This study was classified as
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invalid (MRID 41278119). As with the rat study above, this study by itself
does not satisfy the reregistration requirement for a subchronic study in
non-rodents. However, .this requirement was .satisfied when this study was
considered together with the 2-year feeding study in dogs (MRID
43044201), as discussed below.
A 21-day dermal toxicity study was performed with propamocarb.
hydrochloride in Sprague Dawley rats at doses 0, 100, 500 or 1000
mg/kg/day, 6 hours/day, 5 days/week over a 21-day period (total of 15
doses), The NOEL was equal to or greater than 1000 mg/kg/day for both
sexes. The LOEL was not defined by this study (MRID 42421201).
A 21-day dermal toxicity study was performed with propamocarb
hydrochloride in New Zealand white rabbits at doses 0, 150, 525 or 1500
mg/kg/day, 6 hours/day, 5 days/week,over a 21-day period (total of 15
doses). The LOEL was 525 mg/kg/day based on dose-related skin
irritation and depressed body weight gain in mid-dose females. The NOEL
was equal or greater than 150 mg/kg/day for both sexes (MRID 00071526).
c. Chronic Toxicity and Carcinogenicity
Chronic toxicity and Carcinogenicity studies are not required for
reregistration of propamocarb hydrochloride due to its status as a non-food
use pesticide. However, the Agency is using the available chronic toxicity
and Carcinogenicity studies of propamocarb hydrochloride in rats and dogs,
summarized below, to supplement the respective subchronic toxicity studies
in rodents and non-rodents.
A 2-year feeding/carcinogenicity study was performed in Sprague-
Dawley caesarean derived rats with propamocarb hydrochloride at
concentrations of 0, 40, 200 or 1000 ppm (0, 1.4, 7.3 or 36.5 mg/kg/day
in males and 0, 1.8, 9.3, or 45.4 mg/kg/day in females). No significant
lexicological effect was observed at me highest dose (1000 ppm). The
study was classified as core supplementary because the dose levels tested
were not high enough for Carcinogenicity testing and data on the stability
of the compound in the test diet were not available for examination.
Although the study was considered by the Agency to be unsatisfactory to
fulfill data requirements for Carcinogenicity testing in rats, the study was
considered to be suitable for satisfying chronic toxicity testing in rats
(MRID 00101638). This study, considered together with the above rat
subchronic study, satisfies the 90-day rodent feeding study requirement.
A 2-year feeding study was performed in beagle dogs with
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propamocarb hydrochloride at concentrations of 0, 1000, 3000 or 10000
ppm (0, 33.3, 103.7, or 356.3 mg/kg/day in males and 0, 33.3, 106.8, or
334.3 mg/kg/day in females). This study defined a LOEL of 1000 ppm
(33.3 mg/kg/day) based on the finding of body weight gain depression,
decreased food efficiency and of focal or multi-focal chronic erosive
gastritis and/or acute erosions in males. No NOEL was defined by this
study. However, the absence of such gastric lesions in the dog subchronic
study (MRID 41278119), indicates that the LOEL of 1000 ppm should be
considered a threshold effect level and the NOEL for the above effects
should be only slightly lower than the threshold level. This study (MRID
43044201), considered together with the above dog subchronic study,
satisfies the 90-day non-rodent feeding study requirement.
d. Carcinogenicity Classification
The Agency has assigned propamocarb hydrochloride a
carcinogenicity classification of Group D, not classifiable as to human
carcinogenicity. This classification is generally used for agents with
inadequate human and animal evidence of carcinogenicity or for which no
adequate data are available, as in the case of propamocarb hydrochloride.
e. Developmental Toxicity
New Zealand white rabbits were given gavage doses of
propamocarb hydrochloride of 0, 15, 45, 150, 300, or 600 mg/kg/day on
GD 6-18. The maternal toxicity NOEL was 150 mg/kg/day and the LOEL
was 300 mg/kg/day, based on decreased body weight gains for GD 6-18.
The developmental toxicity NOEL was 150 mg/kg/day and the LOEL was
300 mg/kg/day based on increased post-implantation loss (early resorptions
and fetal death at 300 mg/kg/day, and early and late resorptions at 600
mg/kg/day). (MRID 93193043 reformat of MRID 00072574).
Wistar rats were given gavage doses of propamocarb hydrochloride
of 0, 74, 221, 740 or 2210 mg/kg/day on gestation days (GD) 6-19. The
maternal toxicity NOEL was 740 mg/kg/day and the LOEL was 2210
mg/kg/day, based on mortality, clinical observations (spastic gait, bloody
snout, bloody vaginal discharge), and decreased body weight gains on GD
.6-20. The developmental toxicity NOEL was 221 mg/kg/day and the
LOEL was 740 mg/kg/day, based on increased GD 20 fetal death and
increased incidence of minor skeletal anomalies (incomplete ossification of
some sternebrae and vertebrae). It is noted that the developmental toxicity
NOEL is less than the maternal toxicity NOEL. Due to the high dose at
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which fetal toxicity was observed, no definite conclusion can be made
regarding developmental toxicity (MRID 93193042 reformat of MRID
00101641). "
f. Mutagenicity
Propamocarb hydrochloride was negative (at concentrations of up
to 5000 /zg/plate) in a Salmonella and E. coli assay for gene mutation.
However, the Agency has classified the test as not acceptable because in the
absence of cytotoxicity and/or mutagenic;activity, analytical verification of
the top dosing solution was not-reported. As submitted, this study (MRID
41278121) does not satisfy gene mutation-ames requirements and
constitutes a data gap for this data requirement. The Agency has required
the registrant to upgrade this study by submitting acceptable verification of
the top dosing solution by October 31, 1995.
" • " ' ' • ff
Propamocarb hydrochloride was negative in two mouse
micronucleus assays (MRIDs 00101642. and 00101643) at doses 5 and 2.5
mg/kg, respectively. The Agency initially classified each study as
unacceptable. However, the Agency has decided that these two studies,
considered together, are upgraded to acceptable.
Propamocarb hydrochloride was negative with (at concentrations of
: up to 1100 /u/ml) and without (at concentrations of up to 4700 A^g/ml)
metabolic activation in an acceptable in vitro mammalian cytogenetics assay
in cultured human lymphocytes (MRID 41278122). The Agency concluded
that mutagenicity data on propamocarb hydrochloride are adequate to
satisfy the requirement for structural chromosome aberrations tests.
Propamocarb hydrochloride was negative in a mitotic gene
. conversion assay with (at concentrations of up to 24.6 mg/ml in a
suspension assay, MRID 41278124) and without (at concentrations of up
to 10 mg/plate in a plate assay, MRID 00101645) metabolic activation
using Saccharomyces cerevisiae strain D4. Additionally, propamocarb
hydrochloride was negative in'a mitotic recombination assay with and
without (at concentrations of up to 10 mg/plate in a plate assay, MRID
00101645) metabolic activation using Saccharomyces cerevisiae strain D5.
When considered together, these studies satisfy the requirement for other
genotoxic effects (e.g., mitotic recombination in eucaryotes).
g. Neurotoxicity
An oral acute neurotoxicity study was performed in Sprague-
Dawley rats at dose levels of 0, 20, 200 or 2000 mg of propamocarb
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hydrochloride/kg. The overall LOEL (combined neurotoxicity/systemic
toxicity) was 2000 mg/kg for both sexes, .based on soiled fur coat and
decreased body weight gain in males and soiled fur coat and decreased
motor activity in females. The overall .NOEL (combined
neurotoxicity/systemic toxicity) was 200 mg/kg in both sexes (MRIDs
43062301 and 43013101).
A 90-day feeding subchronic neurotoxicity study was performed in
Sprague-Dawley rats with propamocarb hydrochloride concentrations of 0,
200, 2000, or 20000 ppm (0, 18.2, 189, or 1858 mg/kg/day in males and
0, 20, 209, or 2089 mg/kg/day in females). Neurobehavioral evaluation
did not reveal any treatment-related functional observational battery
findings or changes in motor activity. Plasma, red blood cells and brain
cholinesterase activities were comparable to control values. There were no
treatment-related gross or neuropathological findings. The overall LOEL
(combined neurotoxicity/systemic toxicity) was 1858 mg/kg/day in males
and 2089 mg/kg/day in females (based on decreased body weights and body
weight gains). The overall NOEL (combined neurotoxicity/systemic
toxicity) was 189 mg/kg/day in males and 209 mg/kg/day in females
(MRIDs 43013102, 43440902, 43440903, and 43440904).
h. Toxicity Endpoints of Concern
The lexicological endpoint selected by the Agency for both the
short-term and intermediate-term occupational/residential exposure is a
NOEL of 150 mg/kg/day. This is the maternal NOEL in New Zealand
white rabbits for reduced body weight gain during days 6-18 of gestation
and the developmental NOEL for increased post-implantation loss as
demonstrated in the developmental toxicology study (MRID 93193043)
summarized above. It is also the NOEL from the 21-day dermal
toxicology study with New Zealand white rabbits (MRID 00071526) in
which decreased body weight gain in females was demonstrated.
Based on the fact that the NOEL for systemic effects was 150
mg/kg/day by both the oral and the dermal routes and in the absence of
dermal absorption measurements, the Agency assumes 100% dermal
absorption for the occupational/residential exposure assessment.
The Agency has determined that the Reference Dose (RfD) for
propamocarb hydrochloride should be 0.11 mg/kg/day based on the 2-year
feeding study in beagle dogs (MRID 43044201), as discussed above. This
decision is based on the threshold LOEL of 1000 ppm (33.3 mg/kg/day in
males and females), the lowest dose tested in that study. Body weight gain
depression, decreased food efficiency and gastritis were observed in males
10
-------
-,-. . . of this dose group. The Agency applied an uncertainty factor (UF) of 100
.to account for both interspecies extrapolation and intraspecies variability.
An additional UF of 3 was used to account for,the lack of a NOEL. The
' Agency believes that the NOEL is slightly lower than the lowest dose tested
as explained in the summary of the 2ryear chronic feeding study with
beagle dogs. ,
RfD = (33.3 mg/kg/day)/(100UF x 3UF) = 0.11 mg/kg/day
. ,.,., The Food and Agriculture Organization/World Health Organization
, ; Joint Committee on Pesticide Residues (JMPR) established an Acceptable
Daily Intake (ADI) for this chemical of 0.1 mg/kg body weight/day in
1986, Two studies were considered to be important in the JMPR
assessment: a chronic toxicity study in rats with a NOEL of 200 ppm in the
, diet (equivalent to 10 mg/kg/day), and a chronic toxicity study in dogs with
a NOEL of 1000 ppm (equivalent to 25 mg/kg/day, apparently using the
standard conversion factor and not the actual food intake values as in the
Agency'.s evaluation of the same study).
As propamocarb hydrochloride is not a food use chemical, a dietary
analysis is not needed. However, if the status of propamocarb
hydrochloride as a non-food chemical changes, the feto toxic NOEL of 150
mg/kg/day should be used as the toxicological endpoint for the acute
dietary assessment.
2. Exposure Assessment
a. Dietary Exposure
As uses of propamocarb hydrochloride are currently limited to
applications, to ornamentals and turf only, no dietary exposure to residues
in food/feed commodities are expected.
b. Occupational Exposure
Use patterns
Propamocarb hydrochloride is likely to be applied by
occupational, pesticide handlers,.'rather than homeowners, with
tractor-drawn groundboom sprayers,- backpack sprayers, high-
;volume/low-pressure sprayers, (commercial-lawn), low-pressure
hand-wand sprayers, high-pressure hand-wand sprayers, hose-end
sprayersj hand-held sprinkler cans, and as a hand-dip application to
transplants. Applications can be made as often as every seven days.
11
-------
Handler (Mixer/Loader/Applicators) Exposure
The Agency believes 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,
water-hose-end sprayers, hand-held sprinkler cans, and transplant
dip by hand.
The current product registration is used solely by
occupational pesticide handlers. However, since there are no label
restrictions limiting the product's use in this manner, the Agency
included homeowner applications in its exposure and risk
assessments.
The generic data from the Agency's Pesticide Handler
Exposure Database (PHED) is used to determine the potential
exposure values for the specified uses of propamocarb
hydrochloride. PHED is a compilation of acceptable exposure
studies conducted by registrants with different pesticide chemicals
and for a variety of mixing, loading and application scenarios.
Thus, the Agency can apply this data base as a surrogate, if
necessary. The data base provides the Agency with low to high
confidence in the estimates using the different application methods
depending upon the number of replicates available for each
application method. However, for certain uses, the Agency lacks
data in PHED or from other sources to estimate exposures. These
uses are high volume/low pressure sprays, hand-held sprinkler can,
and transplant dips (by hand).
Exposure scenarios for mixer/loader/applicators using the
different application methods are presented in Table 2 below.
12
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The Agency calculated estimates for dermal and inhalation
exposures using the following formulae:
Daily Dermal Exposure
= Dermal Unit Exposure {
lb AI
. Max. A pL Rate
Acre
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Post-Application Exposure
The Agency believes there is potential exposure to persons entering
treated sites after application is complete. Post-application exposure may
occur: (1) to agricultural workers entering areas of treated turfgrass being
grown for sod or ornamentals grown in commercial or research nurseries
and greenhouses; (2) to employees and the public in treated recreational
areas (especially golf courses, the primary use of propamocarb
hydrochloride); and (3) to homeowners following applications to turfgrass
or ornamentals at residential sites.
The Agency does not have chemical-specific data available to
address post application exposure for persons reentering areas treated with
propamocarb hydrochloride.
3. Risk Assessment
a. Dietary
EPA did not conduct a dietary risk assessment for propamocarb
hydrochloride since it is currently registered for non-food uses.
b. Occupational and Residential
Risk to Handlers (M/L/A)
To assess potential risks from the use of propamocarb hydrochloride, the
Agency compared its estimates of dermal exposure in Table 2 (converted to mg/kg
14
-------
body weight/day for a 60 kg person) to the toxicological endpoint NOEL of 150
mg/kg/day for intermediate term and short term exposure. These exposure
estimates and this NOEL are described above. The ratio of the NOEL to the
estimated exposure level is called the Margin of Exposure (MOE). MOE values
of 100 or higher indicate to the Agency that the human health risks are low and are
not generally a concern (when the NOELs are based on animal data).
MOEs were not calculated for the application scenarios of high volume/low
pressure sprayer, handheld sprinkler can and transplant dip (by hand) due to the
lack of exposure data. Also, EPA did not calculate MOEs for the inhalation
exposure estimates because these values were considerably less than the dermal
exposure estimates for all exposure scenarios and there was no identified
toxicological inhalation endpoints of concern.
Table 3 below summarizes the corresponding risk assessment for the
occupational uses of propamocarb hydrochloride.
15
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Based on the estimate for dermal exposure, the MOE is greater than 100
for the occupational exposure scenario of mixing/loading the liquid formulation for
groundboom applications. This use scenario is based on mixers/loaders wearing
long sleeved shirts, long pants, and chemical resistant gloves. For all the other
occupational and homeowner exposure scenarios for which MOEs could be
calculated, the MOEs are greater than 100 without personal protective equipment
other than long-sleeve shirt, long pants, and shoes and socks. As noted before, the
Agency lacks exposure data for high volume/low pressure sprayer, sprinkler can
and transplant dip (by hand) applications. The Agency is particularly concerned
about the potential risk associated with the high volume/low pressure sprayer
(commercial turfgrass sprayer) use and the hand-dip use, since these application
methods may represent the greatest potential for propamocarb hydrochloride
exposure. Details of these requirements are provided in Sections IV and V below.
Risk From Post-Application Exposures
There are no propamocarb hydrochloride chemical specific data available
to the Agency to address post-application exposures for occupational and
residential uses. However, the Agency believes that the risks from post-application
exposures to treated turf (other than sod-farm turf) appear to be marginally
acceptable. Since contact with the soil subsurface is unlikely at these sites, post-
application risks should be adequately mitigated by restricting entry until the sprays
have dried. Also, the risk to people from post-application exposures to treated
ornamentals not being grown for research or commercial use (ornamentals in
parks, ornamental gardens, interior plantscapes, etc.) should be adequately
minimized by restricting entry .until the treated surface has dried, since the degree
of exposure of the people to residues remaining on such ornamentals should be
relatively infrequent and generally of short duration. .
The Agency also believes that the risks from post-application exposures to
treated turf grown for sod and ornamentals (greenhouse and nursery) grown for
sale may be unacceptable for entry immediately following applications. EPA
assumes that post-application exposures will not pose an unreasonable risk to
persons entering these treated areas, as long as entry is .prohibited until 24 hours
after application, as required under the Worker Protection Standard (WPS) and
personal protective equipment is worn by workers who enter these treated areas
before the REI has expired. Details of these requirements are provided in Sections
IV and V below. .
C. Environmental Assessment
1. Ecological Toxicity Data
, 17.,
-------
The Agency has adequate data to assess the acute hazard of propamocarb
hydrochloride to nontarget terrestrial and aquatic organisms, but lacks data to assess
chronic avian and aquatic invertebrate hazards. Available ecotoxicology studies suggest
propamocarb hydrochloride is practically nontoxic to slightly toxic to birds, small
mammals, freshwater and estuarine/marine fish and invertebrates. However, propamocarb
hydrochloride is toxic to plants based on the limited terrestrial and aquatic plant studies.
a. Toxicity to Terrestrial Animals
(1) . Birds, Acute and Subacute
To establish the toxicity of propamocarb hydrochloride to birds, the
following tests are required: one avian single-dose oral study (LD50) on
one species, preferably mallard or bobwhite quail; and two subacute dietary
studies (LC50). One study should use one species of waterfowl, preferably
the mallard duck, and the other study should use one species of upland
game bird, preferably bobwhite quail. Tables 4 and 5 present these study
results.
Table 4: Avian Acute Oral Toxicity Findings (LDsn)
Species
Ring-necked pheasant
Northern Bobwhite
% A.I.
70.0
71.7
LD,n mg/kg
2,998
> 2,770
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Partially
Yes
Table 5; Avian Subacute Dietary Toxicity Findings
[Species
Northern Bobwhite
Mallard
% A.I.
72.2
72.2
LC5n ppm
> 5,200
> 5,200
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Partially
Partially
These results suggest that propamocarb hydrochloride is practically
nontoxic to avian species on an acute oral and subacute dietary basis (based
on maximum dosage of 5,200 ppm). The guideline requirement for the
acute oral study (LD50) is fulfilled. However, the guideline requirement
for the avian subacute dietary study (LC50) is not fulfilled. This study is
supplemental because the test material was unstable in avian test feed.
Additional dietary toxicity testing with bobwhite and mallard duck may be
required, pending the results of avian reproduction studies as described
below. (MRIDs 93193007, 42567901, 42567902 and 42567903)
18
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(2) Birds, Chronic
Avian reproduction studies are required when birds may be exposed
repeatedly or continuously through persistence or multiple applications.
Use of propamocarb hydrochloride can result in several applications of the
end-use product per growing season. Based on propamocarb hydrochloride
use patterns, avian reproduction studies are being required. These studies
are to be conducted at concentration levels reflecting maximum expected
residue levels on turf following multiple applications (see terrestrial EEC
calculations in the Exposure and Risk Characterization section).
(3)
Mammals
Wild mammal testing is required on a case-by-case basis, depending
on several factors: • results of the lower-tier studies, such as acute and
subacute testing; the intended use pattern; and pertinent environmental fate
characteristics. In most cases, however, an acute oral LD50 study is used
to determine toxicity to mammals. Table 6 shows the lowest LD50 value
for laboratory rats (66.5% - 70% aqueous solution) used in studies
described above in the Human Health Assessment. (MRID 41278115)
Table 6: Mammalian Acute Oral Toxicity Findings
Species
Rat (male)
Rat (female)
LD5n mg/kg
2,900
2,000
Toxicity Category
m
m
: The available mammalian data indicate that propamocarb
hydrochloride is practically nontoxic to small mammals on an acute oral
basis; ' :,-,.•.,,
(4)
Insects
A honey bee acute contact LD50 study is required if the use pattern
results in honey bee exposure. No data are available to characterize
.propamocarb hydrochloride toxicity to bees. These data are being required
because applications to field-grown ornamentals may result in honey bee
exposure. However, if this use is deleted, from the label, this study will not
. be required.
b. Toxicity to Aquatic Animals
19
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(1) Freshwater Fish
To establish the toxicity of a pesticide to freshwater fish, the
minimum data required are two freshwater fish toxicity studies. One study
should use a coldwater species, preferably the rainbow trout, and the other
should use a warmwater species, preferably the bluegill sunfish. Table 7
shows these test results from studies conducted with propamocarb
hydrochloride.
Table 7; Freshwater Fish Acute Toxicity Findings
1 Species
Rainbow trout
Bluegill sunfish
% A.I.
72
72
LCqn ppm a.i.
>99
>92
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Yes
Yes
The results of the 96-hour acute toxicity studies indicate that
propamocarb hydrochloride is practically nontoxic to fish. The maximum
dosage for the rainbow trout and bluegill sunfish was 99 ppm and 92 ppm,
respectively. The guideline requirement is fulfilled. (MRIDs 42083103,
42083102)
(2) Freshwater Fish — Chronic
Fish early life-stage tests are required if the product is expected to
be transported to water from the intended use site, and when the pesticide
is intended for use such that its presence in water is likely to be continuous
or recurrent regardless of toxicity. Fish early life-stage tests also may be
required if the actual or estimated environmental concentration in water
resulting from pesticide use is less than 0.01 of any acute EC50 or LQ0
value and the pesticide is persistent in water. Available data suggest that
propamocarb hydrochloride is stable to hydrolysis. Based on the results of
the fish early life-stage study, the corresponding guideline requirement is
satisfied. Table 8 shows the results of the fish early life-stage tests
conducted with propamocarb hydrochloride. (MRID 42083105)
Table 8; Fish Early Life-Stage Toxicity Findings
Species
Freshwater:
Fathead minnow
% A.I.
72
NOEC
(ppm) A.I.
6.3
LOEC
(ppm)
A.I.
13.0
MATC
(ppm) A.I.
9.0 ppm
Endpoints
Affected
dry weight
Fulfills Guideline
Requirements
yes
20
-------
A fish life-cycle test is required when an end-use product is
expected to be transported to water from the intended use site, and/or when
the EEC is equal to or greater than one-tenth of the NOEL in the fish early
life-stage test. The EECs for turf (following three or more applications)
and ornamentals (based on a single 64 Ib ai/A rate) are greater than one
tenth of the NOEL in the fish early life stage (6.3 ppm). The study is
required since the use of propamocarb hydrochloride is allowed for three
or more applications to turf and ornamentals grown in fields of 10 acres or
more. Thus, this guideline requirement has not been fulfilled under the
current allowable use conditions. • .' •
(3) Freshwater Invertebrates
The minimum testing required to assess the hazard of a pesticide to
freshwater invertebrates is a freshwater aquatic invertebrate acute toxicity
test, preferably using first instar Daphnia magna or early instar amphipods,
Stoneflies, mayflies, or midges. Table 9 shows the results of these tests.
These data characterize propamocarb, hydrochloride as practically nontoxic
to aquatic invertebrates, on an acute basis. This guideline is fulfilled.
(MRIDs 42567904, 93193013)
Table 9: Freshwater Invertebrate Acute Toxicity Findings
Species
Daphnia magna
Daphnia magna
% A.I.
72%
70%
EC,0 (ppm)
> 106 ppm
423 ppm
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Yes
Partially
Aquatic invertebrate life-cycle tests are required if the product is
expected to be transported to water from the intended use site, and when
the pesticide is intended for use such that its presence in water is likely to
be continuous or recurrent, regardless of toxicity. These tests also may be
required if the actual or estimated environmental concentration in water
resulting from use is less than 0.01 of any acute EC50 or LC50 value and the
pesticide is sufficiently persistent to affect aquatic invertebrates in water
(for example, if the t1/2 is > 4 days). Available data suggest that
propamocarb hydrochloride is stable to hydrolysis.
One study was conducted with Daphnia magna; however, several
discrepancies were observed in the study which rendered the study
unacceptable. These discrepancies include: 1) not all test concentrations
were measured; 2) only half of the test animals were retained per
concentration after day 6 (unhealthy or damaged-ones were discarded); 3)
21
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growth of the Fl daphnids was not measured and; 4) temperature was not
monitored during the test. Therefore, a new invertebrate life-cycle study
is needed.
(4) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is
required when an end-use product is expected to reach the marine/estuarine
environment in significant concentrations. The terrestrial non-food use of
propamocarb hydrochloride on turf may result in exposure to the estuarine
environment. The requirements under this category include a 96-hour LC50
for an estuarine fish, a 96-hour LC50 for shrimp, and either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with oysters.
Table 10 presents these test results. (MRIDs 42083104, 41834604 and
41834603)
Table 10; Estuarine/Marlne Acute Toxicity
Species
Eastern oyster, Shell Deposition
Mysid shrimp
Sheepshead minnow
% A.I.
72%
72%
72%
LCSO/EC50
(ppm)
39.2
> 104.7
>96.8
Toxicity Category
Slightly toxic
Practically nontoxic
Practically nontoxic
Fulfills Guideline
Requirement
Yes
Partially
Yes
There is sufficient information to characterize the acute toxicity of
propamocarb hydrochloride to estuarine/marine organisms as slightly toxic
to practically nontoxic. The guideline requirement for acute toxicity to
mysid shrimp is not fulfilled because 3-day-old shrimp were used rather
than ^24-hour old shrimp. However, the value of repeating the study is
low in terms of the information to be gained. Therefore, the acute LC50
study with mysid shrimp does not need to be repeated.
c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence) is required for
fungicides with terrestrial non-residential outdoor use patterns and/or those
which may have endangered or threatened plant species associated with the
application site. Tier 1 toxicity data on the typical end product (TEP)
material (73.8% a.i. at the maximum application rate of 8.19 Ib ai/A)
indicate that propamocarb hydrochloride is toxic to terrestrial plants
(MRID 41834606 and 41834607). Seedling emergence was affected in
22
-------
45% of the wheat plants and 31.2% of the cucumber plants tested. Tier 1
testing is used as a coarse screen to determine whether a pesticide
potentially poses sufficient risk to warrant higher level modelling. Tier 2
testing may be required when Tier 1 tests result in an effect. Subsequently,
Tier 2 testing will provide an ECSO determination. The Tier 1 guideline
requirements for terrestrial plants are fulfilled; however, because of the
toxicity shown in the tests, Tier II emergence studies with wheat and
cucumbers are required.
(2) Aquatic
Aquatic plant testing is required for any fungicide with outdoor non-
residential terrestrial uses that may result in off-site movement through
runoff (solubility > 10 ppm in water). No Tier 1 aquatic plant data are
available. Table 11 presents results from Tier II toxicity testing using
Scenedesmus quadricauda (green alga) and the TEP as the test material.
Scenedesmus quadricauda is not a recommended species for Tier II testing;
therefore, the guideline requirement is not fulfilled. The results indicate
that at 70% ai, the 93-hour EC50 value is 301 mg ai/L. (MRID 41684302)
Table 11: Nontarget Aquatic Plant Toxicity
Species
Scenedesmus quadricauda
%A.I. '
70
Fr1
"'-'SO ras-hcmrt
301 mg ai/L
2.
'A Tier I aquatic plant study with Lemna gibba is also being
required. If the Tier. 1 study shows effects, a Tier n study with Lemna
gibba may be required to determine an EC50.
Environmental Fate
The Agency has reviewed data from environmental fate studies of the persistence
and mobility of propamocarb hydrochloride under laboratory and field conditions. The
environmental fate data base for propamocarb hydrochloride for Terrestrial Nonfood Crop
and Greenhouse Nonfood Crop use patterns is essentially complete. However, the.
environmental fate studies of hydrolysis, anaerobic aquatic metabolism and terrestrial field
dissipation are of only supplemental quality due to deficiencies described below. The
Agency has required the registrant under a separate letter to provide clarifications for these
studies to confirm the findings and conclusions expressed in this document. The following
environmental fate assessment is not expected to change appreciably with the confirmatory
data. ...
23
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a. Environmental Fate Summary
Persistence and mobility studies of propamocarb hydrochloride under
laboratory and field conditions were reviewed and found to be either acceptable,
partially acceptable and supplemental. The studies determining laboratory
persistence (degradation and metabolism processes) indicate propamocarb
hydrochloride is relatively non-persistent [half-life (t1/2) «14 days], with
degradation primarily through biotic processes such as microbial-mediated
metabolism. Based on marginally acceptable information, abiotic hydrolysis is not
a significant dissipation process; however, base-catalyzed hydrolysis may occur at
extremely slow rates. From acceptable information on aqueous photolysis,
propamocarb hydrochloride was reportedly stable to photodegradation in water.
In an acceptable soil photolysis study, propamocarb hydrochloride was shown to
photodegrade on soil with a t1/2 of *35 days. Information provided by four
acceptable aerobic soil metabolism studies suggests propamocarb hydrochloride
degrades fairly rapidly by microbial-mediated metabolism, with a modal t1/2 of 14
days and a range of seven to 30 days. Results of the anaerobic soil metabolism
study suggest propamocarb hydrochloride is persistent to anaerobic metabolism
with a tI/2 of 459 days under- the study's experimental conditions. In a
supplemental anaerobic aquatic metabolism study, propamocarb hydrochloride was
moderately persistent, with an experimentally determined t1/2 of 55 days for a
German sand sediment.
The mobility of propamocarb hydrochloride varies from mobile to
relatively immobile. Propamocarb hydrochloride mobility appears to be a function
of the pH and clay content (i.e., cation exchange capacity, or CEC) of the treated
soil. According to the registrant, propamocarb hydrochloride is an organic base
(pK.^9.1) that can be protonated in certain soil environments; therefore, increased
adsorption may be observed with increasing clay content or CEC and decreasing
soil Ph. Utilizing information in the submitted studies, no relationship with
adsorption of propamocarb hydrochloride and soil organic matter content was
observed. Information provided by the registrant indicate that the vapor pressure
of propamocarb hydrochloride is 6.0 x 10'7 mm Hg (8.1 x 16 Pa; estimated
Henry's Law Constant of 2.6 x 10"13); therefore, volatilization is not considered
a probable route of dissipation. Results of supplemental field dissipation studies
in California and New York suggest propamocarb hydrochloride dissipates rapidly
under field conditions with a DT50 (dissipation time of 50% of the material)
ranging from 10-15 days. The bioaccumulation in fish study indicated limited
potential for bioconcentration in sunfish, with BCFs of 1.5X and 3.OX for edible
and nonedible tissues, respectively. Rapid, nearly complete depuration (seven to
10 days) was also observed in the bioaccumulation in fish study.
24
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b. Environmental Fate and Transport
(1) Degradation
Abiotic Hydrolysis
: The submitted study provides marginally acceptable data on the
abiotic hydrolysis of propamocarb hydrochloride. Hydrolysis studies of
[propyl-l-14C]propamocarb hydrochloride suggest it is stable to abiotic
hydrolytic degradation under elevated temperatures (50-90° C) and pH
extremes (pHs of 1, 12, 13 and 14). Although hydrolysis may occur under
extremely alkaline conditions (pH 14), the rate of hydrolysis appears to be
limited at ambient temperatures. Additional information using an OECD
screening procedure to assess the potential for abiotic hydrolysis supports
the researchers' assertion that propamocarb hydrochloride is resistant to
abiotic hydrolysis in the pH 5-9 range at 25° G.
The experimentally determined half-lives at pH 14 were 6,784 min
(4.71 days) at 25° C, 124 min at 70° C, and 34 min at 90° C. For the pH
13 test conditions, experimentally derived half-lives were 2,766 min (1.92
days) at 70° C and 496 min (8.3 hours) at 90 C. The experimentally
determined half-life at pH 12 (90° C) was 4,127 min (2.87 days).
Calculated half-lives for pH 5, 7, and 9 conditions at 25° C were 1.26 x
107, 1.26 x 105, and 1.26 x 103 years, respectively. [NOTE: Information
on the accuracy of these theoretically determined half-lives is not available.
Based on the experimentally determined half-life of 4.71 days for pH 14 at
25° C, alkaline hydrolysis (i.e., at pH 9) may occur at a faster rate than
indicated by the theoretical value.] The extrapolated half-life values were
calculated using the experimentally derived activation energy and assuming
"pure base catalysis" for propamocarb hydrochloride. The experiment
conducted under extremely acidic conditions (pH 1) at 70° C suggests
propamocarb hydrochloride is stable in acidic environments. (MRID
00071297)
Photodegradation in Water
Propamocarb hydrochloride did not photodegrade in "heat
sterilized" aqueous solutions maintained at «24° C when exposed to
artificial sunlight for a maximum of «22 days. No evidence of degradation
by abiotic hydrolysis was reported for the dark controls. In a supplemental
OECD, Guideline study on the "Phototransformation of Chemicals in
Water," propamocarb hydrochloride was presumed to be photolytically
stable because measurements of the molar decadic absorption coefficients
were < 3 1 mol"1 cm"1 at wavelengths £295 nm in pH 4, 7, and 9 buffer
25
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solutions. (MRID 00071296)
Photodegradation in Soil
Propamocarb hydrochloride photodegraded with a half-life of 35.4
days on loamy sand soil that was irradiated on a 16-hour daylight
photoperiod with a dual-filtered xenon arc light for up to 31 days at 17-23°
C. In contrast, propamocarb hydrochloride did not significantly degrade
during 31 days of incubation in the dark. Only propamocarb hydrochloride
was identified in the irradiated soil; three minor degradates were detected,
each at ^8.7% of the applied radioactivity. Material balances in the
irradiated and dark control soil ranged from 82.7 to 98.7% and 93.3 to
97.5% of the applied, respectively. (MRID 41834608)
Aerobic Soil Metabolism
Propamocarb hydrochloride degraded with a graphically estimated
half-life of 14 days in loamy sand soil treated at 200 mg/kg and incubated
in the dark at 25° C and 75% of maximum water-holding capacity. Only
propamocarb hydrochloride was identified in the soil; 14CO2 was the major
degradate which totaled >70% of the applied at day 30 and 88.6% of the
applied at 1 year post-treatment. Three minor degradates that comprised
up to 1.3% (2.6 ppm), 0.4% (0.8 ppm), and 0.3% (0.6 ppm) of the applied
were not identified. Unextracted [14C]residues, plus14[ C]residues
associated with the fulvic acid and humic acid soil fractions, increased to
a maximum of 20.2% of the applied at 30 days post-treatment, then
decreased to 11.9% at 12 months. Material balances ranged from 92.6 to
100.6% of the applied. (MRID 41278125)
. Propamocarb hydrochloride degraded with an observed half-life of
14-30 days in a California loamy sand soil that was incubated in the dark
at 25° C and 75% of maximum water-holding capacity. Only propamocarb
hydrochloride was identified in the soil; 14CO2 was the major degradate and
totaled 88.5% of the applied at 1 year post-treatment. Three minor
degradates that comprised up to 0.9% (1.8 ppm), 0.8% (1.6 ppm), and
0,2% (0.4 ppm) of the applied were not identified. Unextracted
[14C]residues, plus [14C]residues associated with the fulvic acid and humic
acid soil fractions, increased to a maximum 37.5% of the applied at 14
days post-treatment, then decreased to 11.3% at 12 months. Material
balances ranged from 88.4 to 99.8% of the applied. (MRID 41278126)
Propamocarb hydrochloride degraded with a half-life of seven to 13
days in loamy sand soil that was treated at 200 mg/kg and incubated in the
dark at 25° C and 75% of maximum water-holding capacity. Only
26
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propamocarb hydrochloride was identified in the soil; I4C02 was the major
degradate and totaled 80.0% of the applied at 46 days. Six minor
degradates that comprised up to 1.40% (2.8 ppm), 1.10% (2.2 ppm),
0.86% (1.72 ppm), 0.78% (1.56 ppm), 0.37% (0.74 ppm), and 0.20%
(0.4 ppm) of the applied were not identified. Unextracted [14C]residues
increased to a maximum 23.4% of the applied at 13 days post-treatment,
then decreased to 14.55% at 46 days. Material balances ranged from 93.2
to 102.7% of the applied. (MRID 41278127) ,
Propamocarb hydrochloride degraded with a graphically estimated
half-life of 12-13 days in loamy sand soil treated twice at 200 mg/kg (total
application of 400 mg/kg) and incubated in the dark at 25° G and 75% of
maximum water-holding capacity. Only Propamocarb was identified in the
soil; 14CO2 was the major degradate, which totaled «55% of the applied at
day 31 and 66% of the applied at 87 days post-treatment. Material
balances declined from 89.3% of the applied at three days post-treatment
to 76.2% at 56 days. (MRID 41278128)
Anaerobic Soil Metabolism
Propamocarb hydrochloride degraded with a half-life of 459 days
in anaerobic (flooded with water plus nitrogen atmosphere) loamy sand soil
that was incubated in the dark at 25° C. The major degradation products
were unextracted residues and evolved 14CO2; three unidentified degradates
were isolated, each at £2.0% of the applied. Unextracted [l4C]residues
plus NaOH-extracted [14C]residues ranged from 4.3% to 8.1% of the
applied during the study. Material balances decreased from 96.5% of the
applied at seven days post-treatment to 84.3% at 180 days. (MRID
41278129) ;
Anaerobic Aquatic Metabolism
[Propyl-l-14C]propamocarb hydrochloride (radiochemical purity
>95%), at 200 ppm, degraded with a half-life of 54.8 days in anaerobic
(flooding plus nitrogen atmosphere) sand sediment that was incubated in the
dark at 25° C for 180 days. Propamocarb hydrochloride comprised 87.3%
of the applied radioactivity (sediment plus flood water) at three days post-
treatment (first sampling interval), 66.5% at 32 days, 44.8% at 60 days,
22.6% at 102 days, and 2.6% at 180 days. Four unknowns, I, II, III, and
IV, were isolated. Unknowns I and II were detected at maximums of
0.80% (1.60 ppm) and 0.72% (1.44 ppm) of the applied, respectively. At
180 days post-treatment, unknowns II, HI, and IV were a combined
11.22% of the applied (22.44 ppm).
27
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Evolved 14CO2 was the major degradate, totaling 33.1% of the
applied radioactivity at 180 days post-treatment. Unextracted [14C]residues
plus NaOH-extracted [14C]residues increased to a maximum 3.46% of the
applied at 102 days post-treatment, then decreased to 2.36% at 180 days.
Material balances were 91.8-95.1% of the applied at three to 14 days post-
treatment, decreased to 83.2% by 60 days, and were 51.0% at 180 days.
(MRID 00071465)
The study was determined to be unacceptable for the following
reasons: 1) the material balances were incomplete; up to 49.0% of the
applied radioactivity was unaccounted; 2) no information was provided to
ascertain if the experiment was conducted under anaerobic conditions (e.g.
Eh-pH measurements, Eh is the oxidation reduction potential measured in
millivolts); and 3) the limited information provided suggests the
experimental conditions were aerobic at the onset of the study. The
guideline requirement is not fulfilled.
Photodegradation in Air
No studies were reviewed. The reported vapor pressure of
propamocarb hydrochloride is 6.0 x 10"7 mm Hg (8.1 x 10"5 Pa; estimated
Henry's Law Constant of 2.6 x 10"13). Therefore, volatilization and
subsequent photolysis in the atmosphere are not considered probable routes
of dissipation.
(2) Mobility
Mobility (Batch Equilibrium)
Propamocarb hydrochloride is mobile to relatively immobile in
sand, loamy sand, and sandy loam soils with Freundlich Kads values of
0.67-5.20. Freundlich Kads values were 0.67 for the sand soil (German
standard soil 2.1), 0.85 for the loamy sand soil (German standard soil 2.2),
and 5.20 for the sandy loam soil (Schering soil 170); respective Koc values
were 140, 41, and 359. The K^ values were 0.084-1.73 for the sand soil,
0.216-1.35 for the loamy sand soil, and 0.447-7.96 for the sandy loam soil.
Material balances ranged from 91.5 to 100.3% of the applied radioactivity.
According to the study authors, propamocarb hydrochloride is protonated
in soil environments to form a positively charged (i.e., cationic) species.
Therefore, adsorption increased with increasing soil clay content and CEC,
and decreasing pH. No relationship with adsorption of propamocarb
hydrochloride and soil organic matter was observed. (MRID 41278130)
Mobility (Soil Column Leaching)
28
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Based on column leaching studies, [14C]propamocarb hydrochloride
was very mobile (51.9-60.5% of applied radioactivity in leachates) in 30-
cm columns of German "Speyer" sand soil (soil 2.1) treated with 21 mg
(107 kg ai/ha) of [propyl-l-14C]propamocarb hydrochloride and leached
with 60 cm of water. [14C] Propamocarb hydrochloride was relatively
immobile (<0.07% in leachates and 85.8-88.0% throughout the upper 20
cm of columns) in German loamy sand soil, (soil 2.2) and (
-------
aged (30 days) residues of [14C]propamocarb hydrochloride appeared to be
relatively immobile (0.39-1.96% of the recovered radioactivity in leachates
and 8.1-10.9% in upper 4-5 cm of columns). Material balances were 10.4-
15.1% of the applied radioactivity following leaching.
This study is supplemental because the experimental methodology
was not sufficiently described; it was not specified if the aged samples were
analyzed for propamocarb hydrochloride and degradates; and it was not
clear if the material balances were calculated based on the radioactivity
applied to the soil prior to aging, or based on the radioactivity remaining
on the aged material that was applied to the columns.
Volatility - Laboratory and Field
No studies were reviewed. The reported vapor pressure of
propamocarb hydrochloride is 6.0 x 10"7 mm Hg (8.1 x 10"5 Pa (Pascals);
estimated Henry's Law Constant of 2.6 x 10"13); therefore, volatilization is
not considered a probable route of dissipation.
(3) Bioaccumulation in Fish
Propamocarb hydrochloride residues did not significantly
accumulate in bluegill sunfish exposed to propamocarb hydrochloride at 1.0
ppm for 28 days. Maximum bioconcentration factors were 1.5X in edible
tissues and 3.OX in nonedible tissues. During the exposure period, mean
total [14C]residues in the treated water ranged from 1.06 to 1.14 ppm.
Depuration was rapid; propamocarb hydrochloride residues were not
detected in the fish tissues by days seven to 10 of the depuration period.
(MRID 41278114)
(4) Field Dissipation
Propamocarb hydrochloride dissipated with half-lives of 10.2 and
15.2 days in the upper 8 cm of turf plots (80 x 80 feet) of sandy loam soil
in New York and California, respectively, following four applications
(seven-day intervals) of propamocarb hydrochloride (Banol SC/L; 722 g
ai/L) at 8.97 kg ai/ha/application (36 kg ai/ha total) in early August 1990.
Limited detections of propamocarb hydrochloride were observed to >91
cm at the New York site and up to 46 cm at the California site.
Propamocarb hydrochloride was detected in several subsurface soil samples
at various concentrations during different sampling times, which suggests
sample contamination from improper sampling techniques. However, no
soil sampling information was given to help evaluate this potential problem.
30
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c.
This study is supplemental because the soil at the New York site
was not sampled deep enough to define the potential for propamocarb
hydrochloride to leach under field conditions; thus, the corresponding
guideline requirement is not satisfied. Therefore, the problems with the
portion of this study conducted in New York cannot be resolved with the
submission of additional data. To be able to use the portion of this study
conducted at the California site toward fulfilling the terrestrial field
dissipation data requirement, the registrant must submit acceptable freezer
storage stability data demonstrating that propamocarb hydrochloride is
stable in soil during the maximum storage interval that the field soil
samples were stored from sampling to analysis. Also, the registrant should
describe the soil sampling procedures and provide the missing field test
data. This information has been requested'of the registrant. (MRID
42421202)
(5) Spray Drift
These studies may be required when human or ecological
lexicological considerations are indicated. The registrant is,a participating
member of the Spray Drift Task Force- (SDTF)." Information regarding
spray drift of propamocarb hydrochloride should be provided upon
completion of the SDTF data base. Information on spray drift of
propamocarb hydrochloride from ground application may be estimated
from the forthcoming results of the SDTF studies.
Water Resources
Based on the environmental fate assessment for propamocarb hydrochloride
with consideration of the product formulation and application rates, the Agency
believes use of propamocarb hydrochloride will not pose serious concerns for
either groundwater or surface water media. •
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level of Concern (LOC): The
Agency uses the Levels of Concern (LOG) as criteria to indicate potential risk to
nontarget organisms. The criteria indicate that a chemical, when used as directed,
• has the potential to cause undesirable effects on nontarget organisms. There are
two general categories of LOC (acute and chronic) for each of the four nontarget
faunal groups and one category (acute) for each of two nontarget floral groups.
To, determine if an LOC has been exceeded, a risk quotient is derived and
compared to the LOCs. A risk quotient is calculated by dividing an appropriate
31
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exposure estimate by an appropriate toxicity test effect level, such as the LC50 for
acute effects or NOEL for subchronic or chronic effects .
Typical acute effect levels are:
for terrestrial plants,
EC50 for aquatic plants and invertebrates,
LC50 for fish and birds, and
LD50 for birds and mammals.
Chronic test results are:
for avian and mammalian reproduction studies, the no observed effect level
(NOEL) or concentration (NOEC); and
for chronic aquatic studies, either the NOEC or the maximum allowable
toxicant concentration (MATC). The MATC is the geometric mean of the
NOEC and the lowest observable effect concentration (LOEC).
When .the risk quotient exceeds the LOG, the Agency presumes there is potential
risk to that category. The Agency's risk presumptions and the corresponding
LOCs are shown in Tables 12, 13 and 14.
Table 12; Levels of Concern (LOG) and Associated Risk Presumption; Mammals and Birds
If the
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
LOC
0.5
0.2
0.1
1
Presumption
High acute risk
Risk that may be mitigated through restricted use
Endangered species may be acutely affected
Chronic risk - Endangered species and other non-target
affected
species may be chronically
Table 13; Levels of Concern (LOG) and Associated Risk Presumption; Fish and Aquatic Invertebrates
If the
acute RQ>
acute RQ>
acute RQ>
chronic RQ >
LOC
0.5
0.1
0.05
1
Presumption
High acute risk
Risk that may be mitigated through restricted use
Endangered species may be acutely affected
Chronic risk - Endangered species and other non-target species may be
affected
32
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Table 14; Levels of Concern (LOG) and Associated Risk Presumption; Plants
If the
RQ>
LOG
1
Presumption ||
High risk - Endangered plants
and other non-target plants
'
may be affected |
Currently, no separate criteria exist for restricted use or chronic
effects to plants. •
(1) Exposure and Risk to Nontarget Terrestrial Animals
(a) Birds-Turf
Residues found on dietary food items following
propamocarb hydrochloride application may be compared to LC50
values to predict hazard. The table below demonstrates for the turf
• .-••• use, the maximum concentration of propamocarb hydrochloride
residues that may be expected on selected avian and mammalian
dietary food items following both single and multiple applications.
The resulting avian risk quotients are shown in Table 15.
Table 15: Estimated Environmental Concentrations (EEC) for Avian and Mammalian Dietary Food Items in ppm
and Avian Risk Quotients (RQ) based on the EECs for turf/the highest test concentration in the LC50 studies, 5,200
pm
, Food items
Short grass
Long grass
Broadleaf/'
Insects
Fruit/Seeds
EEC (ppm)
(1 application of
8.19 Ibs ai/acre)
1,966
901
1,106
123
EEC (ppm)
(3 appls. of 8.19 Ibs ai/acre
or 6 appls. of 4.1 Ibs ai/acre
with no degradation)
5,898
2,703
3,318
369
RQ
(single 8.19 Ib
ai/acre appl.)
; <0.38
<0.17
<0.21
<0.02
RQ
(multiple
applications)
<1.1
<0.5
<6.6
<0.06
Precise LC50 values were not determined in the avian dietary
studies summarized in Table 15 because concentrations were not
high enough to cause 50% mortality. The highest concentration
tested (5,200 ppm) was used in the risk quotient calculations.
Propamocarb hydrochloride may be applied to turf at a maximum
rate of 4 fluid oz per 1000 sq ft. This is equivalent to 8.2 Ibs
ai/acre. The EECs following three applications at 8.19 Ibs ai/acre
33
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or 6 applications at 4.1 Ibs ai/acre to turf (no degradation) are
calculated to reach a maximum of 5,898 ppm. This residue level
exceeds the highest test concentration in the avian dietary studies.
However, the risk is uncertain because of several factors, including:
although LC50 values were not determined in the avian
dietary toxicity studies, they were higher than the values
used in the risk quotients;
the test material was unstable in avian test feed; and
available residues on turf in the environment may be lower
than the maximum calculated EECs because of dissipation
and mowing.
No avian reproduction studies are available. However,
based upon developmental and reproductive effects demonstrated in
rats (including fetal death at low doses in developmental
lexicological studies), chronic effects in avian organism may be
expected. Therefore, the effects of propamocarb hydrochloride on
avian reproduction needs to be evaluated for the turf use which may
involve multiple applications. The avian reproduction studies will
enable the Agency to evaluate chronic risks to birds to better clarify
the acute risk for birds.
(b) Birds — Ornamentals
The use of propamocarb hydrochloride on ornamentals
grown in greenhouses and pots within nurseries does not pose a risk
to birds since there is no expected exposure. However,
propamocarb hydrochloride may be applied to field-grown
ornamentals at a maximum rate of 0.0147 Ibs ai/10 sq ft. This is
equivalent to 64 Ibs ai/acre.
Table 16 shows the maximum concentrations of
propamocarb hydrochloride residues that may be expected on
selected avian or mammalian dietary food items following a single
application of 64 Ib ai/acre to ornamentals and the resulting avian
risk quotients. The risk quotients exceed high risk LOCs for birds.
However, the registrant has proposed to amend their propamocarb
hydrochloride label to eliminate the field-grown ornamental use.
Thus, the Agency believes this action will mitigate the LOG
exceedance for birds.
34
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Table 16: Estimated Environmental Concentrations (EEC) for Avian or Mammalian Dietary Food Items in ppm
and Risk Quotients (RQ) based on the EECs for ornamentals/the highest test concentration in the LCSO studies,
5,200 ppm
Food items
Short grasses
Long grasses
Broadleaves/insects
Fruits/seeds
EEC (single application) (64 Ibs ai/A)
15,360
7,040
8,640
960
RQ
<3.0
<1.4
<1.7
<0.2
(c) Mammals
Risk to small mammals is assessed using the acute oral LD50
value of 2,000 mg/kg, the body weight of the animal in grams and
the food consumption in grams per day. The estimated LC50 is
derived using the following formula, and approximates the dietary
toxicity for the animal:
LC50 =LD50 x body weight (g)
food consumption per day (g)
Table 17 lists the estimated LC50s.
Table 17; Small Mammal Food Consumption in ppm based on a laboratory rat LDSO value of 2,000 mg/kg '
Small Mammal
Meadow vole
Oldfield mouse
Least shrew
Body Weight
(grams)
46 -
13
• •• 5
% of Weight
Eaten/Day
61%
16%
110%
Food Consumed/
Day (grams)
28.1
2.1
5.5
Estimated LC50/ Day
(ppm)
3,274
12,381
1,818
D. E. Davis and F. Golly. Principles of Mammology. Reinhold Corporation, 1963.
The estimated LC50 is then compared to the residues (EECs) to
calculate the mammalian risk quotient (EEC/LC50). Table 18 indicates the
mammalian risk quotients for the turf (8.19 Ib a.i./A) and field-grown
ornamental uses (64 Ib a.i./A).
35
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Table 18: Mammalian Dietary Risk Quotients
Small Mammal
Meadow
Oldfield
vole consuming range grasses
mouse consuming seeds
Least shrew consuming forage and insects
Dietary RQ *
8. 19 single
application
(Ibs. a.i./A)
0.6
0.01
0.3
64 single application
(Ibs. a.i./A)
4.7
0.06
2.0
* Dietary RQ = EEC/lowest estimated LC50
Small mammals are potentially at high acute risk for use of
propamocarb hydrochloride on both turf and ornamentals. For
mice, the marginally exceeded LOCs calculated assume maximum
use and that propamocarb hydrochloride does not break down. The
use of propamocarb hydrochloride on ornamentals grown in
greenhouses and pots within nurseries does not pose a high risk to
mammals.
(d) Insects
No data are available to assess the risk of propamocarb
hydrochloride to non-target insects.
(2) Exposure and Risk to Nontarget Aquatic Animals
Expected Aquatic Concentrations
Propamocarb hydrochloride is slightly toxic to practically nontoxic
to the aquatic organisms tested to date. Table 19 lists the EECs calculated
using the Generic Expected Environmental Concentration Program
(GENEEC). GENEEC is a program to calculate both acute and chronic
generic expected environmental concentration values. It considers reduction
in dissolved pesticide concentration due to adsorption of pesticide to soil or
sediment, incorporation, degradation in soil before washoff to a water
body, direct deposition of spray drift into the water body, and degradation
of pesticide within the water body. For turf and field-grown ornamental
uses, the estimates were based on runoff from a 10 hectare field to a one
hectare x two meter deep pond. These generic EECs take into account
degradation in the field prior to a rain event. The following environmental
fate parameters were used in the model: soil KOC, 50.0; solubility, 50,000
ppm; aerobic soil metabolism half-life, 14 days; hydrolysis, 0; photolysis
36
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in water, 0; aquatic metabolism, 0. EECs for the turf use were calculated
for one application and three applications seven days apart.
Table 19: Estimated Environmental Concentrations (EECs) using GENEEC
Crop
Turf: one
Turf: three
Ornamentals:
Application
Method
ground
ground
ground
Application
Rate (Ibs
a.i./A)
8.19
8.19
64
Initial
EEC
(ppb)
353
862
2,760
4-day
EEC
(ppb)
352
861
2,750
21-day
EEC
(ppb)
351
857
2,740
56-day
EEC
(ppb)
347
849
2,710
(a) Freshwater Fish
As presented above in Table 13 (Levels of Concern [LOG]
Associated Risk Presumption: Fish and Aquatic Invertebrates), the
Agency's acute and chronic LOG for freshwater fish are met or
exceeded if the RQ >^ 0.5 to 1.0, respectively. For propamocarb
hydrochloride, the acute and chronic LOCs for freshwater fish are
not exceeded for any current use. For reasons previously
discussed, the precise LC50 values for freshwater fish were not
determined in the studies; therefore, the highest test concentrations
in the acute fish studies were used in the risk quotient calculations.
These were 92.0 and 99.0 ppm for bluegill sunfish and rainbow
trout, respectively. The chronic MATC is 9.0 ppm. Table 20
provides the acute and chronic risk quotients for freshwater fish.
37
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Table 20; Risk Quotients (RQ) for Freshwater Fish
Crop/application rate
Turf/8. 19 Ibsai/A
(one application)
Turf/8. 19 Ibsai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Bluegill
Rainbow trout
Fathead minnow
Bluegill
Rainbow trout
Fathead minnow
Bluegill
Rainbow trout
Fathead minnow
Acute RQ (96-hr)
(EEC/highest test
concentration)
< 0.004
< 0.004
<0.01
< 0.005
<0.03
<0.03
Chronic RQ (60-day)
(EEC/MATC)
0.04
0.07
0 31
(b) Freshwater Invertebrates
The use of propamocarb hydrochloride does not exceed the
acute endangered species LOCs for freshwater invertebrates (RQ >
0.05), as shown in Table 21 below. No chronic toxicity data for
freshwater invertebrates are available for use in a risk assessment.
Table 21: Risk Quotients (RQ) for Freshwater Invertebrates (48 hr. ECSO = 106 ppm)
Crop/application rate
Turf/8. 19 Ibs ai/A
(one application)
Turf/8. 19 Ibs ai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Daphnia magna
Daphnia magna
Daphnia magna
Acute RQ (48-hr)
(EEC/highest test
concentration)
0.003
0.005
0.03
Chronic RQ (21 -day)
(EEC/MATC)
N/A
N/A
N/A
(c) Estuarine and Marine Animals
For the turf use, the acute LOCs for estuarine and marine
animals are not exceeded. However, following propamocarb
hydrochloride applications to 10-acre plots of field grown
ornamentals, the high risk LOG (Acute RQ for oyster = 0.70) is
exceeded. The precise LC50 values for sheepshead minnow and
mysid shrimp were not determined in the studies. Therefore, the
highest test concentrations in the studies were used in the risk
38
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quotient calculations.- These were 96.8 and 104.7 ppm for
sheepshead minnow and mysid shrimp, respectively. The EC50
value for the eastern oyster is 39.2 ppm.
Table 22 presents the acute risk quotients. '
Table 22: Risk Quotients (RQ) for Estuarine and Marine Organisms
Crop/application rate
Turf/8. l'91bsai/A
(one application)
Turf/8. 19 Ibsai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Sheepshead minnow
Oyster j
Mysid
Sheepshead minnow
Oyster
Mysid
Sheepshead minnow
Oyster
Mysid
Acute RQ (96-hr)
<0.004
0.009
< 0.003
<0..005 .
0.015
< 0.005
<0.03
0.70
<0.03
(3) Exposure and Risk to Nontarget Plants
(a) Terrestrial and Semi-Aquatic
Tier 1 toxicity data on the typical end product (TEP)
material (73.8% a.i. at the maximum application rate of 8.19 Ib
ai/A) indicate that propamocarb hydrochloride is toxic to terrestrial
plants. Seedling emergence was affected in 45% of the wheat
plants and 31.2% of the cucumber plants tested. Based on these
results, movement of propamocarb hydrochloride off-target via
runoff or spray drift may be expected to adversely affect non-target
plants. However, risk quotients cannot be calculated for seedling
emergence until Tier II studies are submitted. Such information
will provide EC25 values to perform a plant risk assessment.
(b) Aquatic
Exposure to non-target aquatic plants may occur through
runoff and drift. The Agency estimated EECs using the GENEEC
program and estimated the toxicity using the 93-hour EC50 301 ppm
from the study with Scenedesmus quadricauda summarized above.
Table 23 shows the resulting risk quotients for aquatic plants.
39
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Table 23; EECs and RQ for Aquatic Plant Species
Use Site
Turf
Turf
Ornamentals
Maximum
Application Rate
8.191bsai/A
(1 application)
8.191bsai/A
(3 application)
64 Ibs ai/A
(1 application)
Type of Plant
Algae
Algae
Algae
Type of EEC
(GENEEC)
runoff and 1 %
spray drift
runoff and 1 %
spray drift
runoff and 1 %
spray drift
EEC
(ppb)
353
862
2,760
Risk Quotient
(EEC/ECJ
0.001
0.003
0.009
An algae risk assessment is a useful indicator to determine
impact to food sources for fish, aquatic invertebrates, and
waterfowl. Based on these risk quotients, there appears to be low
risk to organisms relying on algae as a source of food. However,
an additional Tier I aquatic plant test for Lemna gibba has been
required (see section on toxicity to aquatic plants).
(4) Endangered Species
Endangered species LOCs have been exceeded for birds and
mammals for the use of propamocarb hydrochloride on turf and field
ornamentals. In addition, the LOCs for endangered marine animals
(mollusks) have been exceeded for field-grown ornamentals. Application
to woody ornamentals may also exceed endangered species LOCs
depending on the application rate used.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active ingredients
are eligible for reregistration. The Agency has previously identified and required the
submission of the generic (i.e. active ingredient specific) data required to support reregistration
of products containing propamocarb hydrochloride active ingredients. The Agency has
completed its review of these generic data, and has determined that the data are sufficient to
support reregistration of all products containing propamocarb hydrochloride, with modifications
as specified in this document, and that the fungicide can be used without resulting in
unreasonable adverse effects to humans and the environment. Therefore, the Agency concludes
that products containing propamocarb hydrochloride for all uses, except the field-grown
ornamental use plus the high volume/low pressure and hand dipping application scenarios, are
eligible for reregistration. A reregistration decision cannot be made on the field-grown
ornamental use plus the high volume/low pressure and hand dipping application scenarios due
40
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to data deficiencies. Appendix B identifies the generic data requirements that .the Agency
reviewed as part of its determination of reregistration eligibility of propamocarb hydrochloride,
and lists the submitted studies that the Agency found acceptable.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that all uses of propamocarb hydrochloride are eligible for
reregistration, with modifications as specified in this document, and with the exception of the
field-grown ornamental use, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the registration
of products containing propamocarb hydrochloride, if new information comes to the Agency's
attention, including the additional, required confirmatory generic data mentioned in this
document, or if the data requirements for registration (or the guidelines for generating such
data) change. ..;,,.' . . •
1. Uses Eligible or Not Eligible at This Time
The Agency has determined that all uses of propamocarb hydrochloride, with
modifications specified herein, and with the exception of the field-grown ornamental use
plus the high volume/low pressure and hand dipping application scenarios, are eligible for
reregistration. A decision on the field-grown ornamental use plus the high volume/low
pressure and hand dipping application scenarios cannot be made at this time due to data
deficiencies. The registrant has requested the Agency to remove the field-grown
ornamental use from its registration.
B. Regulatory Position
The Agency conducted its risk assessment of propamocarb hydrochloride based on the
currently registered use patterns and available data. The following is a summary of the
regulatory positions and rationales for propamocarb hydrochloride. Where labeling revisions
are imposed, specific language is set, forth in Section V of this document. .. .
1. Use Deletion; Application Rate Reduction
During the drafting of this document, the registrant had submitted to EPA a
proposal to amend their label by deleting the use of propamocarb hydrochloride for field
grown ornamentals and limiting the use of the fungicide to 0.57 Ib ai/1000 sq. ft.
(equivalent to 25 Ib ai/acre/year) of turfgrass per year. These modifications will reduce
ecological exposures and risks. They also eliminate the requirements for a fish-life cycle
,and honey bee toxicity. studies. The Agency will not require these studies for the
remaining uses. However, if the propamocarb hydrochloride registration changes in the
future, the Agency may impose these data requirements. .
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2. Generic Data Gaps
As discussed in Section III.B, the Agency sees a need for additional data.
Requirements for mixer/loader/applicator (i.e., handler) exposure studies are addressed
in Subdivision U of the Pesticide Assessment Guidelines. Review of available exposure
data for other pesticides indicates that these data still are not warranted for most scenarios.
However, there are several scenarios for which there are no exposure data available,
including application by high volume/low-pressure sprayers, by hand-dipping, and by
sprinkling can. Therefore, EPA is requiring exposure data for the high volume/low-
pressure spray equipment and for hand-dipping. For application by sprinkling can, the
Agency anticipates that the amount of product handled using this technique would be less
than that in the garden-hose-end scenario. Therefore, data are not required for application
using a sprinkling can.
The available data on post-application exposure from pesticides are limited.
Additional post-application/reentry exposure studies on propamocarb hydrochloride are
required as confirmatory data to determine definitive REIs for sod-farm and
greenhouse/nursery use sites. The interim REI established in the document (24 hours) will
be adjusted, if necessary, upon Agency review of the additional data. In addition,
confirmatory studies are required to determine the post-application exposure following
applications to turfgrass at residential sites. Requirements for post-applications/reentry
exposure studies are addressed by Subdivision K of the Pesticide Assessment Guidelines.
Although gaps in the database as described above preclude the Agency from
quantifying risk estimates for these scenarios, the Agency does not believe there are
unreasonable risks during the time interval required to obtain these additional data. These
data will be used to confirm its assumption of no unreasonable risks to handlers and those
to enter treated sites. Data are not required for the other post-application exposure
scenarios because it is anticipated that the exposure levels from these uses are lower than
those in the greenhouse/nursery ornamental and two turfgrass scenarios.
Likewise, as noted in Section m.C, the missing data addressing potential chronic
hazard to birds, aquatic invertebrates, plants and the environmental fate studies'
deficiencies preclude conducting definitive chronic risk assessments for these non-target
organisms. To address this, the Agency has directed the registrant to submit the
appropriate studies. Although the Agency is anxious to address the potential for risk to
these organisms, the Agency has decided that in consideration of propamocarb
hydrochloride's known environmental fate and use characteristics, a finding of no
unreasonable risk may be made at this time in the belief that when the missing information
is evaluated it is not likely to be of a magnitude to change the basic regulatory findings
expressed in this document.
3. Endangered Species
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The LOCs have been exceeded for birds and mammals for the use of propamocarb
hydrochloride on turf and field grown ornamentals. In addition, the LOCs for endangered
marine animals (mollusks) have been exceeded for field-grown ornamentals. Application
to woody ornamentals may also exceed endangered species LOC's depending on the
application rate used. The registrant's proposed use deletion for field grown ornamentals
and limiting the use of the fungicide to 0.57 Ib ai/100 sq. ft. of turfgrass. per year will
mitigate these ecological exposures and risks. .
4. Labeling Rationale
Scope of the Worker Protection Standards
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective equipment [PPE],
restricted entry intervals [REI], etc.) to be specified on the label of all products that
contain .uses .within the scope of the WPS. Uses within the scope of the WPS include all
commercial (non-homeowner) and research uses on farms, forests, nurseries, and
greenhouses to produce agricultural plants (including food, feed, and fiber plants, trees,
turf grass, flowers, shrubs, ornamentals, and seedlings).. Uses within scope include not
only uses on plants, but also uses on the soil or planting medium the plants are (or will be)
grown in. .. , ......
At this time, some of the registered uses of propamocarb hydrochloride are within
the scope of the WPS and some uses are outside the scope of the WPS. Propamocarb
hydrochloride uses within the WPS include:
• plants grown for commercial or research purposes, .
: / • turf grown for commercial (sod farms) or research purposes.
Those that are outside the scope of the WPS include: , :
• plants grown for other than commercial or research purposes, which may
include plants in habitations, and home greenhouses,
« plants, including turf, that are in. ornamental gardens, parks, golf courses,
and public or private lawns and grounds and that are intended only for
decorative or environmental benefit.
Compliance With The WPS
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with
the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
43
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Guidance for PR Notice 93-7, which reflect the requirements of EPA's labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed in those notices.
• except as otherwise provided in PR Notices 93-7 and 93-11, all products
within the scope of those notices must bear WPS PR Notice complying
labeling when they are distributed or sold by the primary registrant or any
supplementary registered distributor.
• After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS
PR Notice complying labeling when they are distributed or sold by any
person.
Personal Protective Equipment/Engineering Controls for Handlers
At this time, there are no engineering control requirements, such as closed systems,
currently required on labeling of the end-use product containing propamocarb
hydrochloride. However, current labeling requires workers to wear long-sleeved shirt and
long pants, waterproof gloves and shoes plus socks.
Occupational-Use Products
For each end-use product, personal protective equipment/engineering control
requirements for pesticide handlers will be set during reregistration in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, the personal protective equipment (PPE) for pesticide handlers
will be based on the acute toxicity of the end-use product. For occupational-use
products, PPE will be established using the process described in PR Notice 93-7
or more recent EPA guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects or delayed
effects (cancer, developmental toxicity, reproductive effects, etc):
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE or engineering-control requirements that pertain to
all or most occupational end-use products containing that active ingredient.
44
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• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use
product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection., footwear, eyewear, etc.) must be placed on the label of the end-
. use product.
Because the Agency has concluded there is a toxicity end-point for short and
intermediate term occupational/residential exposure, which is beyond the acute toxicity of
propamocarb hydrochloride, it is prudent to establish an- active ingredient based minimum
PPE/engineering control requirements for occupational handlers. Mixers/loaders for
groundboom applications must wear chemical-resistant gloves in addition to long-sleeve
shirts, long pants, shoes plus socks. For all other handler scenarios, PPE/engineering
control requirements will be based on the acute toxicity of the end-use product.
Post-Application/Entry Restrictions
Occupational-Use Products (WPS Uses)
Restricted-Entry Interval:
EPA has no basis at this time to establish a product-specific restricted-entry
interval due to the lack of foliar dislodgeable residue dissipation, dermal passive dosimetry
exposure, and inhalation passive dosimetry exposure data for residential or commercial
use sites. These data are necessary for the Agency to definitively calculate the REIs for
all use sites for which interim REIs have been established under the WPS.
Under the WPS, interim REI for all uses within the scope of the WPS are based
on the acute toxicity of the active ingredient. The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI. If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours. If none
of the acute toxicity effects are in category I, but one or more of the three is classified as
category II, the interim WPS REI is established at 24 hours. If none of the three acute
toxicity effects are in category I or II, the interim WPS REI is established at 12 hours. A
48-hour REI is increased to 72 hours when an organophosphate pesticide is applied
outdoors in arid areas. In addition, the WPS specifically retains two types of REI's
established by the Agency prior to the promulgation of the WPS: (1) product-specific
REI's established on the basis of adequate data, and (2) interim REI's that are longer than
those that would be established under the WPS.
For propamocarb hydrochloride, the Agency believes it is appropriate to set the
interim REI for a longer period than that based on the acute toxicity of the chemical (12
45
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hours). Since the Agency has identified toxicological endpoints of concern for short term
and intermediated term occupational/residential exposure and post-application exposure
data are not available, EPA is establishing a 24-hour REI and requiring data to confirm
that the 24-hour REI will not result in unacceptable post-application exposure to persons
reentering areas treated with propamocarb hydrochloride.
Early-Entry PPE:
The WPS establishes very specific restrictions on entry by workers to areas that
remain under a restricted-entry interval if the entry involves contact with treated surfaces.
Among the restrictions for workers entering treated areas is a prohibition of routine entry
to perform hand labor tasks and requirement that personal protective equipment be worn.
Personal protective equipment requirements for persons who must enter areas that remain
under a restricted-entry interval are based on the toxicity concerns about the active
ingredient. The requirements are set in one of two ways.
1. If EPA has no special concerns about the acute or other adverse effects of
an active ingredient, it establishes the early-entry PPE requirements based
on the acute dermal toxicity, skin irritation potential, and eye irritation
potential of the active ingredient.
2. If EPA has special concerns about an active ingredient due to very high
acute toxicity or to certain other adverse effects, such as allergic effects,
cancer, developmental toxicity, or reproductive effects, it may establish
early-entry PPE requirements that are more stringent than would be
established otherwise.
Since EPA has identified toxicological endpoints of concern for short term and
intermediate term occupational/residential exposure for propamocarb hydrochloride, the
Agency is establishing PPE for dermal protection that is more stringent than the PPE that
would otherwise be established based on the acute toxicity of the active ingredient. The
PPE required for early entry is: coveralls over short-sleeve shirt and short pants,
chemical-resistant footwear plus socks, chemical resistant headgear for overhead
exposures, and chemical-resistant gloves. Since propamocarb hydrochloride is classified
as toxicity category in for eye irritation potential, no protective eyewear is required.
NonWPS Uses
Since EPA has concerns about immediate (before sprays have dried) post-
application exposures to persons from occupational uses outside the scope of WPS (turf,
golf courses, residential lawns, and other recreational areas) it is establishing entry
restrictions for all nonWPS uses of propamocarb hydrochloride end-use products. The
Agency is requiring that such treated sites be dry before reentry. The Agency believes a
24-hour restriction, as it is imposing for the other uses, is not practical or feasible for the
46
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V.
sites of golf courses, other recreational areas and home lawns. When the Agency reviews
the required confirmatory data specified above, it will adjust this REI as appropriate.
5. Additional Labeling Requirements
The Agency is requiring additional labeling statements to be located on all end-use
products containing propamocarb hydrochloride. For the specific labeling statements, refer
to Section V of this document.
ACTIONS REQUIRED OF REGISTRANTS
This section specifies additional data requirements, label changes, and any other modifications
necessary for the reregistration of both manufacturing-use and end-use products.
A.
Manufacturing-Use Products
1.
Additional Generic Data Requirements
As noted throughout this document, the Agency has identified studies for which
additional information is needed and identified new studies which must be conducted.
EPA believes these additional data are important for it to have a more comprehensive
characterization of the potential hazards and exposures from propamocarb hydrochloride
uses. In addition, the Agency will use these data to confirm the above estimated risks and
its regulatory decision. Outstanding data have been required of the propamocarb
hydrochloride registrant. The two required studies necessary to provide data on
applicators during ground applications using high volume/low pressure spray equipment
(commercial turfgrass) and for hand-dipping (ornamental) applications are-a dermal
exposure study, and an inhalation exposure study. These studies should be conducted
concurrently; i.e., dermal and inhalation samples should be collected from the same
worker and at the same site during each trial. Foliar residue dissipation, post-application
dermal passive dosimetry exposure and post-application inhalation dosimetry exposure are
required. However, the post-application dermal passive dosimetry exposure and post-
application inhalation dosimetry exposure studies for residential turf may be reserved at
this time pending completion of the databases 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. In addition, the Agency has required avian reproduction, chronic aquatic
invertebrate toxicity, aquatic plant growth, and seedling emergence.
The Agency has also identified deficiencies in studies addressing gene mutation,
avian dietary, aquatic invertebrate life-cycle, hydrolysis, anaerobic metabolism, and
terrestrial field dissipation. The registrant has been notified under a separate letter to
upgrade these studies or to submit new studies.
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2. Labeling Requirements for Manufactured Use Products
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, ornamental herbaceous plants, ornamental
woody shrubs and vines, cutting beds, and seedling areas."
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 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)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made.
The product specific data requirements are listed in Appendix F, the Product Specific Data
Call-in Notice.
Registrants must review previous data submissions to ensure that they meet current
EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes
that previously submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
2.
Labeling Requirements for End-Use Products
a. PPE Requirements for Pesticide Handlers
Sole active ingredient end-use products that contain propamocarb
48
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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, see 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".
The glove requirement for propamocarb hydrochloride is the statement
established through the instructions in Supplement Three of PR Notice 93-7.
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 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.
b. 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:
49
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"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.
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:"
c.
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-
50
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6), the handler PPE requirements may be reduced or modified as
• specified in the WPS."
d. 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"
. "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."
e. 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."
f. .- 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 after handling this product. Wash the outside of
51
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c.
gloves before removing. As soon as possible, wash thoroughly
and change into clean clothing."
Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregistration Eligibility Decision (RED). Persons
other than the registrant may generally distribute or sell such products for 50 months from the
date of the issuance of this RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell propamocarb
hydrochloride products bearing old labels/labeling for 26 months from the date of issuance of
this RED. Persons other than the registrant may distribute or sell such products for 50 months
from the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks requirements
applicable to products they sell or distribute.
52
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VI. APPENDICES
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case
3ropamocarb Hydrochloride covered by this Reregistration Eligibility Decision Document. It contains generic data
[requirements that apply to Propamocarb Hydrochloride in all products, including data requirements for which a "typical
(formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR
art 158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment
uidelines, which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield,
A 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
ollowing letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the identifying
umber of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number
f no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study.
57
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of .past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this biblipgraphy is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating.them as a •
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF. ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
.date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency was
unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
65
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d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
66
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BIBLIOGRAPHY
MRID
CITATION
00101637 Allen, P. (1982) Effect of Previcur N on Reproductive Function of Multiple
Generations in the Rat: Reprotox Order No. 126. Final rept. (Unpublished
study received May 18, 1982 under 2139-121; prepared by Huntingdon
Research Centre, W. Ger., submitted by Nor-Am Agricultural Products, Inc.,
Naperville, IL; CDL: 247524-A)
00101638 Hunter, B.; Jones, D.; Heywood, R.; et aL (1981) Previcur N (SN66 752):
Toxicity and Potential Tumorigenicity in Dietary Administration to Rats for 104
Weeks: HRC Report No. SHG/165-G/801056. Final rept. (Unpublished study
received May 18, 1982 under 2139-121; prepared by Huntingdon Research
Centre, Eng., submitted by Nor-Am Agricultural Products, Inc., Naperville,
IL;CDL:247526-A; 247527)
00101639 Nor-Am Agricultural Products, Inc. (1982) Toxicology: Propamocarb
hydrochloride: Teratology and Mutagenicity-Summary. Summary of studies
247529-C through 247529-F. (Unpublished study received May 18, 1982 under
2139-121; CDL:247529-A)
00101640 Kuhne, G.; Aner, B.; Klawa, D.; et al. (1978) Pharmacokinetics of
Propamocarb-hydrochloride on Single and Repeated Oral Administration of 0.5
mg/kg in Rats: Report No. SN 66752-9/5. (Unpublished study received May
18, 1982 under 2139-121; prepared by Schering AG, W. Ger., submitted by
Nor-Am Agricultural Products, Inc., Naperville, IL; CDL:247529-B)
00101641 Poggel, H. (1981) Previcur N (CP 604)~Embryotoxicity Including
Teratogenicity Study in Rats after Daily Intragastric Administration from 6 to
Day 19 of Gestation: Report No. PF 62/87. (Unpublished study received May
18, 1982 under 2139-121; prepared by Schering AG, W. Ger., submitted by
Nor-Am Agricultural Products, Inc., Naperville, IL; CDL:247529-C)
00101642 Hossack, D.; Richold, M.; Richardson, J. (1980) Micronucleus Test on CP 604
(SN 66752, Previcur N): SHG 182/79183. (Unpublished study received May
18, 1982 under 2139-121; prepared by Huntingdon Research Center, Eng.,
submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:247529-D)
00101643 Hossack, D.; Richold, M.; Richardson, J. (1980) Micronucleus Test on CP 604
(SN66752, Previcur N): SHG 191/79737. (Unpublished study received May
18, 1982 under 2139-121; prepared by Huntingdon Research Center, Eng.,
. 67
-------
BIBLIOGRAPHY
MRID
CITATION
submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:247529-E)
00101644 Rushbrook, C.; Jorgenson, T.; Spanggord, R.; et al. (1979) Dominant Lethal
Study of Previcur N: SRI Project LSC-8516. Final rept. (Unpublished study
received May 18, 1982 under 2139-121; prepared by SRI International,
submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:247529-F)
00101645 Jagannath, D.; Hoorn, A.; Goode, S. (1980) Previcur N: Mutagenicity
Evaluation in Yeast. (Unpublished study received May 18, 1982 under
2139-121; prepared by Schering AG, W. Ger., submitted by Nor-Am
Agricultural Products, Inc., Naperville, IL; CDL:247529-G)
00109212 Hunter, B.; Watson, M.; Read, R.; et al. (1981) Previcur N (SN 66752):
Potential Tumorigenicity to Mice in Dietary Administration for 104 Weeks:
HRC Report No. SHG 164/80965. Final rept. (Unpublished study received
May 18, 1982 under 2139-121; prepared by Huntingdon Research Centre,
Eng., submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:247525-A; 247528)
00109540 Riemann, J.; Hoyer, G.; Klehr, M.; et al. (1980) Qualitative and Quantitative
Analysis of ... NDMA in Some Batches of Previcur N (70% Aqueous Solution
of Propamocarb.HCl, SN 66752) and the Precursor Compound ... Diamine:
APC 25/80, SPQ 24/80. Unpublished study; 29 p.
00118416 Frank, G. (1978) Determinations of Cholinesterase Activity in Plasma,
Erythrocytes, and Brain of Experimental Animals with a Centrifugal Analyzer.
(Presented at the X International Congress of Clinical Chemistry; Mar 2, 1978;
Mexico City, Mex.; unpublished study received Nov 16, 1982 under 2139-121;
prepared by Bayer, AG, submitted by Nor-Am Agricultural Products, Inc.,
Naperville, IL; CDL:248884-A)
00125237 Nor-Am Agricultural Products, Inc. (1983) Toxicology-Propamocarb
Hydrochloride: Dogs, Rats. (Compilation; unpublished study received Jan 13,
1983 under 2139-121; CDL:249252-A)
00125238 Kojima, K.; Enomoto, M.; Okamura, T.; et al. (1982) Three-month
Subchronic Oral Toxicity Study in Rats: Report No. 217. (Unpublished study
68
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BIBLIOGRAPHY
MRID
CITATION
received Jan 13, 1983 under 2139-121; prepared by Biosafety Research Center,
Japan, submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:249253-A)
00130267 Bhargava, A.; Kopp, R.; Gunzel, P.; et al. (1981) Influence upon the
Acetylcholinesterase Activity in vitro (Dog and Rat) and in vivo (Dog) after
Single Oral Administration: Previcur N: Prot. No. TX 81.060: Report No. PF
39/81. (Translation; unpublished study received Sep 20, 1982 under 2139-121;
prepared by Schering AG, W. Ger., submitted by Nor-Am Agricultural
Products, Naperville, IL; CDL:248355-A)
41278100 Nor-Am Chemical Co. (1989) Submission of Chemistry, Toxicity, Residue,
Metabolism and Phytotoxicity Data in Support of Propamocarb HCL.
Transmittal of 32 studies.
41278101 Baude, G.; Klehr, M. (1979) C6 Propamocarb HCL: Qualitative and
Quantitative Analysis of N- nitrosodimethylamine (NDMA) in Previcur N
(aqueous solution of Propamocarb HCL, SN 66 752): Lab Project Number:
SPQ/22/79/APC/23/79. Unpublished study prepared by Schering AG 15 p.
41278102 Klehr, M.; Schneider, P. (1980) C8 Propamocarb HCL: Synthesis of Possible
Non-Volatile N-Nitroso Compounds Derived from Propamocarb HCL (66 752)
and Analysis of These Compounds in Previcur N (70% Aqueous Solution of
Propamocarb): Lab Project Number: APC/43/80. Unpublished study
prepared by Schering AG 20 p.
41278103 Muller, T. (1988) C39 Solubility of Propamocarb-Hydrochloride in Water at 20
Degree C: Lab Project Number: 88/102. Unpublished study prepared by
Schering AG 47 p.
41278104 Miklautz, H. (1985) C5-Propamocarb HCL: The Determination of the Vapour
Pressure of SN 66 752: Propyl3-(Dimethylamino)propyl-carbamate
Hydrochloride: Lab Project Number: APC/37A/77. Unpublished study
prepared by Schering AG. 7 p.
41278105 Miklautz, H. (1980) C14-Propamocarb: The Temprature Dependence of the
Vapor Pressure of SN 66 752; Lab Project Number: APC/03/80. Unpublished
study prepared by Schering AG. 8 p.
69
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BIBLIOGRAPHY
MRID
CITATION
41834600 NOR-AM Chemical Co. (1991) Submission of Data To Support Propamocarb
HCL Reregistration: Product Chemistry and Toxicology Studies. Transmittal
of 8 studies.
41834601 Muller, T.; Lehne, V.; Steib, C.; et al. (1990) Propamocarb HCL:Product
Chemistry Study: Lab Project Number: 90/193/1: 89/050/1: 90/077/2.
Unpublished study prepared by Schering Ag. 292 p.
41834602 Wuthric, V. (1990) Previcur N Propamocarb-HCL Techn: 21-Day Prolonged
Toxicity Study Rainbow Trout Under Flow-through Conditions: Lab Project
Number: 223086: TB 88032. Unpublished study prepared by RCC
Umweltchemie Ag. 49 p.
41834603 Schnupner, J. (1991) The Static Acute Toxicity of Propamocarb-HCL to the
Sheepshead Minnow, Cyprinodon variegatus: Lab Project No:504AV.
Unpublished study prepared by NOR-AM Chemical Co., Research Center. 43
P-
41834604 Schupner, J. (1991) The Static Acute Toxicity of Propamocarb-HCL to the
Mysid Shrimp, Mysidopsis bahia: Lab Project Number: 500AV. Unpublished
study prepared by NOR-AM Chemical Co., Research Center. 39 p.
41834605 Downey, S. (1991) Investigation into the Phytotoxic Effects of
Propamocarb.HCL on Seed Germination (Tier 1): Lab Project No: 505 AV.
Unpublished study prepared by NOR-AM Chemical Co. 45 p.
41834606 Downey, S. (1991) Investigation into the Phytotoxic Effects of
Propamocarb.HCL on Seedling Emergence (Tier 1): Lab Project No:506/AV.
Unpublished study prepared by NOR-AM Chemical Co. 62 p.
41834607 Downey, S. (1991) Investigation into the Phytotoxic Effects of
Propamocarb.HCL on Vegetative Vigor (Tier 1): Lab Project No: 507/AV.
Unpublished study prepared by NOR-AM Chemical Co. 90 p.
41834608 Tschampel, M. (1990) W78 Propamocarb: The Photodegradation of
Propamocarb Hydrochloride (Schering Code ZK 66 752) on Soil Surfaces: Lab
Project Number: APC/87/90. Unpublished study prepared by Schering Ag. 44
P-
70
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BIBLIOGRAPHY
MRID
CITATION
42145000 Nor-Am Chemical Co. (1990) Submission of New Study Which Was Part of
Phase 3 Package: Propamocarb HCL: Acute Inhalation Toxicity. Transmittal of
1 study.
42145001 Schuh, W. (1990) Propamocarb HCL: Previcur N (CP 604; ZK 6752): Acute
Inhalation Toxicity Study in the Rat (M+F, 4 h Exposure): Revised Final
Report: Lab Project ID: TX 76.159; T7/2. Unpublished study prepared by
Schering AG Experimental Toxicology. 19 p.
42421200 Nor-Am Chemical Co. (1992) Submission of toxicity and environmental fate
data to support the reregistration of Propamocarb HCL. Transmittal of 2
studies.
42421201 Healing, G. (1992) T80 Propamocarb HCL: Previcur N (Propamocarb
Hcl)—Rat 21-Day Dermal Repeat Dose Study: Lab Project
Number:TOX/92/186-16: 91235. Unpublished study prepared by Schering Ag.
Ltd. 128 p.
42421202 Wrede-Rucker, A. (1992) W115 Propamocarb HCL: Dissipation of
Propamocarb X HCL in Soil Following Application of Banol—USA 1990: Lab
Project Number: UPSR 57/91: PF-R 89093. Unpublished study prepared by
Schering Ag, Berlin. 83 p.
42567900 NOR-AM Chemical Co. (1992) Submission of toxicity data to support
reregistration of Propamocarb. Transmittal of 4 studies.
42567901 Hakin, B. (1992) Previcur N SL: Bobwite Quail Acute Oral Toxicity (LD50)
Study: Lab Project Number: SMS 406/921159. Unpublished study prepared by
Huntingdon Research Centre Ltd. 25 p.
42567902 Hakin, B. (1992) Previcur N SL: Mallard Duck Subacute Dietary Toxicity
(LC50) Study: Lab Project Number: SMS 407/921085. Unpublished study
prepared by Huntingdon Research Centre Ltd.
42567903 Hakin, B. (1992) Previcur N SL: Bobwhite Quail Subacute Dietary Toxicity
(LC50) Study: Lab Project Number: SMS 408/921086. Unpublished study
prepared by Huntingdon Research Centre Ltd. 21 p.
71
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BIBLIOGRAPHY
MRID
CITATION
42567904 Schupner, J.; Stachura, B. (1992) Propamocarb/Wl 11: The Acute Toxicity
Propamocarb-HCl to Daphnia magna in a Static System: Lab Project Number:
512AV. Unpublished study prepared by Nor-AM Chemical Co. 41 p.
43013100 Nor-Am Chemical Co. (1993) Submission of Neurotoxicity Data in Support of
Propamocarb-HCL Phase 4 Data Call-in. Transmittal of 2 Studies.
43013101 Ponnock, K. (1993) T86 Propamocarb: Rat Acute Oral Neurotoxicity Study:
Range-finding Study: Lab Project Number: TOX/93/186-29: 92-4503:
TOX/92271. Unpublished study prepared by Pharmaco LSR Inc. 32 p.
43013102 Ponnock, K. (1993) T88 Propamocarb: Rat Subchronic (3-month)Dietary
Neurotoxicity Study: Lab Project Number: TOX/93/186-31:92-4505:
TOX/92006. Unpublished study prepared by Pharmaco LSR Inc. 630 p.
43044200 Nor-Am Chemical Co. (1993) Submission of Toxicology Data in Supportof
FIFRA 6(a)(2) for Propamocarb-HCL. Transmittal of 2 Studies.
43044201 Bathe, R.; Frei, T.; Luetkemeier, H.; et al. (1985) T-66 Propamocarb: 24
Month Oral (Feeding) Study with Previcur N in Beagle Dogs: Lab Project
Number: PF-81.812: 003688: 018617. Unpublished study prepared by Research
& Consulting Co. AG. 784 p.
43044202 Jackson, C. (1993) T-66, Addendum 1: Propamocarb: Dog Two Year Dietary
Toxicity "Relevance for Humans of Ocular Changes in Dogs". Unpublished
study prepared by Schering Agrochemicals Ltd. 7 p.
43062300 Nor-Am Chemical Co. (1993) Submission of Acute Toxicology Data in Support
of Propamocarb-HCl Reregistration. Transmittal of 1 Study.
43062301 Ponnock, K. (1993) T87 Propamocarb: Rat Acute Oral Neurotoxicity Study:
Lab Project Number: TOX/93/186-30:92-4504. Unpublished study prepared
by Pharmaco LSR Inc. 441 p.
43440900 AgrEvo USA Co. (1994) Submittal of Toxicity Data in Support of
Reregistration of Propamocarb (BANOL). Transmittal of 4 Studies.
72
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BIBLIOGRAPHY
MRID
CITATION
43440901 Chisholm, K. (1994) Addendum 1 to T87 Propamocarb Rat Acute Oral
Neurotoxicity: Lab Project Number: TOX/93/186-31. Unpublished study
prepared by Pharmaco LSR Inc. 5 p.
43440902 Bright, J. (1994) Addendum 1 to T88 Propamocarb Rat Subchronic (3 Month)
Dietary Neurotoxicity Study: Lab Project Number: TOX 92006. Unpublished
study prepared by AgrEvo UK Limited. 13 p.
43440903 Bright, J. (1994) Addendum 2 to T88 Propamocarb C113 Propamocarb:
Propamocarb HC1 Aqueous Solution 71.1% Active Ingredient; Analytical
Method for Rodent Diet: Lab Project Number: 067/01/001. Unpublished study
prepared by AgrEvo UK Limited. 29 p.
43440904 Auletta, C. (1994) Addendum 3 to T88 Propamocarb: Positive Control Data for
Neurotoxicity Studies: Lab Project Number: TOX 92005/TOX 92006.
Unpublished study prepared by Pharmaco LSR Inc. 51 p.
43619600 AgrEvo USA Co. (1995) Submission of toxicology data in support of
propamocarb reregistration. Transmittal of 1 study.
43619601 Kojima, K.; Enomoto, M. (1982) T46 Propamocarb HC1 Previcur N: Three
Month Sub-Chronic Oral Toxicity Study in Rats: Lab Project Number: 217.
Unpublished study prepared by Biosafety Research Center (AN-PYO Center)
and Schering AG. 582 p.
93193000 Nor-Am Chemical Company (1990) Reregistration Phase 3 Response:
Propamocarb propyl 3-(dirnethylamino)propylcarbamate.
93193002 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071300. Qualitative and Quantitative Analysis of NDMA in Some
Batches of Previcur N: APC 25/80; APC 24/80. 14 p.
93193003 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278102. Synthesis of Possible Non-volatile n-nitroso Compounds
Derived from Propamocarb-HCL and Their Analysis in Previcur N (Banol):
APC 43/80. 13 p.
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BIBLIOGRAPHY
MRID
CITATION
93193004 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278101. Qualitative and Quantitative Analysis of
N-nitrosodimethylamine (NDMA) in Previcur N: SPQ 22/79; SPQ 23/79. 11
P-
93193005 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278103 and Related MRIDs 41278107. Physical and Chemical
Characteristics of Propamocarb HC1 (Solubility in Water and Octanol/Water
Partition Coefficient: C39 88/102; C2 APC05/76. 9 p.
93193006 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278108. The Acute Toxicity (LD50) of ZK66752 to the Mallard
Duck: Laboratory ID. No. SHG 153 - LW/77 833; (Wl). Prepared by
Huntingdon Research Centre. 10 p.
93193007 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278109. Acute Oral (LD50) of ZK66752 to the Ring-Necked
Pheasant: Laboratory I.D. No. SHG 153 - WL/77831; (W2). Prepared by
Huntingdon Research Centre, lip.
93193008 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278111. The Subacute Toxicity (LC50) of ZK66752 to the
Ring-Necked Pheasant: Laboratory I.D. No. SHG -153 - WL/77741; (W4).
Prepared by Huntingdon Research Centre, lip.
93193009 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278123 and Related MRIDs 41278124. Mutagenicity Evaluation of
Previcur N in Yeast: Laboratory ID No. E9409. Prepared by Litton Bionetics.
12 p.
93193010 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278110. The Subacute Toxicity (LC50) of ZK66752 to the Mallard
Duck: Laboratory I.D. No. SHG 155 - WL/77611; (W3). Prepared by
Huntingdon Research Centre. 16 p.
93193011 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278112. Acute Toxicity of SN 66752 to Carp and Rainbow Trout:
Laboratory I.D. No. SHG 156/77919; (W37). Prepared by Huntingdon
Research Centre. 12 p.
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BIBLIOGRAPHY
MRID
CITATION
93193012 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278113. Acute Toxicity of SN 66752 to Bluegill and Rainbow
Trout: Laboratory I.D. No. SHG/157/77754;(W38). Prepared by Huntingdon
Research Centre. 13 p.
93193013 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00047370. The Acute Toxicity of SN 66752 (Previcur N) to the
Water Flea; Laboratory I.D. No. 11506-74-05;(W41). Prepared by UNION
CARBIDE CORP. lip.
93193016 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278115. Previcur N: Acute Oral Toxicity Study in Rats:
Laboratory I.D. No. 226; (T53). Prepared by An-Pyo Center. 12 p.
93193017 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278116. PROPAMOCARB HCL - Acute Percutaneous Toxicity
Study in Rats: Laboratory I.D. No. 229; (T56). Prepared by An-Pyo Center.
lip.
93193018 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 93193044. Acute Inhalation Toxicity to the Rat of Aqueous ZK
66.752 Following Single 4 Hr. Continous Exposure (LC50): Laboratory I.D.
Nos. PF 1/90 and TX 76.159; (T7/2). Prepared by Schering AG, Dept. of
Experimental Toxicology. 14 p.
93193019 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278117. PROPAMOCARB-HCI - Primary Eye Irritation after
Single Application with Previcur N in the Rabbit: Laboratory I.D. No. 024333;
(T47). Prepared by Research & Consulting Co. Ltd. 7 p.
93193020 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278118. Propamocarb HCL - Primary Skin Irritation Following A
Single 4-Hour Occlusive Application with Previcur N in the Rabbit: Laboratory
I.D. 018393; (T48). Prepared by Research & Consulting Co. Ltd. 7 p.
93193021 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00083808. Investigation of a Potential Sensitizing Effect of CP604 in
Guinea Pigs: Laboratory I.D. 266/77; (T29/2). Prepared by Schering AG,
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BIBLIOGRAPHY
MRID
CITATION
Dept. of Experimental Toxicology. 10 p.
93193022 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00125238. Three Month Subchronic Oral Toxicity Study in Rats:
Laboratory I.D. 217; (T46). Prepared by An-Pyo Center. 11 p.
93193023 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278119. Subchronic (90-Day) Feeding Study with ZK17.296 in
Dogs: Laboratory I.D. No. R5178; (T32). Prepared by TNO, Central Institute
for Nutrition and Food Research. 9 p.
93193024 Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary of MRID
00101641. Embryotoxicity Including Teratogenicity Study in Rats after Daily
Intragastrical Administration from Day 6 to Day 19 of Gestation - Revised Final
Report: Laboratory Project I.D. No. PF 24/90 (TX 80348 (T41/2). Prepared
by Schering AG. 9 p.
93193025 Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary of MRID
00072574. Embryotoxicity Including Teratogenicity Study in Rabbits After
Daily Intragastrical Administration From Day 6 to Day 18 of Gestation -
Revised Final Report: Laboratory Project I.D. PF 9/90 (TX 80122); (T36/2).
Prepared by Schering AG. 12 p.
93193026 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278120. PROPAMOCARB - PREVICUR N: Effect of
Administration during Organogenesis on Fetuses of the Rabbit:Laboratory I.D.
No. 143/A; (T35/2). Prepared by Huntingdon Research Centre. 14 p.
93193027 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278121. Microbial Metabolic Activation Test to Assess Mutagenic
Potential: Laboratory I.D. Nos. TOX 87250;TOX/87/186-14; SMS 53/87627;
(T70). Prepared by Huntingdon Research Centre. 10 p.
93193028 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278122. Propamocarb-HCL: Metaphase Chromosome Analysis of
Human Lymphocytes Cultures in vitro: Laboratory I.D. No. TOX 87249;
TOX/87/186-13; SMS 54/87808; (T69). Prepared by Huntingdon Research
Centre. 11 p.
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BIBLIOGRAPHY
MRID
CITATION
93193029 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071297. Determination of Rates of Hydrolysis of Propamacarb
Base at pH 5,7, and 9 at 25 Degrees C:Laboratory I.D. No. APC 26/76 with.
Addendum; W6. Prepared by Schering AG. 16 p.
93193030 Chow, N.; Stevens, N. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071296. Photolysis Experiment with Propamocarb HCL in Heat
Sterilized Aqueous Solutions: (W8). Prepared by Schering AG. 23 p.
93193031 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278126. Degradation of Propamocarb-HCL in a California Loamy
Sand: Laboratory I.D. No. R+S 29/79; (W13). Prepared by Schering AG. 15
P-
93193032 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278127. PROPAMOCARB HCL - Degradation of Propamocarb
HCL in a Loamy Sand: R+S 71/80 PA6752 71/6; (W15). Prepared by
Schering AG. 16 p.
93193033 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278128. Degradation of Propamocarb - HCL in a Loamy Sand
After Repeated Application: Laboratory I.D. No. UPSR1/86; PA66752.71;
(W58). Prepared by Schering AG. 25 p.
93193034 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278125. Degradation of SN66752 in a Loamy Sand: Laboratory
I.D. No. PA66752 71/6; (W12). Prepared by Schering AG. 23 p.
93193035 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
. of MRID 41278129. Degradation of SN66752 in a Loamy Sand under
Anaerobic Conditions: Laboratory I.D. No. PA 66752.71/6; W20. Prepared
by Schering AG. 22 p.
93193036 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071465. Anaerobic Degradation of Propamocarb Hydrochloride in
River Sediment: Laboratory I.D. No. R+S 60/80; PA66752 71/6; (W21).
Prepared by Schering AG. 22 p.
93193037 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
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BIBLIOGRAPHY
MRID
CITATION
of MRID 41278130. Adsorption to and Desorption from Soil: Laboratory I.D.
No. UPSR 19/88; (W59). Prepared by Schering AG. 28 p.
93193038 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278131. The Mobility of Propamocarb-HCL in Four Soils as
Determined by Soil TLC: Laboratory I.D. No. UPSR 88/68; (W69). Prepared
by Schering AG. 22 p.
93193039 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 41278132. Mobility of Propamocarb-HCL in Four Soils: Laboratory
I.D. No. PA66752 71/6; (W29). Prepared by Schering AG. 26 p.
93193040 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071472. Mobility of SN66752 in Two Soils after Aging:
Laboratory I.D. No. R+S 28/79; PA66752 71/6; (W30). Prepared by Schering
AG. 27 p.
93193041 Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
of MRID 00071476 and Related MRIDs 41278114. Uptake, Metabolic Fate
and Tissue Residues of Propamocarb in Bluegills and Channel Catfish:
Chemosphere 10(5): 469-478; (W35) and (W34). Prepared by University of
Missouri. 23 p.
93193042 Poggel, H. (1990) Nor-Am Chemical Company Phase 3 Reformat of MRID
00101641. Propamocarb HCL: Previcur N (CP 604) Embryotoxicity Including
Teratogenicity Study in Rats after Daily Intragastrical Administration from Day
6 to Day 19 of Gestation - Revised Final Report: PF 24/90; Study No. TX
80.348. Prepared by Schering AG. Ill p.
93193043 Poggel, H. (1990) Nor-Am Chemical Company Phase 3 Reformat of MRID
00072574. Propamocarb HCL: Previcur N (CP 604) Embryotoxicity Including
Teratogenicity Study in Rabbits after Daily Intragastrical Administration from
Day 6 to Day 18 of Gestation - Revised Final Report: T36/2; Study No. TX
80.122; PF 9/90. Prepared by Schering AG. 69 p.
93193999 Nor-Am Chemical Company (1990) Reregistration Phase 3 Response:
Propamocarb propyl 3-(dimethylamino)propylcarbamate. Correspondence and
Supporting Material.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section in below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section ni-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section ni-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
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your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section in - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
E-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
E-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
m-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance .of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-in Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ni-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
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requirement.
m7C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number la. or 7b)', then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data .
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study) '
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study) .-....•
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with th'e requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s). .
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
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will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to" enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-in Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
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you 'commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study -- If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
; You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in apcordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " 'raw data1 means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
. evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated;
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statem'ent on or attached to the study
signed by an authorized official or representative of the registrant.
You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
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which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
^ If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study - If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA. You
must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies - If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
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generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.. ; . . '
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as.appropriate.
m-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the .
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the ; :
Agency's decision. You must indicate and submit the option chosen on the Requirements Status ;
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a -
waiver request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force. . .
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to -
FIFRA'section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following: ........
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such-is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ni-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE "
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
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to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
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Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
\
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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PROPAMOCARB HYDROCHLORIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing Propamocarb Hydrochloride.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Propamocarb Hydrochloride. This attachment is to be used in conjunction with (1) the Product
Specific Data Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2),
(3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this Propamocarb Hydrochloride Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Propamocarb
Hydrochloride are contained in the Requirements Status and Registrant's Response, Attachment 3.
The Agency has concluded that additional data On Propamocarb Hydrochloride are needed for
specific products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible Propamocarb Hydrochloride
products. '
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Ed Setren at (703) 308-8166.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Ed Setren
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Propamocarb Hydrochloride
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4.
Item 5.
Item 6.
Already completed by EPA.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-in Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
•' letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
Item 7a.
Item 7b.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3
Item 4.
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158 155 through
158.180, SubpartC.
The study title associated with the guideline reference number is identified.
The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in'rare
cases.
The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-in Notice.
I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
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committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-in Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section ffl-C. 1.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
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completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5], I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice. ?
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc. •
Item 5. The study title associated with, the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item?. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases. :
Item 8. • The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary. ,
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
;,-'., .descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. . Enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
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3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-in Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed "
Certification of offer to Cost Share in the Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-In Notice (Section III-
C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-In Notice (Section ni-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may. be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite -an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
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or provide information in support of my request. If the Ageney approves my waiver
request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FEFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not Fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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No toxicology batching is required.
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c.
d.
e.
f.
g-
h.
i.
j-
k.
1.
m.
n.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
All applicable information which is on the product specific data submission must also
be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and pounds
per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and ail
common names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams.
In no case will volumes be accepted. Do not mix English and metric system units
(i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
When new CSFs are submitted and approved, all previously submitted CSFs become
obsolete for that specific formulation.
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief. Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name •
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into ah agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nam a of Flrm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company.named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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