United States .
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-030
December 1995
R.E.D. FACTS
. Pesticide
Reregistration
Use Profile
Hydroxypropyl
methane-
thiosulfonate
; ; -;' -". "-.-.'"- ;.., '''...'''' ' ' :" '.' ' '"'
' All pesticides sold or distributed in the United States must be "'.-'
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 mdre 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
any mitigation measures or regulatory controls needed to effectively reduce
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 3033, hydroxypropyl methanethiosulfonate (HPMTS)i
HPMTS is a microbiocide/microbiostat used to control slime forming
.. algae, bacteria, and fungi in commercial/industrial water cooling* systems,
industrial processing water, and pulp/paper mill water systems. It is also
Used as a preservative in industrial coatings, emulsions, paints and wet-end
additives/industrial processing chemicals.
Formulations include ready-to-use solutions and soluble concentrates.
For the primary use, recirculating water cooling systems, it is applied
mostly by direct pouring. HPMTS may be directly poured or metered into
industrial processing water and pulp/papermill water systems. The ,
chemical is also added to paint, varnish, coatings, polymer emulsions, and
wet-end additives/industrial processing chemicals by metered pump.
IJse practice limitations prohibit release to surface water except by
National Pollutant Discharge Elimination System (NPDES) permit.
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Regulatory HPMTS was first registered as a pesticide in the U.S. in 1968. A
History March 1987 Data Call-in (DCI) required toxicity and exposure data. A
September 1992 DCI required additional chemistry, human health and
ecological effects data. Currently, nine HPMTS products are registered.
Human Health
Assessment
Environmental
Assessment
Toxicity
In studies using laboratory animals, HPMTS generally has been
shown to be of high acute toxicity. It is corrosive and severely irritating to
skin and eyes and has been placed in Toxicity Category I (very highly or
highly toxic) for this effect. HPMTS is also considered to be a dermal
sensitizer. Testing indicated that HPMTS is negative for mutagenic effects.
Dietary Exposure
chronic dietary risk is not expected because HPMTS is not a food-use
pesticide.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to HPMTS during pouring of concentrated .
solutions in industrial settings. Inhalation exposures are not expected
because respirable particles are not expected from the current use pattern
and because of the chemical's low vapor pressure.. Residential exposures
are not expected because of the chemical's low concentration in formulated
paints and varnishes.
Human Risk Assessment
HPMTS generally is of high acute toxicity, but was negative for
mutagenic effects in animal studies. It poses no known chronic risks.
Of greater concern is the risk posed to handlers, particularly
mixers/loaders/applicators who come into contact with concentrated
HPMTS during mixing/loading/pouring of this pesticide. Exposure and risk
to workers is mitigated by the use of PPE required by the Worker
Protection Standard, supplemented by chemical resistant gloves, apron and
face-shield as required by this RED. No Restricted Entry Interval is
required because post-application exposures are not expected.
Environmental Fate
In aqueous solutions, the chemical's half life is dependent on pH.
HPMTS degrades moderately in weak acid solutions, quickly in neutral
solutions, and very quickly in alkaline solutions.
Ecological Effects
HPMTS is moderately toxic to slightly toxic to avian species on an
acute and subacute basis, slightly toxic to fish, and moderately toxic to
aquatic invertebrates.
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Risk Mitigation
Ecological Effects Risk Assessment
'" Current uses of HPMTS are expected to result in minima.1 exposure or
risk to the environment. Releases to surface water are already regulated
Jhrpugh the requirement for NPDES permits. No risks to endangered
species have been identified. Therefore, no additional risk mitigation
measures are being required at thi& time. -
To reduce acute eye and skin irritation risks to applicators/handlers of
HPMTS, use of PPE including chemical-resistant gloves, apron, and face
shield is required for end-use products classified as Toxicity Category I for
, these effects. "
Additional Data EPA is not requiring the submission of any additional generic studies
Required for HPMTS. However, EPA is requiring product-specific data including
" - product chemistry and acute toxicity studies, revised Confidential
, Statements of Formula (CSF), and revised labeling for reregistration.
Product
Required
Labeling All HPMTS End-Use Products must comply with EPA's current
Changes pesticide product labeling requirements, and with the following. Fora
comprehensive list of labeling requirements, please see the HPMTS RED
document.
Personal Protective Equipment (PPE) Requirements:
" ; Sole-active-ingredient end-use products that contain HPMTS must be
revised to remove any conflicting PPE requirements on their current
labeling.
.-.",, V^/Muitipie-actiye-ingredient end-use products that contain HPMTS
. must conipare the handler personal protective equipment requirements set
, ; forth hi this section to the PPE requirements on their current labeling.and
, retain the more protective. For guidance on which PPE is considered more
protective, see PR Notice 93-7. . -''".
7 -___".-. The minimum ^(baseline) PPE for occupational uses of HPMTS end-
^ ";>'.. use products is: :
- "Mixers, loaders, and others exposed to the concentrate must wear:
,r , -"Long-sleeve shirt and long pants, , .
Chemical-resistant gloves*,, , .
--shoes plus socks,
;'-' x- chemical-resistant apron, and.
--face shield."
Other Label Requirements ,
. . ' . - ; The Agency is requiring the followuig labeling statements to be
located on all end-use products containing HPMTS.'.-,'. ;
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Regulatory
Conclusion
For More
Information
Registrants must specify on labeling the complete directions for use
for each use pattern: site of application, type of application, timing of
application, equipment used for application, and the rate of application
(dosage).
Other Labeling Statements
"Do not use this product in a way that will contact workers orother
persons."
"This product may cause skin sensitization reactions in some people."
For all HP WITS end-use products:
"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."
"Do. not use in facilities discharging directly or indirectly to the
estuarine or marine environment."
To reduce environmental risk from HPMTS discharge and disposal,
product labels must include the statements pertaining to effluent discharge
under the NPDES permitting system (refer to PR Notice 93-10) and . -
disposal under any applicable federal laws after the above statement.
For HPMTS end-use products "gloves" if gloves are required PPE:
"Users should remove Personal Protective Equipment immediately
after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly."
EPA has determined that products containing HPMTS are eligible for
reregistration. The use of eligible HPMTS products in accordance with
labeling specified in this RED will not pose unreasonable adverse effects to
humans or the environment. .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 HPMTS will be reregistered when all of their
other active ingredients are also eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for HPMTS 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
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at 703-308-7224. They also are available on the Internet on EPA's gopher':
server, GdPHER.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 HPMTS '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 mqre information about EPA's pesticide, reregistration program, '
the HPMT$ RED, or reregistratiqn of individual products containing
HPMTS, please cqntact the Special Review and Reregistratiori Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.. V -,'."-.'
'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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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.a 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFnH.D MATT.
FEB 27 i996
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 and active
ingredient hydroxypropyl methanethiosulfonate. 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 is due 90 days from
the receipt of this letter. The second set of required responses is 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.
. i - ,"'' * ' " ' '' ' . - " " ' '
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
Moana Appleyard (703) 308-8175. Address any questions on required generic data to the
Special Review and Reregistration Division representative Patrick Dobak (703) 308-8180.
. Sincerely yours,
Enclosures
Lois Rossi, Division Director
Special Review .. " ..'
and Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 - DATA CALL-IN (DCI) 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, a DCI letter will be enclosed listing such requirements. If both generic and"
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have "been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic ,
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, ypur 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 time extensions for product specific data
should be submitted in the 90-day response. Requestsjfor data waivers must be submitted as
part of the 90-day response. 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, but are not
required to, 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).
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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
limits (see 40 CFR ง158.175) 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 ง158.175(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 REVEEWS-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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RERIE^STRATION ELIGIBILITY DECISIO3V
HYDROXYPROPYL METHANETHIOSULFONATE
LIST C
CASE 3033
ENVmONMEOTAL PROTECTION AGENCY
' OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
HYDRQXYPRpPYL METHANETfflOSULFQNATE REREGISTRATION ELIGIBILITY
DECISION TEAM .'.. . ..... . . ... . . . .;. , ..;... -.'. . . r. i
EXECUTIVE SUMMARY ............ . ' . . :.'.;'.:. ; ; .;:', '.. ... ... ...... v
I. INTRODUCTION .; .../... . . .... . ._,'.". . . .;.'. .':'. . 1
ri. CASE OVERVIEW ... , . . ; ... ..... ... . . ... ... ... . . : . 2
A. Chemical Overview ,.,,,.,.,.. , , . . . ... ...,,...:......... 2
B. Use Profile . . ... . .... .'..'-. ... . .., . . ..' . . . ;'. .-;. . . . . . . .... .2
C. Estimated Usage of Pesticide . .... . .... . ....... .'....... . . . . .4
D. Regulatory History and Data Requirements . ...... . . . ;'; . . 4
JH. -SCIENCE ASSESSMENT '.':". . .:. . :..'v/. -..'.;,'. ...... .'. . '." ._.:. .'. . ; . ....'. 4
A. Physical Chemistry Assessment..... ... ..................... 4
B. Human Health Assessment ................... . .... . ....>.. . . . -5
1. Toxicology Assessment . . . ............. ; . .5
a. Acute Toxkity .:.:.........:,.......,. ^.. .. .5
b. SubchronicToxicity -. . : ., ., . . . .; . . .....;.; 6
c. Chronic Toxicity/Carcinogenicity .................. 7
..'.". d. Developmental Toxicity . ; ...... 7
e. Reproductive Toxicity ..... ... .............. ... 7
f. Mutagenicity . . . ... ....... ... ....... -... ...... 8
- g. Metabolism . . . ......... . . , . . . .".....-. 8
h. Toxic Endpoints of Concern .......... ...... ..... 8
2. Exposure and Risk Assessment . . . . . . . . . . . .... ... . . . . . .'9
a. Dietary Exposure and Risk Assessment .....;., ... . . ..9
b. Occupational and Residential Exposure and Risk Assessment
'.'.-... ' -, :".:;-'" " ':, /' -'.'.. ;vv;\.;-.v.. /.:.v-.-.'Vv:.. ';.., ,.->. ...9
r C. Environmental Assessment. .............................. 1Q
1. Ecological Toxicity Data . . . ........................ 10
a. Toxicity to Terrestrial Animals .................. 10
. b. Toxicity to Aquatic Animals . .11
c. Toxicity to Plants ... T: .............. .....^ .. 13
2. .Environmental Fate . 1 .... ... . . .v. , . . . . ..... .... . . . 13
a. . Environmental Fate Assessment . .... .i .......... 13
b. Environmental Fate and Transport . ..'.. ... 13
3- Exposure and Risk Characterization . . 14
TV. RISK MANAGEMENT AND REREGISTRATION DECISION .14
A. Determination of Eligibility . . ..... . . . . . . . .-.. . .... .... .... . 14
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B. Determination of Eligibility Decision 15
1. Eligibility Decision 15
2. Eligible and Ineligible Uses 15
3. Endangered Species Protection 15
C. Regulatory Position 15
1. Risk Mitigation Measures/ Labeling Rationale .; ~16
2. Entry Restrictions 17
3. Addition and Retention of Other Label Statements 17
V. ACTIONS REQUIRED OF REGISTRANTS 17
A. Manufacturing-Use Products . 17
1. Additional Generic Data Requirements 17
2. Labeling Requirements for Manufacturing-Use Products 18
B. End-Use Products 18
1. Additional Product-Specific Data Requirements 18
2. Labeling Requirements for End-Use Products 19
- - C. Existing Stocks ..'. 21
VI. APPENDICES , . 23
APPENDIX A. Table of Use Patterns Subject to Reregistration 24
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision . 33
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Hydroxypropyl methanetbiosulfonate 39
APPENDIX D. Product Specific Data Call-in 45
Attachment 1. Chemical Status Sheets 59
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions . . 60
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions . 62
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 69
Attachment 5. List of All Registrants Sent This Data Call-In (insert)
Notice 73
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 74
APPENDIX E. List of Available Related Documents 82
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HYDRQXYPROPYL METHANETmOSULFONATE REREGISTRATION
ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
'Biological and Economic Analysis Assessment
Ghulam Ali
Steve Jarboe
Cynthia Szymanski ;
Environmental Fate and Effects Assessment
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Ann Stavola
Mary Frankenberry.
Rachelle Kudrik
Jose Melendez
Health Effects Assessment
'"~" ': , * -' " ,r' " "'-.-, "*- '"
Arliene Aikens .',:.,-.
Tom Campbell
Paula Deschamp
Steven Malish.
Registration Support
Valdis Goncarovs
Tina Leyjne
Shyam ]\iathur
Risk Mankgement
~ ... . : : . ~~~~. 1~T= ! -. '. _ _. ; .
Kathleen Depukat
Patrick Dobak
Office of Compliance:
Carol Buckingham
Ecological Effects Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Environmental Fate and Grqundwater Branch
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Risk Characterization and Analysis Branch
Toxicology Branch IE
Antimicrobial Program Branch
Reregistration Support Branch
Reregistration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Agriculture and Ecosystem Division
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
: ADI
AE
a.i.
ARC
CAS
CI
,CNS
CSF
DFR
ORES
. DWEL
EEC '
EP. :.'-'
EPA
FDA-
FIFRA
EFDCA
FOB
GLC
GM
GRAS
HA "
HDT
LC50
LD,
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L"
MOE "
MP
MPI
MRID
N/A
NOEC
Acceptable Daily Intake. A now defiinct term for reference dose (RfD),
Acid Equivalent ,
; Active Ingredient . - ,
Anticipated Residue Contribution ' " .,.'-.
Chemical Abstracts, Service -
Cation '.-.".
Central Nervous System '
Confidential Statement of Formula
Dislodgeabie Foliar Residue
Dietary Risk Evaluation System
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. .
Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End-Use Product , . . ' ,\;
U-S. Environmental Protection Agency ,
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
, Federal Food, Drug, and Cosmetic Act
Functional Observation Battery .
Gas Liquid Chromatography '
Geometric Mean "".
Generally Recognized as Safe as Designated by FDA '
Health Advisory "(HA). The HA values are used as informal guidance to municipalities arid
other organizations when emergency spills or contamination situations occur.
Highest Dose Tested .
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.
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.
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level , ' . . ,
Level of Concern . -
Lirhit of Detection . ,
Lowest Observed Effect Level .
Maximum Acceptable Toxicant Concentration ;
Maxiriium Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per. Liter ,
Margin of Exposure .''.'
Manufacturing-Use Product I , .,'"'"' "
-Maximum Permissible Intake '
Master Record Identification (number). EPA's system of recording and tracking studies
submitted* . " ' . -
Not Applicable ' "-.'.-
No effect concentration . ,
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GLOSSARY OF TERMS AND ABBREVIATIONS
i
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs ' 1
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"i 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 Rbdenticide Act," as amended
in 1988, the U.S. Environmental Protection Agency has completed its reregistration eligibility
decision for the pesticide active ingredient hydroxypropyl methanethiosulfonate (HPMTS).
This decision includes a comprehensive reassessment of the required target' data base and use
patterns of currently registered products. The Agency compared its risk assessment to current
science and regulatory policies. The Agency has determined that the uses as described below
will not cause unreasonable risk to humans or the environment and all uses are eligible for
reregistration. Where appropriate, the Agency has imposed additional use restrictions and
precautionary statements for product labels to reduce risks to human health and the
environment.
Use Patterns ' . ":' ' _ ' " '.-.'. i " '" ',.'.;';" .-' ,.'.' ' > : ,-/,-' -.
HPMTS is a microbiocide/miCrobiostiat used to control slime-forming algae, bacteria,
and fungi in commercial/industrial water cooUng systems, industrial processing water,
pulp/paper mill water systems, and is used as a preservative in industrial coatings, emulsions,
paints and wet-end additives/industrial processing chemicals. It is applied by direct pouring
and metered application. , .
Human Health Assessment _
- From its review of the toxicology data, the Agency concluded that HPMTS is mildly to
moderately toxic when administered by oral or dermal routes. The chemical is corrosive and
is considered to be a severe dermal and eye irritant. The chemical caused delayed contact
hypersensitivity in the guinea pig dermal sensitization studies. The subchronic dermal LOEL
was determined to be 250 mg/kg/day for systemic toxicity and 10 mg/kg/day for dermal
. toxicity. A battery of mutagenicity studies was negative for mutagenic effects. Two
developmental toxicology studies were reviewed. The rat maternal LOEL and NOEL were
Determined to be 30 mg/kg/day and 10 mg/kg/day, respectively. The rabbit maternal LOEL
and NOEL were determined to be 4.0 mg/kg/day and 0.75 mg/kg/day, respectively.
No dietary exposure to HPMTS is expected from the current use patterns. Although
corrosiveness and dermal sensitization were identified as potential effects, significant
occupational exposures are not expected. Therefore, quantitative assessments of exposures
and risks were deemed unnecessary and not conducted. To mitigate the potential risks of
corrosiveness and dermal sensitization to workers, minimum (baseline) personal protective
equipment (PPE) is being required for the handling of concentrated products. Non-
occupational exposures are not expected. >
Environmental Assessment -
v .
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HPMTS is moderately toxic to slightly toxic to avian species on an acute and subacute
oral dietary basis, slightly toxic to fish, and moderately toxic to aquatic invertebrates. Current
uses of HPMTS are expected to result in minimal exposure or risk to the environment.
Therefore, no additional environmental risk mitigation measures are being imposed at this
time.
Product Reregistration
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 for all products containing HPMTS. These data include product chemistry and
acute toxicity testing for each registration. After reviewing these revised labels and finding
them acceptable in accordance with Section 3(c)(5) of FBFRA, the Agency will reregister each
associated product. Those products that contain other active ingredients will be eligible for
reregistration only when the other active ingredients are determined to be eligible for
reregistration.
VI
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i. -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 'refegistfation.' ~ " '' .; '' ' "'.'"'" ''''"' . ,
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 FDFRA. '
This document presents the Agency' s decision regarding the reregistration eligibility of
the registered uses of 2-hydroxypropyl methanethiosulfonate (HPMTS). The document consists
of six sections. Section I is the introduction. Section n describes HPMTS, its uses, data
requirements and regulatory history. Section ffl discusses the human health and environmental
assessment based on the data available to the Agency. Section IV presents the reregistration
decision for HPMTS. Section V discusses the reregistration requirements for HPMTS. 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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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
HPMTS
2-hydroxypropyl methanethiosulfonate
Thiosulfonates
30388-01-3
35604
B.
C4HnS2O3
Trade and Other Names: S-(2-hydroxypropyl) thiomethanesulfonate
Basic Manufacturer: Buckman Labs
Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of HPMTS is in
Appendix A.
For 2-hydroxypropyl methanethiosulfonate:
Type of Pesticide: Microbiocide/microbiostat (slime-forming algae, bacteria and
fungi), Bacteriostat.
Use Sites:
AQUATIC NON-FOOD INDUSTRIAL .
Commercial/Industrial Water Cooling Systems
Industrial Processing Water
Pulp/Paper Mill Water Systems
INDOOR NON-FOOD
Industrial Coatings
Resin/Latex/Polymer Emulsions
-------
Latex/Oil/Varnish Paints (Applied Film)
Wet-End Additives/Industrial Processing Chemicals
: Target Pests: Slime-forming algae, bacteria and fungi
End-use, Manufacturing-use;
Formulation Types TYPE:
Registered:
FORM:
PURITY:
Soluble Concentrate/Liquid, Ready-To-Use Solution
/Liquid .'.', ;
''' : '' ' / ' '
Single Active Ingredient
TGAI:80% ., ...'.., ..' ".'
JEnd-Use Products: 5-80%
Multiple Active Ingredients
End-Use Products: 11.7-28%.
Method and Rates Equipment - Direct pour, metered application (registrant must
of Application: specify on labeling). For Rates of application see Table 1 below.
Timing - During manufacture, Not specified (registrant must supply
, on labeling). , ,
Table 1 - Method and Rate
TREATMENT
TYPE
Water (recirculating)
Water (recirculating)
Water
Industrial '
Preservative . ,
Industrial
Preservative
Industrial
Preservative
Industrial
Preservative
SYSTEM TYPE
Commercial/Industrial Cooling Systems
Industrial Processing
Pulp/Papermill
Industrial Coatings
Resin/Latex/Polymer Emulsions
Latex/Oil/Varnish Paints (applied film)
Wet-End Additives/ Industrial Processing,
Chemicals
RATE (ppm AI
by weight)
0.4 to 8.5
6.4 to 4.3
0.176 to 281
400 to 4050
; ,
400 to 4050
280 to 2800
400 to 4050
-------
Use Practice
Limitations:
NPDES license restriction.
C. Estimated Usage of Pesticide
Information about the use and percentage of sites treated with HPMTS is-not
readily available. However, the aggregate annual use of this pesticide is considered to be
quite small in the United States, based on proprietary sources.
D. Regulatory History and Data Requirements
Products containing HPMTS as an active ingredient were registered in the United
States as early as 1968. Currently, nine products are registered to one registrant for the
uses described above.
In March, 1987, the Agency issued the Anti-Microbial Data Call-in Notice for
toxichy and exposure data requirements for this active ingredient and other antimicrobials.
Additionally, the Agency issued a September, 1992 Phase IV Data Call-In requiring
studies on product chemistry, human health, and ecological effects data to support the uses
listed. 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
Molecular Weight: 171.25
Color: Light yellow/brilliant yellow
Odor: Strong sour, pungent vegetable-like odor
Boiling Point: 164ฐC
Density: . 1.2893 at 22ฐC
Solubility:
-------
Table 2 - HPMTS Solubility
Solvent
Ethanql
Hexane
C8fi8 Fatty Acids
Water
Solubility
Miscible in all proportions ,
< 16 mg in 100 ml : ,
Mean fat solubility at 37ฐC
At concentrations > 40%,
concentrations < 40%, not
is 5.42+0.04 g/100 g
soluble at any concentration; at
completely soluble
Vapor Pressure: 1.40 mm Hg at 20ฐC and 1.70 mm Hg at 25ฐC. .
pH: '''.; 3.7 at 22ฐG.. ' :':".'" ' '>'''',
B, Human Health Assessment ;
,1. Toxicology Assessment
,1he lexicological data base on HPMTS is adequate to support reregistration
- eligibility. .
a. Acute Toxicity
Table 3 - Acute Human Health Studies
Type of Study
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation
Primary Eye Irritation*
Primary -Dermal Irritation*
Dermal Sensitization - guinea pig*
Results [mg/kg]
LD5Q2000
Waived
Waived
Waived
Sensitizer
Toxicity Category
n
m
NA ; " "
I
I
'- NA
* This study is a requirement for manufacturing-use and end-use products (40 CFR 158).
applicable . ',.-.'
NA = not
In an acute oral toxicity study in the rat, HPMTS (81.45% a.i.) was
administered by oral gavage to 5 animals/sex and observed for 14 days.
-------
Compound related clinical signs presented were transient hypoactivity and
staggered gait in surviving rats. Reddening of glandular stomach mucosa
and the gastrointestinal tract were seen. (MRID 41634701)
In an acute dermal toxicity study in the rat, HPMTS (81.45 % a.i.)
was administered by dermal application at 2 gm/kg (limit dose) to 5
animals/sex for 14 days. Dermal irritation was present in all animals and
included erythema, edema, fissuring, hemorrhaging, blanching, atonia, and
a leathery feel to the skin. The dose used in the study was the limit dose
specified hi the guidelines. (MRID 41632401)
An acute inhalation study was waived because the absence for
potential for inhalation exposure (no respirable particles) is indicated by the
current HPMTS use pattern. The primary dermal irritation and eye
irritation studies were waived because HPMTS was corrosive in the 14 and
90-day dermal studies.
In a guinea pig dermal sensitization study, HPMTS (40% a.i.) was
found to be a sensitizer. HPMTS caused delayed contact hyper sensitivity.
(MRID 42349201)
b. Subchronic Toxicity
In a two-week, repeat dose (range finding), dermal toxicity study
conducted in the rat, HPMTS (79.67% a.i.) as a 30% solution [in distilled
water] was applied to 5 animals/sex at doses of 0, 100, 250, 500, 750 or
1000 mg/kg/day, for 6 hours/day, 5 days/week for 14 days. Control
animals received distilled water. A dose related irritation was presented
with eschar, and exfoliation at 500 to 750 mg/kg/day. The dermal no
observable effect level (NOEL) was < 100 mg/kg/day (lowest dose tested).
(MRID 40747102)
In a dermal toxicity study in rats, HPMTS (79.67% a.i.), at a
concentration of 5.0%, was applied to approximately 10% of the body
surface area of 10 animals/sex at doses of 0, 10, 50 or 250 mg/kg/day.
Exposure was for 6 hours/day, 5 days/week for 91 days. Control animals
received distilled water under the same experimental conditions.
Slight treatment-related reductions in body weight and food
consumption were found in the high dose males. Compound-related
reductions in erythrocyte counts, hematocrit and hemoglobin occurred in
both high dose males and females as compared to the respective controls.
A slight but significant increase in the platelet count occurred in the high
dose in both sexes.
-------
. Compound and dose-related dermal irritation was found in the
treated animals at the application site. The severity of the irritation ranged
from minimal in the low-dose animals to severe in the high-dose animals
of both sexes. Surface exudate, dermal inflammation, and fibrosis
occasionally accompanied the ulceration in the high-dose animals.
Microscopic examination confirmed the gross observation of the skin inr the
high dose animals as ulceration and acanthotic epidermal thickening.
Based on changes in body weights and hematology at the high dose,
the lowest observable effect level (LOEL) for systemic toxicity is 250
mg/kg/day and the NOEL is 50 mg/kg/day. The LOEL for dermal toxicity
is 10 mg/kg/day, the lowest dose tested. (MRID 40974701)
c. Chronic Toxicity/Carcinogenicity
, Chrpnic, toxicity and carcinogenicity studies are not required for
HPMTS because the non-food use pattern scenarios currently registered are
not likely to result in significant human exposure.
dv Developmental Toxicity
A developmental toxicity study conducted in the rat, evaluated
HPMTS (79.67% a.i.) at doses of 0, 10, 30 or 75 mg/kg/day by gavage
from gestation days 6 to 15. The maternal NOEL was 10 mg/kg/day and
the maternal LOEL was 30 mg/kg/day based on salivation, rales, and oral-
nasai discharge. The developmental NOEL was 10 mg/kg/day and the
developmental LOEL was 30 mg/kg/day based on reduced fetal weight;
(MRID 41010501)
1 ' ' s' . - ",-." ' ' , '",-..'
Another developmental toxicity study conducted by gavage in the
rabbit, evaluated HPMTS (79,67%) at doses of 0, 0.75, 4.0 or 7.5
mg/kg/day from gestation days 6 to 18. The maternal NOEL and LOEL
were 0.75 mg/kg/day and 4.0 mg/kg/day, respectively, based on decreased
body weights. The developmental NOEL was ;>7.5 mg/kg/day (HDT).
(MRID 41010401) "
e. Reproductive Toxicity
_ A,reproductive toxicity study .is not required to support the
currently registered non-food uses of HPMTS because the use pattern
scenarios are not likely to result in significant human exposure.
f. Mutagenicity
-------
2.
In a gene mutation (Reverse Mutation) study, HPMTS (79.67%
a.i.) did not produce gene mutation in an Ames assay in which S.
typhimurium (TA98, TA100, TA1535 and TA1538) bacteria were tested
without activation up to 0.25 /d/plate and with activation up to 0.5 /xl/plate.
Concentrations zQ.5 /d/plate produced cytotoxicity. (MRID 40229601)
HPMTS (80% a.i.) was negative both with and without activation
in a Sister Chromatid Exchange (SCE) In Vitro/CHO assay when assayed
at concentrations into the toxic range (16.7 Aig/ml). (MRID 40420201)
In the DNA Damage/Repair in Primary Rat Hepatocytes study,
HPMTS (80% a.i.) was negative for inducing UDS at concentration levels
into the toxic range (100 ju,g/ml and higher). (MRID 40420202)
g-
Metabolism
A metabolism study is not required to support non-food uses of
HPMTS because of the expected absence of oral exposure and because the
current use pattern scenarios, are not likely to result in significant human
exposure.
h. Toxic Endpoints of Concern
Based on HPMTS' target database for toxicology, the Agency
concludes there are no lexicological endpoints of concern for HPMTS.
While technical HPMTS has been demonstrated to be corrosive and lead to
dermal sensitization from acute exposures, these concerns are more
appropriately addressed during product reregistration after a re-assessment
of each product's acute toxicity.
Reference Dose (RFD)
s
A reference dose was not established for HPMTS, based on the non-
food use patterns and exposure profile (The Agency's Office of Pesticide
Programs RfD Committee report, February 15, 1995)
WHO/JMPR Status .
The World Health Organization/Joint Meeting on Pesticide Residues
committee has not reviewed this pesticide.
Exposure and Risk Assessment
a. Dietary Exposure and Risk Assessment
8
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There are no registered food uses of HPMTS, therefore, a dietary
exposure and risk assessment are not required.
b. Occupational and Residential Exposure and Risk Assessment
An occupational/residential exposure assessment is required for an
active ingredient if: (1) certain lexicological criteria are triggered and .(2)
there is potential exposure to handlers (M/L/A) during use or to persons
entering treated sites after application is complete. Since toxicology
endpoints of concern, except for corrosiveness and dermal sensitization
from acute exposures, were not identified for occupational/residential
exposures, an occupational/residential M/L/A exposure analysis and
quantitative risk assessment are not warranted at this time.
' .The Agency has determined that products containing HPMTS
labeled and used as specified in this RED will not pose significant risk to
humans. The most significant occupational concerns are for corrosiveness
and dermal sensitization from acute exposures. The use of minimal
(baseline) PPE , including chemical resistant gloves and apron and
faceshield, will adequately mitigate these hazards.
A short term (1 to 7 days) occupational/residential risk assessment
is not required, since results frorri the 14-day dermal toxicity study do not
indicate any toxicological endpoints appropriate for use in the standard
occupational or residential exposure assessments. Also, an intermediate (1
week to several months) occupational/residential risk assessment is not
required based on a comparison of the 90-day repeated-dose dermal toxicity
and the oral developmental toxicity studies conducted in rats. In these
.studies, the LOEL(s) were 250 mg/kg/day and 30 mg/kg/day, respectively.
On the basis that the dermal LOEJ, was significantly higher, it was
determined that dermal absorption of HPMTS is limited. Also, inhalation
exposures are not expected because respirable particles are not anticipated
;..-.;. to be produced from the application methods (open-pour or metered pump)
and because of the chemical's low vapor pressure.
Most of HPMTS' use and exposure are associated with industrial
applications. Additionally, people who apply HPMTS treated paint or who
reside or work in buildings which have painted with such paint may also be
exposed to HPMTS. However, because of the Agency's Conclusion on
: HPMTS' risks from subchronie exposures and because of HPMTS' low
vapor pressure, the Agency believes risks to these individuals are very low.
Environmental Assessment
9
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1.
Ecological Toxicity Data
Toxicity to Terrestrial Animals
a.
(1) Birds, Acute and Subacute
In order to establish the toxicity of HPMTS to birds, the
following tests are required for industrial microbiocides using the
technical grade material: one avian single-dose oral (LD50) study
on one species (preferably the bobwhite quail or mallard duck); one
subacute dietary study (LC50) on one species (preferably the
bobwhite quail). The available information is summarized in the
following tables:
Table 4 - Avian Acute Oral Toxicity Findings
-Species
Mallard Duck
% A.I.
79.82
LDgo mg/kg
> 474.4 mg/kg
Toxicity Category
moderately toxic
Although the avian acute oral study yielded some
information, it was not considered acceptable because the birds
regurgitated shortly after dosing. The registrant is performing a
new study in order to fulfill guideline requirements.
Table 5 - Avian Subacute Dietary Toxicity Findings
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
79.82
79.82
LCgo ppm
>3991
>3991
Toxicity Category
slightly toxic
slightly toxic
The results from the subacute study and the supplemental
results of the acute oral study indicate that HPMTS is slightly to
moderately toxic to avian species on an acute oral and subacute
dietary basis. (MRID 249523 for all three)
(2) Birds, Chronic
Avian reproduction studies are required when birds may be
exposed, repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. Since the currently
10
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registered uses are for indoor use only, repeated exposures are not
expected and chronic avian studies are not required.
(3)
Mammals
;..v Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent environmental
fate characteristics. In most cases, however, an acute oral LD50 is
used to; indicate ^toxicity to mammals. The LD50, as reported in
Table 3 above, indicates that HPMTS is slightly toxic to small
"'x. mammals on an acute oral basis. No additional testing on mammals
is required for these use patterns. (MRID 41634701)
b. Toxicity to Aquatic Animals
,(1) Freshwater Fish
(a) Acute
In order to establish the toxicity of a pesticide to
freshwater fish, theminhtium data required for industrial
microbiocides is one freshwater fish toxicity study on the
technical grade of the active ingredient. The study should
preferably use the rainbow trout (cold water species) or the
bluegill sunfish (warm water species). The available
}S iiformation is summarized in the following table.
Table 6 -Freshwater Fish Acute Toxicity Findings
. Species
Rainbow trout
Bluegill sunfish ...
% A.I.
81.45
81.45
LC50 (ppm)
28.0
38.2
Toxicity Category
slightly toxic
slightly toxic
, The results of the 96-hour acute toxicity studies
indicate that HPMTS is slightly toxic to both cold and warm
water fish. The guideline requirements are fulfilled.
} (MRIDs 41733203 and 41733201, respectively)
(b) Chronic
ii
-------
The fish early life-stage and fish life-cycle tests are
not required because the products are not applied directly to
water or expected to be transported to water from the
intended use site. Additionally, the fish early life-stage test
is not required because the LC50 in this case is greater than
Img/L.
(2) Freshwater Invertebrates
(a) Freshwater Invertebrates, Acute
The minimum testing required to establish the
toxicity of a microbiocide to freshwater invertebrates is a
freshwater aquatic invertebrate toxicity test, preferably
using first instar Daphnia magna or early instar amphipods,
stoneflies, mayflies, or midges. The results of the toxicity
findings are presented in the table below.
Table 7 - Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% A.I.
79.82
ECjo (ppm)
3.13
Toxicity Category
moderately toxic
(3)
There is sufficient information to characterize
HPMTS as moderately toxic to aquatic invertebrates. The
guideline requirement is fulfilled. (MRTD 41733202)
/
(b) Freshwater Invertebrates, Chronic
The same conditions for chronic testing to freshwater
fish also apply to aquatic invertebrates as discussed in (1 .b.)
above. Chronic aquatic invertebrate studies are not required
for HPMTS.
Estuarine and Marine Animals
(a) Acute
Although estuarine/marine testing was originally
required, a waiver for those data requirements was
subsequently granted in response to the registrants'
incorporation of a statement on all HPMTS labels restricting
12
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.: the discharge of HPMTS directly or indirectly into .estuarine
, or marine environments to NPDES permitted discharges.
(b) Chronic :
The same conditions for chronic testing to freshwater
fish and aquatic invertebrates also apply to estuarine and
marine animals as discussed in (1 .b.) above. Therefore, the
chronic estuarine/marine studies for HPMTS are not
required.
c. Toxicity to Plants
('.I,-- ., ,, - ,,,, ; ; .,,, ,..,.., . . ., . ,, , ; : .,-*'* ' " v* < ,. "
'i. I ' 'f ' ' . 'l - , ' ' I - ',"*.,'.*'"" . '' . ,
Terrestrial and aquatic plant testing are currently not required, in
most cases, for industrial microbiocides, including HPMTS.
Environmental Fate
a. Environmental Fate Assessment
Due to the current use patterns for HPMTS, the Agency requires
only a hydrolysis study for the reregistration target data base.
b. Environmental Fate and Transport
(1) Degradation _
Hydrolysis ,
[2-14C]2-hydroxypropylmethanethiosulfonate, at 101 mg/L,
hydrolyzed with half-lives of > 30 days at pH 5, 8.5-9.9 hours at
pH 7, and 5.4-6,1 minutes at pH 9 in sterile aqueous buffered,
solutions at 25ฐC in the dark for. up to 30 days. Two major
degradates were observed.
One degradate, di-(2-hydroxyisopropyl)disulfide, was a
V maximum of 24-29% of the recovered at 20 or 30 days in the pH
5 solution; 61-64% of the recovered at 24.5 hours in the pH 7
solution; and 63-66% at 15.0-15.2 rnmutes in the pH 9 solution.
The other major degradate, di-(2-hydroxypropyl) disulfide, was a
. maximum of 5.9% of the recovered at 22-30 days in me. pH 5
solution; 10-12% at 24.5 hours in the pH 7 solution; and 8:17%' at
10.1-15.2 minutes in the pH 9 solution. This study was found to be
13
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acceptable and satisfies all data requirements for HPMTS. (MRID
41475207)
3. Exposure and Risk Characterization
The Agency requires only a limited set of ecotoxicolpgy and environmental
fate studies for microbicides. HPMTS is slightly to moderately toxic to birds and
aquatic invertebrates. While the hazard to aquatic organisms from HPMTS has
been characterized, a quantitative risk assessment has not been conducted. The
risks to aquatic environments from its industrial aquatic uses are regulated under
the NPDES permitting program of EPA's Office of Water. The Agency currently
requires that labels for all HPMTS products require that discharges to aquatic
. environments comply with an NPDES permit.
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
ingredient 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 the active ingredient HPMTS. 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 HPMTS. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of HPMTS, and lists the submitted studies that
the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of HPMTS and to determine that HPMTS can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing HPMTS as the active ingredient, and as specified in this
document, are eligible for reregistration. The reregistration of particular products is
addressed in Section V of this document.
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, and the data identified in
Appendix B. Although the Agency has found that all uses of HPMTS are eligible for
reregistration, 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 HPMTS, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.
14
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B. Determiriation.of Eligibility Decision
,1. Eligibility Decision
.->.,..- Based on the reviews of the generic data for the active ingredient HPMTS,
the Agency has sufficient information on the health effects of HPMTS and on its
potential for causing adverse effects in fish and wildlife and the environment. The
Agency has determined that HPMTS products, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, the Agency concludes that
products containing HPMTS for all uses are ehgible for reregistration.
2. Eligible and Ineligible Uses
>'. The Agency has determined that all uses of HPMTS> as specified in this
document, are eligible for reregistration.
3. Endangered Species Protection '-.""
.Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measuresithat will eliminate the adverse impacts. The program would require use
restrictions to protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to.newly listed species or from proposed new uses: In the future, the Agency plans
to publish a description of the Endangered Species Program in the Federal Register
and have available voluntary county-specific bulletins. Because the Agency is
taking this approach for protecting endangered and threatened species, it is not
..imposing label modifications at this time through the RED. Rather, any
requirements for product use modifications will occur in the future under the
Endangered Species Protection Program. - '"'
C, Regulatory Position
The following is a summary of the regulatory positions and rationales for HPMTS.
Where labeling revisions are imposed, specific language is set forth hi Section V of this
document.
1. Risk Mitigation Measures/ Labeling Rationale
: Minimum (baseline) PPE requirements
15
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If EPA has no special concerns about the acute effects of other adverse
effects of an active ingredient, the PPE. for pesticide handlers will be based on the
acute toxicity of the end-use product. For occupational-use products, PPE must
be established using the process described in PR Notice 93-7 or more recent
guidelines.
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 requirements that pertain to all or most
end-use products containing that active ingredient.
These minimum PPE requirements must be compared with the PPE
that would be designated on the basis of the acute toxicity of the
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.
Occupational-Use Products
Primary Occupational Handlers: EPA has determined that regulatory
action regarding the establishment of active-ingredient-based minimum PPE
requirements for occupational handlers must be taken for HPMTS. EPA notes that
HPMTS has the potential to cause severe (corrosive) effects to the skin and eyes
and is a dermal sensitizer. No traditional risk assessment needs to be performed
to assess risks due to corrosiveness and sensitization. However, EPA believes that
primary occupational handlers who are exposed to concentrated end-use products
should wear PPE in addition to the baseline long-sleeve shirt, long pants, shoes,
and socks. Therefore, EPA is requiring the use of chemical-resistant gloves,
chemical-resistant apron, and face shield for such handlers.
Secondary Occupational Handlers: At this time, EPA believes that risks
from skin/eye corrosiveness and dermal sensitization would be acceptable for
secondary occupational handlers, since the HPMTS in such products as paints and
adhesives is very diluted, usually far less than one percent.
Homeowner-Use Products
\
Primary Homeowner Handlers: All HPMTS end-use pesticide products
are.intended primarily for occupational use.
16
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Secondary Homeowner Handlers: At this time, EPA believes that risks
from inhalation exposures and skin/eye corrosiveness would be acceptable for
adhesives, metal-cutting fluids, wood products, and textiles is very diluted, usually
far less than one percent. .
2. Entry Restrictions
> EPA is not establishing entry restrictions for end-use products containing
HPMTSbecause the use pattern scenarios are not likely to result in significant
human exposure to HPMTS.
' '.-', ' , : . ' * ' . '' '.."- ^ ... . --'.' ' ' '
.3. Addition and Retention of Other Label Statements
' ' ' '".',/ ^ ; 'j . ' r , ' . , - - .'
The Agency believes it is prudent to require additional use precautions to-
afford product users increased protection from unnecessary exposure to HPMTS.
For similar reasons the Agency is retaining current worker and environmental
restrictions and precautions for risk reduction. Also, all products must have their
labels improved with adequate and specific directions for use including application
' methods, equipment, timing, and rates. These label requirements are specified
below in Section V. - .
" -' '- '' ..-'' '.' .V- ' v: "':". '''-' ''''' .-.''
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistratioii
of both manufacturing-use and end-use products. ,
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of HPMTS for the
- above eligible uses has been reviewed and determined to be substantially complete.
No additional generic data are required at this time. The registrant is in the
process of performing an ayian acute oral study to confirm the potential hazards
to ayian species. The study is due for submission to the Agency by August 19,
' ' '''. 19961 "' ' ' ; '. -' . ,_ , ' ' ' . . ' ' -. .;'.'; ' ' ''
2. Labeling Requirements for Manufacturing-Use Products
.'-." To remain in compHance 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^ust bear the following statement under
....'.- /', Directions for Use:
17
-------
"Only for formulation into a microbiocide/microbiostat, bacteriostat for the
following uses: Commercial/Industrial Recirculating Water Cooling
Systems, Industrial Processing Water, Pulp/Paper Mill Water Systems,
Industrial Coatings, Resin/Latex/Polymer Emulsions, Latex/Oil/Varnish
Paints, and Wet-End Additives/Industrial Processing Chemicals."
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 support of
suchuse(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator or user group has
complied with U.S. EPA submission requirements regarding support of
suchuse(s).'*
Effluent Discharge Labeling Statements
"Do not use in facilities discharging directly or indirectly to the estuarine
or marine environment."
'w * . ' .
To reduce environmental risk from HPMTS discharge and disposal,
product labels must include the statements pertaining to effluent discharge
under the NPDES permitting system (refer to PR Notice 93-10) and
disposal under any applicable federal laws after the above statement.
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 G, the
Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) 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
18
-------
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
2. Labeling Requirements for End-Use Products
a. Occupational Labeling PPE Requirements for Pesticide
Handlers /
SQle-active-ingredient end-use products that contain HPMTS must
be revised to remove any conflicting PPE requirements on their current
. labeling.
: Multiple-active-ingredient end-use products that contain HPMTS
must compare the handler personal protective equipment requirements set
fqrth in this section to the PPE requirements on their current labeling and
; retain the more protective. For guidance on which PPE is considered more
protective, see PR Notice 93-7.
The PPE for each HPMTS occupational end-use product must be
established based on the acute toxicity of each end-use product. If the endr
use product is classified as toxicity category I or II for acute eye irritation
potential (or the eye irritation study is waived due to corrosiveness),
protective eyewear must be required for all handlers of HPMTS. If the
end-use product is classified as toxicity category I or n for acute skin,
irritation potential (or the skin irritation study is waived due to
corrosiveness), chemical-resistant gloves and a chemical-resistant apron
must be required for all handlers of HPMTS.
-.Minimum (Baseline) PPE/Engineering Control Requirements
for Products Intended Primarily for Occupational Use
The minimum (baseline) PPE for occupational uses of
HPMTS end-use products is:
"Mixers, loaders, and others exposed to the concentrate
,-.-" must wear: '
-,'.,' . , Long-sleeve shirt and long pants,
; Chemical-resistantgloves*,
shoes plus socks,
chemical-resistant apron, and
face shield."
* For the glove statement, use the statement established for HPMTS
through the instructions in Supplement Three of PR Notice 93-7,
19
-------
However, the corrosiveness and penetration of HPMTS itself must
be considered and appropriate chemical-resistant materials must be
listed.
Placement in Labeling
The personal protective equipment language 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. Other Label Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing HPMTS.
(1) Directions for use
. Registrants must specify on labeling the complete directions
for use for each use pattern: site of application, type of application,
timing of application, equipment used for application, and the rate
of application (dosage).
(2) Application restrictions
"Do not use this product in a way that will contact workers
or other persons."
(3) Skin sensitizer statement
"This product may cause skin sensitization reactions in some
people." .
(4) User safety recommendations
For- all HPMTS end-use products:
"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."
For HPMTS end-use products "gloves" if gloves are required PPE:
20
-------
"Users should remove Personal Protective Equipment immediately
after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly."
(5) Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for
effluent discharge.
C. 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 tide 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 hydroxypropyl
methanethiosulfonate 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.
21
-------
22
-------
\_
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 Hydroxypropyl methanethiosulfonate covered by this Reregistration
Eligibility Decision Document. It contains generic data requirements that apply to Hydroxypropyl
methanethiosulfonate in all products, including data requirements for which a "typical
formulation" is the test substance. : "
The data table is organized hi the following format:
1. Data Requirement (Column 1). The data requirements are listed, in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
'requirements apply. The following 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 number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRTO number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
30
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34
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GUIDE TO APPENDIX C
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 ia
this bibliography have been the body of data submitted to EPA and its predecessor
agencies hi support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
UNITS OF ENTRY. The unit of entry in this bibliography 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.
IDENTIFICATIdN OF ENTRIES. The entries in this bibliography are .sorted
numerically by Master Record Identifier, or "MRJtD 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 ;
eases, entries added to the bibliography late in .the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRDD entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to {he 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 me author could confidently be identified, the Agency has
<_ chosen to show a personal author. When no individual was identified, the
Agency has shown ah identifiable laboratory or testing facility as the author.
WJtien no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
'...''.' :.--,. -,-t " -.'. .,' , '- -' , ; . -i ซ. .-.-' .';'.', ' , - !'. .'.-
, b. Document date. The date of the study is taken directly from me 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.
35
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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.
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
hi 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.
36
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BIBLIOGRAPHY
MRID
CITATION
00126120 Hazleton Raltech, Inc. (1982) Avian Single-dose Oral LD5G: Mallard Duck (Anas
platyrhynchbs): Study No. 6026-119. Final rept. (Unpublished studyreceived:Feb
:15, 1983 under 1448-78; submitted by Buckmari Laboratories, Inc., Memphis,
TN; CDL:249523-B) > , ,
00126121 , Hazleton Raltech, Inc. (1982) Avian Dietary LC50: Bobwhite Quail (Colinus
vkguiianus): Study No. 6026-121. Final rept. (Unpublished study received Feb
., 15, 1983 under 1448-78; submitted by Buckman Laboratories, Inc., Memphis,
TN; CDL:249523-C)
00126122 Hazleton Raltech, Inc. (1982) Avian Dietary LC50: Mallard Duck (Anas
- ' . platyrhynchos): Study No. 6026-120. (Unpublished study received Feb 15, 1983
under .1448-78; submitted by Buckman Laboratories, Inc., Memphis, TN;
, qDL:249523-D)
40229601 Jagannath, D.R. [1987] "Mutagenicity Test on HPMTS in the Ames
Salmonella/MicrosomQ Reverse Mutation Assay", [HLA 9786-0-401]; Hazleton
Laboratqries America, Inc., Kensington, MD; [HED Doc. No. 010670].
,40420201 ' Murli, H. [1987] ^Mutagenicity Test on HPM;TS in_an In Vitro Sister Chromatid
Exchange (SCE) Assay Measuring Sister Chromatid Exchange Frequencies in
Chinese Hamster Ovary (CHO) CeUs", [HLA 9973-0-438]; Hazleton Laboratories
America, Inc., Kensington, MD; [HED Doc. No. 006594].
.40420202 Cifone, M.A. [1987] "Mutagenicity Test on HPMTS in the Rat Primary
'*' Hepatocyte Unscheduled DNA Synthesis Assay", [HLA 9973-0-447]; Hazleton
Laboratories America, Inc., Kenshigton, MD; [HED Doc. No. 006594].
40747101 RodweU, D.E. [1988] "Pilot Teratology Study in Rats with HPMTS", [SLS
3138.10]]; Springborn Life Sciences, Inc.; Spencerville, OH; [HED Doc. No.
006920].
40747102 Siglin, J.C. [1988] "Two-Week Dermal Toxicity Study in Rats with HPMTS",
[SLS 3138.8]; Springborn Life Sciences, Inc., Spencerville, OH; [HED Doc. No.
006920]. ; ;-
: ,' "'.'. , '.'''.". ' .. : . ' ;. , ' ; "'.- y.. _ I-'--1'
40974^01 / Siglin, J.C., [1988] "91-Day Dermal Toxicity Study in Rats with HPMTS", [SLS
< - :. 3138.9]; Springborn Life Sciences, Inc., Spencerville, OH; [HED Doc. No.
V ; 007483].
37
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BIBLIOGRAPHY
MRTO
CITATION
41010401 Rodwell, D.E. [1988] "Teratology Study in Rabbits :with HPMTS", [SLS
3138.13]; Springborn Life Sciences, Inc., Spencerville, OH; [HED Doc. No.
007453].
41010501 Rodwell, D.E. [1988] "Pilot Teratology Study in Rabbits with HPMTS", [SLS
3138.12], Springborn Life Sciences, Inc., Spencerville, OH; [HED Doc. No.
006984].
41010501 Rodwell, D.E. [1988] "Teratology Study in Rats with HPMTS", [SLS 3138.11];
Springborn Life Sciences, Inc., Spencerville, OH; [HED Doc. No. 007453].
41632401 Glaza, S. M. [1990] "Acute Dermal Toxicity of HPMTS in Rabbits", [HLA 0060-
5-263]; Hazleton Laboratories America, Inc., Madison, WI; [HED Doc. No.
010670].
41634701 Glaza, S. M. [1990] "Acute Oral Toxicity of HPMTS in Rats" [HLA 0060-5-262];
Hazleton Laboratories America, Inc., Madison, WI; [HED Doc. No. 010670].
41733201 Ward, G. (1990) 2-Hydrocypropyl methanethiolsulfonate (HPMTS): Acute
Toxicity to Bluegill, Lepomis macrochirus, Under Flow-through Test Conditions:
Lab Project Number: J9007018C. Unpublished study prepared by Toxikon
Environmental Sciences. 37 p.
41733202 Ward, G. (1990) 2-Hydroxypropyl methanethiolsulfonate (HPMTS): Acute
Toxicity to the Water Flea, Daphnia magna, under Flow-through Test Conditions:
Lab Project Number: J9007018B. Unpublished study prepared by Toxikon
Environmental Sciences. 38 p.
41733203 Ward, G. (1990) 2-Hydroxypropyl methanethiolsulfonate (HPMTS): Acute
Toxicity to Rainbow Trout, Oncorhynchus mykiss, under Flowthrough Test
Conditions: Lab Project Number: J9007018D. Unpublished study prepared by
Toxikon Environmental Sciences. 38 p.
42349201 Karcher, R., Siglin, J.C. arid Becci, P.C. [1986] "Delayed Contact
Hypersensitivily Study in Guinea Pigs with HPMTS", [SIB 3138.7]; Springborn
Institute for Bioresearch, Inc., Spencerville, OH; [HED Doc. No. 009690].
42771801 Mao, J. (1993) HPMTS-Determination of Aqueous Hydrolysis Rate Constants and
Half-Lives: Lab Project Number: 995.0292.6138.715: 93-3-4668. Unpublished
study prepared by Springborn Labs, Inc. 76 p.
38
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MRID
BIBLIOGRAPHY
CITATION
Doyle, E, [1995] "Less than Lifetime/Peer Review Report of [S-(2-
hydroxypropyl)
-------
BIBLIOGRAPHY
MMD
CITATION
40
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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 produces) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section ffi below. Your response must state:
1.
.'3'.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
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.IH-B); or . _^
Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section UI-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
41
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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 HI - 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-Li 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 H. DATA REQUIRED BY THIS NOTICE
H-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 hi this Notice, additional testing may be required.
42
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n-B. SCHEDULE FOR SUBMISSION OF DATA
^- . . - - * ' - ,'' ' '-' : '''', ' s" - > '
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
ini the Pesticide Data Requirements regulation (40 CFR ง 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 ง 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 inresponse to thisData Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
/ - :-r ' ,'"'' '''.','" .- ' \ ',' ' ' \' ; '
fl-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 HE. 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 NQIS due to
failure to comply with this Notice are presented in Section IV-AandIV-B:
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
-------
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 ffl-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-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 hi 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 EI-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 m-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
requirement.
44
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m-C 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 7a 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 Existuig 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 ^AC5), and be in co^ of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the tune
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 origrnal deadline
remains. The Agency will respond to your request in writing. If ERA 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
will not be given hi submitting the 90-day responses. .Extensions will not be considered if the
45
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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 choo~se~to enter
into an agreement to share hi 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 hi 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, hi 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
46
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you commit to submit, and do submit the required data in die 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).
"' J . ',-'.','". "; ' "" " .- . - ' " " , '
You should be aware that if the Agency determines that the study is not acceptable, the
Agency wUl require you to comply with tMs 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.
:' i ,'"-.' ' ''.'.'' V ':'.'. ' . ' ' '''.'..-' ' - ' " . , '. '
To meet the requirements of the DCI Notice for submitting an existing study,' all of the
following three/criteria must be clearly met:
a. You must certify at the time that the existingstudy 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 accordance with the
; requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
':'-..' As stated in 40 CFR 16Q.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."
b. 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
fsubmitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
) signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
.relevant to {he 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
' . ','.* '' ., i .: ', , . . j ' ,',...';', ' ' . -
.' -: ' ' ' v '- ' -. : "-. \ . ' ; ' -47' ' '- ' - '.''"'" ':'
-------
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 riot 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
48
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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. '. -,-' " ' _:'' ' ''.'
t . -. .:- .'..... -.".-': . ,- " ' . '
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 hi 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 me request, mcluding 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 hi 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 hi force.
'.'..' ' ' ...'. '. ' . . '''..'-' ' y v '' "' ; :- ''." ' " ' ' ' '''
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
ly-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 followhig: ,
.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.
49
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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 ffl-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 hi 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
50
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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, arid, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
bf 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 hi PR 86-5. All studies must be submitted inthe 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 produces) 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 tune 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 produces) 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.
51
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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.
52
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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 -'
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
53
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54
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HYDROXYPROPYL METHANETfflOSULFONATE DATA CALL-IN CHEMICAL STATUS
SHEET ; ';/,..' ;, _., ;.__, '.'.;:. ...,.v ,, . -' . - ;' . ,. ;
INTRODUCTION :
You have been sent this, Product Specific Data Call-in Notice because you have procluct(s)
containing Hydroxypropyl methanethiosulfonate. .
This Product Specific Data Call-in Chemical Status Sheet, contains ah overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Hydroxypropyl methanethiosulfonate. 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
Hydroxypropyl methahemiosulfonate 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 Hydroxypropyl
hiethanethiosulfonate are contained in the Requirements Status and Registrant's Response,
Attachment 3. The Agency has concluded that additional data on Hydroxypropyl
mernanethiosulfonate 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 Hydroxypropyl methanethiosulfonate 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 Moana Appleyard at (703) 308-8175
, AIT responses to this Notice for the Product Specific data requirements should be submitted
'.'.' to: ;'"".". '""",' ""'""'"!/ ""-.:'''.:" . .,,,,' ,.. '. , ''...'. '.,.
"Moana Appleyard
..;'.. 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: Hydroxypropyl methanethiosulfonate
55
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. 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).
Item 6. Not applicable since this form calls hi 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.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. 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.
56
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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 transmitted 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 hi 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 wiU 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
58
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4.
5.
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'1 form (EPA Form 8570-29) and (2) two completed
, and signed copies of the Confidential Statement of Formula (EPA Form 857Q-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 parry 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 m-C.i.) 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 IH-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 mat" mis 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 MRTD 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 HI-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
59
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6.
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
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).
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 hi 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 FDFRA. 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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EPA'S BATCHING OF HYDROXPROPYLMETHANE THIOSULFONATE (HPMTS)
PRODUCTS FOR MEETING ACUTE JOXICITY DATA REQUIREMENTS FOR
REREGISTRAflON -
In an effort to reduce the time, resources and number of animals ;needed to fulfill the
acute toxicity data requirements for reregistration of products containing HPMTS as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be ,
considered chemically similar or have identical use patterns. , '.._/
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the, Agency reserves the right to
require; at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery.of six acute toxicological studies to represent all the products within that '
batch. It is the registrants' option to participate in the process with all other registrants, only ,
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously .submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet, the data requirements for each product. The second form, "Requirements Status and.
Registrant's Response," lists the product specific data required for each product, including the
standard six .acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Devel9ping Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends oh another's
65
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data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Nine products were found which contain HPMTS as the active ingredient. The products
have been placed into three batches and a "no batch" category in accordance with the active and
inert ingredients, type of formulation and current labeling. Table 1 identifies the batched
products. Table 2 lists 1 product that was considered not to be similar to any other product and
has been placed in the "no batch" category.
Table 1
Batch
1
-
2
3
EPA Reg. No.
1448-31
1448-36
1448-76
1448-77
1448-78
1448-79
1448-27
1448-30
% Active Ingredient
80.0
80.0
25.0
15.0
10.0
5.0
32.0
14.6
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Table 2 (No Batch)
EPA Reg. No.
1448-90
% Active Ingredient
10.0
Formulation Type
Liquid
The products hi Batch 1 are considered technicals and have been reviewed in the RED
Toxicology Chapter. Data are sufficient to label these products and no additional data needs to
be submitted. In addition, as the active ingredient is considered to be a dermal sensitizer, all
products containing this active ingredient should be labeled for dermal sensitization. No
additional dermal sensitization studies need be submitted. Inhalation toxicity has been waived for
all products also, because the use pattern precludes inhalation exposure.
There is sufficient information on acute toxicity to label the products in Batch 2 with the
following exceptions:
66
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) A primary dermal irritation study is needed for 1448-76 and 1448-77. A category m
result from 1448-76 could be bridged to 1448-77 i
A primary eye irritation study is needed for 1448-79.
For Batch 3, an,acute oral and dermal toxicity study is needed for 1448T27. Primary dermal and
eye irritation studies are needed for both 1449-27 and 1448-30. "
There is sufficient information on acute toxicity to label 1448-90 with the exception of the
acute oral toxicity study. The study on file is inconclusive with regard to the LD50 in female
animals.. The study must be repeated. ,
67
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68
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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.
k.
1.
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 all
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.
m. 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
n.
limits are different than standard certified limits.
^ .
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
70
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72
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?/EPA
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
' 207(MH)57
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 instiuctions, 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
KPA 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 an 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 alf
terms could not be reached otherwise. This offer was made to the following firm{s) on the following
date(s):
Nam* of Flrm(s)
Oat* of Offer
Certification:
I certify lhat 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
Data
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
73
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74
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
. >*"%,-
Form Approved
OMB No. 2O7O-OWT,
2070-0057
Approval Expires
3-31-96 - ; ;
ublic reporting burden for this collection of information is estimated to average 15 minutes penresponse, including time for
sviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
ollection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
icluding suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, 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.
'lease fill in blanks below.
tompany Name ' ,
'roductName :
' . . ' ' :'--' " ' -.- .','.'." ,-'-' " ' '-. ' .'' " ' -T ' "' ' ' ;/
.Company Number
EPA Reg. No.
Certifythat:
, For each study cited in support ฉ^registration or reregistratiion underjhe Federal Insecticide, Fungicide and Rodenticide Act
FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the. original
ata submitter to cite that study. ' ;
That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
riginal data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
ompany(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
equirement of FIFRA and the amount of compensation due; if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
Requirements Status and Registrants'Response Form," -
That I have previously complied with section 3(c)(i)(F) of FIFRA for the'studies I have cited in support of registration or '.,"
eregistration under FIFRA.
Signature. . " " '" : . ,' . . . ' '. ' , .
.'. .. . .- ''.-. .'..' "/" . --.' :' . ' "/ '.. -"-. - * .'-.<", ' '.. "' '.''- '
. Date '
ame and Title (Please Type or Print)
GENERAL OFFER TO PAY: Thereby offer and agree to pay compensation to other persons, with regard to the registration or
eregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature ,.":'' '.','.' "
Date -- :
Name and Title (Please Type or Print)
"vrorm oo/u-oi (4-ab)
; 75
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76
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The following is a list of available documents for Hydroxypropyl methanethiosulfonate that
my further assist you in responding to this Reregistration Eligibility Decision document. These
documents may be obtamed by the following methods:
. . , '.- I - 4 "t '.'/' '.-.,-- ^ . - j. -' ' - --... , ' - ' . . . , -
Electronic,.: v.. J ; ;;-.;,.: ..;.."._.,,;,...,,,,,.,,"',,,,,,.,,. ,-;, ''.... ,:.-.' /,,,; , ~ ,:,,'\. ', . .'_'"'
File format: Portable Document Format .(['.PDF) Requires Adobeฎ Acrobat or compatible
reader. Electronic copies 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., or
contact MoanaAppleyard at (703)-308-8175.
. 1. PR Notice 86-5. -';'.."..'..'.'. .''". . '! .' '..'..;. '//,." ..
2'..,. > PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. .A full copy of this RED document. ,
4. .A copy of the fact sheet for Hydroxypropyl methanethiosulfonate.
The following documents are part of the Administrative Record for Hydroxypropyl
methanethiosulfonate and may included in the EPA's Office of Pesticide Programs Public Docket.
Copies of these documents are not available electronically, but may be obtained by contacting the
person listed on the Chemical Status Sheet.
1.
..*-':'
2.
Realm and Environmental Effects Science Chapters.
.'"... :;";.> ;v '.-.^-V' >':.. ^..:,.'-i/-;s-;!._-- .; "', - -
DetaHed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
. /: V --'','/ ' ..: -.:'.'.'"' ;'; ',,'. ''( ;.-..,'> ; ' ..;- .. '. :'',' .'.-. ;' '.- -. - "..:;."':'.
;1. The Label Review Manual.
2. EPA Acceptance Criteria
77-
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