United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA 738-R-95-031
And Toxic Substances January 1996
(7508W)
vvEPA
Re registration
Eligibility Decision (RED)
Sodium Omadine
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*W7 | UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
*»i^
WASHINGTON, D.C. 20460
CERTIFIED MAIL
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES I;T%|
; '5 FEB'2-9'1996 \'\
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 sodium omadine.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of this chemical, 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.
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 arid timely responses will avoid the Agency taking the enforcement'
action of suspension against your products. ,
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Bruce Kapner at (703) 308-8013. Address any questions on generic data to the Special
Review and Reregistration Division representative, Judy Lorariger at (703) 308-8056.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION
1. DATA CALL-IN (PCD OR "90-DAY RESPQNSE"-If generic data are required fnr
reregistration, a DCI letter will be enclosed describing such data: If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect. ,
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-Y6u
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 arid current regulations
and requirements. Only make labeling changes which are required by. the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as ;
formulation changes, or labeling changes not related to reregistration) separately. You may .
delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-22181 1; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete
and sign EPA form 8570-3 1 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 PCI RESPONSES (90-DAY1 AND
APPLICATIONS FOR REREGISTRATTQN rS-MONTH RESPONSES^
U.S. Mail;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001 .
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy. •'.".'•
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued. ' • . .
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REREGISTRATION ELIGIBILITY DECISION
Sodium Omadine
' • LIST A:
CASE 0209
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
SODIUM OMADINE REREGISTRATION ELIGIBILITY DECISION TEAM
VH
EXECUTIVE SUMMARY I............. . . xi
I. INTRODUCTION ..:.... ................... 1
II. CASEOVERVIEW ....... . . ....... .2
A. Chemical Overview ........ ........ 2
B. UseProfile ............... ....:.....:..!....... 2
C. Estimated Usage of Pesticide ;.......:.... 4
D. Data Requirements 4 '
E. Regulatory History . '. 4
III. SCIENCE ASSESSMENT ,.. .. :.'...,.... ..'.'.'.;;.......... 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment .5
1. Toxicology Assessment ....;.. ............ 5
a. Acute Toxicity : . . . . .5
b. Subchronic Toxicity .'...' .6
c. Chronic Toxicity 8
d. Carcinogenicity ..!......,..... .9
e. Developmental Toxicity .'. ....... 10
f. Reproductive Toxicity . . . '. . . 10
g. Mutagenicity .,....' 11
h. Metabolism ......11
i. Neurotoxicity ........;:.. ... '.-, .12
j. Toxicological Endpoints 12
k. Reference Dose :......... .12
2. Exposure Assessment 13
a. Dietary ......'..... 13
b. Occupational and Residential 13
3. Risk Assessment 17
a. Dietary ....:... 17
b. Occupational and Residential 17
C. Environmental Assessment . . . . '....; . 17
1. Ecological Toxicity Data .17
a. Toxicity to Terrestrial Animals ....-.'. : 17
b. Toxicity to Aquatic Animals . . . . 18
2. Environmental Fate :........ 19
a. Environmental Fate Assessment ..: 19
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b. Environmental Fate and Transport .'. 20
3. Exposure and Risk Characterization 20
4. Endangered Species . ; 20
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 20
A. Determination of Eligibility , 20
1. Eligibility Decision . ... 21
2. Eligible and Ineligible Uses .... '.' . . . 21
B. Regulatory Position 21
1. Effluent Discharge/Aquatic Risk Rationale 22
2. Reference Dose '....... . . .23
3. Cancer Classification . . : 23
4. Environmental Hazard Statements 23
5. Endangered Species Statement .23
6. Occupational Labeling Rationale 23
V. ACTIONS REQUIRED OF REGISTRANTS ... 25
A. Manufacturing-Use Products 25
1. Additional Generic Data Requirements 25
B. End-Use Products ! 25
1. Additional Product-Specific Data Requirements 25
- 2. Labeling Requirements for End-Use Products 26
C. Existing Stocks 28
VI. APPENDICES , , 29
APPENDIX A. Table of Use Patterns Subject to Reregistration 31
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision . . 34
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of sodium omadine 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 61
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 Reregistrataion 66
Attachment 5. List of Registrants Receiving This Notice 69
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 71
APPENDIX E. List of Available Related Documents 79
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SODIUM OMADINE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Michele Cottrill
Phyllis Johnson
Frank Hernandez
Environmental Fate and Effects Division
David Farrar
Curtis Laird
David Jones
Laura Parsons
Health Effects Division
Arliene Aikens
JohnWhalan
Winston Dang
Registration Division
Marshall Swindell
Joanne Hayes
Shyam Mathur
.Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Special Review and Rereeistration Division
Judy Loranger
Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RiD)
AE , Acid Equivalent
a.i. Active Ingredient ,
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI : Cation
CNS Central Nervous System ' .
CSF Confidential Statement of Formula ' - ,
DFR Dislodgeable Foliar Residue' ,
ORES Dietary Risk Evaluation System
DWEL , Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur. . ;
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. ,
EP End-Use Product . .-'*.'.
EPA ' U.S. Environmental Protection Agency
FDA Food and Drug .Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA . Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography .
GM Geometric Mean (
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested ,
LCJO Median Lethal Conce'ntration. A statistically derived concentration of a substance that can b e
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, ah-or feed, e.g., mg/1, mg/kg or ppm.
LDj0 ' ' 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. ' L
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs .
LEL Lowest Effect Level • . . ,
LOG Level of Concern ,
LOD Limit of Detection -
LOEL Lowest Observed Effect Level " .
MATC Maximum Acceptable Toxicant Concentration ._'. - '
MCLG Maximum Contaminant Level Goal. (MCLG) The MCLG is .used by- the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
mg/L Milligrams Per Liter -
MOE' Marghi of Exposure • . , '
MP Manufacturing-Use Product
MPI Maximum Permissible Intakev , • ' . ' •
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration . ,
NPDES National Pollutant Discharge Elimination System
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level, .' .
OP Organophosphate
OPP Office of Pesticide Programs . ; •
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm . Parts Per Million .
PRN Pesticide Registration Notice ,
Q*, The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval .
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product >
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard , ;
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EXECUTIVE SUMMARY
Background '
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide sodium omadine.
Sodium omadine is a broad spectrum antimicrobial compound used as a preservative in
certain manufacturing materials and as an additive in process fluids which may otherwise be
subject to deterioration through bacterial and/or fungal growth. Sodium omadine may be used
as a biocide in: aqueous metalworking, cutting, cooling and lubricating fluids; latex emulsions
used in adhesives, caulks, patching compounds, sealants, pastes and grouts; latex emulsions;
-aqueous fiber lubricants and inks; laundry rinse additives and detergents; carpet cleaners and
analytical and diagnostic reagents. This RED does not address the use of sodium omadine as an
in can preservative of water based chemical or mineral add mixtures used in concrete preparation,
registered by the Agency on March 23, 1995. Currently there are 5 registered products that
contain from 3.6 to 40 percent sodium omadine These products, all end-use products, are
formulated as liquid soluble concentrates. There are two registrants: Cincinnati Milacron and
Olin Corporation, the primary registrant. There are no registered food uses.
Sodium omadine was first registered in the United States in 1968 for use as a biocide. The
Registration Standard on sodium omadine (NTIS # PB86-173929) was issued in July 1985, arid
required submission of product chemistry, toxicology, ecotoxicity and environmental fate data
to support continued registration of products formulated with sodium omadine. The 1987
Antimicrobial Data Call-In (DCI) required the submission of a variety of subchronic and chronic
toxicology and occupational exposure studies.
Reregistration Eligibility
. The Agency has now completed its review of the sodium omadine target data base,
including data submitted in,response to both the Registration Standard and the DCI, and has
determined that the uses of sodium omadine as currently registered will not cause unreasonable
adverse effects to humans or the environment. All generic data requirements have been satisfied
for sodium omadine. All uses of sodium omadine registered prior to March 23, 1995 are eligible
for reregistration. . , • .-
Health Effects
The Agency's Office of Pesticide Program's Reference Dose (RfD) Peer Review
Committee has classified sodium omadine as a Group D chemical (indicating insufficient weight
of evidence of carcinogenicity for humans). Sodium omadine was assigned this classification
because the dermal carcinogenicity study in mice was found to be unacceptable due to inadequate
dose selection. The Agency has concluded that a repeat study is not required as long as the
XI
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product's use patterns do not dramatically change and the potential for human exposure remains
low. . ...
The Agency has used the following studies to derive toxicological endpoints for the
occupational risk assessment described below: a dermal developmental study in rabbits was used
to calculate short-term dermal exposures, and a 90 day dermal toxicity study in rats and a 90 day
inhalation study in rats were used to calculate respective intermediate dermal and inhalation
exposures. In the developmental toxicity study, no evidence of maternal or fetal toxicity was
observed in rabbits given daily dermal applications of sodium omadine at doses of 0, 1, 2.5, or
5 mg/kg/day on days 6-19 of gestation.
In the 90 day dermal toxicity study, rats were given daily doses of sodium omadine at
levels of 0, 5, 15 or 50 mg/kg/day. There was no evidence of dose-related dermal irritation.
Dose related clinical signs seen in high dose females included emaciation, hunched posture, stiff
hindlimbs, incoordination and tremors. Among the males, one high-dose rat was emaciated;
there were no neurologic signs. The NOEL was 15 mg/kg/day in males and 5 mg/kg/day in
females.
In the 90 day inhalation study, rats were administered sodium omadine at concentrations
of 0, 0.00046, 0.0011 and 0.0038 mg/1 (increased to 0.0081 mg/1 at week 6). The systemic
NOELs were 0.0081 mg/1 in males and 0.0011 mg/1 in females. The systemic LOEL was 0.0081
mg/1 in females based on clinical signs of hindlimb dysfunction, skeletal muscle regeneration,
decreased body weight and body weight gain.
Occupational Exposure
The Agency has concerns that workers may be exposed to sodium omadine through
dermal or inhalation routes of exposure from pouring and pumping of sodium omadine in metal
working fluids. Using exposure data from the CMA (Chemical Manufacturer Association)
Antimicrobial Exposure Assessment Study, the Agency has conducted exposure and risk
assessments for these activities and finds that margins of exposure (MOEs) for workers were
greater than 100. Based on these calculations, the Agency has concluded that minimal risks exist
to workers during the pouring and pumping of liquids that contain sodium omadine. The Agency
has not evaluated occupational risk to machinists because these workers are regulated by the
Occupational Safety Administration (OSHA). (Available information indicate that the amount
of active ingredient (0.005 to 0,5%) present in the oil used by machinists would most likely be
even lower than the amount to which the handler would be exposed. Therefore, it is presumed
that exposure to sodium omadine treated fluids would represent a lesser hazard to the machinist
than to handlers involved in pumping and pouring operations described in this document).
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! Environmental Fate and Ecological Effects
^^&^pn^d«^^_i^u^«B*A>AA. -y .,..'• r x
By their nature, industrial biocides are often toxic to aquatic organisms. While the hazard
to aquatic organisms from exposure to sodium omadine has been characterized, a quantitative risk
assessment has not been conducted. The Office of Pesticide Programs has established a policy
that risks to aquatic environments from sodium omadine use as a biocide are best characterized
and regulated under the NPDES permitting program of the Office of Water. All sodium omadine
products are required to state on their labels that discharges to aquatic environments must comply
with an NPDES permit.
Before reregistering the products containing sodium omadine, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the,
Agency will reregister a product. Those products which contain other active ingredients will be
eligible for reregistration only when the other active ingredients are determined to be eligible for
reregistration.
xin
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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 reregistration. .'--.'
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistratibn" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA. .
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of sodium omadine. The document consists of six sections. Section I is the
introduction. Section II describes sodium omadine, its uses, data requirements and regulatory
history. Section IE discusses the human health and environmental assessment based on the data
.available to the Agency. Section IV presents the reregistration decision for sodium omadine.
Section V discusses the reregistration requirements for sodium omadine. 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 Reregistratjon .Eligibility
Decision:
Common Name:
Chemical Name:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
Sodium omadine
Sodium omadine exists as a mixture of two
tautomeric forms: (I.) -l-hydroxy-2(lH)-
pyridinethione, sodium salt and (H) 2-pyridinethio| -
1-oxide, sodium salt
(I.) 15922-78-8 and (II). 3811-73-2
088004 (chemical code only available for CAS
number 15922-78-8)
C5H4NOSNa
Omadine sodium, sodium 2-pyridinethiol 1-oxide,
sodium l-hydroxypyridine-2-thione, sodium 2-
mercaptopyridine-N-oxide
Olin Chemicals
B. Use Profile
Information on the currently registered uses of sodium omadine and application
methods is presented below. A detailed table of the uses of sodium omadine is presented
in Appendix A.
Type of Pesticide:
Use Sites:
Indoor Non-food:
Fungicide, microbiocide/microbiostat (for control of
slime forming bacteria and fungi)
Adhesives, Industrial
Emulsions, Resin/Latex/Polymer
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Metahvorking Gutting Fluids
Aqueous Synthetic Fiber Lubricants
Alkaline Aqueous Based Jet-Printer Inks
Laundry Rinse Additives, Detergents and Carpet Cleaners
Aqueous Analytical and Diagnostic Reagents
Target Pests: Bacteria (including slime-forming bacteria) and fungi
Formulation Types Registered: Soluble concentrate/liquid
Application types and rates:
Types of treatment:
Fungicide, microbiocide/microbiostat for: aqueous metal working,
cutting, cooling, and lubricating fluids and concentrates; latex
emulsions used in adhesives, caulks, patching compounds, sealants,
pastes, and grouts; vinyl acetate latex emulsions; aqueous synthetic
fiber lubricants (spin finishes); aqueous based inks and jet-printer
inks; .laundry rinse additives; laundry detergent; carpet cleaners;
aqueous analytical and diagnostic reagents used in chemical and
clinical analysis - preservative treatment, industrial preservative
treatment
Use Practice Limitations: NPDES (National Pollutant Discharge Elimination
System) License Restriction
„— f ' •
Rate and timing of Application:
* ' - •
Aqueous metalworking, cutting, cooling, and lubricating fluids - 27 to
499 ppm a.i. (initial, subsequent/maintenance); 72 to 128 ppm a.i. (timing
not specified on labeling; registrants need to specify).
Metalworking, cutting, cooling, and lubricating concentrates (where end
use dilution of metalworking, cutting, cooling, or lubricating fluid is 5%) -
1440 to 10,000 ppm a.i. (timing not Specified on labeling; registrants need
to specify).
Latex emulsions used in adhesives - 400 ppm a.i. (during manufacture).
Vinyl acetate latex emulsions - 46 to 400 ppm a.i. (during manufacture).
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Aqueous synthetic fiber lubricants (spin finishes) - 64 to 499 ppm a.i.
(timing not specified on labeling; registrants need to specify).
Alkaline aqueous based jet-printer inks - 320 to 5000 ppm a.i. (during
manufacture).
Laundry rinse additives, laundry detergent, and carpet cleaners - 639 ppm
a.i. (during manufacture).
Aqueous analytical and diagnostic reagents - 64 ppm a.i. (during
manufacture).
C. Estimated Usage of Pesticide
Only proprietary information defining sodium omadihe usage is available at this
time. The Agency has concluded (not confidential) that sodium omadine is a minor use
biocide that is primarily used in metalworking fluids. Other alternative products (also
proprietary information) have a significantly larger market share than sodium omadine.
D. Data Requirements
Data requested in the July 1985 Registration Standard for sodium omadine include
studies on product chemistry, toxicology, environmental fate and ecological effects. The
1987 Antimicrobial Data Call-In (DCI) required the submission of a variety of subchronic
and chronic toxicology and occupational exposure studies. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed to support
reregistration. ."
E. Regulatory History
Sodium omadine was first registered in the United States in 1968 for use as a
biocide. ,The Registration Standard on sodium omadine (NTIS # PB86-173929) was
issued in July 1985. The Registration Standard continued the registration of sodium
omadine but required submission of product chemistry, toxicology, ecotoxicity and
environmental fate data. As stated above, additional toxicology studies were required in
the 1987 Antimicrobial Data Call-in (DCI). This Reregistration Eligibility Decision
reflects a reassessment of all data which were submitted in response to the Registration
Standard and the DCI. .
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Technical sodium omadine is an off-white solid powder with a melting point of
•^250°, C and a vapor pressure of 7 x 10"8 torr at 22° C. The solubility of sodium omadine
in water is -54.7% w/w at 25° C. The following structures depict the resonance between
the two tautomers: . .
••'• - - ' I .',.'-.
S~ Ha*
3811-73-2
15922-78-8
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Chemical Code:
C5H4NOSNa
149.2
3811-73-2 and 15922-78-8 (sodium omadine exists as a
mixture of two tautomers, refer to Section n, A for
chemical names for each tautomers)
088004 . •"'.
B. Human Health Assessment
1. Toxicology Assessment
The generic lexicological data base for sodium omadine is complete and
will support reregi strati on eligibility. The Agency has identified data gaps
(primary eye irritation, acute inhalation and dermal sensitization) for end use
products that will be required in the productspecific Data Call-in notice.
a. Acute Toxicity
The 40% sodium omadine formulation has been evaluated for a variety of acute
toxicity effects. The results are summarized in the table below.
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Test
81-1 Acute Oral LD30 (rat)1
81-2 Acute Dermal LD50 (rabbit)2
81-3 Acute Inhalation LDM (rat)3
81-4 Primary Eye Irritation (rabbit)4"
81-5 Primary Dermal Irritation (rabbit)5"
81-6 Dermal Sensitization (guinea pig)6*
81-6 Dermal Sensitization (human)7* .
/
Results
LDJO = 2000 mg/kg &
LD50 =1100 mg/kg ?
LD50= 1500 mg/kg cN-?
LD50= 1 900 mg/kg
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Both males and females dosed at 0, 0.5, and 2.0 mg/kg/day had similar
body weights throughout the study. The 8.0 mg/kg/day groups consistently gained
.less weight than the other groups, and weighed as much as 21% and 22% less than
controls for males and females, respectively. Significant decreases in weight gains
were seen for males (30%) and females (47%). The body weight and clinical
observation data suggest a steep dose response.
In the high-dose groups, minimum to marked hindlimb atrophy was
observed in 95-100% of the males and females (more severe in females), minimal
paravertebral muscle atrophy was .seen in 2/20 males and 17/20 females, and
atrophy of the subcutaneous panniculus muscle was seen in 20/20 males and 17/20
females. Treatment-related neurotdxic signs observed in the high-dose animals
consisted of slight hypoactivity, piloerection, ataxia (hindlimb), slight head
searching, emaciation, hindlimb paralysis, and hunched posture. As a
consequence of severe hindlimb motor dysfunction, 10 high-dose females were
sacrificed "in extremis. Effects on neuromuscular function included significant
decreases in landing foot spread, hindlimb grip strength, and hindlimb tactile
placing response.
The study LOEL was 2.0 mg/kg/day based on evidence of neurotoxicity
in males and females (neurogenic skeletal muscle atrophy) and the NOEL was 0.5
mg/kg/day.
The neurotoxicity portion of the study was classified as supplemental
because cage observations were limited, many of the usual functional observation
battery (FOB) parameters were not performed, grip strength measurements and
motor activity were not quantified, guideline procedures for preparation of neural
tissues (including perfusion) were not followed, and the histological examination
of neural tissues was inadequate. (MRID No. 40756901)
In a subchronic dermal toxicity study. Sprague-Dawley rats were
administered sodium omadine (41.2% purity, 20/sex) daily for 90 days at dosage
levels of 0, 5, 15, or 50 mg/kg body weight/day. There was no evidence of dose-
related, dermal irritation. Dose-related clinical signs seen in high-dose females
included emaciation, hunched posture, stiff hindlimbs, incoordination, and
tremors. Among the males, one high-dose rat was emaciated; there were no
neurologic signs.
Males and females dosed at 0, 5, and 15 mg/kg/day had similar body
weights throughout the study. The 50 mg/kg/day males and females consistently
gained less weight than the other groups, and weighed as much as 14% and 23%
less than controls, respectively. At termination, high-dose body weights were 9%
-------
and 17% less than controls for males and females, respectively.
consumption was not affected.
Food
There were no dose-related effects on eye health or clinical pathology.
Statistically significant increases in relative brain, pituitary, heart, lung, liver,
kidney, and spleen weights in the high-dose males and females were attributed to
retarded growth. There were no dose-related effects on absolute organ weights.
The only dose-related gross lesion was wasting of the hindlimb skeletal muscle in
3/20 mid-dose females, and in 2/20 males and 19/20 females in the high-dose.
The gross findings were confirmed histopathologically as a reduction of
muscle fiber diameter, fatty replacement, and an increase in the number of
sarcolemmal nuclei. The subcutaneous panniculus muscle displayed atrophy in
the mid-dose females and the high-dose males and females. In addition>
degeneration of sciatic nerve fibers and minimal atrophy in the paravertebral
muscles was seen in 10/20 high-dose females. Degenerated fibers showed a loss
of myelin. The LOEL was 50 mg/kg/day in males and 15 mg/kg/day in females,
based on atrophy of the hindlimb muscles and subcutaneous panniculus muscles.
The NOEL was 15 mg/kg/day in males, and 5 mg/kg/day in females.
At 50 mg/kg/day, both sexes had decreased weight gain compared to
controls, and females showed minimal atrophy of the paravertebral muscle,
neurotoxic symptoms, and degeneration of some sciatic nerve fiber bundles.
(MRID No. 40936201)
In the rat inhalation toxicitv study, sodium omadine (40% aqueous
solution) was administered by whole-body inhalation to male and female Sprague-
Dawley rats for 6 hours/day, 5 days/week, for 13 weeks at analytical
concentrations of: 0, 0.00046, 0.0011, and 0.0038 mg/1. The high concentration
of 0.0038 mg/1 was increased to 0.0081 mg/1 at week 6 because of the lack of
signs of toxicity. Air control groups were included. The systemic NOEL(s) were
0.0081 mg/1 in males and 0.0011 mg/1 in females. The systemic LOEL was
0.0081 mg/1 in females, based on clinical signs of hindlimb dysfunction,
histopathologic skeletal muscle regeneration, and decreases in female body weight
and body weight gain. (MRID No. 41178201)
c. Chronic Toxicity
Sodium omadine (41.41% and 40.5% purity) in 40% aqueous solution was
administered in water by gavage to groups of 5 male and 5 female Cynomolgus
monkeys for 1 year at dose levels of 0, 5, 25, or 150 mg/kg/day. The dose level
of 150 mg/kg/day was.lowered to 75 mg/kgVday at week 6 because of adverse
effects on survival. .
-------
No evidence of toxicity was seen at the 5 mg/kg/day dose other than
emesis in some monkeys, Emesis was observed in all monkeys at higher doses.
Male body weights were unaffected by dosing, but female body weights were
decreased as much as 8%, 17%, and 23% at the 5, 25, and both 75 and 150
mg/kg/day doses, respectively. At 150 mg/kg/day, one female was sacrificed in
extremis at week 6. At 75 mg/kg/day, one male and one female died at weeks 13
and 35, respectively; the cause of death was not apparent for either animal.
Clinical signs noted prior to death in the dead and sacrificed females included
prostration, decreased activity, emesis, thinness, weakness, and cold extremities.
Emesis and ptyalism were seen in the male that died. Hematologic changes (i.e.,
decreases in erythrocyte count, hemoglobin, and hematocrit levels) were slight and
considered of minor lexicological importance. The NOAEL was 5 mg/kg/day.
The LEL was 25 mg/kg/day based on emesis and decreased female body weight.
(MRIDNo. 41178101) .' •'.
d. Carcinogenicity
In an 80-week dermal carcinogenicity study, sodium omadine 40%
aqueous solution (41.2% purity) was administered topically to groups of 50 male
and 50 female CD-I mice at dosage levels of 0, 5, 15, or 40 mg/kg/day.
At 40 mg/kg/day, an increase in the incidence of epidermal hyperplasia at
the application site was seen in males (20% compared to 0% in controls, p <0.01)
and in females (20% compared to 6% for controls; nonsignificant by pairwise
comparison but a significant trend, p
-------
in both sexes. Under the conditions of the study, an increase in neoplasia was not
observed at any site. Dosing was considered adequate to assess carcinogenicity.
The NOEL was 0.5 mg/kg/day. The LOEL was 1.5 mg/kg/day, based on
significant increases in the incidence of degeneration of the skeletal muscle of the
hindlimbs in both sexes. (MRID No. 42100901)
The OPP RfD/Peer Review Committee met on 3/30/95 to discuss the
adequacy of the carcinogenicity studies described abbve. The rat carcinogenicity
study was found to be acceptable. The dermal careinogenicity study in mice was
found to be inadequate because the chemical was not tested at a sufficiently high
dose level. However, the Agency concluded that a new study will not be required
as long as the use patterns do not dramatically change and the potential for human
exposure remains low. Sodium omadine was classified as a Group D carcinogen
•(insufficient weight of evidence). .
e. Developmental Toxicity
In a developmental toxicity study, New Zealand White rabbits were given
sodium omadine by daily dermal application for 6 hours at doses of 0, 1, 2.5, or
5 mg/kg/day on gestation days 6-19, inclusive. There was no evidence of
maternal or fetal toxicity at any dose. Since there was no LEL in this study, and
a range-finding dose of 7.5 mg/kg/day resulted in substantial toxicity, it is
reasonable, to define 5 mg/kg/day as a free-standing NOEL." (MRID No.
40487201) .
f. Reproductive Toxicity
In a two-generation reproduction study, Crl:CD(SD)BR rats received
sodium omadine 40% aqueous solution (41.2% purity) by gavage at dose levels
of 0, 0.5, 1.5, or 3.5 mg/kg/day. The highest dose level was changed from 4,5
mg/kg/day to 3.5 mg/kg/day after 3 weeks of dosing because of marked toxicity
at 4.5 mg/kg/day.
The parental NOEL was 0.5 mg/kg/day. The parental LOEL was 1.5
mg/kg/day in females, and 3.5 mg/kg/day in males, based on increased incidence
of histologic atrophy in the upper hindlimb skeletal muscles (reduction in fiber
diameter) in FJ females (3/25), F0 males (7/23), and F! males (9/25). Additional
parental effects seen at 3.5 mg/kg/day included increased histologic atrophy in the
upper hindlimb skeletal muscles in F0 females (19/24), and F! females (20/23); and
significantly decreased body weight in F0 and Fj females.
The reproductive NOEL was 1.5 mg/kg/day. The reproductive LEL was
3.5 mg/kg/day, based on slightly decreased number of pups per litter born in both
10
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generations (possibly a consequence of reduced mating success due to hindlimb
atrophy), delayed development in pups from both generations (including open ears
and eyes and startle response), and decreased pup body weight and weight gain
in both sexes. (MRID No. 41097201)
g. Mutagenicity
Sodium omadine 40% aqueous, solution (41.4% purity) did not induce
forward gene mutations at the HGPRT locus in cultured Chinese hamster ovary
(CHO) cells at concentrations of up to £0.08 fig/ml without S9 activation or 27
ug/ml with S9 activation. These concentrations were found to be severely
cytotoxic (i.e., <10% cell survival). (MRID No. 40411501) , ,
In the in vivo Micronucleus Assay, sodium omadine 40% aqueous solution
(41.4% purity) did not cause micronucleus induction in the bone marrow cells of
male or female CD-I mice at 30, 48, or 72 hours after the intraperitoneal
administration of 575 mg/kg (238 mg/kg/active ingredient). Clinical signs of ,
toxieity (decreased body tone, body drop> abnormal gait, ptosis, lacrimation, and
tremors) and target cell cytotoxicity were observed at this level. (MRID No.
40343701)
Sodium omadine 40% aqueous solution (41.4% purity) did not induce
unscheduled DNA synthesis (UPS) in primary rat hepatocytes treated with doses
up to 220 ng/ml (300 ng/ml, based on analytical determinations). Concentrations
2*71 ng/ml (>80 ng/ml) were cytotoxic. (MRID No. 40387501) .
h. Metabolism
The absorption, distribution, metabolism, and excretion of sodium omadine
were studied in groups of Sprague-Dawley rats administered a single oral dose, of
0.5 or 25 mg/kg 14C-sodium omadine, 0.5 mg/kg/day of sodium omadine for 14
days followed by a single oral dose of 14C-
-------
the repeated oral low-dose group and in the single oral high-dose group, the
majority of the administered radioactivity was excreted within 24 and 48 hours
postdosing, respectively. There was no evidence of bioaccumulation of sodium
omadine or its metabolites in the tissues.
The metabolic profiles in the urine were similar in all dose groups; 12
urinary metabolites (A-L) were characterized. The major metabolite in rat urine
was 2-pyridinethiol-l-oxide-S-glucuronide (Metabolite K) (41.4%-67.2% of the
recovered radioactivity), while unchanged parent compound was not detected in
the urine. (MRID No. 41269001)
i. Neurotoxicity
Results of a 13 week oral sub chronic toxicify/neurotoxicity study were
previously described in detail in section HI, B, 1, b. Although the neurotoxicity
portion of this study was found to be.supplemental due to reporting deficiencies,
enough information was provided to derive a LOEL of 2.0 mg/kg/day based on
evidence of neurotoxicity in male and female rats (neurogenic skeletal muscle
atrophy). The NOEL was found .to be 0.5 mg/kg/day. In the subchronic dermal
toxicity study, dose-related clinical signs seen in high-dose female rats included
emaciation, hunuied posture, stiff hindlimbs, incoordination, and tremors. Among
the males, one high-dose rat was emaciated; there were no neurologic signs. The
LOEL was 50 mg/kg/day in males and 15 mg/kg/day in females, based on atrophy
of the hindlimb muscles and subcutaneous panniculus muscles. The NOEL was
15 mg/kg/day in males, and 5 mg/kg/day in females.
j. Toxicological Endpoints
The endpoint for risk assessment of short-term (1 to 7 days) dermal
exposure to the active ingredient is a NOEL of 5 mg/kg/day based on the dermal
developmental toxicity. study in rabbits. The endpoint for risk assessment of
intermediate term (1 week to several months) dermal exposure is a NOEL of 5
mg/kg/day based on the 90-day dermal toxicity study in rats. The endpoint for
risk assessment of intermediate term inhalation exposure is a systemic NOEL of
0.0011 mg/1, based on the 90-day inhalation study in rats. Sodium omadine was
not found to be a dermal sensitizer in the tests conducted.
k.
Reference Dose
The RfD for sodium omadine was determined to be 0.005 mg/kg/day based
on a NOEL of 0.5 mg/kg/day and an uncertainty factor of 100. The NOEL was
obtained from a chronic rat study. The rat reproduction study with a parental
NOEL of 0.5 mg/kg/day supports the RfD as a co-critical study. This pesticide
12
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has not been reviewed by the FAO/WHO Joint Committee on Pesticide Residues
(JMPR). ._ ..-:-,
2. Exposure Assessment
a. Dietary
Sodium omadine is not registered for food use. Currently, because there
are no known dietary exposures to sodium omadinej a dietary exposure assessment
is not required. . ,
b. Occupational and Residential
The registrant Olin Chemicals; is a participant in the CMA (Chemical
Manufacturer Association) Antimicrobial Exposure Assessment Study. Based on
the results .of this study, the Agency has sufficient data to assess
mixer/loader/applicator (M/L/A) exposure.
Because sodium omadine is used primarily as a preservative in
metalworking and cutting fluids, the main focus of this occupational exposure
assessment is on the metalworking uses (mixing and loading). Although sodium
omadine may also be used as a preservative in numerous manufacturing materials
and fluids {listed in Section n, B), these uses were not discussed in detail in this
assessment because they most likely represent very limited use and the metal-
working uses represent a reasonable worse case exposure assessment. There are
no registered residential uses for sodium omadine; thus, an exposure assessment
of residential use is not required in this document.
This assessment Of occupational exposure addresses only the potential for
handler exposure to pesticide-products during loading of the products which
contain sodium omadine, into metal-working and -cutting fluids. The products are
loaded using either open-pouring or metering-pump techniques. Although Agency
representatives continue to discuss, through an interagency workgroup (EPA,
Occupational Safety and Health Administration (OSHA), and Nationallnstitute
for Occupational Safety Health (NIOSH)), the roles and responsibilities of
regulating the uses of metalworking fluids, paints and other products in the
industrial setting, OSHA" is most appropriately responsible for regulating
machinists safety and exposure. Therefore, machinists exposures will not be
addressed in detail in this document. Available information indicate that the
amount of active ingredient (0.005 to 0,5%) present in the oil used by machinists
would most likely be even lower than'the amount to which the handler would be
exposed. Therefore, it is presumed that exposure to sodium omadine treated fluids
13
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would represent a lesser hazard ito the machinist than to handlers involved in
pumping and pouring operations described in this document.
Background
Machine shops are the major site in the U.S. where sodium omadine is
used as a preservative in metalworking and cutting fluids. It is estimated that
sodium omadine may be poured or pumped into metalworking or cutting fluids
between 2 and 26 times per year. A worst case scenario for the use of sodium
omadine would be pouring or pumping of sodium omadine solutions (40% a.i.)
into metal-working or -cutting fluids. Approximately 80% of the U.S. use for
metal-working and -cutting fluids are small machine shops.
The Agency has determined that an occupational and residential exposure
assessment is required for active ingredients if: (1) certain toxicological criteria
are triggered and (2) there is a potential exposure to handlers (mixers, loaders,
applicators, etc.) during use or for persons entering treated sites immediately after
completion of product applications/use. Based on toxicity and exposure criteria,
an occupational exposure assessment is required for sodium omadine use as a
metalworking additive.
Handler (M/L/A1 Exposure^ \
As stated earlier, the registrant, OJin Chemicals, is a participant in the
CMA (Chemical Manufacturer Association) Antimicrobial Exposure Assessment
Study. The MCS (Maximum Credible Sum) unit of exposure developed in the
Antimicrobial Exposure Assessment Study is applicable to assess exposure in this
document.
According to the product labels the highest level of sodium omadine (EPA
Reg. 1258-843) in a formulated product is 40% sodium omadine active ingredient
in aqueous solution. Based on label use information, a maximum of 12.5 pounds
of the formulated product is added to 10,000 pounds of water-based fluids to make
metal-working, -cutting arid -cooling fluids. On this basis, a total of 5 pounds of
the active ingredient is handled during this mixing process (12.5 pounds X 0.4 =
5 pounds).
The vinyl acetate emulsion use of sodium omadine was selected to
estimate the amount of .active ingredient used as a preservative in an industrial
setting. Based on label use information, 1.15 pounds of the 40% sodium omadine
product is added into 10,000 pounds of compound to be preserved. This is equal
to 0.46 pounds of active ingredient handled (1.15 pounds x 0.4 = 0.46 pounds).
14
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The Agency is concerned about the potential for exposure to those small
machine shop operators (handlers) who both load this pesticide into the
metalworking fluid and use the treated metal-working and -cutting fluids on a
daily basis. The primary handler exposure would be limited to dermal and
inhalation exposure routes during open-pouring and meter^pump loading of the
pesticide into metal-working and -cutting fluids. However, the total exposure to
the active ingredient may vary widely depending on the amount of coolant used,
as well as upon how frequently the individual uses metal-working and -cutting
fluids. The following tables show the estimated daily exposure and margin of
exposure values for handlers exposed to liquid sodium omadine through open
pouring and pump-metering when used as an industrial preservative
(nonmetalworking uses) or as a metal-working or cutting fluid. Note: mean unit
exposure values used in these calculations were obtained from the previously cited
CMA study. Workers wore gloves, long-sleeve shirt and long pants for this study.
", BSTIM&TSDHAM>L&R'EXP&SU^ \
Use Setting
Preservative
Metalworking
Cutting Fluids
UE*
(/zg/lb ai)
140
133
Ibai/
used
0.46
5
BW**
(kg)
60
60 ,
Estimated Daily
Exposure
Og/kg/day
1.07 .
11.08
MOE
. 4700
450
**
UE- = Unit Exposure for combined dermal and inhalation exposures. Mean UE (cited above) was derived
from the CMA Study. .
BW = Body Weight (average 60 kg for female worker based on the developmental toxicity endpoint).
Actual Daily Exposure (/zg/kg/day) = (UE X Ib ai/used)/BW '
NOEL = 5 mg/kg/day based on rabbit developmental toxicity and rat subchronic dermal toxicity studies!
MOE = NOEL H-Daily Exposure
15
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E&?MA?mi^t;mmW$m£ AKttttgtt 3U^lJQW*Ufttt^ „
Use Setting
Preservative
Metalworking
Cutting Fluids
UE*
Og/lb ai)
••^^^^^^•^B
7.5
325
Ibai/
used
0.46
5
BW**
(kg)
60
60
Estimated Daily
Exposure
Og/kg/day)
0.06
27.08
MOE
83,000
185
UE = Unit Exposure for combined dermal and inhalation exposures! Mean UE (cited above) was derived
from the CMA Study.
BW = Body Weight (average 60 kg for female worker based on the devel opmental toxicity endpoint). Actual
Daily Exposure (^g/kg/day) = (UE X Ib ai/used)/BW
NOEL = 5 mg/kg/day based on rabbit developmental toxicity and rat subchronic dermal toxicity studies.
MOE = NOEL •*• Daily Exposure
The exposure estimates presented above for metalworking operations were
calculated assuming that exposures occurred in small machine shops, where
approximately 80% of U.S. use for metalworking and cutting fluids take place,
rather than in a large industrial setting. The exposure tables above indicate that
worker exposure may be higher for pamping than for pouring operations. This is
possible because activities in a small machine shop routinely require more
pumping operations such as disconnecting hoses and inserting measuring devices
than pouring operations. Further, in a small machine shop one person is likely to
perform all of the activities in pumping applications.
Post-Application Exposure
The Agency has determined that industrial and manufacturing workers may
be exposed to sodium omadine through dermal and inhalation routes after use of
sodium omadine containing fluids. However, based on the use patterns and the
chemical properties of sodium omadine (low vapor pressure, and stable at 100° C
for 120 hours, etc.), inhalation exposure to industrial/manufacturing workers
immediately after sodium omadine use is likely to be minimal (during and after
application process). Also since the amount of diluted sodium omadine for all
registered uses are negligible, the toxic effects are expected to be minimal from
dermal and inhalation exposure when substances containing sodium omadine are
used. Post application exposure criteria are not met for requiring post application
exposure data.
16
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3.
Risk Assessment
C.
a. Dietary
Sodium omadine is not registered for food use. Therefore, a dietary risk
characterization is not required.
b. Occupational and Residential
Based on available toxicity data and use patterns information, the Agency
has determined that estimation of risk for handlers exposed to sodium omadine
during pouring and pumping applications is required. Based on the margins of
exposure (MOEs) presented in the tables in Section in, B, 2, b, the potential.for
•occupational handler health risk is expected to be minimal for workers exposed
to sodium omadine during pumping and pouring operations.
Sodium omadine is not registered for homeowner uses; therefore, risk
characterization of residential exposure is not required. The Agency, however,
believes that the amount of sodium omadine in products that may enter the home
or occupational setting such as laundry rinse additives, detergents, carpet cleaners,
emulsions and jet printer inks would be very low due to dilution. For this reason,
health risks from exposure to consumers products containing sodium omadine are
also expected to be very low.
Environmental Assessment
1. Ecological Toxicity Data '•-.--,
All data requirements for assessing the ecological risk of sodium omadine
have been satisfied. Ecological effects data required to support sodium omadine
reregistration are avian acute oral, avian subacute dietary, fish acute toxicity and
acute aquatic invertebrate studies.
*\ ' • ' .
a. Toxicity to Terrestrial Animals
Avian Acute Toxicity
Avian Acute Oral Toxicity Findings
Species
Bdbwhite Quail
% Test Material '
41.9% '
LC,0 or LD50
185 mg ai/kg*
Conclusions
Moderately toxic
* Converted to TGAI per kg based on end-use concentrations.
17
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An acute oral toxicity study shows that sodium omadine is
moderately toxic to bobwhite quail. (MRID 40363401)
Avian Subacute Dietary Toxicity
Avian Subacute Dietary Toxicity Findings
Species
Mallard Duck
Bobwhite Quail
% Test Material
40%
40%
LC,n
3650mgai/l*
1300mgai/l*
Conclusions
Slightly toxic
Slightly toxic
* Converted to mg/1 TGAI based on end-use concentrations.
On a subacute dietary basis, sodium omadine has been
characterized as slightly toxic to mallard duck and bobwhite quail. (MRID
00073656 and 00073657)
b. Toxicity to Aquatic Animals
Freshwater Fish Acute Toxicity
Freshwater Fish Acute Toxicity
Species
Rainbow Trout
Bluegill Sunfish
% Test Material
41.9 %
41.9%
LC,n ;
<7.3 n.ai/1
8100 |i ai/1
Conclusions
Very highly toxic
Very highly toxic .
Sodium bmadine was found to be very highly toxic to rainbow trout
and bluegill sunfish. The requirement of a fish acute toxicity study is
satisfied by the bluegill sunfish study (MRID 40358501) and supplemental
information from a rainbow trout study (MRID 4094501). The trout study
was found to be supplemental but provided useful information indicating
that the LC^ should be regarded as ah upper bound for the true LC50 value.
A repeat rainbow trout study will not be required.
18
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Freshwater Invertebrates
Freshwater Invertebrates
Species -
Daphnia magna
% Test Material
40%,
LC,0 •
9.2 n ai/1
Conclusions
Very highly toxic ,
Sodium omadine has been found to be very highly toxic to
freshwater invertebrates. (MRID 00103228) /
Environmental Fate
The environmental fate database for sodium omadine is adequate
for reregistration purposes. The only environmental fate data required to
support the reregistration of sodium omadine is a hydrolysis study. A
hydrolysis study was submitted but was found to be only partially
acceptable. However, a repeat of this study is not considered necessary to
support the biocide uses covered in this document. No additional studies
are required at this time.
a.
Environmental Fate Assessment
In the hydrolysis study, measurements at each combination of
concentration (10 mg/1 or 100 mg/1), temperature (5°C or 40°C), and pH
(4, 7, or 10), indicate that a half-life of 23 days was obtained at 40 °C, pH
10, and. 10 mg/1 concentration. At other levels of concentration,
temperature, and pH, sodium omadine hydrolyzed more slowly, or was
stable to hydrolysis.
Hydrolytic products were more readily formed at an alkaline pH
than at neutral and acidic pH. It has been hypothesized that omadine
disulfide is formed by oxidation at all pH's, and at alkaline conditions
omadine disulfide reacts with hydroxide ions to form omadine sulfinic
acid.
r
Photolysis is probably a more important route of dissipation than
hydrolysis. Photqlytic half-lives of 40-126 minutes have been reported at
a concentration of 100 mg/1, with irradiation by natural sunlight. Raw data
have been provided to the Agency by Olin Corporation, but the
methodology was not documented in sufficient detail, and decline of
specific degradates was not addressed. ;
19
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b. Environmental Fate and Transport
As discussed above, a hydrolysis study has been submitted to the
Agency. Although this study does not conform to Agency guidelines, no
further hydrolysis data will be required by the Agency. Sodium omadine
was incubated in sterile, aqueous buffer solutions at each combination of
concentration '(10 mg/1 or 100 mg/1), temperature (5°C or 40°C), and pH
(4,7, or 10). A half-life of 23 days was obtained at 40 °C, pH 10, and 10
mg/1 concentration. At other levels of concentration, temperature, and pH,
sodium omadine hydrolyzed more slowly, or was stable to hydrolysis. The
Agency assumes that at normal environmental temperatures the hydrolytic
half-life of sodium omadine will be 23 days or longer.
No further characterization of degradation or transport can be made
from the required data. •
3. Exposure and Risk Characterization
While the hazard to aquatic organisms from exposure to sodium
• omadine has been characterized, a quantitative risk assessment has not
been conducted. The Office of Pesticide Programs has established a policy
that risks to aquatic environments from sodium omadine use as a biocide
are best characterized and regulated under the NPDES permitting program
of the Office of Water. All sodium omadine products are required to state
on their labels that discharges to aquatic environments must comply with
an NPDES permit. Refer to Section IV for further details.
4. Endangered Species .
The Agency expects little exposure to endangered fish and wildlife.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing sodium omadine active ingredients. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing sodium omadine.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
20
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its determination of reregistration eligibility of sodium omadine, 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 sodium omadine and to determine that sodium omadine can be used
without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing sodium omadine as the active
ingredients 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, etc. and the data identified
in Appendix B. The Agency has found that all uses of sodium omadine registered prior
to March 23, 1995 and listed in Appendix A 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 sodium
omadine, if new information comes to the Agency's attention or if the data requirements
for registration (or the guidelines for generating such data) change.
1.
Eligibility Decision
* •
Based on the reviews of the generic data for the active ingredients sodium
omadine, the Agency has sufficient information on the health effects of sodium
omadine and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that sodium omadine products,
labeled and used as specified in this Reregistration Eligibility Decision, wil} not
pose unreasonable risks or adverse effects to humans or the environment. Uses
registered after March 23,1995 are not included in this document. Therefore, the
Agency concludes that products containing sodium omadine for all uses registered
prior to March 23, 1995 are eligible for reregistration.
2. Eligible and Ineligible Uses
i ' ' ' , •
The Agency has determined that all uses bf sodium omadine registered
prior to March 23, 1995 are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for sodium
omadine. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
21
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1. Effluent Discharge/Aquatic Risk Rationale
By their nature, industrial biocides are often toxic to aquatic organisms.
This is evident from the ecotoxicity data presented in the Science Assessment
presented above. The effect to the environment of discharges containing biocides
depends heavily upon the volume, concentration, and other constituents of a
particular discharge, as well as such features as the size, nature, and flow rate of
waters receiving the discharge.
FIFRA permits EPA to require the generation of data on the effects of
biocides and to set general limits and conditions of use of a biocide through
statements on its labeling. However, these mechanisms do not readily provide for
adaptation to varied and changing local conditions. Consequently, generalized
regulation of a pesticide under FIFRA could inadequately restrict pesticide use
under some local conditions. The NPDES process is designed to take local
conditions into account through the issuance of permits for the discharge of
pollutants to bodies of water. However, historically, specific information about the
toxicological and environmental properties of biocides in effluent streams was not
always readily available or considered in writing permits.
EPA's Office of Pesticide Programs and Office of Water intend to
cooperate in the oversight of biocide uses to better employ the advantages offered
by each program while avoiding unnecessary overlap in regulation. Under FIFRA,
OPP will require the generation and submission to the Agency of information that
will be used by OPP to identify extraordinary hazards that could affect national
registration of biocide products use. Current information and that gathered in the
future will be shared with the Office of Water where it can be made available to
NPDES permit writers in addressing local aquatic effects of biocide use. In
addition, OW will alert OPP to any additional information that becomes available
concerning unanticipated aquatic effects of the use of this biocide for OPP's use
in national registration-decisions for these products. This approach should provide
'sufficient environmental safeguards while avoiding redundant effort since it allows
OPP to control the general approval of the biocide as required by FIFRA, but
includes a mechanism for recognizing and dealing with potential unacceptable
effects on a local level through the NPDES program. Improved limitations on use
under FIFRA and more accurate NPDES permitting decisions and accompanying
permit limits for industrial biocides may be developed in the future as the
information gathering and exchange program between the Offices progresses.
The Agency believes thafthe above process adequately addresses the test
for reregistration of a pesticide under FIFRA — "when used in accordance with
widespread and commonly recognized practice it will not generally cause
unreasonable adverse effects on the environment."
22
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Therefore, despite some concerns about potential effects to aquatic
organisms exposed to the effluent resulting from its use, the Agency has
concluded that unreasonable adverse effects from.the uses of sodium omadine
involving discharge to water are generally unlikely provided any such discharge
is subject to the NPDES permit process.
2.
Reference Dose
A reference dose of 0.005 mg/kg/day has been established based on a
NOEL pfO,.5 mg/kg/day in a chronic rat study and an uncertainty factor of 100.
3.
Cancer Classification
The Agency has classified sodium omadine as a Group D chemical
(indicating insufficient weight of evidence of carcinogenicity for humans).
Sodium omadine was assigned this classification because the dermal
carcinogenicity study in mice was found to be unacceptable due to inadequate
dose selection. The Agency has concluded that a repeat study is not required as
long as the use patterns do not dramatically change and the potential for human
exposure remains low.
4.
Environmental Hazard Statements
Certain environmental hazard statements are required for sodium omadine
products because of toxicity to aquatic organisms. Specific language is found in
Section V of this document. .
5. -. Endangered Speci'es Statement
No endangered species labeling is required at this time.
6. Occupational Labeling Rationale
The following is a summary of the regulatory positions and rationales for
the sodium omadine. Where labeling revisions are imposed, specific language
is set forth for this document. (Refer to Section V).
23
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Occupational and Residential Labeling Rationale/Risk Mitigation
Personal Protective Equipment/Engineering Controls for Handlers
For each end-use product, PPE requirements for pesticide handlers are set
during reregistration in one of two ways:
1. If the Agency has no special concerns about the acute effects or 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 Agency guidelines.
2. If the Agency 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, the Agency 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.
The Agency is establishing active-ingredient-based minimum PPE
requirements for occupational handlers. Since gloves were worn by the handlers
in the CMA studies that .were used to estimate exposures, chemical-resistant
gloves are required for occupational handlers of sodium omadine.
Post-Application/Entrv Restrictions
Occupational-Use Products
The Agency is not establishing entry restrictions at this time for
occupational uses of sodium omadine end-use products because the potential
24
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exposures to sodium omadine are expected to be minimal due to the dilution
factor, industrial process, and .the stability of products.
Other Labeling Requirements '
, The Agency is also requiring other use and safety information to be placed
on the labeling of all end-use products containing sodium omadine. For the
specific labeling statements, refer to Section V of this document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of sodium omadine products. ~ . '
A. Manufacturing-Use Products
, There are no manufacturing use products registered for sodium omadine
at this time. According to PR Notice 93-10 almost all products, including
manufacturing-use products must contain the effluent discharge statement listed
below (Section V, B, 2). (Exceptions for small, end-use containers are outlined
in PR Notice 95-1). Any new manufacturing-use products must contain this label
language.
•"' '•"'"»
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of sodium omadine for
the above eligible uses has been reviewed and determined to be complete. No
additional studies are required at this time.
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 D,
the Product Specific Data Call-in Notice.
" Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria and if not, commit to conduct new studies. If a
registrant believes that previously submitted data meet current testing standards,
then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
25
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2. Labeling Requirements for End-Use Products
Effluent Discharge and Aquatic Hazard Labeling Statements:
The following labeling statements are required on all end-use products.
"This pesticide is toxic to fish and aquatic invertebrates.. Do
not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public waters unless in accordance with
the requirements of a National Pollutant Discharge Elimination
System (NPDES)' permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of the EPA."
"This pesticide is a chelating agent and should not be used
with other chelating agents or with chlorine."
Worker Protection Labeling Statements
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain sodium
omadine, the product labeling must be revised to adopt the handler
personal protective equipment/engineering control requirements set forth
in this section. Any conflicting PPE requirements on the current labeling
must be removed. '
For multiple-active-ingredient end-use products that contain
sodium omadine, the. handler personal protective equipment/engineering
control requirements set forth in this section must be compared to the
requirements on the current labeling and the more protective must be
retained. For guidance on which requirements are considered more
protective, see PR Notice 93-7. .
Products Intended Primarily for Occupational Use
Minimum (Baseline^ PPE/Engineering Control Requirements
The Agency is establishing active-ingredient-based minimum
(baseline) PPE/engineering control requirements for sodium omadine end-
use products that are intended primarily for occupational use. The
26
-------
minimum '(baseline) PPE for such occupational .uses of sodium omadine
end-use products is chemical-resistant gloves. (For the glove statement, use
the statement established for sodium omadine through the instructions in
Supplement Three of PR Notice 93-7).. Please note: All end-use product
labels must also require, at a minimum, that applicators and other
mixer/loader handlers wear long-sleeve shirt, long pants and socks plus
shoes. If the end-use product is classified as toxicity category I or If for
eye irritation potential, protective eyewear is also required. (Note: eye
irritation data will be required in the product specific Data Call-In notice).
Entry Restrictions
No entry restrictions are required for sodium omadine.'
Other Labeling Requirements
Products Intended Primarily for Occupational Use ;
The Agency is requiring the following labeling statements to be
located on all end-use products containing sodium omadine that are
intended primarily for occupational use. .
Application Restrictions
"Do not apply this product in a way that will contact workers or
other persons.". ,'-,,..'
User Safety Requirements ,
Follow manufacturer's instructions for cleaning/maintaining PPE.
If no such instructions exist for washables, use detergent and hot water.
Keep and wash PPE separately from other laundry.
User Safety Recommendations
. f
• . "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."
27
-------
• "Users should remove PPE immediately after
handling this product. Wash the outside of gloves
before removing."
Application Method Timing and Equipment
All labeling must contain instructions stating when (i.e., as needed,
during manufacture, etc.) and how (i.e., pour from container, applied
through a closed delivery system, etc.) the preservative is added.
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 the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell sodium
omadine 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:
28
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VI. APPENDICES
29
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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 sodium omadine covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to sodium omadine in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR 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:
t_ .• ....
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 MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
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 in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included. -..-•
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 6f 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.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted -
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded'by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRED), each entry '
consists of a citation1 containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the .author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
• 39 ;
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the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document. •
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. -For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The thud element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study
within the volume.
40
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BIBLIOGRAPHY
MRID
CITATION
00073656 Fink, R; (1976) Final Report: Eight-Day Dietary LC50-Bobwhite Quail:
Project No. 133-103. (Unpublished study received Nov 16, 1976 under
1258-842; prepared by Truslow Farms, Inc., submitted by Olin Corp.,
Stamford, Conn.; CDL:226871-BO)
00073657 Fink, R. (1976) Final Report: Eight Day Dietary LC50~Mallard Ducks: Project
No. 133-104. (Unpublished study received Nov 16, 1976 under 1258-842;
prepared by Truslow Farms, Inc., submitted by Olin Corp., Stamford, Conn.;
CDL:226871-BP)
00103228 Union Carbide Corp. (1976) Acute Toxicity of Sodium Omadine, 40%
Aqueous Solution to Daphnia magna. (Unpublished study received Jun 3,
1982 under 1258-842; submitted by Olin Corp., Stamford, CT;
CDL:247630-A)
00159036 Olin Corp. (1986) 40% Sodium Omadine: Manufacturing Process &
Discussion of Impurities: Raw Materials Specifications and Material Safety
Data Sheets. Unpublished compilation. 68 p.
00159037 Olin Corp. (1983) Product Specifications and Material Safety Data Sheet:
Sodium Omadine. Unpublished study, 4 p.
00159038 Olin Corp. (1986).Quality Control Methods: Sodium Omadine. Unpublished
compilation. 38 p. '
00159039 Putnam, E. (1985) Color, Gardner: Sodium Omadine: CL-5-763. Unpublished
study prepared by Olin Corp. 2 p.
40170101 Hyde, G. (1987) Sodium Omadine; Preliminary Analysis & Certification of
Limits. Unpublished study prepared by Olin Corp. 81 p.
40247801 Moreno, O. (1987) Sodium Omadine: Oral LD50 in Rats: Laboratory Project
ID: MB 86-8370A. Unpublished study prepared by MB Research
Laboratories, Inc. 25 p.
40247802 Moreno, O. (1987) Sodium Omadine: Acute Dermal Toxicity in Rabbits/ LD50
in Rabbits: Laboratory Project ID: MB 86-8370B. Unpublished study prepared
by MB Research Laboratories, Inc. 26 p.
-,- ; ' ... • . 41 ••-''' •. . •
_
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BIBLIOGRAPHY
MRID
CITATION
40247803 Moreno, O. (1987) Sodium Omadine: Primary Dermal Irritation in Albino
Rabbits: Laboratory Project ID: MB 86-8370C. Unpublished study prepared by
MB Research Laboratories, Inc. lip.
40247804 Moreno, O. (1987) Sodium Qmadine: Guinea Pig Maximization Test
(Magnusson-Kligman): Laboratory Project ID: MB 86-8370F. Unpublished
study prepared by MB Research Laboratories, Inc. lip.
40339001 Drummond, J. (1987) Acute Inhalation Toxicity Evaluation on Na Omadine in
Rats: Laboratory Project ID: 397-045. Unpublished study prepared by
International Research and Development Corp. 67 p.
40343701 Sorg, R. (1987) Sodium Omadine: Micronucleus Test: Laboratory Project ID:
PH309-OL-001-87. Unpublished study prepared by Phafmakon Research
International, Inc. 52 p.
40358501 Ewell, W.; O'Boyle, R. (1987) Acute Aquatic Effects of Sodium Omadine on
the Bluegill Sunfish, Lepomis macrochirus: Laboratory Project ID: HAEL No.
87-0300; Accession No. YLX001. Unpublished study prepared by Eastman
Kodak Co., Health and Environment Laboratories. 54 p.
40363401 Grimes, J.; Jaber, M. (1987) Sodium Omadine: An Acute Oral Toxicity Study
with the Bobwhite: Final Report: Project No.: 133-108. Unpublished study
prepared by Wildlife International Ltd. 21 p.
40383001 . Fenn, R. (1980) Sodium Omadine: Hydrolysis Study: Laboratory Project ID:
CASR-1-80. Unpublished study .prepared by Olin Corp. 60 p. ,
40387401 Product Investigations, Inc. (1987) Evaluation of the Skin Irritating and
Sensitizing Propensities of Sodium Omadine Antimicrobial Agent, Sample
#H51196A in Humans: Report No. PI-4750. Unpublished study. 27 p.
40387501 Barfknecht, T. (1987) Sodium Omadine: Rat Hepatocyte Primary Culture/DNA
Repair Test: Laboratory Project ID: PH.31 l-OL-001-87. Unpublished study
prepared by.Pharmakon Research International, Inc. 73 p.
42
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BIBLIOGRAPHY
MRID
CITATION
40411501 Stankowski, L. (1987) CHO/HPRT Mammalian Cell Forward Gene Mutation
Assay: Sodium Omadine: Study No. PH 314-OL-001-87. Unpublished study
prepared by Pharmakon Research International, inc. 50 p.
40487201 Keller, K. (1987) Dermal Developmental Toxiciry Study in New Zealand
White Rabbits with Sodium Omadine: 397-044. Unpublished study prepared
by International Research and Development Corp. 119 p.
,''"'' / .' • - ' : ' • '
40494501 O'Bbyle, R.; Ewell^ W. (1988) Acute Aquatic Effects of Sodium Omadine on
the Rainbow Trout, Salmo'gairdneri: HAEL No. 87-0300. Unpublished study
prepared by Eastman Kodak Co. 63 p.
40756901 Husband, R.; Wood, C.; Shirley, E. (1988) Sodium Omadine: 90 Day Oral
(Gavage) Toxicity Study in the Rat: Laboratory Project ID OLA/2/88.
Unpublished study prepared by Toxicol Laboratories Limited. 335 p.
40936201 Taupin, P.; Wood, C. (1988) Sodium Omadine: 90 Day Dermal Toxiciry Study
in the Rat:-OLA/5/88. Unpublished study prepared by Toxicol Laboratories
; Limited, 373 p.
40974101 Hyde, G. (1988) Sodium Omadine Physical and Chemical Characteristics, I:
SCE No. 8806. Unpublished study prepared by Olin Corp. in cooperation with
Safety Consulting Engineers, Inc. 91 p.
' ' ' -- '
41097201 Ridgway, P.; Wood, C. (1989) Sodium Omadine: Rat Two-Generation
Reproduction Toxicity Study: Project ID: OLA/9/88, Unpublished study
prepared by Toxicol Laboratories Ltd. 648 p.
41178101 Johnson, D. (1989) One Year Oral Toxicity Study in Cynomolgus Monkeys:
Report No. 397-047, Unpublished study prepared by International Research
and Development Corp. ,389 p.
41178201 Ulrich, C. (1989) Thirteen Week Subchronic Inhalation Toxiciry Study on Na
Omadine in Rats: Laboratory Project ID 397-042. Unpublished study prepared
by International Research and Development Corp. 380 p.
41189901 Flaherty, P. (1988) Sodium Omadine 40%: Nitrosoamine formation,Study: ,
Project ID 5450-3726. Unpublished study prepared by Olin Corp. 39 p.
43
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BIBLIOGRAPHY
MRID
CITATION
41269001 Chadwick, M.; Silveira, D.; McComish, M.; et al. (1989) Sodium Omadine:
Disposition and Metabolism in Rats after Oral and Intravenous Administration:
Project ID: ADL 59798A. Unpublished study prepared by Arthur D. Little,
Inc. 168 p.
41412201 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study: Lab Project ID: Q626.
Unpublished study prepared by Univ. of Iowa, Institute of Agriculture
Medicine and Occupational Health. 209 p.
42100801 Husband, R.; Newman, A.; Lee, P. (1991) Sodium Omadine: 80 Week Dermal
Carcinogenicity Study in the Mouse: Lab Project Number: OLA/7/90.
Unpublished study prepared by Toxicol Labs, Ltd. 1104 p.
42100901 Husband, R.; Newman, A.; Lee, P. (1991) Sodium Omadine: 104 Week Oral
(Gavage) Combined Carcinogenicity and Toxicity Study in the Rat: Lab Project
Number: OLA/3/90. Unpublished study prepared by Toxicol Laboratories, Ltd.
1050 p. .
44
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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 m below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or .
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section ffl-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section DI-D),
' 45
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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
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31^96). .
» ' " \
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
\
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section in - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI- Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms arid Confidential Statement of
Formula
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.
46
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SECTIONII. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED ''"'•.
, . • ' . / •-•,••-. ...
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-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 PortRoyal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements, when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350). '...•.'•"
; All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2V&} 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.
47
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SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
m-A. SCHEDULE FOR RESPONDING TO'THE AGENCY
The appropriate responses initially required by this Notice for product specific data must be
submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for. issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
IH-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 HI-C. A discussion of options relating to
requests for data waivers is contained in Section m-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you'choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions of
this Notice which are contained in Section IV-G
48
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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 HI-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 HI-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
IH-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 developdata jointly
(Cost Sharing) :
(3) I have made offers to cost-share (Offers to Cost Share) ,
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study) :
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study) .'•'•-
Option 1. Developing Data -^ If you choose to develop the required data it must he in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not ,
49
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submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s). . ,
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must
explain any technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original deadline remains. The
Agency will respond to your request in writing. If EPA does not grant your request, the original
deadline remains. Normally, extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request for extension is
not made in a timely fashion; in no event shall an extension request be considered if it is submitted
at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the group.
The registration number of the product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
. offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development ~ This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you dp 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 registrants) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
50
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to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and
must hot 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.
: • " J
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
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study —If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated. .
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 GFR Part 160.
As stated in 40 CFR 160.3(j)" 'raw data' 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."
-.••-.-••'• ' 51 ' .,.-.•''.'''
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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
submitting the existing study that sucn 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 the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available
from NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above. . >
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in the Agency's files, you need only
cite it along with the notification. If not in the Agency's files, you must submit a summary and
copies as required by PR Notice 86-5.
Option 5. Upgrading a Study— If a study has been classified as partially acceptable and .
upgradeable, you may submit data to upgrade that-study. The Agency will review the data
submitted and determine if the requirement is satisfied: If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct aH. 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 MRDD
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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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
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements. .
Registrants who select one of the above 6 options must meet all of the requirements,
described in the instructions for completing the Data Call-In Response Form and the Requirements
Status and Registrant's Response Form, as appropriate. :
m-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons^
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental.
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for •
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver
only under extraordinary circumstances. You should also be aware that submitting a waiver
request will not automatically extend the due date for the study in question. Waiver requests
submitted without adequate supporting rationale will be denied and the original due date will
remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE .
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Gall-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
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
54
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c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice. .
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, ntimber of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices. .
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act. :
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes, Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act., You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
•'-•'-'. 55 ' .
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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.
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.
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.
56
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring .the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Date
Requirements for Reregistration
List of Registrants Receiving This Notice -
Cost Share and Data Compensation Forms, and Confidential Statement of Formula
57
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SODIUM OMADINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION ,
You have been sent this Product Specific Data Call-In Notice because you have produces)
containing sodium omadine. -.'.,' .
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of sodium
omadine. 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) a list of
registrants receiving this DCI (Attachment 5) and (6) the Cost Share and Data Compensation
Forms in replying to this sodium omadine Product Specific Data Call-In (Attachment 6).
Instructions and guidance accompany each form.
DATA REQUIRED BY TFflS NOTICE '
The additional data requirements needed to complete the database for sodium omadine
are contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on sodium omadine are needed for specific products. The$e
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 sodium omadine products.
TNOTTTRTRS AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of sodium omadine, please
contact Judy Loranger at (703) 308-8056.
' If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Bruce Kapner at (703) 308-8013. :
All responses to this Notice for the Product Specific data requirements should be
submitted to: :: ,
.Bruce Kapner _ .
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: Sodium Omadine
59
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Sodium omadine DATA CALL-IN CHEMICAL STATUS SHEET
No generic data are required for sodium omadine at this time.
60
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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.
Item 6.
Item 7a.
Item 7b.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C),
Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this
form, provide the EPA registration numbers of your source(s); you would not
complete the "Requirements Status and Registrant's Response" form. Examples
of such products include repackaged products and Special Local Needs (Section
24c) products which are identical to federally registered products.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
61
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattem(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases. ,
Item 8. The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-in Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice. 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 8570r4).
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
62
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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 committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29)
and (2) two completed, and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4).
I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-in Notice that my
. product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am including a copy of my offer and proof of the other registrant's receipt
of that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 In the Data
Call-In Notice (Section III-C.1.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4).
By the specified due date, I will submit- an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
I certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notice (Section ffi-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I
have indicated this choice. By the specified due date, I will also submit a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) to show what data compensation
option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
63
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upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions
for this option outlined Option 5 in the Data Call-In Notice (Section III-C.l.)
apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or
Accession number(s) for the cited data on a "Product Specific Data Report" form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
.product has already been transferred to another company or that you have already
64
-------
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
65
-------
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EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING
SODIUM OMADINE FOR PURPOSES OF MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill ,the acute
toxicity data requirements for reregistration of end-use products containing the active ingredient
sodium omadine, the Agency considered batching end-use products. This process involves
grouping similar products for purposes of acute toxicity. Factors considered in the sorting
process include each product's active and inert ingredients (identity, percent composition arid
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.).
However, batching of end-use products containingsodium omadine was not possible after
considering the available information described above. Table I lists all the end-use products
containing sodium omadine. These products were either considered not to be similar for purposes
of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
each product.
Registrants must generate all the required acute toxicolbgical studies for each of their
products. 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 cited, the registrant
must clearly identify the material tested by its 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 day s 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 must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). Since the end-use products containing
sodium omadine could not be batched, registrants cannot choose from the remaining options:
Cost sharing (Option 2) or Offers to Cost Share (Option 3).
66
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EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING
SODIUM OMADINE FOR PURPOSES OF MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
Table I. End-Use Products Containing sodium omadine
EPA Reg. No.
1258-843
1258-990
1258-1205
1258-1213
4808-3
% of sodium omadine & Other Active Ingredients
40% sodium omadine
6.4% sodium omadine
63.6% Bioban GK Brand of hexahydro-1,3,5-tris(2-hydroxyethyl)-
s-triazine
3.6% sodium omadine
71 .4% Bioban GK Brand of hexahydro-1 ,3,5-tris(2-hydroxyethyl)-
s-triazine
10% sodium omadine
4.0% sodium omadine
Formulation Type
Ready-to-Use-Solution
Ready-to-Use-Solution
Ready-to-Use-Solution
Ready-to-Use-Solution
Ready-to-Use-Solution
67
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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. . The CSF must be signed, dated and the telephone number of the responsible party
must be provided. ^
d. All applicable information which is on the product specific data submission must
also be reported oh the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. . Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported: <
i. 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.
j. 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). v
k; All the items under column 13.b. must total 100 percent.
1. 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
limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
71
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vvEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief. Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, .DC 20503.
Please fill In blanks below.
Company Name , . , '
Product Name . ' • • . .
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into 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 ail
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s): -
NIDI* of Flrm(»)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'* Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which Is obsolete
75
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
[reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
Ing instrucions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing th
lion of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
Ing suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
ly, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
|0106), Washington, DC 20503. . '
>e fill in blanks below.
>y Name . v • ".• - .
Name • . .
Company Number
EPA Reg. No.
I .
fythat:
- . ;
.or each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
k) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
|ibmitter to cite that study. •
lat for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
I data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
Jny(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with section
I(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
Iment of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
Je companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
(rements Status and Registrants' Response Form,"
lat I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
tration under FIFRA. . • . • ;
•e "• • • - -.''.•"'
^H • -
•nd Title (Please Type or Print) :
Date
. • • •
•RAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with
Id to the registration or reregistration of my products, to the extent required by FIFRA section
"l)(F)and3(c)(2)(D).
1
Date
B • . • ,.'.'••••••••
•nd Title (Please Type or Print)
3570-31 (4-96)
.77
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The following is a list of available documents related to sodium omadine. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents are
part of the Administrative Record for sodium omadine and are included in the EPA's Office of
Pesticide Programs Public Docket. ^
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Sodium Omadine RED Fact Sheet , .
4. PR Notice 86-5 (included in this appendix) ....-• :
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
79
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-026
January 1996
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Sodium Omadine
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 years ago be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 209, sodium omadine. .
Sodium omadine is a broad spectrum antimicrobial compound used as
a preservative in certain manufacturing materials and as: additive in process
fluids which may otherwise be subject to deterioration through bacterial
and/or fungal growth; Sodium omadine may be used as a biocide in:
aqueous metalworking, cutting, cooling and lubricating fluids; latex ,
emulsions used in adhesives, caulks, patching compounds, sealants, pastes
and grouts; latex emulsions; aqueous fiber lubricants and inks; laundry rinse
additives and detergents; carpet cleaners and analytical and diagnostic
reagents. This RED did not address the use of sodium omadine as an in can
preservative of water based chemical or mineral add mixtures used in
concrete preparation, registered by the Agency on March 23> 1995.
Currently there are 5 registered products that contain from 3.6 to 40 percent
sodium omadine. All of these end-use products are formulated as liquid
soluble concentrates. There are no registered food uses.
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Regulatory
History
Human Health
Assessment
Sodium omadine was first registered in the United States in 1968 for
use as a biocide. The Registration Standard on sodium omadine (NTIS #
PB86-173929) was issued in July ,1985, and required submission of product
chemistry, toxicology, ecotoxicity and environmental fate data. The 1987
Antimicrobial Data Call-In (DCI) required the submission of a variety of
subchronic and chronic toxicology and occupational exposure studies.
Toxicity
Sodium omadine caused slight erythema and edema in a dermal
irritation study using rabbits. Sodium omadine was found to be moderately
toxic by the dermal route (Toxicity Category II), slightly toxic by the oral
and inhalation routes (Toxicity Category III) and did not cause skin
sensitization in animals studies.
In a 90-day rat dermal toxicity study, there was no evidence of dose-
related dermal irritation. Dose related clinical signs seen in females
included emaciation, hunched posture, stiff hindlimbs, ihcoordination and
tremors. In a subchronic oral toxicity/neurotoxicity study, high dose rats
exhibited treatment related neurotoxic signs.
In a chronic toxicity study, clinical signs of toxicity noted in monkeys
administered sodium omadine by gavage included prostration, decreased
.activity, emesis, thinness, weakness and cold extremities. Slight
hematologic changes were observed and were considered of minor
toxicologic importance.
In a rat oral carcinogenicity study, an increase in neoplasms was not
observed at any site. In a mouse dermal carcinpgenicity study, application
of sodium omadine did not induce any benign or malignant neoplasms.
Although this study was found to be inadequate because the chemical was
not tested at a sufficiently high dose level, the Agency concluded that a new
study will not be required as long as the use patterns do not dramatically
change and the potential for human exposure remains low. Sodium
omadine has been classified as a Group D carcinogen based on the
insufficient weight of evidence regarding its cancer-causing potential.
In a developmental toxicity study in rabbits, there was no evidence of
maternal or fetal toxicity at any dose. In a two-generation reproduction
study, rats showed parental (skeletal muscle atrophy and decreased body
weight) and reproductive effects (slightly decreased number of pups per
litter, delayed develppment, decreased pup body weight and weight gain).
Sodium omadine was negative in three mutagenicity studies. Metabolism
studies indicated that it was rapidly absorbed, metabolized, and excreted at
all dosing levels tested.
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Dietary Exposure .
No dietary exposure is expected from the pesticide uses of sodium
omadine since no food or feed uses are registered.
Occupational and Residential Exposure
Based on current use patterns, handlers may be exposed to sodium
omadine through dermal or inhalation routes from pouring and pumping of
sodium omadine in metal working fluids. ,
EPA has conducted exposure and risk assessments for workers
exposed to sodium omadine during pouring and pumping operations and
finds that margins of exposure (MOEs) for workers are greater than 100.
Thus, minimal risks are posed to workers during the pouring and pumping
of liquids that contain sodium omadine. The Agency has not evaluated
occupational risk to machinists because these worker's exposure is
regulated by the Occupational Safety Administration (OSHA). Available
information indicates that the amount of active ingredient (0.005 to.0,5%)
present in the oil used by machinists would most likely be even lower than
the amount to which handlers would be exposed. Therefore, exposure to "
sodium omadine treated fluids would represent a lesser hazard to the
machinist than to handlers involved in pumping and pouring operations!
Sodium omadine is not registered for homeowner uses; therefore, risk
characterization of residential exposure is not required. The Agency,
however, believes that the amount of sodium omadine in products that may
enter the home or occupational setting such as laundry rinse additives,
detergents, carpet cleaners, emulsions and jet printer inks would be very
low due to dilution. For this reason, health risks to consumers from
exposure to products containing sodium omadine are also expected to be
very low. • .
Human Risk Assessment
Because sodium omadine is slightly to moderately acutely toxic, the
Agency is establishing active-ingredient-based minimum (baseline)
personal protective equipment (PPE) and engineering control requirements
(chemical resistant gloves) for end-use products that are intended primarily
for occupational use. All end-use product labels must also require, at a
minimum, that applicators and other mixer/loader handlers a wear long-
sleeve shirt, long pants and socks plus shoes. If the required eye irritation
study indicates that the end-use product is classified as toxicity category I
or n for eye irritation potential, protective eyewear is also required.
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Environmental
Assessment
Additional Data
Required
Product Labeling
Changes
Required
Environmental Fate.
Under normal environmental conditions, the hydrolytic half-life of
sodium omadine will likely be 23 days or longer. Photolysis is probably a
more important route of dissipation than hydrolysis. Photolytic half-lives of
40-126 minutes have been reported with irradiation by natural sunlight.
Ecological Effects
An acute oral toxicity study shows that sodium omadine is moderately
toxic to bobwhite quail. On a subacute dietary basis, sodium omadine has
been characterized as slightly toxic to mallard ducks and bobwhite quails.
Sodium omadine was found to be very highly toxic to rainbow trout,
bluegill sunfish and freshwater invertebrates.
Ecological Effects Risk Assessment
While the hazard to aquatic organisms from exposure to sodium
omadine has been characterized, a quantitative risk assessment has not been
conducted. The Office of Pesticide Programs has established a policy that
' risks to aquatic environments from use of biocides such as sodium omadine
are best characterized and regulated under the NPDES permitting program
of EPA's Office of Water. All sodium omadine products are required to
state on their labels that discharges to aquatic environments must comply
with an NPDES permit.
All generic data requirements have been satisfied for sodium
omadine. The Agency is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
All sodium omadine end-use products must comply with EPA's
current pesticide product labeling requirements, and with the additional
requirements summarized below. Please see the RED document for the
complete text of these labeling requirements.
Effluent Discharge and Aquatic Hazard Labeling Statements:
"This pesticide is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans; or public waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge! Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
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plant authority. For guidance contact your State Water Board or Regional
Office of the EPA." ,
"This pesticide is a chelating agent and should not be used with other
chelating agents or with chlorine."
Worker Protection Labeling Statements , '' •
•Minimum (Baseline) PPE/Engineering Control Requirements
For sole-active-ingredient end-use products that contain sodium
omadine, revise the product labeling to adopt these handler
PPE/engineering control requirements and remove any conflicting PPE
requirements.
For multiple-active-ingredient end-use products, compare these
handler PPE/engineering control requirements to those on current labeling
and retain the more protective. To determine which requirements are
considered more protective, see PR Notice 93-7.
The minimum (baseline) PPE for occupational uses of sodium
omadine end-use products is chemical-resistant gloves. (For the glove
statement, use the statement established for sodium omadine through the
instructions in Supplement Three of PR Notice 93-7). Please note: All
end-use product labels must also require, at a minimum, that applicators and
other mixer/loader handlers wear a long-sleeve shirt, long pants, and socks
plus shoes. If the end-use product is classified as toxicity category I or II
for eye irritation potential, protective eyewear is also required.
•Other Labeling Requirements for Occupational Use Products
Application Restrictions
"Do not apply this product in a way that will contact workers or other
persons."
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions exist for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations
• "Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide
gets inside. Then wash thoroughly and put on clean
clothing."
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Regulatory
Conclusion
For More
Information
• "Users should remove PPE immediately after handling
this product. Wash the outside of gloves before
removing.",
Application Method Timing and Equipment
All labeling must contain instructions stating when (i.e., as needed,
during manufacture, etc.) and how (i.e., pour from container, applied
through a closed delivery system, etc.) the preservative is added.
The use of currently registered products containing sodium omadine
in accordance with approved labeling will not pose unreasonable risks or
adverse effects-to humans or the environment.. Therefore, all uses of
sodium omadine registered prior to March 23, 1995, are eligible for
reregistration. (Uses registered on or after that date not included in this
RED).
Sodium omadine products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
"revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for sodium omadine during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special, Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695,. .
Following the comment period, the sodium omadine RED document
also will be available from the National Technical Information Service
(N-TIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-
4650.
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For more information about EPA's pesticide reregistration program,
the sodium omadine RED, or reregistration of individual products
containing sodium omadine, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
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