United States Office of Prevention, Pesticides EPA 738-R-93-OI9
Environmental Protection And Toxic Substances September (993
Agency .(7508W) .
xvEPA Registration
""" ibiiity Decision
Inorganic Halides
Printed on Recycled Paper
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA-738-F-93-01 5
And Toxic Substances September 1993
. (H-7508W)
R.E.D. FACTS
inorganic Halides
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration 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 undue hazards 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 for sodium bromide
and sodium chloride, which made up the reregistration case called
Inorganic Halides.
Use Profile
Sodium bromide is used as a microbiocide. to control algae, bacteria
and fungi in pasteurizer and cannery cooling water recirculation systems, .
pulp and paper mill water systems, and ornamental ponds and aquaria. It
also is an active ingredient in pesticide products used to repel moths from
clothing, and fleas from pets and their sleeping quarters. Products are
formulated as liquid or solid soluble concentrates, tablets or granules.
Sodium bromide has been used for many years in medicine as a sedative.
Regulatory
History
Sodium chloride is one of two active ingredients in a disenfectant
used to treat feeding and watering appliances, equipment and premises in
poultry operations. Sodium chloride is also the sole active ingredient
impregnated into polyethylene whcih is placed around gardens as a barrier
to slugs and snails.
Sodium bromide was first registered as a pesticide in the U.S. in
1975. Currently, 32 pesticide products contain the active ingredient
sodium bromide.
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Products containing sodium chloride were first registered as
pesticides in the U.S. in 1954. At present, 2 pesticide products contain
sodium chloride as an active ingredient.
Human Health Toxicity
Assessment Sodium bromide is of low acute oral and moderate dermal toxicity,
and has been placed in Toxicity Category m for these effects. (Category I
indicates the highest and Category IV the lowest degree of acute, toxicity.)
It causes mild eye and skin irritation, and for those effects it has been
placed in Toxicity Category IV. • '
The human health effects of bromides following oral exposure are
well known. The bromine salts have a depressant effect on the nervous
system when administered at levels of 1 to 2 grams per day. This effect is
slowly reversed when treatment is stopped.
Sodium chloride is of low acute oral toxicity and causes moderate
eye irritation; it has been placed in Toxicity Category HI for these effects.
It causes mild skin irritation and for this effect has been placed hi. Toxicity
Category IV.
Sodium chloride, known as salt, sea salt and table salt, is abundant in
nature. It is used primarily to season or preserve food and is consumed by
people daily, especially in commercially prepared and preserved foods.
Consumption of more than the minimum daily requirement of salt may
contribute to high blood pressure in some populations.
Dietary Exposure
Dietary exposure to sodium bromide and sodium chloride is not
expected to occur as a result of their pesticidal uses. None of the currently
registered pesticide products involve food or feed uses, and no tolerances
(residue limits in food) are established, for these pesticides as a result of
these uses. _' ' :
Occupational and Residential Exposure
The potential for mixer/loader/applicator exposure exists primarily
from fogging- or misting-type applications of the disenfectant containing
sodium chloride, and from handling the liquid formulation of sodium
bromide. These exposures are considered minimal or low, however, and
are do not pose human toxicity concerns.
Human Risk Assessment
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Applicator Exposure
The risk from occupational exposure to sodium bromide and sodium
chloride is considered to be minimal. Their toxicity (or lack of toxicity) in
humans is well documented. No additional hazard or exposure data are
required for reregistration eligibility. Based on the low toxicity, minimal
exposure risk and limited pesticidal uses of sodium bromide and sodium
chloride, the risks to humans are considered negligible.
Environmental EPA did not perform an environmental assessment of sodium
Assessment chloride. The registered uses result in insignificant exposure to the
environment. Sodium chloride occurs abundantly hi the natural
environment. It is a component of seawater, and is in the diets of most
terrestrial animals. Although it can be toxic in large amounts, especially to
freshwater aquatic organisms, the use of sodium chloride as registered will
not result in any significant exposure to non-target organisms in the
environment.
The following assessment addresses sodium bromide only.
Environmental Fate
Sodium bromide itself has no pesticidal activity. It dissociates in
water to sodium and bromide ions. Activators such as chlorine and sodium
hypochlorite react with the bromine ion to form hypobromous acid, which
is the actual pesticide. The chemistry of hypobromous acid has been well
documented in the literature.
When used in cooling towers and water systems, sodium bromide
effectively controls algae, bacteria and fungal slime. It is injected into the
service water with or after an activator (either chlorine gas or sodium
hypochlorite), producing the active disinfectant hypobromous acid, an
effective microbiological control treatment. As hypobromous acid passes
through a heat exchange unit, it is converted back to bromide ion and
water. Discharge of hypobromous acid is limited by the National Pollutant
Discharge Elimination System (NPDES) permit program. .
> . _
The Agency conducted a Tier Ic Estimated Environmental
Concentration (EEC) model for hypobromous acid, to demonstrate the
maximum concentration likely to occur immediately downstream from an
industrial (point source) discharge site. EECs were calculated for both
"high exposure case" and "typical" sites. The worst case EEC for all use
sites tested was 450 parts per billion (ppb), and the typical sites ranged
from 0.38 to 0.75 ppb. These estimated concentrations are discussed hi
relation to ecological effects, below.
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Ecological Effects
Sodium bromide is practically non-toxic to upland game birds and
waterfowl on both an acute oral and a dietary basis. However, sodium
bromide as hypobromous acid is highly toxic to freshwater fish, aquatic
invertebrates and estuarine and marine organisms.
In two aquatic residue monitoring studies conducted at powerplants
on the Potomac River in Maryland, bromine as hypobromous acid
measured at the point of discharge exceeded the levels of concern for
estuarine species hi one study, and for all aquatic species in the second
study. Significant residue levels were detected 80 meters downstream;
residues were no longer detectable between 80 and 130 meters
downstream.
Ecological Effects Risk Assessment
As discussed earlier, EPA conducted a Tier Ic EEC screening model
for hypobromous acid to estimate the maximum concentration that occurs; :
immediately downstream from an industrial point source discharge site.
The results for the high exposure case are comparable to the amounts
detected in the two Potomac River aquatic residue studies, one of which
showed high concentrations of hypobromous acid as far downstream as 80
meters. Based on these studies, the Agency presumes risk to freshwater
and estuarine fish and invertebrates at the point of discharge and
downstream to 80 meters.
However, the modeling results for "typical" sites are well below the
levels of concern for fish and invertebrates. These results indicate that
sodium bromide can be used at typical sites without impact most of the
time. Since the discharge of hypobromous acid is limited by the NPDES
permit program administered by EPA's Office of Water, the Agency will
be able to control the discharge of hypobromous acid on a site-by-site basis
so that toxic levels are avoided. . •
Based on this modeling, EPA also presumes a 'risk to endangered .
freshwater and estuarine/maruie organisms in "worst case" situations.
However, "typical" discharge levels are below those of concern for
endangered species. •
Additional Data EPA has sufficient generic data to support reregistration of all
Required products containing sodium bromide. Due to the nature of the pesticide
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and the amount of information available in the public literature, EPA
required no generic data for reregistration of sodium chloride.
EPA is requiring product-specific data including acute toxicology,
chemistry and efficacy studies, as well as revised Confidential Statements
of Formula and revised labeling, for reregistration of pesticide products
containing sodium bromide and sodium chloride.
Product Labeling The labels of all registered pesticide products containing sodium bromide
Changes Required and sodium chloride must comply with EPA's current pesticide labeling
requirements. In addition, all products containing sodium bromide must
contain the following effluent discharge statement:
"This product is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other water unless hi accordance
with the requirements of a National Pollution 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 EPA."
Regulatory The use of currently registered pesticide products containing sodium
Conclusion bromide and sodium chloride as labeled and specified in the RED
document will not pose unreasonable risks or adverse effects to humans or
the environment. Therefore, all uses of these products are eligible for
reregistration. . .
These products will be reregistered once the product-specific data,
revised (if necessary) Confidential Statements of Formula and revised
labeling are received and accepted by EPA.
For More EPA is requesting public comments on the Reregistration
Information Eligibility Decision (RED) document for the Inorganic Halides (sodium
bromide and sodium chloride) during a 60-day time period, as announced
in a Notice of Availability published in the Federal Register. To obtain a
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copy of the RED document or to submit written comments, please contact
the Pesticide Docket, Public Response and Program Resources Branch,
Field Operations Division (H-7506C), Office of Pesticide Programs (OPP),
US EPA, .Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the Inorganic Halides RED document
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the Inorganic Halides RED, or reregistration of individual products .
containing sodium bromide or sodium chloride, please contact the Special
Review and Reregistration Division (H-7508W), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for
assistance hi 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 6:00 pm
Central Tune, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION
Inorganic Halides
LIST D
CASE 4051
ENVmONMENTAL'PROTECTION-AGENCY
OFFICE-OF-PESTICIDE-PROGRAMS
SPECIAL-REVIEW-AND-REREGISTRATION-DIVISION
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TABLE OF CONTENTS
INORGANIC HALIDES REREGISTRATION ELIGIBILITY TEAM . i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY • *v
I. INTRODUCTION . i r . 1
H. CASE OVERVIEW . .-;. . . 2
A. Chemical Overview -. 2
B. Use Proffle 2
C. Regulatory History • • • • • 5
HI. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment • • • 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity ; . . . 7
b. Other Toxicological Considerations 8
2. Exposure Assessment 9
a. Dietary . . . 9
b. Occupational and Residential 9
3. Risk Assessment 9
C. Environmental Assessment 9
.1. Environmental Fate of Sodium Bromide 10
2. Ecological Effects 12
a. Ecological Hazard . . 12
(1) Avian Testing 12
(2) Aquatic Organism Testing 13
(a) Freshwater Fish Toxicity . 13
(b) Freshwater Invertebrate Toxicity 13
(c) Estuarihe/Marine Toxicity 14
(d) Aquatic Residue Monitoring 14
(e) Disciplinary Review Summation- . : 15
3. Ecological Risk Assessment . ._ . .;. "15
4. Endangered Species 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 16
A. Eligibility Decision '. 16
1. Eligible and Ineligible Uses 17
V. ACTIONS REQUIRED BY REGISTRANTS 17
A. Manufacturing-Use Products 17
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1. Additional Generic Data Requirements 17
2. Labeling Requirements for Manufacturing-Use Products 17
B. End-Use Products 18
1. Additional Product-Specific Data Requirements 18
2. Labeling Requirements for End-Use Products . . . : . 18
C. Existing Stocks 19
VI. APPENDICES • 21
APPENDIX A. Table of Use Patterns Subject to Reregistration 23
APPENDIX B. Table of the Generic Data Requirements and .Studies Used
to Make the Reregistration Decision —35—
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Inorganic Halides —43—
APPENDIX D. List of Available Related Documents —53—
APPENDIX E —57—
PR Notice 86-5 —59—
PR Notice 91-2 —79—
APPENDIX F. Product Specific Data Call-in —85—
Attachment 1. Chemical Status Sheet • • • —99—
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions —101—
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions ..... —105—
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration —111—
Attachment 5. EPA Acceptance Criteria —119—
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice —133—
Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form . —135—
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INORGANIC HALIDES REREGISTRATION
Office of Pesticide Programs:
Biological and Economic Analysis Division
Cynthia Szymanski
" Rafael Prieto
Michele Pethel
Environmental • Fate • and -Effects • Division
Betsy Grim
Constance Hoheisel
R. David Jones
Renee Lamb
Health- Effects- Division
Jane Smith
Flora Chow
Registration- Division
Rob Travaglini
Shyam Mathur
Van Seabaugh
Special Review and Reregistration Division
Mark Wilhite
Bruce Sidwell
ELIGIBILITY TEAM
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Chemical Coordination Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of Compliance Monitoring:
Beverly Updike
Office of General Counsel:
i
Victoria Mattison
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF . Confidential Statement of Formula
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
GRAS Generally Recognized As Safe as designated by FDA
HDT Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water, air or feed,
e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg. • . ,
LDte Lethal Dose-low. Lowest Dose at which lethality occurs • • ' • '
LEL Lowest Effect Level ' •
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
LD
50
n
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GLOSSARY OF TERMS AND ABBREVIATIONS
MPI Maximum Permissible Intake
MOE Margin Of Exposure (PAD)
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable '.
NPDES National Pollutant Discharge Elimination System .
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution..
m
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EXECUTIVE SUMMARY
The Environmental Protection Agency, hereafter referred to as the "Agency" has
completed its reregistration assessment of the available information on the pesticide active
ingredients sodium bromide and sodium chloride, which make up the case named Inorganic
-Halides. It has been determined that the currently registered uses will not cause unreasonable
• risk to humans or the environment and are therefore eligible for reregistration.
Sodium bromide is registered for use as a microbiocide hi water recirculation systems
associated with pasteurizer/cannery cooling systems, pulp/paper mill water systems, ornamental
ponds and aquaria. It is also used in pesticide products to repel moths from clothing and fleas
from pets, and their sleeping quarters.
Sodium chloride is one of two active ingredients hi a disenfectant used to treat feeding and
watering appliances, equipment and premises hi poultry operations. Sodium chloride is the sole
active ingredient impregnated into polyethylene which is placed around gardens as a barrier to
slugs and snails. ,
The Agency has determined that the uses of these active ingredients as currently
registered pose no unreasonable risk to humans or the environment. Although there is some
concern about effects to aquatic organisms exposed to the effluent resulting from the industrial
use of sodium'bromide, such discharge is limited under the Agency's National Pollutant
Discharge Elimination System (NPDES) permitting program.
Before reregistering products containing sodium bromide or sodium chloride, the Agency
is requiring that product specific data on acute toxicology, chemistry, and efficacy, revised
Confidential Statements of Formula, and revised labeling be submitted within eight months of
the issuance of this document. After reviewing these data and revised labels and finding them
acceptable hi accordance with Section 3(c)(5) of FIFRA, the Agency will reregister products.
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.
IV
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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
hi 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 registration" before calling
in data on products and either reregistering products or taking other appropnate 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 chloride and sodium bromide. The document consists of six
sections Section I is the introduction. Section H describes the inorganic halides, then: uses, data
requirements and regulatory history. Section HI discusses the human health and environmental
assessment based on the data available to the Agency. Section IV presents the reregistration
decision for sodium chloride and sodium bromide. Section V discusses the reregistration
requirements for sodium chloride and sodium bromide . 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.1
'EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Registration Eligibility
Decision:
Chemical Name:
Chemical Code: ,
Empirical Formula:
Basic Manufacturer:
Sodium bromide
CAS Registry Number: 7647-15-6
013907
NaBr
Great Lakes Chemical Corporation and Ethyl
Corporation.
• Chemical Name:
• Common Name:
4 CAS Registry Number:
• Chemical Code:
• Empirical Formula:
Sodium Chloride
Common salt or Salt
7647-14-5
013905
NaCl
B. Use Profile
CHEMICAL: Sodium Bromide
TYPE OF PESTICIDE: .
Water disinfectant, Sanitizjer, Slimicide (slime-forming algae, bacteria and fungi),
Bactericide, Algicide, Fungicide, Mollusc control agent
USE SITES:
AQUATIC NON-FOOD INDUSTRIAL:
Pulp/paper mill water systems (fresh and sea water effluent water systems)
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Industrial waste disposal systems (waste water treatment systems)
Air washer water systems
Recirculating and once-through industrial and commercial water cooling systems, Influent
systems (flow-through filters, lagoons)
Evaporative condenser water systems
Sewage systems (secondary and tertiary waste water systems)
Heat exchanger water systems
Industrial processing water
Industrial scrubbing system
AQUATIC NONrFOOD RESIDENTIAL:
Swimming pool water systems (spas, hot tubs)
Ornamental ponds/aquaria (fountains)
Domestic/commercial non-potable water (waterbed water and therapeutic pools)
INDOOR FOOD:
Food processing water systems
INDOOR NON-FOOD:
Pasteurizer/warmer/cannery cooling water systems (brewery pasteurizers)
PESTS:
Aquatic environmental bacteria; Slime forming algae, bacteria and fungi; Asiatic clam
(Corbiculd), Barnacle, Zebra mussel (Dreissena)
FORMULATION TYPES REGISTERED:
TYPE: End use, Manufacturing use
FORM: Liquid soluble concentrate; Solid soluble concentrate -Tablets, Granules
METHODS AND RATES OF APPLICATION:
TYPES OF TREATMENT:
Water recirculating system treatment, Water once-through system treatment, Water
treatment, Sewage wastewater effluent treatment .
EQUIPMENT: , . " .'
Tablet feeder or Not specified
TIMING:
Continuous feed (initial and subsequent), Intermittent (slug, initial and subsequent),
Initial, Subsequent/maintenance, Shock/slug or Not specified
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RATE OF APPLICATION:
Aquatic non-food industrial:
From less than 1 ppm up to 27 ppm of active ingredient by weight
Aquatic non-food residential:
From less than 1 ppm up to 44 ppm of active ingredient by weight.
(Pulp and paper mills: 0.5 to 5.0 ppm residual bromine)
Indoor non-food: :
From 1 ppm up to 13 ppm of active ingredient by weight
Indoor food: .
22 ppm of active ingredient by weight
USE PRACTICES LIMITATIONS:
pH: Maintain a minimum of 7.2 up to a maximum of 8.0 (Swimming pools, Spas and
Hot tubs)
CHEMICAL: Sodium Chloride
TYPE OF PESTICIDE: Molluscicide, Disinfectant in combination with 20.4%
potassium peroxymonosulfate (general/broad spectrum control of animal pathogens),
Virucide, Fungicide (mold/mildew), Fungicide/Fungistat (fungi pathogenic to animals)
USE SITES:
INDOOR RESIDENTIAL:
Air treatments (commercial/household)
TERRESTRIAL NON-FOOD & OUTDOOR RESIDENTIAL:
Perimeters of Gardens
INDOOR FOOD: .
Poultry (egg/meat) - poultry house premises
Poultry Processing Plant Premises (nonfood contact)
INDOOR NON-FOOD: .
Egg Handling Equipment (hatching) ,
Egg Handling Rooms (hatching) "
PESTS:
Snails and slugs; Bacteria- Streptococcus pyogenes. Campvlobacter pvforidas. Klebsiella
pneumoniae. Salmonella typhimurium. Salmonella choleraesuis. Staphylococcus aureus.
Pseudomonas aeruginosa. Staphvlococcus epidermidis. Mvcoplasma gallisepticum:
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Viruses- Newcastle Disease, Infectious Bronchitis, Infectious Bursal Disease, Avian
Laryngotracheitis, Avian Influenza, Marek's Disease; Fungi- Aspergillus flayus,
Aspergillus fumigatus. Candida albicans.
FORMULATION TYPES REGISTERED:
Impregnated Material
(10% sodium chloride)
Soluble Concentrate/Solid . ,
(1.5% sodium chloride with 20.4% potassium peroxymonosulfate)
METHODS AND RATES OF APPLICATION:
Impregnated Material
Place slug and snail barrier around perimeter of garden. Recess into soil 1/2 inch. No
application rate specified.
Soluble Concentrate/Solid
Apply a 1% or 2% solution (= 150 ppm NaCl or 300 ppm NaCl) to surfaces to be
disinfected. For cleaning and disinfecting, use at a rate of 15 gallons of solution per
1000 sq. ft.; for disinfecting, use at a rate of 7.5 gallons of solution per 1000 sq. ft.
Allow 10 minute contact time, then rinse with potable water. For air sanitizing, fog with
a 1-2% solution until surfaces are moist. Allow at least 2 hours before entering area that
has been fogged.
USE PRACTICES LIMITATIONS
Impregnated Material
Do not use for three consecutive seasons.
Soluble Concentrate/Solid
See Methods and Rates of Application above.
C. Regulatory History
Products containing sodium chloride as an active ingredient were first registered
in 1954 for use as wood preservatives, a use which is no longer registered. There are
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currently only two products registered containing sodium chloride as an active ingredient.
Products containing sodium bromide as an active ingredient have been registered
since 1975. There are currently 32 such products registered.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Chemical Name:
Empirical Formula:
Molecular weight:
Melting Point:
Density:
Solubility:
Dissociation constant:
pH:
Chemical Name:
Empirical Formula:
Molecular weight:
Melting Point:
Density:
Solubility:
Sodium bromide
NaBr
102.90
755 °C
3.210 at 0°C
Sodium bromide is soluble in water.
As a water solution of a strong electrolyte, sodium
bromide is 100% dissociated.
Sodium bromide is a neutral salt. Aqueous solution
(46%) has a pH of 7.
Sodium Chloride
NaCl
58.44
800°C , ' .
2.165 at 0°C ". / .
100 parts by weight of water dissolves 36.0 parts of
salt at 20°C; 39.1 parts at 100°C; and 39.2 parts at
107°C(the b. p. of saturated solution); the salt is
soluble hi glycerine, slightly soluble in alcohol or
liquid ammonia and insoluble in concentrated HC1.
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B. Human Health Assessment
I. Toxicology Assessment
a. Acute Toxicity
The table below summarizes the toxicity results and categories for technical grade
sodium chloride and sodium bromide. Because of its abundance in the
.environment and low toxicity to humans, no toxicity data were required for
sodium chloride. For sodium bromide, acute inhalation data were not required
because of the lack of potential inhalation exposure to humans and because of its
low toxicity. ;
Acute Toxicity - Sodium Chloride
Test
Acute Oral (rat)
Acute Dermal (rabbit)
Acute Inhalation
Eye Irritation
Dermal Irritation
Skin Sensitization
*Sax and Lewis, 1989
Acute
Test
Acute Oral (rat)2
Result*
3000 mg/kg
WAIVED
WAIVED
moderate
mild
WAIVED
Toxicity - Sodium Bromide
Result
4200 mg/kg (males and
Category
m
-
.
m
rv
' -
Category
ni
Acute Dermal (rabbit)3
Acute Inhalation
females)
4500 mg/kg (females)
3900 mg/kg (males).
>2000mg/kg
WAIVED
m ,
2MRID 14889, 40670804
3MRID 148890
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Eye Irritation4 mild ' IV
Dermal Irritation5 mild IV
Skin Sensitization6 nonsensitjzing -;_
b. Other lexicological Considerations
Sodium.chloride, commonly known as salt, sea salt, and table salt, is
abundant in nature and primarily used to season or preserve food or in industrial
processes: It is consumed daily by humans especially in commercially prepared
and preserved foods. It is hypothesized that consumption of salt in excess of the
rninimum daily requirement may contribute to high blood pressure in some
individuals.
Sodium and potassium salts of bromide have been used for many years hi
prescription and proprietary sedatives. Consequently, the health effects of
bromides following oral exposure are well known. The central nervous system
depressant effects of the bromide salts hi humans occur when administration is
repeated daily at dose levels on the order of 1 to 2 grams per day. The effect is
slowly reversed when dosing is stopped. Bromide ion acts hi the organism by
replacing chloride ion and inhibiting depolarization and transmission hi nerve
cells.
A Salmonella tvphimurium reverse mutation assay (Ames assay) was
conducted using a 99% technical sodium bromide. Strains TA 1535, TA 1537,
TA 1538, TA 98, and TA 100 were tested with and without S9 metabolic
activation. No increase hi reverse mutations were observed at concentrations up
to 5000 ug/plate (MRID 40670808). .
An in vitro cytogenic assay was performed using human lymphocytes and
99% technical sodium bromide. The tests were negative for chromosomal
aberrations at concentrations up to 5000 ug/ml with and without metabolic
activation (MRID 40670809). .
An unscheduled DNA synthesis assay was conducted using hela cells and
99% sodium bromide. The tests were negative with: and without metabolic
4MRID 148891
5MRID 148892, 40670807
6MRID 41019601
8
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activation even at concentrations causing toxicity (25,600 ug/ml) (MRID
40670810).
2. Exposure Assessment
a. Dietary
Dietary exposure to sodium chloride and sodium bromide is not expected
to occur as a result of pesticidal uses on.food since no, currently registered
products involve food or animal feed uses.
b. Occupational and Residential
The potential for mixer/loader/applicator exposure exists primarily from
the fogging/misting type applications associated with the disenfectant containing
sodium chloride and from handling the liquid formulation of sodium bromide.
The exposure, however, is considered minimal or low. Since the exposure is
minimal and no human toxicity concerns exist, no additional exposure data are
required.
3. Risk Assessment -
The risks from occupational exposure are considered to be minimal based on the
low toxicities of sodium bromide and sodium chloride. The toxicity (or lack of toxicity)
of these compounds is well documented hi humans. The inherent function of sodium
chloride and the metabolic pathways of sodium bromide in humans and domestic animals
are known. No additional hazard or exposure data are required for reregistration
eligibility. Based on these factors and the limited pesticidal uses, the human risks are
considered to be negligible . . .
C. Environmental Assessment
The Agency did not perform an environmental assessment of sodium chloride.
The registered uses, as an ingredient in a poultry cage and equipment disinfectant and
as a barrier to slugs around gardens, are insignificant with regard to exposure of sodium
chloride to the environment. Sodium chloride occurs abundantly 'hi the natural
environment. It is a component of seawater, and hi the diets of most terrestrial animals.
Although it can be toxic in, large amounts, especially to freshwater aquatic organisms,
the use of sodium chloride as registered will not result in any significant exposure to non-
target organisms hi the environment. For the currently registered uses, sodium chloride
is present in low amounts, or is used hi indoor situations only. Since sodium chloride
readily dissolves, no environmental fate assessment was necessary. Therefore, the
Agency does not require any environmental fate or ecological effects data for sodium
-------
chloride. The following environmental assessment addresses sodium bromide only.
1. Environmental Fate of Sodium Bromide
Sodium bromide per se is a stable salt with no pesticidal activity. The salt
dissociates hi water to sodium and bromide ions which do not undergo any further
degradation. Activators such as chlorine and sodium hypochlorite react with the
dissociated bromine ion to form hypobromous acid (HOBr), which is the actual pesticide.
The chemistry of hypobromous acid has been well documented hi the literature.
Sodium bromide is used hi conjunction with chlorine and sodium hypochlorite
during waste-water treatment.process. Hypobromous acid can oxidize organic, and
inorganic material present in effluent water and has a reported half life of about 125
hours. Depending on the amount of material present with which hypobromous acid can
react, a shorter half life than 125 hours is expected. Another mode of dissipation of
hypobromous acid in waste water is via reaction with ammonia to form bromamines.
These chemical reactions can result hi as much as 50% reduction hi the amount of
hypobromous within seconds. However, "fresh" hypobromous acid is continuously
introduced into the system.
Hypobromous acid is reported hi the literature to be a weaker oxidizing agent than
hypochlorous acid (HOC1), which is currently registered for use hi once-through cooling
towers. In equivalent amounts hypobromous acid should pose a lesser environmental risk
than hypochlorous acid since the amount of total residual oxidant is lower.
When used hi commercial and industrial cooling towers, recirculating cooling-
water systems, once-through water systems, effluent water systems such as flow-through
filters, heat-exchange water systems, and industrial water scrubbing systems, sodium
bromide effectively controls algae, bacteria, and fungal slime. The sodium bromide
solution usually is mixed with activators such as chlorine gas, calcium hypochlorite (60%
available chlorine), sodium hypochlorite (5% available chlorine), potassium
monopersulfate (4.5%. active oxygen), and ozone.
The chemistry of the fouling control agent, sodium bromide, is straightforward.
The sodium bromide is injected into the service water-either before, after,,or at the same
point as the activator (either 99.9% chlorine gas or-12.5% sodium hypochlorite). No
matter what the sodium bromide/activator mole ratio is (usually one-to-one), the active
disinfectant is hypobromous,acid Because of its superior performance hi high pH and
ammonia-containing water,, hypobromous acid is an effective microbiological control
treatment. As hypobromous acid passes through the heat-exchange unit, it is converted
back to bromide ion (Br) and water. The major portion of the hypobromous acid is
converted to bromide ion as it reacts with the fouling organism present hi the water. All
but a small portion is fed to the service water and subsequently discharged to the source
as the bromide ion. A small portion of the hypobromous acid reacts with organic
10
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substances (ultimately producing carbon dioxide and water).
In water, hypobromous acid ionizes to form hydrogen and hypobromite ions,
which are powerful oxidants and will oxidize organic substances present in water to form
bromide ion and water. At a pH of 8, 88% of the bromine is in the form of
hypobromous acid, while only 26% of the chlorine is in the form of hypochlorous acid.
In solution, the bromide ion does not hydrolyze and is not altered by ultraviolet radiation
(sunlight).
A Tier Ic EEC7 (estimated environmental concentration) model was conducted
by the Agency. A Tier Ic EEC demonstrates the maximum concentration likely to occur
immediately downstreamrfrom an industrial (point source) discharge site. The EEC's are
high exposure case, 1 in. 10 year EEC's. For the high exposure case site, it would be.
expected that the EEC would be equaled or exceeded once every 10 years, i.e., there is
a 10% chance in any given year that the EEC will be equaled or exceeded. This is
similar to the site and frequency assumptions that are generally being used for
agricultural pesticides. EECs for a 50% (typical site) at mean flow were also calculated.
Results are as follows:
Tier Ic EECs for Hypobromous Acid
•===========================
Use Site, Type
Food Processing
Pulp and Paper Mills
General Industrial Waste Disposal, Air
Washer Systems, Sewage Systems
Water Cooling Towers, Evaporative
Condensers, Heat Exchangers
.
High Exposure
Case
270 ppb
270 ppb
270 ppb
270 ppb
=======
=—======
Typical
0.38 ppb
0.75 ppb
0.38 ppb
0.43 ppb
=a=
A Tier Ic EEC is a preliminary or lower tier exposure assessment for industrial biocides.
11
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Tier Ic EECs for Hypobromous Acid on a Bromine Basis
Use Site, Type
Food Processing
Pulp and Paper Mills . . ,-
General Industrial Waste Disposal, Air
Washer Systems, Sewage Systems
Water Cooling Towers, Evaporative
Condensers, Heat Exchangers
High Exposure
Case
450 ppb
450 ppb
450 ppb
450 ppb
Typical
0.63 ppb
1.2 ppb
0.63 ppb
0.72 ppb
A discussion of these results as they pertain to risk assessment follows in the
Ecological Risk Assessment section below.
2. Ecological Effects .
a. Ecological Hazard
(1) Avian Testing
In order to establish the toxicity of microbiocides to birds, one avian.
single-dose oral (LD50) study on one species (preferably mallard or bobwhite
quail) and one subacute dietary study (LC50) were required. The results follow.
Avian Acute Toxicitv
Species
Bobwhite quail
% Test Material
(TGAI) (Sodium
bromide) ,
99.23
LDjo
> 2250 mg/kg
Conclusion
practically non
toxic
12
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Avian Subacute Toxicitv
Species
Bobwhite quail
Mallard duck
% Test
Material
99.23
99.23
LC50
> 5633 ppm
> 5633 ppm
Conclusion
practically non toxic
practically non toxic
(2) Aquatic Organism Testing
Since hypobromous acid is formed from both bromine chloride and sodium
bromide when added to water, studies using technical bromine chloride (100%
a.i.) have been used to support the data requirements for aquatic organism testing
for sodium bromide. Results from these studies are presented below.
(a) Freshwater Fish Toxicity
The minhnum data required to establish toxicity of sodium bromide
to fish is a 96-hour acute toxicity study with either a cold water (rainbow
trout) or warm water (bluegill sunfish) species.
Species
Rainbow trout
Bluegill sunfish
% Test Material
(TGAI) bromine
chloride
100
100
LC50 (as bromine)
0.31 ppm
0.52 ppm
Conclusion
highly toxic
highly toxic
(b) Freshwater Invertebrate Toxicity,
The minimum data required to establish toxicity of sodium bromide
to freshwater invertebrates is a 48-hour acute toxicity test.
13
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Species
Daohnia magna
% Test
Material
(TGAI)
bromine
chloride
100
LC50 (as
bromine)
1.07 ppm
Conclusion
-
highly toxic
(c) Estuarine/Marine Toxicity
• Estuarine/marine testing is required to support use in once-through
cooling towers, oil recovery drilling muds/packer fluids, secondary oil
recovery injection waters, and pulp and paper mills.
Species
Sheepshead minnow
Mysid shrimp
Eastern oyster
% a.i. (TGAI)
sodium bromide
measured as
bromide
46
46
46
96-hour LC50 (as
bromine)
0.19 ppm
0.18 ppm
0.47 ppm
Conclusion
highly toxic
highly toxic
highly toxic
(d) Aquatic Residue Monitoring
Aquatic residue monitoring studies of once-through cooling systems in
freshwater and estuarine environments have been submitted to support registration
of sodium bromide.
One study was conducted at a powerplant on the Potomac River hi Charles
County, MD. At this point, the river is estuarine. A once-through cooling
system is employed at the plant. This study was designed to examine bromine
chloride as a potential substitute for chlorine when used in condenser cooling
systems. Two 15 day trials were made using continuous dose rates of bromine
chloride and chlorine. Application rates were 510 and 135 ppb bromine chloride.
The study indicates that the highest discharge residue (104 ppb, measured
at the point of discharge) of bromine as hypobromous acid, from an initial
continuous application of 510 ppb, exceeds the LOG (Level of-Concern - 1/2
LC50) for mysid shrimp, 90 ppb, and sheepshead minnow, 95 ppb.
14
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Another study was conducted at a powerplant in Carroll County, MD.
This Publicly Owned Treatment Works (POTW) uses aeration followed by
disinfection, and in this study chlorine in the absence of bromide and chlorine
with bromide (bromide in both cases from sodium bromide) were used as
disinfection.
This study indicates that the highest bromine or hypobromous acid
concentration (1081.6 ppb) in the effluent exceeds the LOCs (level of concern)
for all aquatic species at the point of discharge. Residue concentrations as high
as 135.2 ppb were detected 80 meters downstream. Residues were no longer
detectable between 80 and 130 meters downstream.
(e) Disciplinary Review Summation
Sodium bromide has been found to be practically non-toxic to both upland
game birds and waterfowl on both an acute oral and a dietary basis. Sodium
bromide (as hypobromous acid) is considered highly toxic to both warm water
and cold water fish, as well as to aquatic invertebrates and to estuarine/marine
organisms.
3. Ecological Risk Assessment
As noted above the Agency conducted a Tier Ic EEC (estimated environmental
concentration) for hypobromous acid. The results for the "high exposure case" are
comparable with the values obtained from the previously mentioned residue monitoring
studies. These studies showed high concentrations of hypobromous acid as far
downstream as 80 meters.
The calculated "high exposure case" EEC, i.e. cases of extreme exposure, for.
hypobromous acid as bromine for all use sites tested is 450 ppb. This EEC exceeds the
Levels of Concern (LOCs) for fish (1/2 LC50s = 155 ppb rainbow trout and 260 ppb for
the bluegill sunfish), and for estuarine/marine fish and invertebrates (1/2 LC50s = 90 ppb
mysid shrimp, 95 ppb sheepshead minnow and 235 ppb eastern oyster), but not for
Daphnia magna (1/2 LC50 = 535 ppb). Also, the residue monitoring studies, which were
conducted with application rates exceeding the permitted levels, indicate .that the highest
bromine or hypobromous acid concentration (1081.6 ppb) in the effluent exceeds the
LOCs for all aquatic species at the point of discharge. Residue concentrations as high
as 135.2 ppb were detected 80 meters downstream. Therefore, the Agency presumes risk
to freshwater and estuarine fish and invertebrates at the point of discharge and
downstream to 80 meters.
However, results for "typical" sites, i.e. industrial sites. with median
concentrations, resulted hi a range from 0.38 ppb to 0.75 ppb for all sites tested. These
15
-------
values are well below the LOCs for fish and invertebrates as given above. This would -
indicate that this chemical can be used at typical sites without impact most of the time.
Since the discharge of hypobromous acid is regulated by the National Pollutant Discharge
Elimination System (NPDES) permit program of the Office of Water, the Agency would
be able to control the discharge of hypobromous acid so that toxic levels are avoided on
a site-by-site basis . Results from the modeling indicate that hypobromous acid can be
used at typical sites most of the tune, without producing effluents above levels of
concern.
4. Endangered Species ' \ '
\
The calculated EEC (45.0 ppb) exceeds 1/20 the LCjo (risk criteria for endangered
aquatic species) for rainbow trout (15.5 ppb), for bluegill sunfish (26 ppb), for
sheepshead minnow (9.5 ppb), for mysid shrimp (9.0 ppb), for eastern oyster (23.5 ppb)
and for Daphnia magna (53.5 ppb). Therefore, the Agency presumes a risk to endangered
freshwater and estuarine/marine organism for "high exposure case" discharge of.
hypobromous acid. Results from the modeling indicate that hypobromous acid can be
used at typical use sites, most of the time, without producing effluents above the levels
of concern for endangered species.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Eligibility Decision ,- .
s
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. As discussed hi the previous sections of this
document, no generic data were required for sodium chloride due to its nature and the
amount of information already available hi the public literature. Generic data were
required for sodium bromide. Appendix B identifies these.generic data, which the
Agency reviewed as part of its determination of reregistration eligibility for sodium
bromide, and lists the submitted studies that the Agency found acceptable. The Agency
has completed its review of these generic data and information, and has determined that
the data are sufficient to support reregistration of all products containing either of these
' active ingredients. This information and data enabled the Agency to determine that
sodium bromide and sodium chloride can be used without resulting in unreasonable
adverse effects to humans and the environment. The Agency" therefore finds that, all
products containing sodium bromide or sodium chloride as "an active ingredient are
eligible for reregistration. The reregistration of particular products is addressed hi
Section V of this document.
The Agency has determined that sodium bromide products and sodium chloride
products, labeled and used as specified hi this Reregistration Eligibility Decision
16
-------
document, will not pose unreasonable risks or adverse effects to humans or the
environment. Although the Agency has found that all uses of sodium bromide and sodium
chloride 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 bromide and sodium chloride, 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. Eligible and Ineligible Uses
The Agency has determined that all uses of all currently registered sodium
bromide and sodium chloride products are eligible for reregistration.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of [NAME OF
CHEMICAL] for the above eligible uses has been reviewed and determined to be
substantially complete.
2. Labeling Requirements for Manufacturing-Use.Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be contained hi an
effluent discharged tq the waters of the United States or municipal sewer systems
must bear the following revised effluent discharge labeling statement.
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other 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
17
-------
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."
All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix.
G, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions hi the Requirement .Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
Worker Protection Standard
Any product whose labeling reasonably permits use hi the production of
an agricultural plant on any farm, forest, nursery, or greenhouse must comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 9311, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 136, subpart K).
These labeling revisions are necessary to implement" the" Worker Protection
Standard for Agricultural Pesticides (40 CFR part 170) and must be completed
in accordance with, and within the deadlines specified hi, PR. Notices 93-7 and
93-11. Unless otherwise specifically directed hi this RED, all statements required
by PR Notices 93-7 and 93-11 are to be on the product label exactly as instructed
hi those notices.
18
-------
After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided hi PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by any person.
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.
Effluent Discharge Labeling Statements ,
Refer to subsection A. above for labeling requirements for effluent
discharge.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products
for 50 months from 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 [add chemical
names here] 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. . .
19
-------
20
-------
VI. APPENDICES
21
-------
22
-------
APPENDIX A. Table of Use Patterns Subject to
Reregistration
23
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24
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
—35—
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—36—
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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 Inorganic Halides covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Inorganic Halides hi
all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized hi the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order hi .
which they appear hi 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from, the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry .
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data hi 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.
—37—
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—38—
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Inorganic
Halides
—43^
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-44-
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere hi the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies hi support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included. , ,
2. UNITS OF ENTRY. The unit of entry hi 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 hi which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries hi 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 hi the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed. .
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, hi the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual" was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the. document.
When the date is followed by a question mark, the bibliographer has deduced
-------
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the .
following elements, describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element hi 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.
-------
BIBLIOGRAPHY
MRID
CITATION
00148889 Stroderd, A. (1990) Acute Oral Toxicity (LD50) Study in Albino Rats with
Sodium Bromide Solution, 46%: Project Number: WIL-12036. Prepared by
WIL Research Laboratories, Inc. 26 p.
00148890 Stroderd, A. (1990) Acute Dermal Toxicity (LD50) Study in Albino Rabbits
with Sodium Bromide Solution, 46%. Prepared by WIL Research
Laboratories, Inc: 25 p.
00148891 Stroderd, A. (1990) Primary Eye Irritation Study in Albino Rabbits with
Sodium Bromide Solution, 46%: Project Number: WIL-12039. Prepared by
WIL Research Laboratories, Inc. 20 p.
00148892 Stroderd, A. (1990) Primary Dermal Irritation Study in Albino Rabbits with
Sodium Bromide Solution, 46%: Project Number: WIL-12038. Prepared by
WIL Research Laboratories, Inc. 17 p.
00160134 Great Lakes Chemical Corp. (1986) Product Chemistry/Manufacturing and
Analytical Methods for Sodium Bromide. 8 p.
40086301 Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished
compilation. 27 p.
40086302 Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished
compilation. 18 p.
40086303 Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished study.
3p. .
40669900 Sodium Bromide/Bromine Chloride Industry task Force (1988) Submission of
Toxicology Data to Support the Conditional Registration for Sodium Bromide
and Bromine Chloride. Transmittal of 4 studies. ~ • ;
40669901 Fletcher, D. (1988)'21-Day Acute Oral LD50 Study with Sodium Bromide
Technical in Mallard Ducks: BLAL Study No. 87DD53. Unpublished study
prepared by Bio-Life Associates, Ltd. 27 p.
40669902 Surprenant, D. (1990) Acute Toxicity of Bromine Chloride to Rainbow Trout
(Salmo gairdneri): Study Number: 1199.0387.6100.103. Prepared b
Springborn Bionomics, Inc. 61 p.
—47—
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BIBLIOGRAPHY
MMD
CITATION
-40669903 Surprenant, D. (1990) Acute Toxicity of Bromine Chloride to Bluegill
(Lepomis macrochirus): Study Number: 1199.0387.6100.100, Prepared by
Springborn Bionomics, Inc. 36 p.
40669904
40670801
40670802
40670803
40670804
Hughes, J. (1990) Acute Toxicity of Bromine Chloride to the Water flea
(Daphnia magna): Project Number: 0950-02-1100-1. Prepared by Malcolm
Pirnie, Inc. 21p.
Frances, J., comp. (1988) Product Identity: Sodium Bromide. Unpublished
compilation prepared by Dead Sea Bromine Co. 13 p.
Frances, J., comp. (1988) Analysis and Certification of Product Ingredients:
2270/8806/62. Unpublished compilation prepared by Dead Sea. Bromine Co.
Frances, J., comp. (1988) Physical and Chemical Characteristics: Sodium
Bromide: 2270/8806/63. Unpublished study prepared by Dead Sea Bromine
Co. 7 p.
Gardner, J. (1988) Acute Oral Toxicity to Rats of Sodium Bromide, Technical
Grade: Rept. No. 88278D/DSB 8/AC. Unpublished study prepared by
Huntingdon Research Centre Ltd. 18 p.
40670805 Kynoch, S.; Parcell, B. (1988) Acute Dermal Toxicity to Rabbits of Sodium
Bromide, Technical Grade: Rept. No. 88584D/DSB 9/AC. Unpublished study
prepared by Huntingdon Research Centre Ltd. 17 p. • .
40670806 Liggett, M. (1988) Irritant Effects on the Rabbit Eye of Sodium Bromide
Technical Grade: Rept. No. 88201D/DSB 11/SE. Unpublished study prepared
by Huntingdon Research Centre Ltd. 9 p.
40670807 Liggett, M. (1988) Irritant Effects on Rabbit Skin of Sodium Bromide
Technical Grade: Rept. No. 88111D/DSB 10/SE. Unpublished study prepared
by Huntingdon Research Center Ltd. 9 p.
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BIBLIOGRAPHY
MRID
CITATION
40670808 Jones, E.; Wilson, L. (1988) Ames Metabolic Activation Test to Assess the
Potential Mutagenic Effect of Sodium Bromide: Kept. No. DSB 4/88137.
Unpublished study prepared by Huntingdon Research Centre Ltd. 21 p.
40670809 Brooker, P.; Akhurst, L.; Gray, V.; et al. (1988) Sodium Bromide Technical
Grade Metaphase Chromosome Analysis of Human Lymphocytes Cultured in
vitro: Kept. No. DSB 5/88447. Unpublished study prepared by Huntingdon
Research Centre Ltd. 22 p.
40670810 Henderson, L.; Proudlock, R. (1988) Assessment of Unscheduled DNA Repair
Synthesis in Mammalian Cells After Exposure to Sodium Bromide (Technical
Grade): Rept. No. DSB 6/88454. Unpublished study prepared by Huntingdon
Research Centre Ltd. 23 p. ,
40670811 Grimes, J.; Jaber, M. (1988) Sodium Bromide: An Acute Oral Toxicity Study
with Bobwhite: Final Report: Proj. No. 238-103. Unpublished study prepared
by Wildlife International Ltd. 19 p.
40670812 Grimes, J.; Jaber, M. (1988) Sodium Bromide: A Dietary LC50 Study with
the Mallard: Proj. No. 238-102. Unpublished study prepared by Wildlife
International Ltd. 18 p.
40670813 Grimes, J.; Jaber, M. (1988) Sodium Bromide: A Dietary LC50 Study with
the Bobwhite: Proj. No. 238-101. Unpublished study prepared by Wildlife
International Ltd. 18 p. . :
40701001 Surprenant, D. (1990) Acute Toxicity of Hypobromous Acid to Mysid Shrimp
(Mysidopsis bahia) under flow-through conditions: SLS Study
#1199.0188.6190.515. Prepared by Springborn Life Sciences, Inc. 33 p.
40701002 Surprenant, D. (1990) Acute Toxicity of Hypobromous Acid to Eastern
Oysters (Crassosstrea virginica) under flow-through conditions: SLS Study No.
1199.0188.6109.504= Prepared by Springborn Life Sciences, Inc. 36 p.
^ . •
40701003 Surprenant, D. (1990) Acute Toxicity of Hypobromous Acid to Sheepshead
Minnow (Cyprinodon variegatus) under flow-through conditions: SLS Study -
#1199.0188.6190.505. Prepared by Springborn Life Sciences, Inc. 34 p.
40757001 Bongers, L.; O'Connor, T. (1990) Bromine Chloride An Alternative to
Chlorine for Fouling Cotrol in Condenser Cooling Systems: Study Number:
-------
BIBLIOGRAPHY
MRTO
CITATION
EPA-600/7-77-053. Prepared by Martin Marietta Corporation. 171 p.
41019601 Kynoch, S.; Parcell, B. (1988) Delayed Contact Hypersensitivity in the
' Guinea-Pig with Sodium Bromide Technical Grade: 881235D/DSB 30/SS.
Unpublished study prepared by Huntingdon Research Centre Ltd. 21 p.
41064101 Enright, A.; Bongers, L. (1989) Residue Monitoring An Evaluation of the
Decay and Dissipation of Oxidants Resulting from the Use of Bromine-based
Disinfectants for the Treatment of POTW Effluents. Unpublished study
prepared by Versar, Inc. 85 p.
42128601 Cowlyn, T. (1991) Sodium Bromide: Determination of Vapour Pressure: Final
Report: Lab Project Number: 91/BMP012/0600. Unpublished study prepared
by Life Science Research Ltd. and Department of Physical Chemistry at Leeds
University. 37 p.
42484201 Van Logten, M.; Rauws, A.; Kroes, R. et al. (1976) Semichrpnic tpxicity
studies of sodium bromide in rats on a normal diet amd a low chloride diet.
Med. Fac. Landbouw. Rijksuniv. Gent. 41:(2): 1976:1499-1507
42484202 Sangster, B.; Blom J.; Sekhuis, V. (1983) The influence of sodium bromide in
man: a study in human volunteers with special emphasis on the endocrine and
the central nervous system. Fd. Chem. Toxic. 21(4), 1883:409-419.
—50—
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BIBLIOGRAPHY
The following are references from the open literature cited in this document:
Clayton, G. D., and Clayton, F. E., eds., 1982. Patty's Industrial Hygiene and Toxicology.
3rd Revised Ed. Wiley Interscience, NY.
' Sax, N. I., and Lewis, R. J. Sr, 1989. Dangerous Properties of Industrial Materials. 7th Ed.
Van Nostrand . Reinhold, New York. •
Windholz, Martha, et al:, eds., 1983. The Merck Index. Tenth Edition. Merck and
Company: Rahway, NJ. . • ,
•> Zendzian, R., 1990. EPA internal memorandum.
—51—
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-52—
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APPENDIX D. List of Available Related Documents
—53—
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—54—
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The following is a list of available documents related to inorganic halides. 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 inorganic halides 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. Inorganic Halides 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
-55—
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—56—
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APPENDIX E. PR Notices 86-5 and 91-2
—57—
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—58—
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PR Notice 86-5
—59—
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—60—
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF '
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATOKS, DISTRIBUTORS
• . AND REGISTRANTS
Attention: Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the - .
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data ,to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to -be,.submitted
differently under separate cover. • ' . • .
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted"prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to.the
submitter for necessary revision. _• • • •
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include.Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
—61—
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 40'9 of FFDCA, and procedures which .
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before_the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
' v. Relationship of this Notice to Other QPP Policy and Guidance
While this Notice contains requirements for organizing* and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of ...
the screen is to avoid the additional costs and prolonged delays.,; •
associated with handling significantly incomplete application
packages. 'As of the effective date of this Notice,_the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with-Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket. .
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list of all_applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application. ' • • .
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.- >
VI. Format Requirements
A more detailed discussion of these format requirements •
follows the index on the next page, and samples of some of the
requirements are attached. Except for. the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
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- INDEX-
. Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4 •
C. 1 Special Considerations for Identifying Studies . . 5
-D. Organization of each Study Volume ..... 6 17
D. 1 '.Study Title Page . ., 7 , 12
D. 2 Statement-of Data Confidentiality Claims
. (based on FIFRA §10 (d) (1) ) 8'- 13
D. 3 Confidential Attachment ; 8 15
D. 4 Supplemental Statement of Data Confidentiality ' • -
Claims- (other than those based on FIFRA §10 (d) (I)'). 8. . 14
> D. 5 Good Laboratory Practice Compliance Statement . . .*9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies ..... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and-any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are.
intended to clarify, emphasize, or otherwise comment'to' help
Product Managers and reviewers better understand the submittal..
- -if such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the'submittal
package as a separate study (with title page and statement
of confidentiality claims).
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP) , §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or, a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
-each one. The EPA-assigned number for the regulatory action
• (e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an ,
acceptable transmittal. document.
The list of included -studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.) ' ' .
Each study must be consecutively paginated,.beginning from .
the title page as page 1, The total number of pages in the com-
plete study must be showji on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
-------
When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title'and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species ,
tested should be reported as a separate study, and bound
separately.- ' ,
Extensive supplemental reports of pathology reviews, feed .
analyses, historical control data, and the like are often assoc- . •
iated with safety studies. Whenever possible these should be-
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single- study for each Guideline series (61, 62, ..and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three -studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and.151-16; the third
would cover Guideline 151-17. The first study for a microbial .
pesticide would cover Guidelines 151-20, 151-21, and'151-22; the
second would cover Guidelines 151-23 and "151-25; the third would
cover Guideline 151-26. - -
. Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C) , and if so must be handled as described
in section D.3. of this notice. . .
—65—
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirement's must thus be defined at a level
below'that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues_
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
"single crop (such as beet tops and beet roots) residue data on
"all such commodities should be reported as a single study. When
multiple field trials.are associated with a single crop, all sucn
trials should be reported as a single study. ,
D. Organization-of Bach Study Volume
Each complete'study must include all applicable elements"in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative.
forms of this statement
is always required.
If study reports laboratory
work subject to GLP require-
ments
Example
Page 12
Page 13
Page 16
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claime.d under FIFRA
§10 (d) (1) (A), (B) , or (C).
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) , Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA'§10(d)(1)(A), (B), or (C)
-------
D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
/the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) ^addressed by"
the study. .... .
c. Author(s). . Gite only individuals with primary intellectual -
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work.. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be. appended to and bound with
the primary study. Do not include supplements to more than one.
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identity on the title page all-relevant facts of
publication, . such as the' journal title, volume, issue., inclusive
page numbers, and publication date.
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D.2. Statements of Data Confidentiality Claims Under FIFRA
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10 (d) (1) (A) , (B) , or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §10 (d) (1) data confidentiality (§158. 33 (b)) or
to waive such a claim (§158 .33 (c) ) . In either case, the
-statement must be signed and dated, arid must include the typed
'name and title of the official who signs it. Do not. make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13) .
D.3. Confidential Attachment .
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10 (D) (1) (A), (B) , or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5) .
The Confidential Attachment to a study must be .identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment.." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from 'the body of the study, beginning with page _ 1 of X
on the title page. Each passage confined to. the Confidential
Attachment must -be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage (s) of FIFRA
§10 (d) (1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10 (d)
(1) (A) , (B) , or (C) , the following provisions apply: •
- The specific information to which the claim applies must'
be clearly marked in the body of the' study -as -subject to a-..
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi- ,
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is .
included in Attachment 4 on Pg 14 .
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
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D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient -
-to allow us to retrieve the study immediately for review. This
- prevents duplicate entries in the Agency files, and saves you
the cost of. sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of • •
the method of suppprt for the application. .
F. Physical Format Requirements
'>
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out •
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any.
attachments or appendices, are present and'in' correct
sequence. " • ' •
Number of Copies Required - All submittal packages except
those associated with a ^Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
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G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following -
-special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims". , .
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover 'and its
title page with the phrase "Public Docket Material.-
contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240. '
W. Ak*rain
freting otrtctor,
Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality •
Claims ' . •
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT'1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson:Blvd
Cincinnati, OH 98765 Covington, KY 56789
+Smith Chemical Corp will act as sole agent for all, submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal . (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so-
long as.all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.•
Company Official:.
Name Signature- :-
•' ' O
Company Name: _, . _ •
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
• Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X'
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or
(0 .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6§10(d) (1) (A) , (B) , or. (C) .
Company
Company Agent:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(1)(A), (B), or (C) has been
removed to a confidential appendix, and is cited by
cross-reference number in the body of the study.
Company:
Company Agent:
Title
Typed Name
Date:
Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating -an
analytical method, can be approved unless the applicant' waives
all claims of confidentiality for the analytical method. These.
analytical methods are published in the FDA Pestlci-de Analytical .
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which you claim
•confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims: . , ' ;
• Identify specifically by page and line number(s) each
portion of -the study for which you claim
confidentiality'. •' ' .
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has_been
disclosed, and what precautions have been taken in con-
nection with those disclosures. >''
• Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If you assert that disclosure of this-.information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the'availability to
EPA of similar information in the future, and if so,
how. -• •: •
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cros^ reference number is used in the study
in place £ff the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE: _
PAGE LINE REASON FOR THE DELETION
PJ-V.y1c.nt.
6
12
100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
§10(d) (1) (C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S):
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION , FIFRA REFERENCE
2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential
that have been deleted from the study)
CROSS REFERENCE NUMBER 7. This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page. • • .
PAGE LINES REASON FOR THE DELETION . .FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process' §10(d)(1)(A)
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• ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
This study meets the requirements for 40 CFR Part 160
Submitter • '
Sponsor
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways:
1..
2..
3.
Submitter_
Sponsor
Study Director_
Exc
3le 3
The submitter of this study was neither the sponsor of this j*tudy nor
conducted it, and does not know whether it has be_en .conducted in
accordance with 40 CFR Part 160. _ ;
Submitter
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ATTACHMENT 7.
FORMAT OP THE SUBMJTTAL PACKAGE
LEGEND
Transmittal Docunent.
Related Administrative Materials
fe.g.. Method of Support Statement, «tc.J
Other materials about the subnittal
<••««* su»nafi*8 of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, accordino
to the format below.
FORMAT OP SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claim.
,'„
CLP and flagging* statement* - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title rao* off the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims,
* When _flagging requirements
are finalised.
Documents which Must be submitted as
_ appropriate to »««t eitaOiisrted r«quir«»ents.
f Documents submitted at submitter's ootion.
-J
—77—
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—78—
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PR Notice 91-2
—79—
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—80—
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
•• AND ''REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of .-
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND - '
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the.
percentage of the ingredient(s) that would be expected'to be
present in their product at the end of the product's .shelf-life.
Unfortunately, this led to a great deal of confusion among the,
regulated industry, the -regulators, and the consumers as, to
exactly how much of a given ingredient was in a given- product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product. . . .
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
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CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA _
section 12 (a) (1) (C)", while the nominal concentration_appearing on
the label would be the routinely achieved concentration used tor
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
-degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in ..the product.
It is important"for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10 (b). In this respect-the,
certified limits will be routinely provided by EPA to States tor
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. 'All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a- .case by case
basis as specified by EPA. These limits are to be set based on.
representative sampling and chemical analysis(i.e., quality
control) of the product. .•
The format of the ingredient statement must conform to 40 .
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredie&t Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA .
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
„products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the -shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency s
intention to implement the requirements of this notice js
smoothly as possible so as not to disrupt or delay the Agency s
hiqh priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice. .-'
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
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(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
i ^ t
Contact Tyrone Aiken., for information or questions concerning
this notice on (703) -308-7031.
Ann* S. f&ndaay. Director
Division (H-75O5
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APPENDIX F. Product Specific Data Call-In
—85—
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—86—
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DATA CALL-IN N(
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 III below. Your response must state:
1. How you will comply with the requirements set forth hi this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
hi Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-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 ffl-D),.
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the,,registration of
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 hi 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
(expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
—87—
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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 H - Data Required By This Notice
Section HI- Compliance With Requirements Of This Notice
Section IV- Consequences Of FaUure To Comply With This Notice
Section V - Registrants' Obligation To Report PossibleUnreasonable Adverse
Effects " ••** •••^ • .;- ". >.-.-i:
Section VI - Inquiries* And Responses to This Notice
The Attachments to this Notice
•• ";-.*• "JfSM1^"-»"• • JT
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 Groupinp of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria^
6 - List of Registrants Receiving This Notice
7 _ Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU AKF. RECETvTNrT THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of fie subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional.
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient. ..
SECTION II. DATA REQUIRE RY THIS NOTICE
II-A. DATA REQUIRED . --
The product specific data required by this Notice are specified hi Attachment 3,
Requirements Status and Reentrant'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 Regent's Response Form, within the time frames
provided.
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H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established. •"
These EPA Guidelines are available from the National Technical Information Service
" (NTIS), Arm: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols they should be modified as appropriate so that the data generated by the study wdl 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, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
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)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV^fg> NOTICES
TSSUED BY THE AGENCY
s.
Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
requirements of anv previous Data Call-MsX 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.
SFrTTON TTT COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-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 andTCB.
*. . ' •
ffl-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
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requirements of this Notice is contained in Section m-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Pp-gnirements Status and Registrant's Response Form, Attachment 2 and
Aiit^y^t 7 TH» r»ats raii-Tn 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 r>ata rail-Tn 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 hi preparing your response, call
or write the contact person(s) identified hi Attachment 1.
1 Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your produces) 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 Gallon 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 hi Section IV-C.
2 Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section IH-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.
m-C SATISFYING THE DATA REOUIRFMENTS 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
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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 info an agreement with one or more registrants to develop data jointly
(Cost Sharing),
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study) .
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with 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
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registrations).
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^), 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 hi 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; hi 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 hi the attached
data tables that your product and at least one other product are similar for purposes of depending
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on the same data. If this is the case, data may be generated for just one of the products hi the
group. The registration number of the product for which data will be submitted must be noted hi
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 then* differences through binding arbitration.
Option 3. Offer to Share hi the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described hi option 2 above. If you have made an offer
to pay hi 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^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has hi good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share hi the burden
of developing that data. You must also submit to the Agency .a completed EPA Form 8570-32,
Certification of Offer to Cost Share hi the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, hi addition to
anything else, offer to share hi the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share hi 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 Noticed If fhe 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 hi 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 hi
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.
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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 tune 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 atthetime 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 CFR 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."
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 such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant. .
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to 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, hi 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.
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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 §U deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5. . .
s
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.11 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.
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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.
IH-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 hi force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
TV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant .to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
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).
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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 Gall-In Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data hi 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, number of animals,
sex and distribution of animals, dose and effect levels to be tested Or attained, duration of
test, and, as applicable, Good Laboratory Practices. ,. , • ' .
* * * ^ '
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended produces) only hi exceptional
circumstances. If you believe such disposition of existing stocks of your produces) which may be
suspended for failure to comply-with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other man the registrant such as
independent distributors, retailers and end users to sell, distribute pr 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 hi 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 hi 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 RFPQRT POSSIBLE
UNREASONABLE ADVERSE EFFECTS .
Registrants are reminded that FIFRA section 6(a)(2) states that if at any tune 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.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by Jhis
Notice, call the contact £rson(s) listed in Attachment 1, the IHtu mil-Tti Chemical Status Sheet.
AU responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data 0.11-Tn Response Form and » .5"ggg
p^Lments Stater -~« ^ctrsnfs Resnonse Form (Attachment 2 f d /^hment 3 fDrpraduct
mdfic data) and any other documents required by this Notice, and should to submitted to the
Set pLon(s) identified in Attachment 1. If the voluntary cancellation or, generic data
exemption option is chosen, qdy the Data Call-Tn Response Form need be submitted. .
The Office of Compliance Monitoring (OCM) of the Office of
Substances (OPTS), EPA, wiU be monitoring the data being generated in response to this Notice.
Attachments
Sincerely yours,
Daniel M. Barolo, Di
Special Review and
Reregistration Division
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 Groupinp of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria . ,
6 - List of Registrants Receiving This Notice '
7 _ Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
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INORGANIC HALIDES DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have
produces) containing inorganic halides .
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
inorganic halides . 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 Tojacology Data Requirement (Attachment 4), (5) the EPA . •
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this inorganic halides
Product Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for inorganic halides
are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on inorganic halides are needed for specific
products These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible inorganic halides
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you .have any questions regarding the generic database of inorganic halides , please
contact Mark Wilhite at (703) 308-8586.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact C.P. Moran (703) 308-8590
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Accelerated Reregistration Branch, Chemical. Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W _ ,;
•' 0 -
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Inorganic Halides
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
. product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls 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 reregistration 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.
ItemTa. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another that you have already voluntarily cancelled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records
are correct. .: ..."
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
, continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In, the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 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 Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed hi this table. Fuller
descriptions of each option are contained hi 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 hi
the Data Call-In Notice. _ .
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required study
is not submitted on tune, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
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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 hi the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require data; if the required study is not submitted on time, my product may be
•subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section m-C.l.) apply as well.
4. By me 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 hi option 4 in the Data Call-In Notice (Section m-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study.
classified by the Agency as partially acceptable and .upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my product, an identical product
or a product which EPA has "grouped." with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number (s)
number (s) for the cited data on a "Product Specific Data Report" form or in a
similar format. If I cite another registratrant's data, J wffl submit a completed
"Certification With,Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted hi the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
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request, I will not be require 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 chosen. I also understand that the deadline
for submission of data as specified by the original data cal-in notice will not change.
-Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its.records
are correct.
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-110—
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S BATCHING OF PRODUCTS CONTAINING SODIUM BROMIDE AND SODIUM
CHLORIDE (INORGANIC HALIDES) FOR 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 products containing the active ingredients sodium
bromide or sodium chloride, the Agency has batched products which can be considered similar
. for purposes of acute toxicity. Factors considered in the sorting process include each product's
'active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wetlable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency
is not describing batched products as "substantially similar" since some products within a batch
may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described hi the
preceding paragraph. Frequently acute toxicity data on individual products has been found to be
incom- plete. Notwithstanding the batching process, the Agency reserves the right to require,
at any tune, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooper- atively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate hi the process with all other registrants, only
some of the other registrants, or only their own products within a batch, of to generate all the
required acute toxicological studies for each of their own pro- ducts. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously sub- milled 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 registration, the registrant
must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific dala require- ments, registrants must follow the
directions given hi the Data Call-In Notice and its attachments appended to Ihe RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for .each product. The second form, *Requiremenls Slatus and
Registrant's Response," lists the product specific data required for each product, including the.
standard six acute toxic- ity tesls" A registrant who wishes to participate hi a batch must decide
whether he/she will provide the data or depend on someone else to do so. .If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate hi a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
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—114—
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Table I indicates 3 batches including 29 products containing the active ingredient sodium
bromide.
'Table I. " ,
% Sodium Bromide (NiBr), And Any
Other Active hgradfent
Ready-To-Use-Solution
Soluble Concentrate
Soluble Concentrate
Technical Chemical
Reidy-To-Use-Sokition
Ready-To-Use-Sokrbon
Ready-To-Use-Solution
Formulation Intermediate
Ready-To-Use-Solution
Ready-To-Uje-Solution
Ready-To-Use-Solution
Ready-To-Use-Solution
Ready-To-Use-Solution
Formulation bitermediate
Ready-To-Use-Solution
Ready-To-Use-Solution
Formulation 'Intermediate
Formulation Intermediate
4.0 NaBr
9E.O Sodium dkhloro-
iwcyanurate
dihvdrate
7.0 NaBr
89.0 Trichloro-j-triarine-
trione
7.0 NaBr
89.0 Sodium dichloro-s-
triazinetrione
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—115—
Batch No.
EPA Reg. No.
•MBMMMI^HIi^M
935-73
935-74
935:75 . ,
935-76
935-78
5185-376 ,
% Sodium Bromide (NaBr), And Any
Other Active Ingredient
••^••••••••••i
7.0 NaBr
92.0 Trichtoro-s-triazine-
tronB
7.0 NaBr
89.0 Sodium dichloro-s-
triarinetrione
7.0 NaBr
92.0 Trichloro-s-triazine-
trkme
7.0 NaBr
92.0 Sodium dfchoro-s-
triarinetrione
9.2 NaBr
88.0 Trichloro-s-triazine-
trione
14.6 NaBr
81.6 Sodium dichloro-s
triazinetrione
Formulation
•••^••••••••••B
PelletedrTableted
Granular
PeSetedJTableted :
.PeHetedfTableted
Pelleted/Tableted
Granular
Table II lists 6 products containing sodium bromide or sodium
chloride as an active ingredient, which were not considered to be
similar for purposes of acute toxicity or the Agency lacked suffic-
ient information for decision making and were not placed in any
batch. Registrants of these products are responsible for meeting
the acute toxicity data requirements for each product.
Table II.
EPA Registration Number
170B-168
5736-90
5736-94
62432-1
65501-1
7616-65
% Sodium Bromide (NaBr), and any other -
active ingredient
42.8 NaBr
2.6 'NaBr
1.7 NaBr
1.5 Sodium chloride
20.4 Potassium peroxymonosulfate
20.0 Sodium chloride
3.8 NaBr
Formulation
Ready-To4JseSolution
Ready-To-Use-Sokition
Ready-To-Use-Sokition
Soluble Concentrate
Impregnated Material
Ready-To-Use-Solution
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-117—
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—119—
Attachment 5. EPA Acceptance Criteria
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—120—
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—121—
SUBDIVISION D
Guideline Study Title
Series 61 . Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients «t'.
Series 63 Physical and Chemical Characteristics ics
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—122—
61 Product Identity and Composition
ACCEPTANCE CRITERIA
-Does your study meet the following acceptance criteria?
j. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3 Name and upper certified limit for each impurity or each group of impurities present at >_ 0.1 % by
' weight and for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at
4. Purpose of each active ingredient and each intentionally-added inert.
5 Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
" Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
" assigned experimental or internal code numbers for each active ingredient.
7 Description of each beginning material in the manufacturing process.
* EPA Registration Number if registered; for omer beginning materials, the Mowing:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity. .
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
~~~ Description of equipment. .
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained. .
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction. • .
Duration of each step of process. - • •
Description of purification procedures. -, 1
Description of measures taken to assure quality of final product.
9 Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
* which may be present at >: 0.1% or was found at .> 0.1% by product analyses and (2) .certain
toxicologically significant impurities (see #3).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch;process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or. closure J>.ca 98%.
3.j Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
fresh and stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
g. Upper certified limit proposed for each impurity present at >_ 0.1% and for certain lexicologically
significant impurities at <0.1 % along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
1 Does your study meet the following acceptance criteria?
63-2 Color • . '
_ Verbal description of coloration (or lack of it)
- Any intentional coloration.also reported in terms of Munsell color system
ption of physic*! state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point -
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C . -' '
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
D^^f^hSgrade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20° C. [Note: Bulk density of registered products may be reported in Ibs/tt
or Ibs/gallon.] • .
-SjMubi^rndned in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
_ Measured at about 20-25° C - , . ,
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble). ,
63-9
at 250 c (or canted by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units.
63-10 Dissociation Constant
Experimental method described
' Temperature of measurement specified (preferably about
20-25 °C)
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—125—
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C * * i. A A* * * v^^r
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal.ions and metal determined
•' stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitizatiori in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
_ Does your study meet the following acceptance criteria?
1. identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group. . -
3. Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to.determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toricity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
-Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.Okg or guinea pigs 35CM50 gm.
4. Dosing, single dermal. , "%
5. Dosing duration at least 24.hours.
6.* Vehicle control, only if toxipity of vehicle is unknown.
7.'Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
3'. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. individual observations at least once a day.
12. Observation period to last at least 14 days.
13, Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 Identify material tested (technical, end-use product, etc).
2 Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
' or contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sexygroup.
4 ~"~ Dosing, at least 4 hours by inhalation. •
5 Chamber air flow dynamic, at least 10. air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
g. Monitor actual concentrations of test material in breathing zone.
9 Monitor aerodynamic particle size for aerosols.
lo'.IT Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe '
dermal irritation or has a pH of <2 or .>.! 1.5.
3. 6 adult rabbits. ". -
4._ Dosing, instillation into the conjunctiva! sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 inl or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
g, Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
p.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary DermSl Irritation. Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria? cep;
- i. Identify material tested (technical, end-use product! .etc).
2. Study not required if material is corrosive or hasiapH of <2 or ^.11.5.
3. 6 adult animals.
4. Dosing, single dermal. •
5.__ Dosing duration 4 hours. :
6. Application site shaved or clipped at least 24 hotpecprior to dosing.
7. Application site approximately 6 cm2. • 6 >
g. Application site covered with a gauze patch helda^place with nonirritating tape.
9 Material removed, washed with water, without tflauma to application site.
10 ~7 Application site examined and graded for irritatiograt 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter).
11 * Individual daily observations.
Criteria marked with an * are supplemental!and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof.<2or >_11.5. • ;
3. One of the following methods is utilized:
Freund's complete adjuvant test
~~~~~~" Guinea pig maximization'.test
• Split adjuvant technique
Buehler test
Open epicutaneous test
3HH Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6 Test followed essentially as described in reference document.
7 Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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Attachment 6. List of All Registrants Sent This Data CaH-In (insert)
Notice
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—135—
Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
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—136—
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—137—
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—138—
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—139—
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. T.wo legible, signed
copies of the form are required. Following are basic instructions:
4 '
: 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 on 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).
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.
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—140—
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—141—
?/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0108
2070-0057
Approve! Exp!r»t 3-31-96
Public reporting burden for this cofiection 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
compteting-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 Poficy
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 Xante
Product >"amc
Company Number
KPA Reg.\o.
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)(Iu) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(*>
Date of Offer
Certification: • -T •
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 afl 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
Nam« and
of Company'* Authorized RepreeentaHve
Dal*
Till* (Plus* Type or Print)
EPA Form 8570-32 (S/91) Replaces EPA Form 8580. which is obsolete
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wEPA
United State* Environmental Prottctlon Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OKI N*. 2070-010?
2070-WI7
Apfr*nl fspltM 3J1-96
Public reporting buftJen for this colection of Information is estimated to average 15 minutes per response, inducing
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, inducing suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Prelection 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 blank* below.
ewnpiny NMM .
Product N«M
Company Number
DA tog. Mo.
I Certify that:
1. For each study tited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticjde Act (FIFRA) that is an exclusive use study, I am the original ora suborner, or I have obtained the
written permission of the original data submitter» dte that study.
2. That lor each study cted in support of registration or nuegistration under FIFRA that is NOT an exclusive use
study, I am the original data submtoer.or I have obtained the wrtten permission of me origirtai data sgbmfter. or I
have notified in writing thecompanyfjes) that submited data 1 have eked and have oHeredio: (a) Pay
compensation tor those data in accordance wBh sections 3(C)(1)(D) and 3(0(2)(D) of FJFRA: and (b) Commence
negotiation to dtleimint which data are subject to the condensation nM^rtimrt of nFIM and the amount of
compensation due. f any. Hie companies I htve notified are: (check one)
IJ The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"
3. That t have previously compDed wBi section 3(0(1X0} of FIFRA for the studies I have died in support ol
registration or rengistration under F1FRA.
Signature
Nwm w* Till* (PIMM Ty»* *r Print)
Dfltf
.'
QEMERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wUh regard to the
registration or reregistration of my products, to the extent required by FlFRA sections 3(cKl)(D) and 3(0{2)(b).
Dab-
KMH« «M Till* (PtMM Typ« «r Print) .'
EPA Form »J70.J1 (4*0)
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