United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA 738-R-93-023
And Toxic Substances December 1993
(7508W)
&EPA Registration
Eligibility Decision (
Lithium Hypochlorite
Printed on Recycled Paper
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8W)
EPA-738-F-93-018
December 1993
R.E.D. FACTS
Lithium Hypochlorite
Pesticide All pesticides sold or distributed in the United States must be registered
Reregistration by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
feet sheet summarizes the information in the RED document for lithium
hypochlorite.
Use Profile
Lithium hypochlorite is an algicide, disinfectant, fungicide and food
contact surface sanitizer. Its primary pesticidal use is to control algae,
bacteria and mildew in swimming pool water systems, hot tubs and spas;
approximately 2,000,000 pounds of the active ingredient were used for this
purpose in 1989. It also is used to sanitize food and cheese processing plant
equipment, dairies, and eating establishment equipment and utensils. Lithium
hypochlorite is formulated as a .ready-to-use liquid and a soluble solid
concentrate. It is applied to swimming pool water using a skimmer basket,
and to equipment or utensils by hand or through use of a dish washing
machine. Lithium is an element that occurs naturally at low levels in food
and drinking water.
Regulatory Lithium hypochlorite was first registered in the U.S. in 1963, and has
History been used chiefly as a sanitizer in swimming pools. The Food and Drug
Administration (FDA) lists the chemical as a sanitizer on food contact
surfaces (please see 21 CFR 178.1010). EPA's Office of Water regulates
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discharges into water systems through the National Pollutant Discharge
Elimination System (NPDES) permit program.
EPA issued a Data Call-in (DCI) Notice in September 1992 requiring
product chemistry and ecological effects data for lithium hypochlorite.
Currently, 40 pesticide products are registered which contain this active
ingredient, and no new uses are pending.
Human Health
Assessment
Toxicity
In laboratory animal studies, technical grade lithium hypochlorite has
been shown to be highly corrosive, placing it in Toxicity Category I
(indicating the highest degree of acute toxicity) for both eye and, skin
irritation. It is moderately acutely toxic in acute oral and dermal toxicity
studies, placing it in Toxicity Category m for oral toxicity and Toxicity
Category IV for dermal toxicity. No mutagenic effects were seen in a battery
of studies.
Studies on human use of lithium-containing drugs, including chronic
use, have not shown any reason for concern over continued human exposure
to lithium following its use as a pesticide. The medicinal exposures are at a
much higher level than that which results from the compound's pesticide uses.
Studies of people who swam in pools or bathed in spas treated with lithium
hypochlorite/ chloride show no significant absorption of lithium through
human skin. Accidentally swallowing pool or spa water should not increase
exposure to lithium beyond that which occurs ordinarily through ingesting
food and drink.
Dietary Exposure
No dietary exposure is expected from the pesticide uses of lithium
hypochlorite since no food or feed uses are registered.
Occupational and Residential Exposure
During application of pesticide products that contain lithium
hypochlorite, workers may experience dermal and inhalation exposure (for
example, while hand-washing utensils). However, this exposure does not
pose significant concerns except to the eye and skin of workers who handle
concentrated or solid formulations. Appropriate label precautions requiring
eye and skin protection will continue to mitigate these risks. Post-application
exposure is considered minimal, as the exposure is to a diluted material.
Human Risk Assessment
Since lithium hypochlorite has no food or feed uses, dietary risk is not
expected. The chemical causes severe irritation and is corrosive to eyes and
skin, but exhibits only moderate acute oral and dermal toxicity. To protect
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applicators' eyes and skin, appropriate label precautions regarding use of
protective clothing (including safety glasses or goggles and chemical-resistant
gloves) continue to be required. No human health risk of concern is
expected.
Environmental
Assessment
Environmental Fate
Lithium hypochlorite, like all the hypochlorite salts, forms hypochlorous
acid when dissolved in water; it is hypochlorous acid that exhibits actual
pesticidal activity. Its mode of action is its oxidizing (sanitizing) effect on
organic and inorganic contaminants. This disinfection by chlorination is
achieved by maintaining a "free residual chlorine" concentration.
The major environmental/ecological concern would be if discharged
effluent treated with hypochlorites showed free residual chlorine
concentrations that exceeded those stipulated under NPDES permits. Since
there are many forms of cations used to form hypochlorite salts (e.g.,
calcium, sodium, and lithium), it would be difficult to trace the source of
contamination in cases where free residual chlorine concentrations are too
high.
EPA conducted a Tier Ic Estimated Environmental Concentration (EEC)
model to assess the residue levels of lithium hypochlorite in the receiving
stream from several use sites. This model provides a reasonable worst case
estimate of the maximum concentrations that may occur immediately
downstream from an industrial point source discharge site under typical and
high exposure scenarios. Results are discussed below.
Ecological Effects
Lithium hypochlorite is considered slightly toxic to nontoxic to avian
species, and it is not expected to be found in the environment at levels of
concern. Therefore, risk to avian species is expected to be minimal. Toxicity
to fish and aquatic invertebrates, however, is considered very high.
Ecological Effects Risk Assessment
The results of the Tier Ic EEC stream flow screening model described
above show that levels of concern would be exceeded during both high
exposure and typical exposure scenarios for fish and aquatic invertebrates.
Therefore, aquatic organisms may be at risk from typical use/exposure as well
as from high use/exposure.
The discharge of water containing residues of lithium hypochlorite is
regulated by the NPDES permit program administered by EPA. Exposure
and risk to freshwater aquatic organisms should be considered in determining
acceptable levels for such permits so that toxic levels are avoided.
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Endangered Species
Both the typical and the high exposure scenarios described above exceed
the levels of concern for endangered aquatic organisms. Effluent containing
lithium hypochlorite should not be discharged into streams or waterways that
endangered aquatic organisms are known to frequent. EPA is working with
the U.S. Fish and Wildlife Service to develop a program to avoid jeopardizing
the continued existence of identified species by the use of pesticides. When
this program goes into effect, endangered species labeling will be required.
Additional Data The generic data base for lithium hypochlorite is substantially complete.
Required The Agency is requiring product-specific data, including product chemistry
and acute toxicity studies, as well as revised Confidential Statements of
Formula (CSF) and revised labeling for reregistration.
Product Labeling
Changes Required
All end-use products containing lithium hypochlorite must comply with
EPA's current pesticide product labeling requirements. In addition:
• Effluent Discharge Statement - All end-use (and manufacturing use)
products that may be contained in an effluent discharged to the waters of the
U.S. or municipal sewer systems must bear the following statement:
"This product is toxic to fish. 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
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
Conclusion
The currently registered uses of lithium hypochlorite could pose risks
to aquatic organisms under certain conditions as industrial effluent containing
the parent chemical is released into receiving waters. However, the uses will
not cause unreasonable adverse effects to humans or the environment, and are
eligible for reregistration.
Products containing lithium hypochlorite as the sole active ingredient
will be reregistered once the required product-specific data, CSF and revised
labeling are received and accepted by EPA. Products also containing other
active ingredients will be reregistered only after the other active ingredients
also are determined to be eligible for reregistration.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for lithium hypochlorite during a 60-day time
•period, as announced in a Notice of Availability published in the Federal
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Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the lithium hypochlorite 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
lithium hypochlorite RED, or reregistration of individual products containing
lithium hypochlorite, contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday through
Friday.
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REREGISTRATION ELIGIBILITY DECISION
Lithium Hypochlorite
LISTC
CASE 3084
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
LITHIUM HYPOCHLORITE REREGISTRATION ELIGIBILITY DECISION
TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS iii
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 3
IH. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Reproductive and Developmental Toxicity 6
c. Mutagenicity 7
d. Metabolism 7
e. Other Toxic Endpoints 7
2. Exposure Assessment 8
a. Dietary Exposure 8
b. Occupational and Residential 8
3. Risk Assessment 8
a. Dietary 9
b. Occupational and Residential 9
C. Environmental Assessment 9
1. Environmental Fate 9
a. Environmental Chemistry, Fate and Transport 9
b. Environmental Fate Assessment 11
2. Ecological Effects 13
a. Ecological Effects Data 13
(1) Terrestrial Data 13
(2) Aquatic Data 13
b. Ecological Effects Risk Assessment 13
(1) Industrial Biocide Use Pattern
...... ... 13
(2) Swimming Pool Use Pattern
:. 14
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 16
A. Determination of Eligibility 16
1. Eligibility Decision 17
2. Eligible and Ineligible Uses 17
V. ACTIONS REQUIRED BY REGISTRANTS 17
A. Manufacturing-Use Products 17
1. Additional Generic Data Requirements 18
2. Labeling Requirements for Manufacturing-Use Products 18
B. End-Use Products 18
1. Additional Product-Specific Data Requirements 18
2. Labeling Requirements for End-Use Products 19
C. Existing Stocks 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 27
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Lithium Hypochlorite 33
APPENDIX D. List of Available Related Documents 41
APPENDIX E 45
PR Notice 86-5 47
PR Notice 91-2 67
APPENDIX F. Product Specific Data Call-in 73
Attachment 1. Chemical Status Sheet 87
Attachment 2. Product Specific Data Call-in Response Forms (Form
A inserts) Plus Instructions 89
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 93
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 99
Attachment 5. EPA Acceptance Criteria 105
Attachment 6. List of All Registrants Sent This Data Call-in (insert)
Notice 119
Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form 121
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LITHIUM HYPOCHLORITE REREGISTRATION ELIGIBILrrY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Martin S. Lewis
Rafael Prieto
Environmental Fate and Effects Division
Sharlene Matten
Silvia Termes
R. David Jones
Dana Lateulere
Health Effects Division
Linda Kutney
Pat McLaughlin
William Hazel
Winston Dang
Registration Division
Wallace Powell
Shyam Mathur
JoAnne Hayes
Policy and Special Projects Staff
Deborah Hartman
Special Review and Reregistration Division
Ron Kendall
Teung Chin
Office of Compliance Monitoring:
Shruti Sanghavi
Office of General Counsel:
Bret R. Williams
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Toxicology Branch n
Chemistry Branch-Reregistration Support
Occupational and Residential Exposure Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Enforcement Policy Branch
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11
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a.i.
CAS
CSF
EEC
EP
EPA
FDA
FIFRA
FFDCA
GRAS
HDT
LCSO
LD
'50
LD,0
TJRT.
LOEL
MP
MPI
GLOSSARY OF TERMS AND ABBREVIATIONS
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Generally Recognized As Safe as designated by FDA
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, ing/kg orppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Lowest Observed Effect Level
Manufacturing-Use Product
Maximum Permissible Intake
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
MEED 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*i 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.
IV
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EXECUTIVE SUMMARY
Lithium hypochlorite is an algicide, disinfectant, fungicide and food contact sanitizer.
It is produced by FMC Lithium Division and Olin Corporation and is registered for use in
swimming pool water systems (including hot tubs and spas), and also on food processing plant
equipment, dairies/cheese processing plant equipment, and in eating establishments for
equipment/utensils. Lithium hypochlorite is listed by the FDA for use as a sanitizer on food
contact surfaces in 21 CFR 178.1010. Lithium discharges into water systems are regulated
through NPDES permits.
The Agency has determined that the uses of lithium hypochlorite as currently registered will not
cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration. The Agency does have some concern about possible adverse effects to aquatic
organisms from the discharge of effluent from industrial uses into the environment. However,
such discharge is limited through the National Pollution Discharge Elimination System which
the Agency defers to for regulation.
Before reregistering the products containing lithium hypochlorite, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing for each registration. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section 3(c)(5)
of FEFRA, the Agency will reregister a product. Those products which contain other active
ingredients will be eligible for reregistration only when all the other active ingredients in those
products are determined to be eligible for reregistration.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data
on products and either reregistering products or taking "other appropriate regulatory action."
Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of lithium hypochlorite. The document consists of six sections. Section I is the
introduction. Section n describes lithium hypochlorite, its uses, data requirements and
regulatory history. Section m discusses the human health and environmental assessment based
on the data available to the Agency. Section IV presents the reregistration decision for lithium
hypochlorite . Section V discusses the reregistration requirements for Lithium Hypochlorite .
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 request1.
l. EPA's review of data in the set of registered uses considered for EPA analysis may be
obtained from the EPA Public Docket, Field Operations Division, 7506C, EPA, Washington
D.C. 20461.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: Lithium hypochlorite
• Chemical Name: Lithium hypochlorite
• CAS Registry Number: 13840-33-0
• OPP Chemical Code: 14702
Empirical Formula:
LiOCl
Trade and Other Names: Lithio™ Lithium hypochlorite; Formula 2™
Basic Manufacturer:
Olin Corporation
EMC Lithium Division
B. Use Profile
The following is information on the current registered uses with an overview
of use sites and application methods. A detailed table of these uses of lithium
hypochlorite is in Appendix A.
Lithium Hypochlorite:
Type of Pesticide: Algicide, Disinfectant, Fungicide and Food contact sanitizer.
Use Sites: Aquatic Non-Food Residential: swimming pool water systems
(including hot tubs and spas).
Indoor Food: Food processing plant equipment, Dairies/cheese
processing plant equipment, Eating establishments equipment/utensils.
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Target Pests: Bacteria, Aquatic Algae and bacteria, Mildew.
Formulation Types Registered: Type-Manufacturing use, End use.Fonn-Liquid
Ready-to-use, Soluble solid concentrate.
Method and Rates of Application:
Equipment- Aquatic non-food residential: skimmer basket.
Indoor Food: By Hand, Dish washing machine.
Method and Rate - Aquatic non-food residential: Water treatment, from 1 to
13 ppm available chlorine by weight.
Indoor food: Equipment treatment, from 43 ppm by
weight to 181 ppm available chlorine by volume.
Timing - Aquatic non-food residential: Initial, Subsequent/maintenance,
Shock/slug, Winterizing
Indoor-food: Not specified
Use Practices Limitations:
Minimum pH of 7.2 and maximum pH of 7.8 for aquatic non-food
residential, Preclean claim for sanitizing.
C. Regulatory History
Pesticide products containing lithium hypochlorite as an active ingredient were
first registered in the United States in 1963. Currently, there are 40 products
registered by 17 companies. These products are chiefly used in swimming pools as a
sanitizer. Most of the registered products are granular and ready-to-use. A few
products are registered for use in indoor food areas.
As part of the reregistration process, a Data Call-in Notice was issued on September
24, 1992, for lithium hypochlorite requiring registrants to generate and submit
product chemistry and ecological effects data to complete the target data base for
reregistration. These data have been submitted to the Agency and are incorporated
into this reregistration decision.
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Lithium hypochlorite is listed by the FDA for use as a sanitizer on food contact
surfaces in 21 CFR 178.1010. Discharges of effluent containing lithium into water
systems are regulated through National Pollutant Discharge Elimination System
(NPDES) permits. No new uses are pending as of the date of this RED.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The chemical lithium hypochlorite is manufactured by chlorinating a solution
containing lithium hydroxide and sodium hydroxide in the presence of diluents such as
sodium sulfate and potassium sulfate.
LiOH + NaOH + C12
> LiOCl + NaCl + H,0
The solution of LiOCl thus produced is continuously cooled (to avoid thermal
decomposition) and spray dried. The spray dried fines (maximum particle size 30
mu) are compacted, granulated, and screened to produce a granular product of about
-10 to +70 mesh particle size. The Physical/Chemical Properties of lithium
hypochlorite are summarized below:
Molecular Weight: 58.4
Physical State: Granular solid
Odor: Odorless or with slight odor of chlorine
Melting Point: 135 °C with decomposition
Bulk Density: 58 Ibs/ft3
Solubility: Total solubility in water-43 % by weight at 25°C
Vapor Pressure: Water (22 mm Hg) at 20 °C
Dissociation Constant: 3.2 x 10'8 (of HOC1 in aqueous solution)
pH: 9.9(available C12 - 100 ppm); 10.3(available C12 - 200 ppm); 10.7
(available C12 - 300 ppm) in water at 25 °C.
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Stability:
Oxidizing/
Reducing:
Stable and retains 90% of available chlorine when stored in fiber
containers with aluminum overwrap at 75°F(23.88° C)
and 75% relative humidity for 4 months.
Lithium hypochlorite with 39% available chlorine has some oxidizing
effect.
Explodability:
Storage Stability:
Formulations of 39 % available chlorine or less are not classed
as dangerous articles under Interstate Commerce Commission
Regulations.
During 60 days' storage at 43 °C lithium hypochlorite loses 12%
of available chlorine. The storage stability data for lithium
hypochlorite containing 1% to 10% available chlorine show that
it is identical or similar to that of sodium hypochlorite solution.
B. Human Health Assessment
1. Toxicology Assessment
The lexicological data base on lithium hypochlorite is adequate and will
support reregistration eligibility. The primary toxicological consideration is
the effect from exposure to the lithium ion that is produced from the reaction
of lithium hypochlorite with water produces hypochlorous acid and lithium
ions. Hypochlorous acid (which is an oxidizing agent and the chemical species
showing actual pesticidal activity) acts by oxidizing organic and inorganic
chemical contaminants. As hypochlorous acid exerts its oxidizing effect, the
chlorine reduces to chloride ions. Thus the end - products of lithium
hypochlorite are chloride and lithium ions, both ubiquitous in the environment,
and adverse effects from the incremental lithium hypochlorite contribution are
not expected.
a. Acute Toxicity
Data from an acute oral toxicity study in rats indicated LD50s of
748 rag/kg for males and 555 mg/kg for females. This study, which
used technical lithium hypochlorite, indicates category HI toxicity
(MRID 40803901). A second acute oral toxicity study (MRID 234351)
in rats that was conducted only in male animals is useful for indicating
the nature of the observed effects. The effects in the rats were
primarily due to the corrosive nature of the substance and included
inflamed gastric mucosa and lungs, distended stomach, congested
kidneys, yellow purulent material in chest cavity, and labored
respiration. The oral LD50 for males in this study was 286 mg/kg.
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The dermal LDJO was approximately 8100 mg/kg for female and male
rabbits, which is category IV toxicity (MRID# 234351). The effects
were dermal necrosis, severe erythema, anorexia, depression, and lack
of body fat.
The corrosive nature of lithium hypochlorite puts this compound in
toxicity category I for both eye irritation and dermal irritation. A
dermal sensitization study, which used solid lithium hypochlorite as a
10% solution in saline, did not demonstrate any dermal sensitization
(MRID 252294).
Acute Toxicity Study Results- Lithium Hypochlorite
TEST
Oral LD50 - Rat '
Dermal LD50 - Rabbit
Eye Effects - Rabbit
Skin effects - Rabbit
Dermal sensitization -
Guinea pig
RESULT (MG/KG)
746 mg/kg for males
555 mg/kg for females
8100 mg/kg both sexes
Severe irritation
Severe irritation
Not sensitizing
CATEGORY
m
IV
I
I
N.A. ,
b. Reproductive and Developmental Toxicity
In a developmental toxicity study four groups of 25 female rats
were given, by gavage, lithium hypochlorite on gestation days six through
fifteen (MRID 40648101) with one additional group of 25 rays as control.
The dose levels were 0, 10, 50, 100, or 500 mg/kg/day using 30% test
substance in water. The maternal and developmental NOELs were 100
mg/kg/day of lithium hypochlorite, which is equivalent to 4.1 mg/kg/day
of lithium. The maternal LOEL was at 500 mg/kg/day, based on deaths,
reduced weight gain, reduced food consumption, and inflamed and
congested respiratory system. The developmental LOEL was also at 500
mg/kg/day, where the fetuses showed reduced fetal weight, dilated renal
pelvis, bifid vertebrae, wavy ribs, and unossified foot bones.
A survey of animal studies in the published literature (MRID 41367401)
generally found the no-effect levels at or above 4.5 mg/kg/day of lithium.
None of the studies showed developmental effects at levels below those
which showed maternal toxicity. Human studies related to pregnancy and
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lithium drag consumption were of various types and had varied findings,
but all dealt with much higher levels of lithium intake than are expected
from pesticide use.
c. Mutagenicity
Technical lithium hypochlorite was negative, with and without
metabolic activation, in an Ames test for mutagenicity using five strains
of Salmonella (MRID 40545702). A study of unscheduled DNA synthesis
in rat hepatocytes using technical lithium hypochlorite was also negative
(MEED 40545704). Lithium hypochlorite was negative in the
CHO/HGPRT mutation assay with and without activation (MRED
40545701). A test for chromosome aberration in CHO cells with
technical lithium hypochlorite was positive (MRED 40545703). However,
a test for chromosomal aberrations in rat bone marrow cells was negative
with lithium hypochlorite (MRED 40907500).
d. Metabolism
The lithium ion is rapidly absorbed after ingestion and is
distributed through the body. It is excreted by the kidney and most of the
ion is excreted within 6-8 hours after ingestion (MRED 240927).
e. Other Toxic Endpoints
The average background level of lithium in human serum has been
reported as 0.014 mg/L, which comes primarily from the natural content
of lithium in food and drinking water (MRED 41367401). It has been
estimated that the natural sources of lithium provide 2.3-4.9 tag/day of
lithium.
Lithium carbonate has been used as a human drug since about 1970. The
intake levels are 179 to 282 mg/day of lithium ion and they provide about
4.16 to 8.33 mg/L of lithium in the serum (MRED 41367401). For the
therapeutic use, the reported maximum no-toxicity levels are 10.41 to
13.88 mg/L in serum. These levels are far higher than the background
levels and higher than any expected from pesticide use of lithium
hypochlorite. In addition, lithium orotate and lithium aspartate salts are
sold as over-the-counter mineral supplements that provide about 5 mg of
lithium per daily dose. Clinical and epidemiologic studies on human use
of lithium-containing drugs, including chronic use, have not shown any
reason for concern over continued human exposure to lithium in a
pesticidal use scenario.
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Information on the effects to humans exposed to lithium not by natural
sources or by therapeutic treatment is also available. One study looked
at the levels of lithium in the urine of people who had been swimming in
pools treated with lithium hypochlorite. No indication was found that
these exposures led to significant lithium absorption (MRCD 240927).
A controlled study on dermal absorption was conducted with humans who
bathed in spas containing lithium chloride in the water. The subjects were
exposed to solutions containing 40 to 45 ppm lithium ion for 20
minutes/day, 4 days/week for two weeks. Lithium levels in the serum of
the bathers were not increased above normal serum levels (MRED
40746701). This study demonstrates that there is no significant absorption
of h'thium through intact human skin. Without significant absorption,
there would not be intake or accumulation of lithium in the body by this
route and thus, no reason for particular concern about long term dermal
exposure in spas and swimming pools. There is no indication that intake
by accidental drinking of water while swimming would increase the serum
level of lithium nor increase intake over that ingested in ordinary food and
drink. Certainly any intake in pools is not significant compared to the
levels ingested in drug use.
Exposure Assessment
a. Dietary Exposure
There are no direct food/feed uses for this chemical; consequently
there are no dietary exposure concerns and a dietary exposure assessment
was not performed. Residues of lithium hypochlorite from the use of
products on food contact surfaces in food processing plants and eating
establishments are limited under the FFDCA regulations, 21 CFR
178.1010, to solutions containing no more than 200 ppm of available
chlorine and 30 ppm of lithium.
b. Occupational and Residential
Workers who handle lithium hypochlorite may be exposed to the
formulated soluble concentrate or solid. The potential for dermal and
inhalation exposures of workers exists (such as in hand washing of
utensils). Post-application exposure is considerably less and is minimal,
as the exposure is to a diluted material such as dermal exposure to
swimmers.
There are no significant exposure concerns other than appropriate label
precautions for eye and dermal hand protection for workers who handle
8
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concentrated or solid lithium hypochlorite.
3. Risk Assessment
a. Dietary
As stated above there are no direct food/feed uses for this
chemical; consequently there are no dietary exposure concerns and a
dietary risk assessment was not performed. Regulations in 21 CFR
178.1010 state that solutions of lithium hypochlorite used on food handling
surfaces can be considered safe provided they do not exceed the
concentration limits referenced above.
b. Occupational and Residential
Lithium hypochlorite is a Toxicity Category I eye and dermal
irritant. It is in Toxicity Category in for acute oral and Toxicity
Category IV for dermal toxicity.
Because of the potential for eye and dermal exposure, appropriate label
precautions are required. The current requirements for protective
clothing, including safety glasses or goggles and chemical-resistant gloves
while using MP or end-use products must be continued to reduce exposure
potential. Post-application exposure to the compound in swimming pools
is expected to be minimal. Because these exposures are expected to be
low no human health risk of concern is expected.
C. Environmental Assessment
1. Environmental Fate
The Agency is relying on data available in the scientific literature to assess
the environmental fate and transport of lithium hypochlorite used as a pesticidal
compound.
a. Environmental Chemistry, Fate and Transport
Lithium hypochlorite, like all of the other hypochlorite salts
(sodium, potassium, calcium) form hypochlorous acid when dissolved in
water.(1> 2> 3) Thus, lithium hypochlorite can be considered as a precursor
to hypochlorous acid. Hypochlorous acid is the chemical species
exhibiting actual pesticidal activity. The pesticidal mode of action of
hypochlorous acid is linked to its oxidizing effect on organic and inorganic
-------
contaminant sources.® The environmental fate of lithium hypochlorite is
essentially that of hypochlorous acid. The advantage of lithium
hypochlorite over calcium hypochlorite is that lithium hypochlorite can be
used in hard waters (that is, waters in which the concentrations of calcium
and magnesium ions are above 3 milliequivalents per liter (5)), where the
use of a calcium salt would be contraindicated.(1)
Hypochlorous acid is a weak acid; the pK^ of hypochlorous acid at 25° C
is 7.4.(4) In acidic pH, the predominant species is undissociated
hypochlorous acid; in the neutral range small amounts of hypochlorite
anions are present together with hypochlorous acid. The acid is
completely dissociated into hypochlorite anions and hydronium ions only
at very high pH. The maximum decomposition rate of hypochlorous acid
occurs at pH 6.89.(4) For swimming pool sanitation it is recommended
that the pH be maintained between 7.2 and 7.6, where hypochlorous acid
predominates together with hypochlorite anions.
The mechanisms and rates of decomposition of hypochlorous acid and
hypochlorite anions are not only dependent on pH, but also on
concentration and temperature/1'2> 4) Sunlight affects the decomposition
of hypochlorous acid/ hypochlorite as these species absorb in the 292 to
380 nm region.(4) The concentration and nature of organic and inorganic
matter present in the aqueous media have an effect on the decomposition
of hypochlorous acid; redox reactions are involved in this case. The
oxidation state of chlorine in hypochlorous acid and hypochlorite is +1.
The oxidizing effect (and hence the sanitation properties) can be either
associated with hypochlorous acid or with the hypochlorite anion, but
rarely to both species simultaneously.(1) In disinfection by chlorination
operations it is customary to use the expression "free residual chlorine"
to define the sum of the concentrations of hypochlorous acid and
hypochlorite anions; "free residual chlorine" is often used as a measure
of the effectiveness of chlorination, which is also a measurement of the
available chlorine in solution.(5)
The aim in disinfection is to add sufficient chlorinating agent to achieve
"free residual chlorine." The most common redox reactions are (1) the
oxidation of iron(n), sulfide and organic matter, in which chlorine (+1)
is reduced to chlorine (-1) (that is, to chloride). This is followed by
formation of chloroamines and chloroorganic compounds, which are then
further oxidized by addition of sufficient disinfectant to achieve a "free
residual chlorine". The recommended rates of application (in terms of
available chlorine by weight) for aquatic non-food (residential) uses of
lithium hypochlorite varies from 1 to 13 ppm; for indoor food handling
10
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establishment uses it varies from 43 ppm by weight to 181 ppm by
volume.
b. Environmental Fate Assessment
Water sanitation with hypochlorite salts is widely used. Products
containing lithium hypochlorite carry NPDES permit restrictions. The
major environmental/ecological concern would be if discharged effluent
treated with hypochlorites show free residual chlorine concentrations that
exceed those stipulated under the NPDES permits. Note that free residual
chlorine can be independent of the source of chlorination (lithium,
sodium, calcium, potassium hypochlorites; chlorinated isocyanurates;
chlorine gas) since all of these materials form hypochlorous acid in water.
Thus, in cases where free residual chlorine levels may be found above
recommended levels, it may be difficult to trace the source of
contamination considering that the counter cations (lithium, sodium,
calcium and potassium) are ubiquitous in nature.
A fate model was used to determine the Tier lc2 estimated environmental
concentration (EEC) for lithium hypochlorite from effluent discharge after
lithium hypochlorite products are used in food processing plants and eating
establishments. A single EEC was calculated to represent the milking
equipment, food processing plants, and eating establishment uses (Table
1). The EEC has been presented in several different representations for
easy comparisons to hazard data. Although the primary use of lithium
hypochlorite is for swimming pools, no EEC was calculated for this use
as discharge data are not available for swimming pools. However, it
would be expected that the exposure from the swimming pool use pattern
is small as discharges may occur only once or twice a year should pools
be drained.
A Tier lc EEC provides the maximum concentration that occurs
immediately downstream from an industrial (point source) discharge site.
The EECs calculated are those for a high exposure site with a return
frequency of 1 in 10 years. The high exposure site represents a site that
would be expected to produce larger EECs than 90% of all sites with the
specified use pattern. A one in 10 year EEC has a 10% probability of
being equalled or exceeded in any single year at a given site, or, would
be equalled or exceeded once every ten years at that site on a long term
average. This is similar to the site and frequency assumptions that are
2 A tier lc EEC is a preliminary or lower exposure assessment for industrial biocides.
11
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generally being used for agricultural pesticides: EECs for a 50% (typical
site) at mean stream flow were also calculated. These values are listed in
Table 1 on a lithium hypochlorite basis.
Table 1. Tier Ic EECs for Lithium Hypochlorite at Food Processing
Facilities
Chemical
Representation
LiOCl
as Cl, CT1, or
"available chlorine"
as O-JCL
High Exposure Case
88 mg»L.!
53 mg-L-1
77 rag*!/1
Typical Exposure Case
0.300 jig*!/1
0.179 /ig'L-1
0.260 fig'U1
Following is a description of the Agency's method for estimating the
environmental concentrations. Two products, E-Z Chlor Litho Industrial
Sanitizer (EPA Reg. # 8791-51), manufactured by E-Z Chlor Systems,
Inc, and Lithco Lithium Hypochlorite (EPA Reg. # 7675-4), manufactured
by FMC Lithium Division, have uses for sterilizing milking equipment,
in food processing plants, and in eating establishments. All these uses are
represented as Publicly Owned Treatment Works (POTW) (SIC Code
4952) as recommended by the Agency's, Office of Pollution Prevention
and Toxics (OPPT). The concentration in the waste stream is assumed to
be the same as the application rate, 210 ppm; this assumes that no
degradation of the hypochlorite occurs in the processing stream. The
concentration in the waste stream is then used to calculate the
concentration in the receiving stream immediately downstream from the
discharge site. Dilution factors are taken from a compilation of dilution
factors compiled for the Agency(6). All sites in the classification are then
ranked from best to worst based on the mean flow in water body receiving
the waste stream. The typical EEC is then calculated by dividing the
waste stream concentration by the tabulated dilution factor for the mean
flow condition at the median site. The high exposure EEC is calculated by
using the dilution factor tabulated for the 90% site (90% of the sites had
greater mean stream flows) for the low flow condition at the site, which
is the seven day mean low flow that would be expected to occur once in
10 years.
Because Tier Ic EECs make many very conservative assumptions and do
not address the environmental fate of the pesticide, they may significantly
12
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overestimate the true exposure to the chemical. A higher tier EEC
calculation which more accurately reflects the fate and transport properties
of hypochlorite would likely show that the risk is less than that reported
in the Ecological Effects section below. There is some evidence that
hypochlorite degrades within hours in aquatic environments m which
would significantly reduce the exposure. Waste water treatment prior to
discharge, restriction on discharge during low flow periods and other
methods which may be available through the NPDES permitting process
may reduce EECs below the level of concern at each site using the
pesticide.
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
The acute toxicity of lithium hypochlorite to mallard ducks
is classified as slightly toxic with an LD50 of 567.0 mg/kg active
ingredient(MKID# 94673). The dietary toxicity to bobwhite quail
is classified as almost nontoxic with an LC50 of greater than 5,000
ppm(MRID# 104674).
(2) Aquatic Data
The 96-hour acute toxicity to rainbow trout was reported as
an LC50 of 0.20 mg a.i./L.; thus, classifying lithium hypochlorite
as highly toxic to cold water fish(MRID# 94672). The 48-hour
acute toxicity to Daphnia magna was reported as an EC50 of 23.0
pg a.i./L; thus, classifying lithium hypochlorite as very highly
toxic to aquatic invertebrates(MEID# 94674).
b. Ecological Effects Risk Assessment
(1) Industrial Biocide Use Pattern
Lithium hypochlorite is considered slightly toxic to nontoxic to
avian species. Due to hypochlorite's reactivity, any level of exposure
would be expected to dissipate rapidly as contact is made with organic
matter in the environment. In addition, it is not expected to be found in
the environment at levels that are hazardous. Therefore, risk to avian
species is expected to be minimal. Toxicity to fish and aquatic
13
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invertebrates is considered very high. The Agency determined a single
Tier Ic EECs, as documented above, (estimated environmental
concentration) to represent the aquatic residues occurring immediately
downstream from the milking equipment, food processing plants, and
eating establishment use discharges.
Toxicity to fish and aquatic invertebrates is considered extremely high. A
stream flow screening model was utilized by the Agency to determine a
"high exposure case" and a "typical exposure case" EEC - these numbers
depict the highest value that could occur in these situations. The Agency
determined a single Tier Ic EEC (estimated environmental concentration),
as documented above, to represent the aquatic residues occurring
immediately downstream from the milking equipment, food processing
plants, and eating establishment use discharges. Even though the
freshwater LOCs have been triggered for the high exposure scenario, there
is significant experience in the use and NPDES permitting of industrial
microbicidal uses of lithium hypochlorite to mitigate the aquatic risk. The
permitting system that is in place is the appropriate mechanism to set the
appropriate discharge limits based on the receiving body of water.
When the EEC is greater than or equal to 1/2 the LC50, the level of
concern (LOG) for acute effects is exceeded. As the high level of
exposure EEC of 88 ppm is greater than and the typical exposure EEC of
0.300 ppb is less than 1/2 the LC50 values for rainbow trout and Daphnia
magna (100 ppb and 11.5 ppb, respectively), LOC's for acute aquatic risk
are exceeded only for the high exposure scenario. Therefore, aquatic
organisms may be at high risk from only the high use exposure, but not
from the typical use exposure. However, the Agency cannot state with
any degree of certainty whether there will be a significant risk under the
high exposure scenario due to the use of lithium hypochlorite as an
industrial biocide.
(2) Swimming Pool Use Pattern
The Agency could not calculate a Tier Ic EEC for swimming pools
because there is no discharge and site data available on the receiving
water. At best, The Agency can only make an intuitive risk assessment
of the swimming pool use pattern. That is, there is no data to support any
risk assessment conclusion for the swimming pool use pattern. However,
there are mitigating factors in which the Agency may conclude that the
aquatic organism exposure resulting from swimming pool drainage is
minimized. First, it is not customary to routinely empty and refill pools.
Swimming pools may be emptied at the end of the swimming season or
for maintenance. It is not expected that these drainings would be very
14
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frequent, at most, twice per year. Second, one would be unlikely to treat
a swimming pool with lithium hypochlorite and then immediately
discharge the water into a lake or stream. Third, direct discharge of
swimming pool water into a lake or stream is probably not typical. Pools
are most often drained either directly into the area immediately
surrounding the pool or into municipal sewage systems. In either case,
the reactivity of hypochlorite ions with organic matter and the pathway to
a natural body of water, as well as the organic matter in the receiving
body of water, greatly reduces the levels of hypochlorite available to
aquatic organisms.
The Ambient Water Quality Criteria for Chlorine - 1984 (Office of Water,
EPA 440/5-84-030, 1985) is used to regulate the discharge of chlorine
forming chemicals into receiving waters. The document states:
"..except possibly -where a locally important species is very sensitive,
freshwater aquatic organisms and their uses should not be affected
unacceptable if the four-day average concentration of total residual
chlorine does not exceed 11 fig/1 (ppb) more than once every three years
on the average and if the one-hour average concentration does not exceed
19 ng/L (ppb) more than once every three years on the average.
....except possibly where a locally important species is very sensitive,
saltwater aquatic organisms and their uses should not be affected
unacceptabfy if the four-day average concentration of total residual
chlorine produced oxidants does not exceed 7.5 pg/L (ppb) more than once
every three years on the average and if the one-hour average
concentration does not exceed 13 pg/L (ppb) more than once every three
years on the average.
The recommended exceedence frequency of three years is the Agency's best
scientific judgment of the average amount of time it mil take an unstressed
system to recover from a pollution event in which exposure to chlorine
exceeds the criterion. Stressed systems, for example, one in which several
outfalls occur in a limited area, would be expected to require more time
for recover. The resilience of ecosystems and their ability to recover differ
greatly, however, and site-specific criteria may be established if adequate
justification is provided."
The EECs as determined by the Agency, exceed the Agency's Office of
Water Criteria for 'unacceptable exceedence' for freshwater organisms.
The uses for lithium hypochlorite are covered under NPDES permit
regulation; the exposure and subsequent risk to freshwater organisms
should be included in the determination of acceptable regulatory levels for
15
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this permit.
.Endangered Species
When the EEC is greater than or equal to 1/20 the LC50, the LOG
for endangered species is exceeded. As the high exposure EEC of 88 ppm
is greater than and the typical exposure EEC of 0.300 ppb is less than
1/20 the LC50 values for rainbow trout and the Daphnia magna (10 ppb
and 1.15 ppb), LOC's for acute risk are exceeded only for the high
exposure scenario. Therefore, endangered aquatic organisms may be at
high risk from only the high use exposure but not from the typical use
exposure.
Based on the registered uses, lithium hypochlorite is expected to be
discharged at a number of different sites; endangered species may be
present in these aquatic sites. Based on these EEC screening values
effluent containing lithium hypochlorite should not be discharged into
streams and other waterways where endangered aquatic organisms are
known to frequent.
At the present time, the Agency is working with the U.S. Fish and
Wildlife Service and other federal and state agencies to develop a program
to avoid jeopardizing the continued existence of listed species by the use
of pesticides. When the Endangered Species Protection Program is
implemented and subsequent guidance is given, endangered species
labeling amendments may be required on affected end-use products.
Labeling statements for end-use products will likely refer users to county
specific bulletins specifying detailed limitations on use to protect
endangered species.
IV. RISK MANAGEMENT AND REREGISTRATTON DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FDFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing lithium hypochlorite. The Agency has
completed its review of these generic data, and has determined that the data are sufficient
to support reregistration of all products containing lithium hypochlorite. 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. Appendix B
16
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.identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of lithium hypochlorite, and lists the submitted
studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of lithium hypochlorite and to determine that lithium hypochlorite can be
used without resulting in unreasonable adverse effects to humans. Conversely, the
Agency has some concerns about possible adverse risks to aquatic species from discharge
of effluent containing lithium hypochlorite. Since this discharge is regulated through the
NPDES permitting program for specific sites the Agency defers to that program to
regulate the use of lithium hypochlorite products at specific sites. Likewise, the Agency
will incorporate in the future appropriate risk mitigation measures to minimize impacts
on endangered species. The Agency therefore finds that all products containing lithium
hypochlorite as the active ingredients are eligible for reregistration. The reregistration
of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies
to generate such data and the data identified in Appendix B. Although the Agency has
found that all uses of lithium hypochlorite 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 lithium
hypochlorite, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
1.
Eligibility Decision
Based on the reviews of the generic data for the active ingredients lithium
hypochlorite, the Agency has sufficient information on the health effects of lithium
hypochlorite and on its potential for causing adverse effects in fish and wildlife and the
environment. Therefore, the Agency concludes that products containing lithium
hypochlorite for all uses are eligible for reregistration. The Agency is requiring
precautionary labeling on all registered products because lithium hypochlorite is highly
toxic to fish and aquatic invertebrates.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of lithium hypochlorite 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.
17
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A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of lithium hypochlorite
for the above eligible uses has been reviewed and determined to be complete. No
additional generic data are required at this time.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems
must bear the following revised effluent discharge labeling statement.
"This product is toxic to fish. 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 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 FJPRA 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
18
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to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
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; State of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell lithium
hypochlorite 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
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VI. APPENDICES
21
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APPENDIX A. Table of Use Patterns Subject to
Reregistration
23
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
27
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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 Lithium Hypochlorite covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Lithium Hypochlorite
in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road. Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3- Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record'
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
29
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Lithium
Hypochlorite
33
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered
are included. . '
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes 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.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
35
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the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the .
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The thkd element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed
by an alphabetic suffix which shows the relative position of the study
within the volume.
36
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BIBLIOGRAPHY
MRID
CITATION
00234351 a. Acute Oral Toxicitv Study in Rats. (1977) Unpublished study prepared by
Hazleton and submitted by Lithium Corp. of America. Study No. 668-103.
b. Acute Dermal Toxicitv Study in Rabbits. (1977) Unpublished study
prepared by Hazleton and submitted by Lithium Corp. of America. Study No
668-104.
c. Primary Skin Irritation Study in Rabbits. (1977) Unpublished study prepared
by Hazleton and submitted by Lithium Corp. of America. Study No. 668-105.
d. Acute Eve Irritation Potential Study in Rabbits. (1977) Unpublished study
prepared by Hazleton and submitted by Lithium Corp. of America. Study No
668-106.
Nelli, J. R. The Build-up of Lithium Ion in Swimming Pool Waters and Its
Effect on Swimmers. (1964) Unpublished study submitted by Lithium Corp of
America.
Guinea Pig Maximization Test with Lithcoa Lithium Hvpochlorite (1984)
Unpublished study prepared by Hazleton. Study No. 668/115.
Lithium Corporation of America (1969) Analysis of Lithium hypochlorite.
Includes R & D method no. 210 dated Nov 1969. (Unpublished study
received Dec 29, 1972 under 7675-1; CDL: 008072-A)
Lithium Corporation of America (19??) Product Information: LCA Lithium
hypochlorite: Data Sheet 111-463. (Unpublished study received Aug 28, 1964
under 7675-2; CDL:008073-A)
Lithium Corporation of American (1977) Storage Stability Data for Lithcoa
Lithium Hypochlorite. (Unpublished study received Aug 24, 1979 under
7675-4; CDL:246731-B)
Buccafusco, RJ. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to
Rainbow Trout (n -Salmo gairdneri—, ): Report #BW-782-031.
(Unpublished study received Apr 25, 1978 under 7675-4; prepared by EG & G
Bionomics, submitted by Lithium Corp. of America, Gastonia N C •
CDL:246732-C)
00094673 Piccirillo, V.J. (1977) Final Report: Acute Oral LDaj50-> Study in Mallard
Ducks: Project No. 668-107. (Unpublished study received Apr 25, 1978
240927
252294
00007257
00007258
00094669
00094672
37
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BIBLIOGRAPHY
MRID
CITATION
under 7675-4; prepared by Hazleton Laboratories America, Inc. and Truslow
Farms, Inc., submitted by Lithium Corp. of America, Gastonia, N.C.;
CDL:246732-D)
00094674 LeBlanc, G. A. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to the
Water Flea (n -Daphnia magna—| ): Report #BW-78-2-032. (Unpublished
study received Apr 25, 1978 under 7675-4; prepared by EG & G Bionomics,
submitted by Lithium Corp. of America, Gastonia, N.C.; CDL:246732-E)
00104674 Piccirillo, VJ. (1977) Final Report: Subacute Dietary LCae50-> Study in
Bobwbite Quail: Project No. 668-109. (Unpublished study received Apr 25,
1978 under 7675-4; prepared by Hazleton Laboratories America, Inc. and
Truslow Farms, Inc., submitted by Lithium Corp. of America, Gastonia,
N.C.; CDL:246732-B)
40545701 Yang, L. (1988) CHO/HGPRT Mutation Assay: 11945 CLithium
Hypochlorite | : Study No. T5674.332005. Unpublished study prepared by
Microbiological Associates Inc. 30 p.
40545702 Batt, K. (1987) Salmonella/Mammalian-Microsome Plate Incorporation
Mutagenicity Assay (Ames Test): Study No. 187-0975. Unpublished study
prepared by FMC Corp., Genetic Toxicology Laboratory. 33 p.
40545703 Putman, D. (1988) Chromosome Aberrations in Chinese Hamster Ovary
(CHO) Cells: 11945 CLithium Hypochlorite | : Study No. T5674. 337020.
Unpublished study prepared by Microbiological Associates, Inc. 29 p.
40545704 Curren, R. (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
11945 CLithium Hypochlorite | : Final Report: T5674.380017. Unpublished
study prepared by Microbiological Associates, Inc. 28 p.
40648101 Lochry, E. (1988) Developmental Toxicity (Embro/Fetal Toxicity and
Teratogenic Potential) Study of Lithium Hypochlorite Administered Orally via
Gavage to Crl:CD(SD)BR Presumed Pregnant Rats: Sponsor's Study No.
187-0978. Unpublished study prepared by Argus Research Laboratories, Inc.
236 p.
40746701 McCarty, J.; Carter, S.; Fletcher, M.; et al. (1988) Study of Lithium
Absorption by Users of Spas Treated with Lithium Ion: Study No. 187-0981.
38
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BIBLIOGRAPHY
MRID
CITATION
Unpublished study prepared by FMC Toxicology Dept. 225 p.
40803901
40907500
41367401
42940801
42967001
42967002
42967003
42991801
93138001
Freeman, C. (1988) Lithium Hypochlorite: Acute Oral Toxicity Study in Rats:
Study No. 187-0982. Unpublished study prepared by FMC Toxicology
Laboratory. 47 p.
Lithium Corporation of America (1988) Submission of Toxicity Data in
Support of Lithium Hypochlorite Products. Transmittal of 1 study.
Todhunter, J.; Mandava, N. (1990) Supplemental Data and Documentation in
Support of Data Waiver Requests filed by Lithium Corporation of America
dated November 24, 1989: FMC Study No. 190-1108. Unpublished study
prepared by SRS International. 1424 p.
Hatch, H. (1993) Beginning Materials and Manufacturing Process: FIFRA
Reregistration of Lithium Hypochlorite: Product Class-C: Data Gaps in Phase
HE Submission. Unpublished study. 18 p.
Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
Class-C: (Response to) Data Gaps in Phase m Submission: Solubility.
Unpublished study prepared by FMC Corp. 7 p.
Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
Class-C: (Response to) Data Gaps in Phase m Submission: Vapor Pressure.
Unpublished study prepared by FMC Corp. 4 p.
Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
Class-C: (Response to) Data Gaps in Phase m Submission: Dissociation
Constant. Unpublished study prepared by FMC Corp. 10 p.
Eschbach, J. (1993) Method Validation and Determination of Lithco Lithium
Hypochlorite for Swimming Pool/Spa Sanitation and Algea (sic) Control.
Final Report: Lab Project Number: 93/9078: P93/0035. Unpublished study
prepared by Pharmaco-LSR. 55 p.
Cinq-Mars, R. (1990) Lithium Corporation of America Phase 3 Summary of
MRID 00051222 and Related MRIDs 00007258, 00031511, 00094670,
00007261, 00094669, 00094670. Chemical and Physical Properties of Lithium
Hypochlorite. 34 p.
39
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BIBLIOGRAPHY
MRID
CITATION
REFERENCES
1. Greenwood, N.N. and Earnshaw, A. The Chemistry of the Elements. 1984, Pergamon Press,
Oxford, UK. pp. 988-1013.
2. Cotton, A.F. and Wilkinson, G. Advanced Inorganic Chemistry. Fifth Edition, 1988, John
Wiley and Sons, New York, pp. 560-570.
3. Wojtowicz, J.A., "Chlorine Monoxide, Hypochlorous Acid and the Hypochlorites" in
Kirk-Othmer Encyclopedia of Chemical Technology. Third Edition, Vol. 5, Wiley-Interscience,
New York, pp. 580-611.
4. Adam, L.C., Fabian, I., Suzuki, K. and Gordon, G. "Hypochlorous Acid Decomposition in
the pH 5-8 Region", Inorganic Chemistry. 1992, vol.31, pp. 3534-3541.
5. Tchobanoglous, G. and Schroeder, E.D. Water Quality-Characteristics: Modeling:
Modification. 1985, Addison-Wesley Publishing Company, Reading, MA, pp. 92; 560-571.
6. Office of Prevention and Toxic Substances. 1992. Summary of Stream Dilution Factor
Program (SDFP) Outputs for 40 Industrial Categories (Updated January, 1991, 1Q10 & 3Q5
Added October, 1992.
7. Jolley, R. L. 1983. A review of the chemistry and environmental fate of reactive oxidant
species in chlorinated water, in Water Chlorination: Environmental Impact and Health Effects
vol. 4. pp. 3-47.
40
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APPENDIX D. List of Available Related Documents
41
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The following is a list of available documents related to Lithium Hypochlorite. 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 Lithium Hypochlorite and
are included in the EPA's Office of Pesticide Programs Public Docket.
1.
2.
3.
4.
5.
Health and Environmental Effects Science Chapters
Detailed Label Usage Information System (LUIS) Report
Lithium HypochloriteRED Fact Sheet
PR Notice 86-5 (included in this appendix)
PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
43
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APPENDIX E. PR Notices 86-5 and 91-2
45
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PR Notice 86-5
47
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
Attention:
Subject:
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Persons responsible for Federal registration of
pesticides.
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 l, 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
DatatSubmission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
49
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 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 OPP 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, whic
applies only to data submitted with an application.
which
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.
50
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- INDEX-
A.
B.
C.
D.
E.
F.
G.
Organization of the Submittal Package 3
Transmittal Document 4
Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
Organization of each Study Volume 6
D. 1 Study Title Page 7
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1) ) 8
D. 3 Confidential Attachment '....!!" 8
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8
D. 5 Good Laboratory Practice Compliance Statement . . 9
Reference to Previously Submitted Data 9
Physical Format Requirements & Number of Copies .... 9
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).
Text Example
Page Page
17
11
17
12
13
15
14
16
51
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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 transmxttal
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 shown 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.
52
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
xnated 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) (l) (A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
53
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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 requirements 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 such
trials should be reported as a single study.
D. Organization of Each 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 Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A), (B), or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B), or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10 (d) (1) (A) , (B) , or (C)
54
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•D.I. Title Page
A title page is always required for each submitted study,
publxshed 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) . Cite 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).
?: ,_ 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.
55
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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)(l) data confidentiality (§158. 33 (b) ) or
to waive such a claim (§158.33 (c) ). In either case, the
statement must be signed and dated, and 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_l 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 support 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
- 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.)
57
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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.
/ACtine Sirtctor,
"'JtegiatratLon Division
Attachment 1.
Attachment 2.
Attachment 3,
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
58
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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
1234 West Smith Street
Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd
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.
Vol 2.
Vol n
Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Title of first study in the submittal (Guideline
No.)
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:.
Company Name:.
Company Contact:
Name
Signature
Name
Phone
59
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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)
60
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10 (d) (1) (A), (B) , or
\ ^ / *
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
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(l)(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 Pesticide 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. *
61
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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.
62
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example l. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NOMBER 1 This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE:.
Kt-Ky-1c.no
6
12
100
14
25
19
REASON FOR THE DELETION
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 pages that have been deleted from the study)
CROSS REFERENCE NOMBER 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)
63
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
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.
3.
Submitter_
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter •
64
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LEGEND
ATTACHMENT 7.
^FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document.
Qp SUBMITTED STUDIES
and
title page.
Statement of Conridertciality dates
of tn«
.ppropcfate
-r
U
i
1 ^^-App«ndice« to the «tudy.
—1
r
~J"~'1 Confidential Attachment.
.->—l
1
^ J
«**"^wn"M* Statement
of Confidentiality Claims.
*
finalized.
^j Documents submitted at fEmitter's option.
65
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PR Notice 91-2
67
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tSR
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(1). 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
69
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CFR 158.175(0)(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 for
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_for
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 ingredient 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 as
smoothly as possible so as not to disrupt or delay the Agency's
high 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.
71
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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
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* fi. fcindaay, Director
Registration Division (H-75O3
72
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APPENDIX F. Product Specific Data Call-in
73
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DATA CALL-IN NQTTCR
CER'llblBD MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status Sh«* 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 JH below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
Why you believe you are exempt from the requirements listed in this Notice and
in Attachment C, Requirements Status and Registrant's Response Form (see
section m-B); or '
Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section HI-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 yourproducts subject to this Notice in Attachment B, Data Call-in Response Form as well
as a list of all registrants who were sent this Notice (Attachment F).
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).
2.
3.
This Notice is divided into six sections and seven Attachments. The Notice itself contains
75
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information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical infonnation and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section m- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
FJPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report
1
2
3
4
5
7
8
SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION H.
)UIRED BY THIS NOTICE
n-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment C,l
Requirements Status and Registrant's Response Form. Depending on the results of the studie
required in this Notice, additional testing may be required.
H-B. SfTHBHTTT Jj FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified ii
Attachment C, Requirements Status and Registrant'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), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
hi the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the QECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 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)].
n-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2)(E) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
requirements of any previous Data Call-InCsV or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
HI-A. SCTranTTT.T; FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
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
77
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requirements of this Notice is contained in Section m-C.
requests for data waivers is contained in Section ni-D.
A discussion of options relating
There are two forms that accompany this Notice of which, depending upon your respons
one or both must be used in your response to the Agency. These forms are the
Response Form, and the Requirements Status and Registrant's Response Form. Attachment B an(|
Attachment C. The Data Call-In Response Form must be submitted as part of every response to
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form mus
be submitted for each product listed on the Data Call-in Response Form unless the voluntai
cancellation option is selected or unless the product is identical to another (refer to the instructior
for completing the Data Call-in Response Form in Attachment B). Please note that the company'!
authorized representative is required to sign the first page of the Data Call-in Response Form anJ
Requirements Status and Registrant's Response Form (if this form is required) and initial anj
subsequent pages. The forms contain separate detailed instructions on the response options. Do nc
alter the printed material. If you have questions or need assistance in preparing your response, ca
or write the contact person(s) identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by request
voluntary cancellation of your product(s) containing the active ingredient that is the subject of r
Notice. If you wish to voluntarily cancel your product, you must submit a completed DataCal
Response Form, indicating your election of this option. Voluntary cancellation is item number
on the Data Call-in Response Form. If you choose this option, this is the only form that you
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your produc
after the effective date of cancellation must be in accordance with the Existing Stocks provision|
of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are varioul
options available to satisfy the product specific data requirements of this Notice. These options
discussed in Section M-C of this Notice and comprise options 1 through 6 on the
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-in
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
discussed in Section m-D of this Notice and are covered by option 7 on the Requirements Statuj
and Registrant's Response Form. If you choose one of these options, you must submit both formj
as well as any other information/data pertaining to the option chosen to address the
requirement.
TTT-f. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the produc
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of th^
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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 into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with 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 registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data - Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
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on the same data. If this is the case, data may be generated for just one of the products in the!
group. The registration number of the product for which data will be submitted must be noted in I
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 hi 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 I
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the!
agreement they may resolve their differences through binding arbitration. I
Option 3." Offer to Share in the Cost of Data Development -- This option only applies to!
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer!
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the!
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this!
option) to exercise its discretion not to suspend your registration(s), although you do not comply!
with the data submission requirements of this Notice. EPA has determined that as a general policy, I
absent other relevant considerations, it will not suspend the registration of a product of a registrant!
who has in good faith sought and continues to seek to enter into a joint data development/cost!
sharing program, but the other registrant(s) developing the data has refused to accept your offer.!
To qualify for this option, you must submit documentation to the Agency proving that you have!
made an offer to another registrant (who has an obligation to submit data) to share in the burden!
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32,1
Certification of Offer to Cost Share hi the Development of Data, Attachment G. In addition, you!
must demonstrate that the other registrant to whom the offer was made has not accepted your offer!
to enter imxra cost sharing agreement by including a copy of your offer and proof of the other!
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to!
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing!
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must!
not qualify this offer. The other registrant must also inform EPA of its election of an option to!
develop and submit the data required by this Notice by submitting a Data Call-In Response Form!
and a Requirements Status and Registrant's Response Form committing to develop and submit the!
data required by this Notice. I
In order for you to avoid suspension under this option, you may not withdraw your offerl
to share in the burdens of developing the data. In addition, the other registrant must fulfill itsl
commitment to develop and submit the data as required by this Notice. If the other registrant fails!
to develop the data or for some other reason is subject to suspension, your registration as well asl
that of the other registrant will normally be subject to initiation of suspension proceedings, unlessl
you commit to submit, and do submit the required data in the specified time frame. In such cases,!
the Agency generally will not grant a time extension for submitting the data. I
Option 4. Submitting an Existing Study - If you choose to submit an existing study inl
response to this Notice, you must determine that the study satisfies the requirements imposed byl
this Notice. You may only submit a study that has not been previously submitted to the Agencyl
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice. I
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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 time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 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.
You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
c.
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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 m«
the criteria outlined above but does contain factual information regarding unreasonable advei
effects, you must notify the Agency of such a study. If such study is in the Agency's files, yoi
need only cite it along with the notification. If not in the Agency's files, you must submit -
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study - If a study has been classified as partially acceptable anc
upgradable, you may submit data to upgrade that study. The Agency will review the date
submitted and determine if the requirement is satisfied. If the Agency decides the requirement i
not satisfied, you may still be required to submit new data normally without any time extension]
Deficient, but upgradable studies will normally be classified as supplemental. However, it ij
important to note that not all studies classified as supplemental are upgradable. If you havd
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment A. If you submit data to upgrade an existing study yoi
must satisfy or supply information to correct all deficiencies in the study identified by EPA. Yoi
must provide a clearly articulated rationale of how the deficiencies have been remedied or correc
and why the study should be rated as acceptable to EPA. Your submission must also specify
MRID number(s) of the study which you are attempting to upgrade and must be in conformanc
with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as unacceptable]
and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade!
a study, but has not yet been reviewed by the Agency. You must provide the MRID number o|
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
data submissions intended to upgrade studies. Additionally your submission of data intended
upgrade studies must be accompanied by a certification that you comply with each of those criteri^
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 musj
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studie
generally will have been classified as "core-guideline" or "core minimum." For all othe
disciplines the classification would be "acceptable." With respect to any studies for which you
to select this option you must provide the MRID number of the study you are citing and, if
study has been reviewed by the Agency, you must provide the Agency's classification of the studyj
If you are citing a study of which you are not the original data submitter, you must sut
a completed-copy of EPA Form 8570-31, Certification with Respect to Data Compensatioil
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.
m-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be -the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should also be aware that submitting a waiver request will
not automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.
TV- CONSEQUENCES OP FAILURE TO COMPLY WITH THIS NQTTra
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1.
2.
3.
4.
5.
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
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.
Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
Failure to submit on the required schedule acceptable data as required by this Notice.
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
developing data and provided proof of the registrant's receipt of such offer or fail
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 Notic
on a Data Call-In Response Form and a Requirements Status and Regist
Response Form:
b. fulfill the commitment to develop and submit the data as required by
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in
Notice, unless you commit to submit and do submit the required data in
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any ti
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMT1THD STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time)
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds foi]
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 incorporat
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Da
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the designj
conduct, and reporting of required studies. Such requirements include, but are not limite
to, those relating to test material, test procedures, selection of species, number of animalsJ
sex and distribution of animals, dose and effect levels to be tested or attained, duration oij
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation 01
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting J
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 containe
in PR 86-5. All studies must be submitted in the form of a final report; a prelii
report will not be considered to fulfill the submission requirement.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the.Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by thij
Notice, call the contact person(s) listed in Attachment A, the Data Call-in Chemical Status She
All responses to this Notice (other than voluntary cancellation requests and generic dat
exemption claims) must include a completed Data Call-In Response Form and a complete
Requirements Status and Registrant's Response Form (Attachment B for generic data and
Attachment C for product specific data) and any other documents required by this Notice, anJ
should be submitted to the contact person(s) identified in Attachment A. If the volunt?
cancellation or generic data exemption option is chosen, only the Data Call-in Response Form ne
be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and ToxiJ
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments"
2
3
4
5
6
7
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute Toxicology Dat
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Fc
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Attachment 1. Chemical Status Sheet
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uraiuM HYPOCHLOETTE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have
produces) containing Lithium Hypochlorite.
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
Lithium Hypochlorite. 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
B), (3) the Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of
End[-]Use Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the
EPA Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI
(Attachment F) and (7) the Cost Share and Data Compensation Forms in replying to this
Lithium Hypochlorite Product Specific Data Call[-]In (Attachment G). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Lithium
Hypochlorite are contained in the Requirements Status and Registrant's Response. Attachment
C. The Agency has concluded that additional data on Lithium Hypochlorite 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 Lithium
Hypochlorite products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Lithium Hypochlorite, please |
contact Ron Kendall at (703) 308-8068.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Veronica Dutch (703) 308-8585. All
responses to this Notice for the Product Specific data requirements should be submitted to:
ARE, Product Manager Team 52
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Lithium Hypochlorite
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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.
ItemS.
Item 6.
Already completed by EPA.
If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-in Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA 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.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another 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.
Item 7a.
Item 7b.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
93
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3.
Item 4.
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
The 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, Subpart c.
The study title associated with the guideline reference number is identified.
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.
The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in'rare
cases.
The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required study
is not submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
95
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I understand that this option is available only for acute toxicity or certain efficaci
data and only if EPA indicates in an attachment to this Data Call-In Notice that ml
product is similar enough to another product to qualify for this option. I ail
submitting evidence that I have made an offer to another registrant (who has al
obligation to submit data) to share in the cost of that data. I am also submitting I
completed " Certification of offer to Cost Share in the Development Data" forml
I am including a copy of my offer and proof of the other registrant's receipt of thM
offer. I am identifying the party which is committing to submit or provide thl
require data; if the required study is not submitted on time, my product may bl
subject to suspension. I understand that other terms under Option 3 in the Datl
Call-In Notice (Section m-C.l.) apply as well. . I
4. By the specified due date, I will submit an existing study that has not beel
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 datl
outlined in option 4 in the Data Call-In Notice (Section m-C.l.) and will meet thl
attached acceptance criteria (for acute toxicity and product chemistry data). I wil
attach the needed supporting information along with this response. I also certify th J
I have determined that this study will fill the data requirement for which I havl
indicated this choice. I
5. By the specified due date, I will submit or cite data to upgrade a studl
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 bl
upgraded and what information is required to do so. I will provide the MRID ol
Accession number of the study at the due date. I understand that the conditions fol
this Option outlined Option 5 in the Data Call-in Notice (Section m-C.l.) apply.I
6. By the specified due date, I will cite an existing study that the Agency hal
classified as acceptable or an existing study that has been submitted but not reviewel
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 efficaci
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 fol
purposes of depending on the same data. I may also choose this option if I am citinl
my own data. In either case, I will provide the MRID or Accession number (a
number (s) for the cited data on a "Product Specific Data Report" form or in I
similar format. If I cite another registratrant's data, I will submit a completel
"Certification With Respect To Data Compensation Requirements" form. I
7. I request a waiver for this study because it is inappropriate for my produd
(Waiver Request). I am attaching a complete justification for this request, includinl
technical reasons, data and references to relevant EPA regulations, guidelines oj
policies. [Note: any supplemental data must be submitted in the format required b|
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reason]
or provide information in support of my request. If the Agency approves my waivd
96
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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.
97
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
99
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EPA'S DECISION ONBATCHING PRODUCTS CONTA1MNGIITHIUMHYPOCHLORITE
FOR PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATTON
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 ingredient
lithium hypochlorite, the Agency considered batching products. This process involves grouping
similar products for purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.)'
and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within
a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
above. Acute toxicity data on individual products has frequently been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
require^ acute toxicological studies for each of their own products. If a registrant chooses to
rely upon previously submitted acute toxicity data, he/she may do so provided that the data base
is complete and valid by today's standards (see acceptance criteria attached), the formulation
tested is considered by EPA to be similar for acute toxicity, and the formulation has not been
significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is cited, the registrant must clearly identify the
material tested by its EPA registration number. If more than one Confidential Statement of
Formula (CSF) exists for a product, the registrant must indicate the formulation actually tested
by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response", asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response", lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend
101
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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 in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not preclude
other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
Table I lists 3 batches of lithium hypochlorite products.
Table I.
Batch
1
EPA Reg. No.
3525-33
3525-96
7152-15
7152-19
7368-68
7675-1
7675-4
8791-51
5185-384
5185-385
7368-75
7675-5
7675-7
7675-8
7675-9
12014-31
24310-1 '
45309-13
% of Lithium
hypochlorite
29.0
ft
tt
ft
Tt
tf
If
If
n
tt
«
n
tt
n
tt
H
n
tr
Formulation
Type
granules
n
n
H
n
"
n
«
R
tt
n
ti
n
n
tt
ft
tt
H
102
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Table I (cont.)
3432-56
3432-57
6809-6
5185-323
5185-336
5185-340
5185-419
5185-431
6284-50
7124-84
7124-88
7675-6
8791-34
42177-15
42177^9
42177-54
42177-55
45309-5
45309-58
57787-14
Table H lists the products which could not be batched. For the purposes of acute toxicity
batching, these products were not considered similar, or their similarity could not be determined
using the information available. The registrants of these products are responsible for meeting
the acute toxicity data requirements specified in the data matrix for end-use products.
Table H.
EPA Reg. No.
==
1258-1194
=====
5185-369
"-~
10079-4
of Lithium Hypochlorite
65.0
—__
27.0
—
29.0
103
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Attachment 5. EPA Acceptance Criteria
105
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
107
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. 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.
Description of each beginning material hi the manufacturing process.
EPA Registration Number if registered; for other beginning materials,
the following:
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.
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 hi 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.
Description of measures taken to assure quality of final product.
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?
L Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at >_ 0.1 %.
Degree of accountability or closure .>. ca 98 %.
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.].
Complete and detailed description of each step in analytical method used to analyze above samples.
Statement of precision and accuracy of analytical method used to analyze above samples
Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
Upper certified limit proposed for each impurity present at >_ 0.1% and for certain toxicologically
significant impurities at < 0.1 % along with explanation of how limit determined.
Analytical methods to verify certified limits of each active ingredient and impurities flatter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described
Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
2.
3."
4.
5."
6."
7."
8.
9.
10.
109
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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.
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
63-3 Physical State
Verbal description of physical 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
Measured at about 20-25° C
Density of technical grade 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/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used hi
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 Vapor Pressure
Measured at 25° C (or calculated 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)
110
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63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
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
111
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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 Sensitization 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.
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Kg
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 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. 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.
114
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
3.
4."
5."
6-]
7.
Identify material tested (technical, end-use product, etc).
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 /tm or less).
At least 5 young adult rats/sex/group.
Dosing, at least 4 hours by inhalation.
Chamber ah- flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
Chamber temperature, 22° C (±2°), relative humidity 40-60%.
Monitor rate of air flow.
Monitor actual concentrations of test material in breathing zone.
Monitor aerodynamic particle size for aerosols.
10- 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.
9.
115
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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 >11.S.
3. 6 adult rabbits.
4,_• Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. 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).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
116
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1- Identity material tested (technical, end-use product, etc).
2- Study not required if material is corrosive or has a pH of <2 or _>.!!.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6- Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8- Application site covered with a gauze patch held in place with nonirritating tape.
9- Material removed, .washed with water, without trauma to application site.
10- Application site examined and graded for irritation at 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.
-------
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
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.
118
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Attachment 6. List of All Registrants Sent This Data Call-in (insert)
Notice
119
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Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
121
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tractions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c.
d.
e.
f.
g-
h.
i.
k.
1.
m.
n.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
All applicable information which is on the product specific data submission must
also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14. a. and 14.b. for the active ingredients must represent
pure active form.
The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
125
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svEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-D106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this coBection of information is estimated to average 15 minutes per response including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and
completing and reviewing the collection of information. Send comments regarding the buiden 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 Jhe Office
of Management and Budget, Paperwork Reduction Project {2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company INmnber
KPA Kff.Xn.
J Certify that:
My company is witling to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenitaide 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):
Nam* of Flrm(»>
Date of Offer
Certification:
I certify that 3 am duly authorized to represent the company named above, and that the statements that I have made on
this form and an attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fme or imprisonment or both under applicable law.
Signature ef Company'* Authorized R»pr«a*ntaHv«
Maim and Title (P1«a»« Typo or Print}
Dal*
127
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
OIU M*. 3070-0101
2070-MS7
• •• '«»«-«•»*»•» nun ncor Cv« I Iw
DATA COMPENSATION REQUIREMENTS; «••••»« «w.«. ww,
Please nil In blanks below.
iCertSytnat:
"
a'
•
IJ TT» companies who hav* submitted the
shwts. or mdica.d on tne ait^tHM -Requirement
rereglstration under FIFRA.
N««i we Tlti* (PIMM Type er
feregBtntcn o« ny products, to tnt««em required ^
Mat)
EPA Fwm U70-31 (4-eO)
129
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